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Exceptional Access criteria on record are for Brand(s): Tecfidera and generics; DOSAGE FORM/ STRENGTH: 120 mg delayed-release capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Dimethyl fumarate Brand(s): Tecfidera and generics DOSAGE FORM/ STRENGTH: 120 mg delayed-release capsule For the treatment of Relapsing–Remitting Multiple Sclerosis (RRMS) in patients who meet all of the following criteria: • The patient’s physician provides documentation setting out the details of the patient’s most recent neurological examination (which must have been conducted within ninety [90] days of the request, including a description of any recent attacks, the dates of attacks, and neurological findings). • Patient has had one (1) or more clinical relapses in the previous year. • The drug is requested by and followed by a neurologist experienced in the management of RRMS. • The patient has a recent Expanded Disability Status Scale (EDSS) score ≤ 5. Dosage: Initial: 120 mg twice daily Maintenance: 240 mg twice daily Renewal requests will be considered. Renewals for Tecfidera can be submitted through the Telephone Request Service. The date and details of the most recent neurological examination and EDSS scores must be provided (exam must have occurred within the last ninety [90] days); AND • The patient must be stable or experienced no more than one clinical relapse* in the past year; AND • The patient has a recent EDSS score ≤ 5. Dosage: 120 mg twice daily. Maintenance: 240 mg twice daily Duration of Approval: 1 year *Renewal requests where patients have experienced more than one (1) clinical relapse in the past year are to be externally reviewed. As applicable, please also include information regarding the requesting physician’s specialty (e.g. is the physician a neurologist or a physician with specialized experience with multiple sclerosis (MS), the name of the MS clinic where the patient was examined, or an MS consult note as this information may reduce the turnaround times for assessment. Duration of Approval: First Renewal: 2 years Second and subsequent renewals: 5 years 223  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 223, record 131, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Tecfidera; DOSAGE FORM/ STRENGTH: 120mg and 240 mg capsule — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Dimethyl Fumarate Brand(s): Tecfidera DOSAGE FORM/ STRENGTH: 120mg and 240 mg capsule EAP will renew coverage of dimethyl fumarate for patients who are stable and experienced no more than one disabling attack/relapse in the past year and have an EDSS score less than or equal to 5. Prescriber must provide the following information: • Description of the patient’s clinical course in the last year, including details of all attacks; • Date and details of the most recent neurological examination (within the last 90 days); and • EDSS score Dosage: 120 mg twice daily Maintenance: 240 mg twice daily Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent renewals EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 321, 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-Dimethyl Fumarate · DIN 02505770 Manufacturer: Apotex Inc.; listing date 2021-11-30 Health Canada: Marketed since 2021-10-04 · brand APO-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Apotex inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02505770). DIN 02505770: Apo-Dimethyl Fumarate Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id APX Source form: DR Cap; strength: 240mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $18.3867; ministry $18.3867 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02505770 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99515

Interchangeable products

Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867 Auro-Dimethyl Fumarate · DIN 02540754 · $8.6888 GLN-Dimethyl Fumarate · DIN 02494817 · $18.3867 Jamp Dimethyl Fumarate · DIN 02516055 · $18.3867 Mar-Dimethyl Fumarate · DIN 02502704 · $18.3867 PMS-Dimethyl Fumarate · DIN 02497034 · $18.3867 Sandoz Dimethyl Fumarate DR Capsules · DIN 02513803 · $18.3867 Tecfidera · DIN 02420201 · $18.3867

Shortage status: not checked (no credentials)