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Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Apo-Lenalidomide · DIN 02507927 Manufacturer: Apotex Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand APO-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Apotex inc · schedule Prescription

DIN 02507927: Apo-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id APX Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02507927 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99730

Interchangeable products

Jamp Lenalidomide · DIN 02506130 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02507927

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Jamp Lenalidomide · DIN 02506130 Manufacturer: Jamp Pharma Corporation; listing date 2022-03-31 Health Canada: Marketed since 2022-02-02 · brand JAMP LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Jamp pharma corporation · schedule Prescription

DIN 02506130: Jamp Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id JPC Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02506130 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99548

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02506130

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Nat-Lenalidomide · DIN 02493837 Manufacturer: Natco Pharma (Canada) Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand NAT-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Natco pharma (canada) inc · schedule Prescription

DIN 02493837: Nat-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id NAT Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02493837 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98383

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Jamp Lenalidomide · DIN 02506130 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02493837

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Reddy-Lenalidomide · DIN 02484714 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand REDDY-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02484714: Reddy-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id DRR Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02484714 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97500

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Jamp Lenalidomide · DIN 02506130 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02484714

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Revlimid · DIN 02459418 Manufacturer: Bristol Myers Squibb Canada Inc; listing date 2021-10-29 Health Canada: Marketed since 2024-11-22 · brand REVLIMID · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Bristol-myers squibb canada · schedule Prescription

DIN 02459418: Revlimid Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id BQU Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $329.5000; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02459418 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94664

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Jamp Lenalidomide · DIN 02506130 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02459418

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Sandoz Lenalidomide · DIN 02518562 Manufacturer: Sandoz Canada Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-07 · brand SANDOZ LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02518562: Sandoz Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id SDZ Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02518562 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100787

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Jamp Lenalidomide · DIN 02506130 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Taro-Lenalidomide · DIN 02507862 · $82.3750

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02518562

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Taro-Lenalidomide · DIN 02507862 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2022-07-29 Health Canada: Marketed since 2022-06-13 · brand TARO-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 2.5 MG · company Taro pharmaceuticals inc · schedule Prescription

DIN 02507862: Taro-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000720; group id 927; item number 2207; lccId 00358; manufacturer id TAR Source form: Cap; strength: 2.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $82.3750; ministry $82.3750 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02507862 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99724

Interchangeable products

Apo-Lenalidomide · DIN 02507927 · $82.3750 Jamp Lenalidomide · DIN 02506130 · $82.3750 Nat-Lenalidomide · DIN 02493837 · $82.3750 Reddy-Lenalidomide · DIN 02484714 · $82.3750 Revlimid · DIN 02459418 · $82.3750 Sandoz Lenalidomide · DIN 02518562 · $82.3750

Shortage status: anticipated shortage (last updated 2026-08-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02507862

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Apo-Lenalidomide · DIN 02507935 Manufacturer: Apotex Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand APO-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 5 MG · company Apotex inc · schedule Prescription

DIN 02507935: Apo-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000586; group id 927; item number 2211; lccId 00358; manufacturer id APX Source form: Cap; strength: 5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $85.0000; ministry $85.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02507935 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99731

Interchangeable products

Jamp Lenalidomide · DIN 02506149 · $85.0000 Nat-Lenalidomide · DIN 02493845 · $85.0000 Reddy-Lenalidomide · DIN 02483017 · $85.0000 Revlimid · DIN 02304899 · $85.0000 Sandoz Lenalidomide · DIN 02518570 · $85.0000 Taro-Lenalidomide · DIN 02507870 · $85.0000

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02507935

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Jamp Lenalidomide · DIN 02506149 Manufacturer: Jamp Pharma Corporation; listing date 2022-03-31 Health Canada: Marketed since 2022-02-02 · brand JAMP LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 5 MG · company Jamp pharma corporation · schedule Prescription

DIN 02506149: Jamp Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000586; group id 927; item number 2211; lccId 00358; manufacturer id JPC Source form: Cap; strength: 5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $85.0000; ministry $85.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02506149 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99549

Interchangeable products

Apo-Lenalidomide · DIN 02507935 · $85.0000 Nat-Lenalidomide · DIN 02493845 · $85.0000 Reddy-Lenalidomide · DIN 02483017 · $85.0000 Revlimid · DIN 02304899 · $85.0000 Sandoz Lenalidomide · DIN 02518570 · $85.0000 Taro-Lenalidomide · DIN 02507870 · $85.0000

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02506149

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Nat-Lenalidomide · DIN 02493845 Manufacturer: Natco Pharma (Canada) Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand NAT-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 5 MG · company Natco pharma (canada) inc · schedule Prescription

DIN 02493845: Nat-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000586; group id 927; item number 2211; lccId 00358; manufacturer id NAT Source form: Cap; strength: 5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $85.0000; ministry $85.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02493845 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98384

Interchangeable products

Apo-Lenalidomide · DIN 02507935 · $85.0000 Jamp Lenalidomide · DIN 02506149 · $85.0000 Reddy-Lenalidomide · DIN 02483017 · $85.0000 Revlimid · DIN 02304899 · $85.0000 Sandoz Lenalidomide · DIN 02518570 · $85.0000 Taro-Lenalidomide · DIN 02507870 · $85.0000

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02493845

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access criteria on record are for Brand(s): Revlimid; DOSAGE FORM/ STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Reddy-Lenalidomide · DIN 02483017 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2021-10-29 Health Canada: Marketed since 2021-09-01 · brand REDDY-LENALIDOMIDE · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 5 MG · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02483017: Reddy-Lenalidomide Raw flags: sec12=Y, sec3=Y Item: 920000586; group id 927; item number 2211; lccId 00358; manufacturer id DRR Source form: Cap; strength: 5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $85.0000; ministry $85.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02483017 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97342

Interchangeable products

Apo-Lenalidomide · DIN 02507935 · $85.0000 Jamp Lenalidomide · DIN 02506149 · $85.0000 Nat-Lenalidomide · DIN 02493845 · $85.0000 Revlimid · DIN 02304899 · $85.0000 Sandoz Lenalidomide · DIN 02518570 · $85.0000 Taro-Lenalidomide · DIN 02507870 · $85.0000

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02483017

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 630 Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 631 Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 632 Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR as part of a quadruple regimen in combination with bortezomib, dexamethasone and subcutaneous (SC) daratumumab (Note 3); OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day. Coverage limit: Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP. Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 659 Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program. Reason for Use code 741 Multiple Myeloma - Induction and Consolidation Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with daratumumab, bortezomib and dexamethasone (DVRd) as induction therapy before, and consolidation therapy after an autologous stem cell transplantation, in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 6 Cycles (i.e. 4 Induction Cycles, and 2 Consolidation Cycles). Recommended Dose: 25mg daily Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of these criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria govern for the purpose of funding under the Ontario Drug Benefit Program. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid DOSAGE FORM/STRENGTH: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsule Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS) may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. 23 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 23, record 5, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Lenalidomide Brand(s): Revlimid and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 2.5mg, 5 mg,10 mg, 15 mg, 20 mg, 25 mg capsule Updated: August 19, 2022 Effective with the April 29, 2022 formulary update, lenalidomide for the treatment of anemia due to myelodysplastic syndrome (MDS), for multiple myeloma as first line, relapsed refractory or as maintenance therapy may be accessed upon meeting limited use criteria on the Ontario Drug Benefit Formulary. Requests not meeting LU criteria may be submitted to the Exceptional Access program to be evaluated on a case-by-case basis. 1Lenalidomide sensitive” is defined as a patient whose disease has not been refractory to a lenalidomide-based regimen and/or has not experienced disease progression while on a lenalidomide-based regimen. Refractory disease is defined as; i) disease progression within 60 days after stopping treatment while on lenalidomide (and/or bortezomib); or ii) progression while on any dose of lenalidomide (and/or bortezomib) including while on maintenance therapy with these therapies; or iii) non-responsive disease during therapy (either failure to achieve minimal response or experiencing disease progression) iv) Patients who are refractory to lenalidomide will not be eligible for daratumumab or carfilzomib-based triplets that are used in combination with lenalidomide. Progressive disease is defined as having one or more of the following; i) An increase of 25% from lowest response value in serum M-component (the absolute increase must be greater than or the equal to 0.5g/dL), and/or urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. You may also wish to review the Ontario Health – Cancer Care Ontario website for information for funding of NDFP drugs used for the treatment of multiple myeloma. 324 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 324, record 194, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Revlimid · DIN 02304899 Manufacturer: Bristol Myers Squibb Canada Inc; listing date 2021-10-29 Health Canada: Marketed since 2025-01-31 · brand REVLIMID · ATC L04AX04 LENALIDOMIDE · form Capsule · route Oral · ingredients LENALIDOMIDE 5 MG · company Bristol-myers squibb canada · schedule Prescription

DIN 02304899: Revlimid Raw flags: sec12=Y, sec3=Y Item: 920000586; group id 927; item number 2211; lccId 00358; manufacturer id BQU Source form: Cap; strength: 5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $340.0000; ministry $85.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02304899 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79016

Interchangeable products

Apo-Lenalidomide · DIN 02507935 · $85.0000 Jamp Lenalidomide · DIN 02506149 · $85.0000 Nat-Lenalidomide · DIN 02493845 · $85.0000 Reddy-Lenalidomide · DIN 02483017 · $85.0000 Sandoz Lenalidomide · DIN 02518570 · $85.0000 Taro-Lenalidomide · DIN 02507870 · $85.0000

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02304899

Shortage record checked 2026-09-13T08:10:21.292534+00:00