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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 Montelukast Brand(s): Singulair DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Updated criteria: October 28, 2010 For the treatment of asthma patients who cannot manage the use of an inhalation device despite assistance with a spacer (e.g. physically or mentally disabled patients or pediatric patients). Duration of Approval: 5 years OR For the treatment of asthma in children and adolescents whose asthma cannot be controlled on ICS alone and where the condition remains uncontrolled despite using full doses of ICS with addition of LABA, and with assurance of good adherence and inhaler technique Duration of Approval: 5 years (up until age of 18) Renewal of requests that meet the above criteria will be provided where the following apply: • Current medications and dosages must be clearly specified; AND Objective evidence of positive response from treatment (spirometry OR decrease in health care utilization) must be provided Duration of Approval: 5 years (up until age of 18) 65  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, 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 ↗)

Singulair · DIN 02238216 Manufacturer: Organon Canada Inc.; listing date 2012-01-19 Health Canada: Marketed since 2022-06-23 · brand SINGULAIR · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Organon canada inc. · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02238216). DIN 02238216: Singulair Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id OCI Source form: Chew Tab; strength: 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): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02238216 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=61609

Interchangeable products

Apo-Montelukast · DIN 02377616 · $1.2075 Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077 Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075 Jamp-Montelukast · DIN 02442361 · $1.2075 Mar-Montelukast · DIN 02399873 · $1.2075 Mint-Montelukast · DIN 02408635 · $1.2075 Montelukast · DIN 02379325 · $1.2075 Montelukast · DIN 02382466 · $1.2075 Nat-Montelukast · DIN 02522128 · $1.2077 PMS-Montelukast · DIN 02354985 · $1.2075 Ran-Montelukast · DIN 02402807 · $1.2075 Sandoz Montelukast · DIN 02330393 · $1.2075 Teva-Montelukast · DIN 02355515 · $1.2077

Shortage status: not checked (no credentials)