FINGOLIMOD
All products: not a benefit
Other products in the same Health Canada class (L04A) — coverage varies; not interchangeable
- Azathioprine (Imuran): general benefit
- Cyclosporine (Neoral): general benefit
- Leflunomide (Arava): general benefit
- Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
- Mycophenolate (Myfortic): general benefit
- Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634
15 more in the class list below
Ach-Fingolimod · DIN 02475669 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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-Fingolimod · DIN 02475669
Manufacturer: Accord Healthcare Inc.; listing date 2019-11-29
Health Canada: Marketed since 2019-12-11 · brand ACH-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Accord healthcare inc · schedule Prescription
Check this DIN again · Health Canada product recordAch-Fingolimod: Formulary list price $73.9100/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9100 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=96603 · Verify on the e-Formulary ↗ (DIN 02475669)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02475669).
DIN 02475669: Ach-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id ACH
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9100; ministry $73.9100
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02475669
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96603
Interchangeable products
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: active shortage (reported 2022-03-04, last updated 2022-03-05) — report may be stale, confirm; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02475669
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Gilenya · DIN 02365480 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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
Gilenya · DIN 02365480
Manufacturer: Novartis Pharma Canada Inc.; listing date 2019-10-31
Health Canada: Marketed since 2011-03-28 · brand GILENYA · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Novartis pharmaceuticals canada inc · schedule Prescription
Check this DIN again · Health Canada product recordMinistry pays: $73.9100 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=85038 · Verify on the e-Formulary ↗ (DIN 02365480)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02365480).
DIN 02365480: Gilenya
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id NOV
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $86.9525; ministry $73.9100
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02365480
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=85038
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
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=02365480
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Fingolimod · DIN 02487772 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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 Fingolimod · DIN 02487772
Manufacturer: Jamp Pharma Corporation; listing date 2020-01-31
Health Canada: Marketed since 2019-10-31 · brand JAMP FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Jamp pharma corporation · schedule Prescription
Check this DIN again · Health Canada product recordJamp Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=97793 · Verify on the e-Formulary ↗ (DIN 02487772)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02487772).
DIN 02487772: Jamp Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id JPC
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02487772
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97793
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: resolved shortage (ended 2024-03-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02487772
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mylan-Fingolimod · DIN 02469715 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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
Mylan-Fingolimod · DIN 02469715
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2019-11-29
Health Canada: Marketed since 2019-09-25 · brand MYLAN-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Mylan pharmaceuticals ulc · schedule Prescription
Check this DIN again · Health Canada product recordMylan-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=95854 · Verify on the e-Formulary ↗ (DIN 02469715)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469715).
DIN 02469715: Mylan-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id MYL
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469715
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95854
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: active shortage (reported 2025-07-07, last updated 2025-09-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02469715
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Fingolimod · DIN 02469782 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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-Fingolimod · DIN 02469782
Manufacturer: Pharmascience Inc.; listing date 2019-10-31
Health Canada: Marketed since 2019-08-30 · brand PMS-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Pharmascience inc · schedule Prescription
Check this DIN again · Health Canada product recordPMS-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=95865 · Verify on the e-Formulary ↗ (DIN 02469782)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469782).
DIN 02469782: PMS-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id PMS
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469782
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95865
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
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=02469782
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Fingolimod · DIN 02482606 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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 Fingolimod · DIN 02482606
Manufacturer: Sandoz Canada Inc.; listing date 2019-12-20
Health Canada: Marketed since 2019-10-31 · brand SANDOZ FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product recordSandoz Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=97303 · Verify on the e-Formulary ↗ (DIN 02482606)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02482606).
DIN 02482606: Sandoz Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id SDZ
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02482606
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97303
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
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=02482606
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Taro-Fingolimod · DIN 02469618 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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
Taro-Fingolimod · DIN 02469618
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2019-12-20
Health Canada: Marketed since 2019-10-24 · brand TARO-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Taro pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product recordTaro-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=95841 · Verify on the e-Formulary ↗ (DIN 02469618)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469618).
DIN 02469618: Taro-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id TAR
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469618
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95841
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: resolved shortage (ended 2022-04-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02469618
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Fingolimod · DIN 02469936 · 0.5mg · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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-Fingolimod · DIN 02469936
Manufacturer: Apotex Inc.; listing date 2019-12-20
Health Canada: Dormant since 2025-06-12 · brand APO-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product recordApo-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=95885 · Verify on the e-Formulary ↗ (DIN 02469936)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469936).
DIN 02469936: Apo-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id APX
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469936
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95885
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: active shortage (reported 2024-05-07, last updated 2024-05-10) — report may be stale, confirm; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02469936
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2025-06-12 — choose a marketed DIN from the same-category list.
Mar-Fingolimod · DIN 02474743 · 0.5mg · capsule
Off-Formulary Interchangeable, not an ODB benefitDormant since 2022-07-06 · 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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-Fingolimod · DIN 02474743
Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2019-12-20
Health Canada: Dormant since 2022-07-06 · brand MAR-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Marcan pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product recordMar-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=96493 · Verify on the e-Formulary ↗ (DIN 02474743)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02474743).
DIN 02474743: Mar-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id MAR
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02474743
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96493
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Teva-Fingolimod · DIN 02469561 · $73.9096
Shortage status: resolved shortage (ended 2022-07-06); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02474743
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2022-07-06 — choose a marketed DIN from the same-category list.
Teva-Fingolimod · DIN 02469561 · 0.5mg · capsule
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-27 — choose a marketed DIN from the same-category list.Discontinued 2025-10-27 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2025-10-27 — 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 2025-10-27 — 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 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
As monotherapy for the treatment of patients with Relapsing Remitting Multiple
Sclerosis (RRMS) 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 within ninety (90) days of the
submitted request. This must include a description of any recent attack(s), the
date(s) of the attack(s), and the neurological findings; AND
• Failure to respond to full and adequate courses1 of at least one of interferon OR
glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR
documented intolerance or contraindication to 2 of the above listed therapies;
AND
• Experienced one or more clinically disabling relapses in the previous year; AND
• Has had a significant increase in T2 lesion load compared with that from a
previous MRI scan (i.e. 3 or more new lesions) OR at least one gadolinium-
enhancing lesion.
• Is being followed by a neurologist experienced in the management of RRMS.
• Has a current EDSS of less than or equal to 5.5 (i.e. patients must be able to
ambulate at least 100 meters without assistance).
Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be
funded):
• Patient’s receiving combination therapy of Gilenya with other disease modifying
therapies (e.g. Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif,
Extavia, Ocrevus, Tysabri, and Tecfidera).
• Patients with EDSS greater than 5.5
• Patients who have had a heart attack or stroke in the last 6 months of the
funding request, history of sick sinus syndrome, atrioventricular block, significant
QT prolongation, bradycardia, ischemic heart disease, or congestive heart
failure.
• Patients younger than 18 years of age.
• Patients requesting Gilenya due to needle phobia or preference for oral therapy
over injection who do not have a clinical contraindication to interferon or
glatiramer therapy.
• Skin reactions at the site of injection do NOT qualify as a contraindication to
interferon or glatiramer therapy.
224
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg capsule
Dosage: 0.5 mg once daily
1Failure to respond to full and adequate courses: defined as having received a trial of at
least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide
AND experienced at least one disabling relapse (attack) while on interferon or
glatiramer or dimethyl fumarate or teriflunomide.
MRI reports do NOT need to be submitted with the initial request.
Duration of Approval: 1 year
Renewals are considered. Renewals can be submitted through the Telephone Request
Service and will be considered for patients who have benefited from therapy.
Physicians must provide the following information:
• Documentation providing the date and details of the Patient’s most recent
neurological examination and EDSS scores (exam must have occurred within the
last ninety (90) days); AND
• Evidence that the patient is stable and has experienced no more than one (1)
disabling attack/relapse in the past year. (Note: If the Patient has had more than
one attack/relapse, the request will be sent for external review. Please include
details of the attack(s) including the dates on which they occurred); AND
• A recent Expanded Disability Status Scale (EDSS) that is less than or equal to
5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded).
Dosage: 0.5 mg once daily.
Duration of Approval: First Renewal: 2 years
Second and subsequent renewals: 5 years
225
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 224, record 132, 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
Fingolimod
Brand(s): Gilenya and generics
DOSAGE FORM/ STRENGTH: 0.5 mg Capsule
EAP will renew coverage of Fingolimod for patients with RRMS 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 5.5.
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
Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent
renewals
Renewal requests where patients have experienced more than 1 attack in the past year
will be externally reviewed.
480
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 480, record 322, 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
Teva-Fingolimod · DIN 02469561
Manufacturer: Teva Canada Limited; listing date 2019-12-20
Health Canada: Cancelled post market since 2025-10-27 · brand TEVA-FINGOLIMOD · ATC L04AE01 FINGOLIMOD · form Capsule · route Oral · ingredients FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5 MG · company Teva canada limited · schedule Prescription
Check this DIN again · Health Canada product recordTeva-Fingolimod: Formulary list price $73.9096/unit (unit not stated in source; not the patient's cost)
Ministry pays: $73.9096 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=95837 · Verify on the e-Formulary ↗ (DIN 02469561)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469561).
DIN 02469561: Teva-Fingolimod
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000681; group id 916; item number 2189; lccId None; manufacturer id TEV
Source form: Cap; strength: 0.5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $73.9096; ministry $73.9096
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469561
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95837
Interchangeable products
Ach-Fingolimod · DIN 02475669 · $73.9100
Apo-Fingolimod · DIN 02469936 · $73.9096
Gilenya · DIN 02365480 · $73.9100
Jamp Fingolimod · DIN 02487772 · $73.9096
Mar-Fingolimod · DIN 02474743 · $73.9096
Mylan-Fingolimod · DIN 02469715 · $73.9096
PMS-Fingolimod · DIN 02469782 · $73.9096
Sandoz Fingolimod · DIN 02482606 · $73.9096
Taro-Fingolimod · DIN 02469618 · $73.9096
Shortage status: discontinued (2024-12-20, reported by TEVA CANADA LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02469561
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2025-10-27 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered
Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM
Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL
92:00 UNCLASSIFIED THERAPEUTIC AGENTS
· 3 products · General benefit · strengths: 50mg · Tab
· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L
· 16 products · General benefit · strengths: 10mg, 20mg · Tab
· 16 products · General benefit (14),
Limited Use, codes 556 (2) · strengths: 250mg, 200mg/mL, 500mg · Cap, Pd for Oral Susp-175mL Pk, Tab
· 8 products · General benefit · strengths: 180mg, 360mg · Ent Tab
· 42 products ·
Limited Use, codes 630, 631, 632, 659, 741 · strengths: 2.5mg, 15mg, 20mg, 25mg, 5mg, 10mg · Cap
· 2 products ·
Limited Use, codes 392 · strengths: 1mg/mL, 1mg · O/L, Tab
· 20 products ·
Limited Use, codes 173 (10),
Limited Use, codes 410 (8),
Limited Use, codes 383 (2) · strengths: 5mg/mL, 0.5mg, 1mg, 5mg, 3mg, 0.03%, 0.1% · Amp, Cap, ER Cap, Oint
· 10 products · Listed, not a benefit (1),
Limited Use, codes 647 (9) · strengths: 14mg · Tab
· 14 products ·
Limited Use, codes 669, 670, 671, 672 (5),
Limited Use, codes 668, 669, 671, 672 (2),
Limited Use, codes 669, 671, 672, 733 (3),
Limited Use, codes 669, 671, 672, 742 (2),
Limited Use, codes 671, 672 (2) · strengths: 45mg/0.5mL, 90mg/1.0mL, 90mg/mL, 130mg/26mL, 5mg/mL · Inj Sol-0.5mL Pref Autoinj (Preservative-Free), Inj Sol-0.5mL Pref Syr Pk, Inj Sol-0.5mL Pref Syr Pk (Preservative-Free), Inj Sol-0.5mL Vial Pk, Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr Pk, Inj Sol-26mL Vial Pk, Inj Sol-26mL Vial Pk (Preservative-Free), Inj Sol-Vial Pk (Preservative-Free)
· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 267mg · Cap
· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00
and 75 more
Full class listing
Related classes:
Same formulary class, not same indication: class membership alone does not establish equivalent uses.