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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

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 ↗)

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 ↗)

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

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