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Reason for Use code 535 As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) meeting ALL the following criteria: -Recent neurological examination consistent with the diagnosis of RRMS; AND -Lesions typical of multiple sclerosis on brain magnetic resonance imaging (MRI); AND -Experienced at least 2 clinical attacks in their lifetime with one attack occurring within the prior year; AND -EDSS score less than or equal to 6.0 prior to start of treatment; AND -Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis. Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy. Coverage limit: LU Authorization Period: 1 year Reason for Use code 536 As monotherapy for the treatment of patients who have experienced a single demyelinating event/ Clinically Isolated Syndrome (CIS) meeting ALL the following criteria: - CIS occurred within the prior 12 months; AND - Recent neurological examination; AND - Lesions typical of CIS confirmed on brain magnetic resonance imaging (MRI); AND - EDSS score less than or equal to 6.0 prior to start of treatment; AND - Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy. Coverage limit: LU Authorization Period: 1 year Reason for Use code 537 Renewal of therapy for patients diagnosed with relapsing remitting multiple sclerosis (RRMS) or a single demyelinating event /Clinically Isolated Syndrome (CIS) who meet ALL the following criteria: - Used as monotherapy for the treatment of RRMS or CIS; AND - EDSS score less than or equal to 6.0; AND - Disease activity is stabilized as determined by a neurological exam and the number of clinical relapses experienced while on treatment; AND - Prescribed by a neurologist experienced in the treatment of Multiple Sclerosis (MS) OR a prescriber in consultation with a neurologist overseeing the patient's MS. Coverage limit: LU Authorization Period: 1 year 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 Glatiramer acetate – See Formulary listing for Glatect Brand(s): Copaxone, Glatect (available as Limited Use drug on ODB formulary) DOSAGE FORM/ STRENGTH: 20 mg/mL pre-filled syringe for subcutaneous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 226, record 133, 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 Glatiramer acetate (Coverage is provided for Glatect) Brand(s): Glatect; Copaxone will only be funded for patients who meet a medical exemption as of December 29, 2023 (Refer to the Biosimilar policy) DOSAGE FORM/ STRENGTH: 20 mg/mL pre-filled syringe for subcutaneous injection Interferon beta-1a Brand(s): Avonex PS, Avonex Pen DOSAGE FORM/ STRENGTH: 30 mcg/0.5mL prefilled syringe for intramuscular injection, 30 mcg single-use prefilled autoinjector Brand(s): Rebif DOSAGE FORM/ STRENGTH: 22 mcg and 44 mcg prefilled syringe for subcutaneous injection, 66 mcg/ml and 132 mcg/ml pre-filled cartridge Interferon beta-1b Brand(s): Betaseron DOSAGE FORM/ STRENGTH: 0.3 mg/vial subcutaneous injection Brand(s): Extavia DOSAGE FORM/ STRENGTH: 0.3 mg/vial subcutaneous injection For the treatment of Clinically Isolated Syndrome (CIS): requests for patients who have experienced a single demyelinating event will be reviewed by external medical experts when the following information is provided: • Date and details of the most recent neurological examination which must have been conducted within the last ninety days of the request; • The patient’s EDSS is less than or equal to 6.0 (please provide EDSS score); AND • The patient’s clinically isolated syndrome occurred within the last twelve months. Duration of Approval: 1 year Renewal requests will be assessed according to the following criteria: • the requesting physician provides the date and details of the patient’s most recent neurological examination and EDSS scores; • the patient’s neurological examination occurred within that last ninety days; • the patient is stable (i.e. no relapses or attacks during the last year) and • the patient’s EDSS is less than or equal to 6.0 242 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 242, record 143, corpus 2025-01-01; name match only, not an eligibility decision

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 ↗)

Glatect · DIN 02460661 Manufacturer: Pharmascience Inc.; listing date 2018-09-27 Health Canada: Marketed since 2017-08-21 · brand GLATECT · ATC L03AX13 GLATIRAMER ACETATE · form Solution · route Subcutaneous · ingredients GLATIRAMER ACETATE 20 MG/ML · company Pharmascience inc · schedule Prescription

DIN 02460661: Glatect Raw flags: sec12=Y, sec3=Y Item: 922000001; group id 992; item number 2327; lccId 00309; manufacturer id PMS Source form: Inj Sol-Pref Syr 1mL Pk; strength: 20mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $35.8400; ministry $35.8400 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02460661 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94809

Shortage status: not checked (no credentials)