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Reason for Use code 676 For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria: - 65 years of age or older; AND - Has a documented bone mineral density [BMD] T-score of less than or equal to -3; AND - Has a history of prior fragility fracture(s); AND - Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture. Note: The maximum lifetime exposure to teriparatide for an individual patient is 24 months Coverage limit: LU Authorization Period: 2 years 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 Teriparatide Brand(s): Forteo and generics DOSAGE FORM/ STRENGTH: Please refer to the ODB Formulary for a list of funded products Effective with the May 31, 2024 Ontario Drug Benefit Formulary/ Comparative Drug Index update, Teriparatide as Forteo has transitioned to the ODB formulary with its generic versions. Also, please note that the Teriparatide biosimilar (Osnuvo) is also publicly funded as a limited use benefit on the Ontario Drug Benefit formulary effective on September 29, 2022. Refer to the ODB formulary for the Limited Use Criteria for all teriparatide products. 401 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 401, record 230, 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 ↗)

Teva-Teriparatide Injection · DIN 02486423 Manufacturer: Teva Canada Limited; listing date 2020-07-31 Health Canada: Marketed since 2020-07-08 · brand TEVA-TERIPARATIDE INJECTION · ATC H05AA02 TERIPARATIDE · form Solution · route Subcutaneous · ingredients TERIPARATIDE (TERIPARATIDE ACETATE) 250 MCG/ML · company Teva canada limited · schedule Prescription

DIN 02486423: Teva-Teriparatide Injection Raw flags: sec12=Y, sec3=Y Item: 682400014; group id 788; item number 1918; lccId 00392; manufacturer id TEV Source form: Inj Sol-2.4mL Pref Pen; strength: 250mcg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $535.4700; ministry $535.4700 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02486423 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97663

Interchangeable products

Apo-Teriparatide Injection · DIN 02498804 · $535.4700 Forteo · DIN 09857535 · $535.4700

Shortage status: resolved shortage (ended 2026-02-25); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02486423

Shortage record checked 2026-09-13T08:10:21.292534+00:00