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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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RILUZOLE

All products: not a benefit

Other products in the same Health Canada class (N07XX) — coverage varies; not interchangeable

  • Fampridine (Fampyra): not a benefit
  • Tetrabenazine (Nitoman): not a benefit

Rilutek · DIN 02242763 · 50mg · tablet

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 Riluzole Brand(s): Rilutek DOSAGE FORM/ STRENGTH: 50 mg tablet Approvals will be provided for: Patients who have probable or definite amyotrophic lateral sclerosis (ALS) as defined by World Federation of Neurology (WFN) criteria with onset within 5 years, who have a vital capacity of >60% predicted and do not have a tracheostomy. Discontinuation Criteria: Reimbursement will be discontinued if the patient progresses to require permanent assisted ventilation. This is defined as assisted ventilation required for 23 out of 24 hours for greater than or equal to 14 consecutive days. Renewal Criteria: Renewals will be considered in patients who do not meet the discontinuation criteria. Approval period of initials and renewals: 12 months 104 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 104, record 64, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)
1 brand, same coverage
Rilutek · DIN 02242763 Manufacturer: Sanofi-Aventis Canada Inc.; listing date 2012-11-27 Health Canada: Marketed since 2007-01-08 · brand RILUTEK · ATC N07XX02 RILUZOLE · form Tablet · route Oral · ingredients RILUZOLE 50 MG · company Sanofi-aventis canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $7.3630 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=66576 · Verify on the e-Formulary ↗ (DIN 02242763)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02242763). DIN 02242763: Rilutek Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000417; group id 951; item number 2257; lccId None; manufacturer id SAC Source form: Tab; strength: 50mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $10.5500; ministry $7.3630 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02242763 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=66576
Interchangeable products
Apo-Riluzole · DIN 02352583 · $7.3630 Mylan-Riluzole · DIN 02390299 · $7.3630
Shortage status: resolved shortage (ended 2021-09-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02242763
Shortage record checked 2026-09-13T08:10:21.292534+00:00
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

TETRABENAZINE

· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 25mg · Tab

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · 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.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE RILUTEK (riluzole): ƒ may extend survival and/or time to tracheostomy in some patients with amyotrophic lateral sclerosis (ALS). There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. RILUTEK has not been shown to be effective in the late stage of ALS. Initially, RILUTEK should be prescribed only by physicians experienced in the diagnosis and management of ALS. If necessary, subsequent follow up and continuing treatment of the patient may be undertaken by non-specialized physicians, under the supervision of a specialist. The symptomatic management of patients with ALS is not changed by the addition of RILUTEK. Knowledge of the disease natural history and use of management strategies that assist the patient in coping with complications of the inevitable decline in motor power, such as non-invasine positive pressure ventilation (NIPPV), remain the most effective means to prolonging quality survival. Page 3 of 37 RILUTEK is not a cure for ALS, but a modest pro… https://pdf.hres.ca/dpd_pm/00010806.PDF PM date: May 11, 2010 Source product: RILUTEK; DIN 02242763; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
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 |
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.
Source; updated September 15, 2026

Riluzole (Rilutek)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 104

Riluzole Brand(s): Rilutek DOSAGE FORM/ STRENGTH: 50 mg tablet
Approvals will be provided for:
Patients who have probable or definite amyotrophic lateral sclerosis (ALS) as defined by World Federation of Neurology (WFN) criteria with onset within 5 years, who have a vital capacity of >60% predicted and do not have a tracheostomy.
Discontinuation Criteria:
Reimbursement will be discontinued if the patient progresses to require permanent assisted ventilation. This is defined as assisted ventilation required for 23 out of 24 hours for greater than or equal to 14 consecutive days.
Renewal Criteria:
Renewals will be considered in patients who do not meet the discontinuation criteria.
Approval period of initials and renewals: 12 months
104

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.