POMALIDOMIDE
All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules
Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.
Other products in the same Health Canada class (L04A, L04AX) — coverage varies; not interchangeable
- Methotrexate (Methotrexate Sodium): general benefit, Not a benefit
- Everolimus (Afinitor): not a benefit
Apo-Pomalidomide · DIN 02520427 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Apo-Pomalidomide · DIN 02520427
Manufacturer: Apotex Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand APO-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Apotex inc · schedule Prescription
Apo-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100962 · Verify on the e-Formulary ↗ (DIN 02520427)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02520427).
DIN 02520427: Apo-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id APX
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02520427
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100962
Interchangeable products
Jamp Pomalidomide · DIN 02538059 · $425.0000
Nat-Pomalidomide · DIN 02506394 · $425.0000
Pomalyst · DIN 02419580 · $425.0000
Reddy-Pomalidomide · DIN 02504073 · $425.0000
Sandoz Pomalidomide · DIN 02523973 · $425.0000
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=02520427
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Pomalidomide · DIN 02538059 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Jamp Pomalidomide · DIN 02538059
Manufacturer: Jamp Pharma Corporation; listing date 2023-08-31
Health Canada: Marketed since 2023-08-01 · brand JAMP POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Jamp pharma corporation · schedule Prescription
Jamp Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102681 · Verify on the e-Formulary ↗ (DIN 02538059)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02538059).
DIN 02538059: Jamp Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id JPC
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02538059
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102681
Interchangeable products
Apo-Pomalidomide · DIN 02520427 · $425.0000
Nat-Pomalidomide · DIN 02506394 · $425.0000
Pomalyst · DIN 02419580 · $425.0000
Reddy-Pomalidomide · DIN 02504073 · $425.0000
Sandoz Pomalidomide · DIN 02523973 · $425.0000
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=02538059
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Nat-Pomalidomide · DIN 02506394 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Nat-Pomalidomide · DIN 02506394
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand NAT-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99576 · Verify on the e-Formulary ↗ (DIN 02506394)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02506394).
DIN 02506394: Nat-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id NAT
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02506394
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99576
Interchangeable products
Apo-Pomalidomide · DIN 02520427 · $425.0000
Jamp Pomalidomide · DIN 02538059 · $425.0000
Pomalyst · DIN 02419580 · $425.0000
Reddy-Pomalidomide · DIN 02504073 · $425.0000
Sandoz Pomalidomide · DIN 02523973 · $425.0000
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=02506394
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Pomalyst · DIN 02419580 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
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 ↗)1 brand, same coverage
Pomalyst · DIN 02419580
Manufacturer: Bristol Myers Squibb Canada Inc; listing date 2023-04-28
Health Canada: Marketed since 2024-11-11 · brand POMALYST · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Bristol-myers squibb canada · schedule Prescription
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90423 · Verify on the e-Formulary ↗ (DIN 02419580)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02419580).
DIN 02419580: Pomalyst
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id BQU
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $500.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02419580
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90423
Interchangeable products
Apo-Pomalidomide · DIN 02520427 · $425.0000
Jamp Pomalidomide · DIN 02538059 · $425.0000
Nat-Pomalidomide · DIN 02506394 · $425.0000
Reddy-Pomalidomide · DIN 02504073 · $425.0000
Sandoz Pomalidomide · DIN 02523973 · $425.0000
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=02419580
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Reddy-Pomalidomide · DIN 02504073 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Reddy-Pomalidomide · DIN 02504073
Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-03-15 · brand REDDY-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Dr reddy's laboratories ltd · schedule Prescription
Reddy-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99353 · Verify on the e-Formulary ↗ (DIN 02504073)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02504073).
DIN 02504073: Reddy-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id DRR
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02504073
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99353
Interchangeable products
Apo-Pomalidomide · DIN 02520427 · $425.0000
Jamp Pomalidomide · DIN 02538059 · $425.0000
Nat-Pomalidomide · DIN 02506394 · $425.0000
Pomalyst · DIN 02419580 · $425.0000
Sandoz Pomalidomide · DIN 02523973 · $425.0000
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=02504073
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Pomalidomide · DIN 02523973 · 1mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Sandoz Pomalidomide · DIN 02523973
Manufacturer: Sandoz Canada Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand SANDOZ POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 1 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101302 · Verify on the e-Formulary ↗ (DIN 02523973)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02523973).
DIN 02523973: Sandoz Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000242; group id 180; item number 0325; lccId None; manufacturer id SDZ
Source form: Cap; strength: 1mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02523973
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101302
Interchangeable products
Apo-Pomalidomide · DIN 02520427 · $425.0000
Jamp Pomalidomide · DIN 02538059 · $425.0000
Nat-Pomalidomide · DIN 02506394 · $425.0000
Pomalyst · DIN 02419580 · $425.0000
Reddy-Pomalidomide · DIN 02504073 · $425.0000
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=02523973
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Pomalidomide · DIN 02520435 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Apo-Pomalidomide · DIN 02520435
Manufacturer: Apotex Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand APO-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Apotex inc · schedule Prescription
Apo-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100963 · Verify on the e-Formulary ↗ (DIN 02520435)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02520435).
DIN 02520435: Apo-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id APX
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02520435
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100963
Interchangeable products
Jamp Pomalidomide · DIN 02538075 · $425.0000
Nat-Pomalidomide · DIN 02506408 · $425.0000
Pomalyst · DIN 02419599 · $425.0000
Reddy-Pomalidomide · DIN 02504081 · $425.0000
Sandoz Pomalidomide · DIN 02523981 · $425.0000
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=02520435
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Pomalidomide · DIN 02538075 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Jamp Pomalidomide · DIN 02538075
Manufacturer: Jamp Pharma Corporation; listing date 2023-08-31
Health Canada: Marketed since 2023-08-01 · brand JAMP POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Jamp pharma corporation · schedule Prescription
Jamp Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102682 · Verify on the e-Formulary ↗ (DIN 02538075)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02538075).
DIN 02538075: Jamp Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id JPC
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02538075
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102682
Interchangeable products
Apo-Pomalidomide · DIN 02520435 · $425.0000
Nat-Pomalidomide · DIN 02506408 · $425.0000
Pomalyst · DIN 02419599 · $425.0000
Reddy-Pomalidomide · DIN 02504081 · $425.0000
Sandoz Pomalidomide · DIN 02523981 · $425.0000
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=02538075
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Nat-Pomalidomide · DIN 02506408 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Nat-Pomalidomide · DIN 02506408
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand NAT-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99577 · Verify on the e-Formulary ↗ (DIN 02506408)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02506408).
DIN 02506408: Nat-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id NAT
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02506408
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99577
Interchangeable products
Apo-Pomalidomide · DIN 02520435 · $425.0000
Jamp Pomalidomide · DIN 02538075 · $425.0000
Pomalyst · DIN 02419599 · $425.0000
Reddy-Pomalidomide · DIN 02504081 · $425.0000
Sandoz Pomalidomide · DIN 02523981 · $425.0000
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=02506408
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Pomalyst · DIN 02419599 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
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 ↗)1 brand, same coverage
Pomalyst · DIN 02419599
Manufacturer: Bristol Myers Squibb Canada Inc; listing date 2023-04-28
Health Canada: Marketed since 2025-01-31 · brand POMALYST · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Bristol-myers squibb canada · schedule Prescription
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90424 · Verify on the e-Formulary ↗ (DIN 02419599)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02419599).
DIN 02419599: Pomalyst
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id BQU
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $500.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02419599
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90424
Interchangeable products
Apo-Pomalidomide · DIN 02520435 · $425.0000
Jamp Pomalidomide · DIN 02538075 · $425.0000
Nat-Pomalidomide · DIN 02506408 · $425.0000
Reddy-Pomalidomide · DIN 02504081 · $425.0000
Sandoz Pomalidomide · DIN 02523981 · $425.0000
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=02419599
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Reddy-Pomalidomide · DIN 02504081 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Reddy-Pomalidomide · DIN 02504081
Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-03-15 · brand REDDY-POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Dr reddy's laboratories ltd · schedule Prescription
Reddy-Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99354 · Verify on the e-Formulary ↗ (DIN 02504081)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02504081).
DIN 02504081: Reddy-Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id DRR
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02504081
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99354
Interchangeable products
Apo-Pomalidomide · DIN 02520435 · $425.0000
Jamp Pomalidomide · DIN 02538075 · $425.0000
Nat-Pomalidomide · DIN 02506408 · $425.0000
Pomalyst · DIN 02419599 · $425.0000
Sandoz Pomalidomide · DIN 02523981 · $425.0000
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=02504081
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Pomalidomide · DIN 02523981 · 2mg · capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
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
Pomalidomide
Brand(s): Pomalyst and generics
DOSAGE FORM/ STRENGTH: 1 mg, 2 mg, 3 mg, 4 mg capsules
Effective date: February 6, 2015
Updated: May 31, 2023
Initial criteria:
For the treatment of patients with relapsed and/or refractory multiple myeloma who meet
ALL of the following criteria:
1. Patient has failed treatment on a lenalidomide-based regimen administered either
alone or in combination in any prior line of treatment (Note 1); AND
2. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g.
bortezomib, carfilzomib) administered either alone or in combination in any prior line
of treatment (Note 1); AND
3. Patient is deemed to be pomalidomide sensitive, defined as having disease that has
not been refractory to a pomalidomide-based regimen, and/or has not experienced
progression while on a pomalidomide-based regimen (Note 2); AND
351
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3 mg, 4 mg capsules
4. Patient is using pomalidomide in one of the following circumstances;
a) As dual therapy in combination with dexamethasone; OR
b) As a triple therapy regimen in combination with isatuximab and
dexamethasone after two prior lines of therapy in a patient who has not been
refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab,
isatuximab) used in another prior line of treatment (Note 3).
AND
5. Patients must have been refractory to the last line of therapy; AND
6. Patient has good performance.
Notes:
1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not
bortezomib resistant, they must have experienced disease progression on another
proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or
has unacceptable toxicities to lenalidomide and/or bortezomib, please include
details in your request application for case-by-case consideration.
2. Refractory disease is defined as;
a) Disease progression within 60 days after stopping treatment or
b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while
on maintenance therapy or
c) 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:
a) 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 200 mg/24 hours).
b) 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).
c) Definite development of new bone lesions or soft tissue plasmacytomas or definite
increase in the size of existing bone lesions or soft tissue plasmacytomas.
d) 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.
352
Pomalidomide
Brand(s): Pomalyst and generics
Dosage form/Strength: 1 mg, 2 mg , 3mg, 4 mg capsules
3. Although pomalidomide with isatuximab and dexamethasone is funded after
progression on two prior lines of therapy, if a patient is resistant or refractory to first
line lenalidomide and bortezomib as part of an earlier lenalidomide-bortezomib-
dexamethasone regimen (RVD), the patient would be eligible for funding of second
line isatuximab as part of IsaPd upon meeting other initial criteria.
4. Patients must meet the eligibility requirements for isatuximab through the New Drug
Funding Program (NDFP).
5. Isatuximab can be added to pomalidomide and dexamethasone provided the
patient met the eligibility criteria for isatuximab (See note 4) and has not
progressed.
Exclusions:
1. Patients with primary amyloidosis
Renewal criteria:
Pomalidomide 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 pomalidomide-based regimen.
Dosing regimen:
Pomalidomide 4 mg on days 1–21 of each 28 day cycle
If pomalidomide is given in combination with isatuximab and dexamethasone:
Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and
22 of each cycle.
Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15
[1 cycle = 28 days]
Approval duration of initials and renewals: 1 year
353
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 351, record 204, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)How long EAP takes
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 ↗)1 brand, same coverage
Sandoz Pomalidomide · DIN 02523981
Manufacturer: Sandoz Canada Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-02-28 · brand SANDOZ POMALIDOMIDE · ATC L04AX06 POMALIDOMIDE · form Capsule · route Oral · ingredients POMALIDOMIDE 2 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Pomalidomide: Formulary list price $425.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $425.0000 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101303 · Verify on the e-Formulary ↗ (DIN 02523981)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02523981).
DIN 02523981: Sandoz Pomalidomide
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000243; group id 180; item number 0326; lccId None; manufacturer id SDZ
Source form: Cap; strength: 2mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $425.0000; ministry $425.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02523981
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101303
Interchangeable products
Apo-Pomalidomide · DIN 02520435 · $425.0000
Jamp Pomalidomide · DIN 02538075 · $425.0000
Nat-Pomalidomide · DIN 02506408 · $425.0000
Pomalyst · DIN 02419599 · $425.0000
Reddy-Pomalidomide · DIN 02504081 · $425.0000
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=02523981
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (10:00 ANTINEOPLASTIC AGENTS) and how they are covered
Matched class: 10:00 ANTINEOPLASTIC AGENTS
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: ABIRATERONE ACETATE, ALTRETAMINE, ANASTROZOLE, BUSERELIN ACETATE, BUSULFAN, CAPECITABINE, CHLORAMBUCIL, CYPROTERONE ACETATE, DAUNORUBICIN, DEGARELIX ACETATE, ETOPOSIDE, EXEMESTANE, FLUOROURACIL & SALICYLIC ACID, FULVESTRANT, GOSERELIN ACETATE, HYDROXYUREA, IMATINIB MESYLATE, LETROZOLE, LEUPROLIDE ACETATE, MELPHALAN, MERCAPTOPURINE, MITOTANE, PROCARBAZINE HCL, TEMOZOLOMIDE, THIOGUANINE, TRIPTORELIN PAMOATE
Some products covered without a code (check the product listing): BICALUTAMIDE, CYCLOPHOSPHAMIDE, FLUTAMIDE, LOMUSTINE (CCNU), MEGESTROL ACETATE, METHOTREXATE, TAMOXIFEN CITRATE, VINCRISTINE SULFATE
10:00 ANTINEOPLASTIC AGENTS
· 34 products · General benefit (29), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 20mg/2mL, 50mg/2mL, 10mg/0.2mL, 12.5mg/0.25mL, 15mg/0.3mL, 17.5mg/0.35mL, 20mg/0.4mL, 22.5mg/0.45mL, 25mg/0.5mL, 2.5mg, 10mg · Inj Sol-2mL Pk, Inj Sol-Pref Syr, Tab
· 18 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 2.5mg, 5mg, 10mg · Tab
· 18 products · General benefit · strengths: 250mg, 500mg · Tab
· 1 products · General benefit · strengths: 50mg · Cap
· 17 products · General benefit · strengths: 1mg · Tab
· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 50mg · Tab
· 4 products · General benefit · strengths: 6.3mg, 9.45mg, 1mg/mL · Implant Kit, Inj Sol-5.5mL Pk, Nas Sp-10mL Pk
· 1 products · General benefit · strengths: 2mg · Tab
· 15 products · General benefit · strengths: 150mg, 500mg · Tab
· 1 products · General benefit · strengths: 2mg · Tab
· 3 products · General benefit (2), Listed, not a benefit (1) · strengths: 25mg, 50mg · Tab
· 4 products · General benefit · strengths: 50mg · Tab
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 10:00
and 34 more