DIMETHYL FUMARATE
All products: not a benefit
Apo-Dimethyl Fumarate · DIN 02505762 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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-Dimethyl Fumarate · DIN 02505762
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 120 MG · company Apotex inc · schedule Prescription
Apo-Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=99514 · Verify on the e-Formulary ↗ (DIN 02505762)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02505762).
DIN 02505762: Apo-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id APX
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02505762
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99514
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02505762
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Dimethyl Fumarate · DIN 02540746 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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
Auro-Dimethyl Fumarate · DIN 02540746
Manufacturer: Auro Pharma Inc.; listing date 2024-08-30
Health Canada: Marketed since 2024-06-07 · brand AURO-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Auro pharma inc · schedule Prescription
Auro-Dimethyl Fumarate: Formulary list price $4.4266/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.4266 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=102941 · Verify on the e-Formulary ↗ (DIN 02540746)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02540746).
DIN 02540746: Auro-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id AUR
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $4.4266; ministry $4.4266
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02540746
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102941
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02540746
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Dimethyl Fumarate · DIN 02516047 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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 Dimethyl Fumarate · DIN 02516047
Manufacturer: Jamp Pharma Corporation; listing date 2021-12-17
Health Canada: Marketed since 2021-10-04 · brand JAMP DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Jamp pharma corporation · schedule Prescription
Jamp Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=100540 · Verify on the e-Formulary ↗ (DIN 02516047)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02516047).
DIN 02516047: Jamp Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id JPC
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02516047
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100540
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02516047
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mar-Dimethyl Fumarate · DIN 02502690 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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
Mar-Dimethyl Fumarate · DIN 02502690
Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2021-11-30
Health Canada: Marketed since 2021-10-04 · brand MAR-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Marcan pharmaceuticals inc · schedule Prescription
Mar-Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=99224 · Verify on the e-Formulary ↗ (DIN 02502690)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02502690).
DIN 02502690: Mar-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id MAR
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02502690
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99224
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02502690
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Dimethyl Fumarate · DIN 02497026 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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
PMS-Dimethyl Fumarate · DIN 02497026
Manufacturer: Pharmascience Inc.; listing date 2021-11-30
Health Canada: Marketed since 2021-10-04 · brand PMS-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Pharmascience inc · schedule Prescription
PMS-Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=98689 · Verify on the e-Formulary ↗ (DIN 02497026)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02497026).
DIN 02497026: PMS-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id PMS
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02497026
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98689
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02497026
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Tecfidera · DIN 02404508 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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
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 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
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
Tecfidera · DIN 02404508
Manufacturer: Biogen Idec Canada Inc.; listing date 2021-11-30
Health Canada: Marketed since 2013-04-12 · brand TECFIDERA · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Biogen canada inc · schedule Prescription
Ministry pays: $9.1933 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=88926 · Verify on the e-Formulary ↗ (DIN 02404508)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02404508).
DIN 02404508: Tecfidera
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id BIG
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $18.3866; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02404508
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88926
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
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=02404508
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Dimethyl Fumarate · DIN 02505770 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
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
Apo-Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=99515 · Verify on the e-Formulary ↗ (DIN 02505770)
Source record
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: 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=02505770
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Dimethyl Fumarate · DIN 02540754 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
Auro-Dimethyl Fumarate · DIN 02540754
Manufacturer: Auro Pharma Inc.; listing date 2024-08-30
Health Canada: Marketed since 2024-06-07 · brand AURO-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Auro pharma inc · schedule Prescription
Auro-Dimethyl Fumarate: Formulary list price $8.6888/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.6888 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=102942 · Verify on the e-Formulary ↗ (DIN 02540754)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02540754).
DIN 02540754: Auro-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id AUR
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): $8.6888; ministry $8.6888
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02540754
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102942
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $18.3867
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: 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=02540754
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Dimethyl Fumarate · DIN 02516055 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
Jamp Dimethyl Fumarate · DIN 02516055
Manufacturer: Jamp Pharma Corporation; listing date 2021-12-17
Health Canada: Marketed since 2021-10-04 · brand JAMP DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Jamp pharma corporation · schedule Prescription
Jamp Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=100541 · Verify on the e-Formulary ↗ (DIN 02516055)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02516055).
DIN 02516055: Jamp Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id JPC
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=02516055
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100541
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $18.3867
Auro-Dimethyl Fumarate · DIN 02540754 · $8.6888
GLN-Dimethyl Fumarate · DIN 02494817 · $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: 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=02516055
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mar-Dimethyl Fumarate · DIN 02502704 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
Mar-Dimethyl Fumarate · DIN 02502704
Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2021-11-30
Health Canada: Marketed since 2021-10-04 · brand MAR-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Marcan pharmaceuticals inc · schedule Prescription
Mar-Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=99225 · Verify on the e-Formulary ↗ (DIN 02502704)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02502704).
DIN 02502704: Mar-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id MAR
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=02502704
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99225
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $18.3867
Auro-Dimethyl Fumarate · DIN 02540754 · $8.6888
GLN-Dimethyl Fumarate · DIN 02494817 · $18.3867
Jamp Dimethyl Fumarate · DIN 02516055 · $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: 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=02502704
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Dimethyl Fumarate · DIN 02497034 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
PMS-Dimethyl Fumarate · DIN 02497034
Manufacturer: Pharmascience Inc.; listing date 2021-11-30
Health Canada: Marketed since 2021-10-04 · brand PMS-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Pharmascience inc · schedule Prescription
PMS-Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=98690 · Verify on the e-Formulary ↗ (DIN 02497034)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02497034).
DIN 02497034: PMS-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id PMS
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=02497034
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98690
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $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
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513803 · $18.3867
Tecfidera · DIN 02420201 · $18.3867
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=02497034
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Tecfidera · DIN 02420201 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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 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
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
Tecfidera · DIN 02420201
Manufacturer: Biogen Idec Canada Inc.; listing date 2021-11-30
Health Canada: Marketed since 2014-02-04 · brand TECFIDERA · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Biogen canada inc · schedule Prescription
Ministry pays: $18.3867 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=90480 · Verify on the e-Formulary ↗ (DIN 02420201)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02420201).
DIN 02420201: Tecfidera
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id BIG
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): $36.7734; ministry $18.3867
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02420201
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90480
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $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
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=02420201
Shortage record checked 2026-09-13T08:10:21.292534+00:00
GLN-Dimethyl Fumarate · DIN 02494809 · 120mg · DR capsule
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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
GLN-Dimethyl Fumarate · DIN 02494809
Manufacturer: Glenmark Pharmaceuticals Canada Inc.; listing date 2021-11-30
Health Canada: Dormant since 2024-10-28 · brand GLN-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Glenmark pharmaceuticals canada inc. · schedule Prescription
GLN-Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=98478 · Verify on the e-Formulary ↗ (DIN 02494809)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02494809).
DIN 02494809: GLN-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id GLP
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02494809
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98478
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02494809
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2024-10-28 — choose a marketed DIN from the same-category list.
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitDormant since 2026-07-27 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
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 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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 Dimethyl Fumarate DR Capsules · DIN 02513781
Manufacturer: Sandoz Canada Inc.; listing date 2021-11-30
Health Canada: Dormant since 2026-07-27 · brand SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Dimethyl Fumarate DR Capsules: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=100300 · Verify on the e-Formulary ↗ (DIN 02513781)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02513781).
DIN 02513781: Sandoz Dimethyl Fumarate DR Capsules
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id SDZ
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02513781
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100300
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495341 · $9.1933
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
Shortage status: discontinued (2024-12-10, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02513781
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2026-07-27 — choose a marketed DIN from the same-category list.
GLN-Dimethyl Fumarate · DIN 02494817 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitDormant since 2024-11-29 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
GLN-Dimethyl Fumarate · DIN 02494817
Manufacturer: Glenmark Pharmaceuticals Canada Inc.; listing date 2021-11-30
Health Canada: Dormant since 2024-11-29 · brand GLN-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Glenmark pharmaceuticals canada inc. · schedule Prescription
GLN-Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=98479 · Verify on the e-Formulary ↗ (DIN 02494817)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02494817).
DIN 02494817: GLN-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id GLP
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=02494817
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98479
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $18.3867
Auro-Dimethyl Fumarate · DIN 02540754 · $8.6888
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: 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=02494817
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2024-11-29 — choose a marketed DIN from the same-category list.
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513803 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefitDormant since 2026-07-27 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513803
Manufacturer: Sandoz Canada Inc.; listing date 2021-11-30
Health Canada: Dormant since 2026-07-27 · brand SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Dimethyl Fumarate DR Capsules: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=100301 · Verify on the e-Formulary ↗ (DIN 02513803)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02513803).
DIN 02513803: Sandoz Dimethyl Fumarate DR Capsules
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id SDZ
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=02513803
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100301
Interchangeable products
Ach-Dimethyl Fumarate · DIN 02495368 · $18.3867
Apo-Dimethyl Fumarate · DIN 02505770 · $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
Tecfidera · DIN 02420201 · $18.3867
Shortage status: discontinued (2024-12-10, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02513803
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2026-07-27 — choose a marketed DIN from the same-category list.
Ach-Dimethyl Fumarate · DIN 02495341 · 120mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.Discontinued 2025-10-28 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.
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 ↗); Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list. Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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
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
Ach-Dimethyl Fumarate · DIN 02495341
Manufacturer: Accord Healthcare Inc.; listing date 2021-12-17
Health Canada: Cancelled post market since 2025-10-28 · brand ACH-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 120 MG · company Accord healthcare inc · schedule Prescription
Ach-Dimethyl Fumarate: Formulary list price $9.1933/unit (unit not stated in source; not the patient's cost)
Ministry pays: $9.1933 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=98527 · Verify on the e-Formulary ↗ (DIN 02495341)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02495341).
DIN 02495341: Ach-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200051; group id 536; item number 1452; lccId None; manufacturer id ACH
Source form: DR Cap; strength: 120mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $9.1933; ministry $9.1933
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495341
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98527
Interchangeable products
Apo-Dimethyl Fumarate · DIN 02505762 · $9.1933
Auro-Dimethyl Fumarate · DIN 02540746 · $4.4266
GLN-Dimethyl Fumarate · DIN 02494809 · $9.1933
Jamp Dimethyl Fumarate · DIN 02516047 · $9.1933
Mar-Dimethyl Fumarate · DIN 02502690 · $9.1933
PMS-Dimethyl Fumarate · DIN 02497026 · $9.1933
Sandoz Dimethyl Fumarate DR Capsules · DIN 02513781 · $9.1933
Tecfidera · DIN 02404508 · $9.1933
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=02495341
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.
Ach-Dimethyl Fumarate · DIN 02495368 · 240mg · DR capsule
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.Discontinued 2025-10-28 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives; Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.
Patient paysPatient pays: program not supplied; amount cannot be determined.
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 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
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 ↗)1 brand, same coverage
Ach-Dimethyl Fumarate · DIN 02495368
Manufacturer: Accord Healthcare Inc.; listing date 2021-12-17
Health Canada: Cancelled post market since 2025-10-28 · brand ACH-DIMETHYL FUMARATE · ATC L04AX07 DIMETHYL FUMARATE · form Capsule (delayed-release) · route Oral · ingredients DIMETHYL FUMARATE 240 MG · company Accord healthcare inc · schedule Prescription
Ach-Dimethyl Fumarate: Formulary list price $18.3867/unit (unit not stated in source; not the patient's cost)
Ministry pays: $18.3867 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=98528 · Verify on the e-Formulary ↗ (DIN 02495368)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02495368).
DIN 02495368: Ach-Dimethyl Fumarate
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 289200053; group id 536; item number 1453; lccId None; manufacturer id ACH
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=02495368
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98528
Interchangeable products
Apo-Dimethyl Fumarate · DIN 02505770 · $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: 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=02495368
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2025-10-28 — choose a marketed DIN from the same-category list.