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Exceptional Access criteria on record are for Brand(s): Mavenclad; DOSAGE FORM/ STRENGTH: 10 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet Initiation Criteria For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following; i) 2 or more attacks1 and clinical evidence of 2 or more lesions2; OR ii) 2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; 1If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: • Additional clinical attack • Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan) • Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands 2 If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: • Additional clinical attack implicating different CNS site • 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND 4. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 5. Patient has an EDSS score less than 6.0 before start of therapy; AND 6. Cladribine is used as monotherapy for the treatment of RRMS; AND 221 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet 7. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinical recognized by the MS Society of Canada supporting the diagnosis. Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.) *Note: Requests for patients who is under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Submit MRI and relevant history with your request. Exclusion criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0 Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year). Approval Duration: Two treatment courses over 2 years are funded 222  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 221, record 130, corpus 2025-01-01; name match only, not an eligibility decision

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

Apo-Cladribine · DIN 02553295 Manufacturer: Apotex Inc.; listing date 2026-01-30 Health Canada: Marketed since 2025-12-22 · brand APO-CLADRIBINE · ATC L04AA40* CLADRIBINE · form Tablet · route Oral · ingredients CLADRIBINE 10 MG · company Apotex inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02553295). DIN 02553295: Apo-Cladribine Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 924400007; group id 1045; item number 2397; lccId None; manufacturer id APX Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1606.0000; ministry $1606.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02553295 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104223

Interchangeable products

Auro-Cladribine · DIN 02566443 · $1606.0000 Mavenclad · DIN 02470179 · $1606.0000

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=02553295

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

Exceptional Access criteria on record are for Brand(s): Mavenclad; DOSAGE FORM/ STRENGTH: 10 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet Initiation Criteria For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following; i) 2 or more attacks1 and clinical evidence of 2 or more lesions2; OR ii) 2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; 1If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: • Additional clinical attack • Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan) • Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands 2 If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: • Additional clinical attack implicating different CNS site • 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND 4. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 5. Patient has an EDSS score less than 6.0 before start of therapy; AND 6. Cladribine is used as monotherapy for the treatment of RRMS; AND 221 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet 7. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinical recognized by the MS Society of Canada supporting the diagnosis. Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.) *Note: Requests for patients who is under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Submit MRI and relevant history with your request. Exclusion criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0 Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year). Approval Duration: Two treatment courses over 2 years are funded 222  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 221, record 130, corpus 2025-01-01; name match only, not an eligibility decision

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

Auro-Cladribine · DIN 02566443 Manufacturer: Auro Pharma Inc.; listing date 2026-07-31 Health Canada: Marketed since 2026-07-06 · brand AURO-CLADRIBINE · ATC L04AA40* CLADRIBINE · form Tablet · route Oral · ingredients CLADRIBINE 10 MG · company Auro pharma inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02566443). DIN 02566443: Auro-Cladribine Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 924400007; group id 1045; item number 2397; lccId None; manufacturer id AUR Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1606.0000; ministry $1606.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02566443 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106895

Interchangeable products

Apo-Cladribine · DIN 02553295 · $1606.0000 Mavenclad · DIN 02470179 · $1606.0000

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=02566443

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

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 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet Initiation Criteria For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following; i) 2 or more attacks1 and clinical evidence of 2 or more lesions2; OR ii) 2 or more attacks1 and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; 1If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: • Additional clinical attack • Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan) • Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands 2 If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: • Additional clinical attack implicating different CNS site • 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND 4. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 5. Patient has an EDSS score less than 6.0 before start of therapy; AND 6. Cladribine is used as monotherapy for the treatment of RRMS; AND 221 Cladribine Brand(s): Mavenclad DOSAGE FORM/ STRENGTH: 10 mg tablet 7. The drug request is from a neurologist experienced in the management of RRMS or includes a consult note from a neurologist from an MS clinical recognized by the MS Society of Canada supporting the diagnosis. Requests from community neurologists not working with an MS Clinic will be considered case-by-case. (Please include MRI reports or labwork to support the diagnosis pf RRMS aligned with McDonald 2017 criteria.) *Note: Requests for patients who is under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Submit MRI and relevant history with your request. Exclusion criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0 Dosage: Refer to the Mavenclad product monograph for dosing regimen based on body weight. Taken as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. 1.75 mg/kg per year administered as a treatment course in year 1 and a second treatment course starting 12 months after the first course in the respective year upon monitoring for recovery of lymphocytes before the second course of treatment is administered in accordance with prescribing information. The recommended cumulative dose of is 3.5 mg/kg body weight over 2 years (1.75 mg/kg per year). Approval Duration: Two treatment courses over 2 years are funded 222  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 221, record 130, corpus 2025-01-01; name match only, not an eligibility decision

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

Mavenclad · DIN 02470179 Manufacturer: EMD Serono Canada Inc.; listing date 2026-01-30 Health Canada: Marketed since 2017-11-30 · brand MAVENCLAD · ATC L04AA40* CLADRIBINE · form Tablet · route Oral · ingredients CLADRIBINE 10 MG · company Emd serono, a division of emd inc., canada · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02470179). DIN 02470179: Mavenclad Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 924400007; group id 1045; item number 2397; lccId None; manufacturer id EMS Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3212.0000; ministry $1606.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02470179 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95915

Interchangeable products

Apo-Cladribine · DIN 02553295 · $1606.0000 Auro-Cladribine · DIN 02566443 · $1606.0000

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=02470179

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