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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 Zoledronic Acid Brand(s): Zometa Concentrate DOSAGE FORM/ STRENGTH: 4 mg/ 5 mL Vial Zoledronic acid as Zometa Concentrate will only be considered for the treatment of bony metastases in those with hormone refractory prostate cancer as well as other cancers through the Exceptional Access Program (EAP) in those receiving outpatient care who cannot obtain Zometa through the Systemic Treatment-Quality Based Procedure (STQBP). Zometa is considered through STQBP CCO for those receiving prostate cancer treatment from a cancer clinic. https://www.cancercareontario.ca/en/cancer-treatments/chemotherapy/funding- reimbursement/systemic-treatment-quality-based-procedure Duration of Approval: 6 Months For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease1, despite castrate serum testosterone levels (<50 ng/dL). 1Progressive bony disease should be demonstrated by: progressive changes in radionucleotide bone scan or clinical signs of disease progression (e.g., via radionucleotide scanning, pathologic fracture or increasing bone pain). Requests for patients who have undergone orchidectomy do not need to provide a serum testosterone level. • For the prevention of skeletal related events in patients who have not experienced previous skeletal related events2 and who have bony metastases secondary to: • Solid tumours (e.g. renal, small cell lung, pancreatic cancers) who have good performance status 3 OR • Breast cancer or multiple myeloma who are intolerant to pamidronate. • 2 A skeletal related event is defined as: pathologic fracture, spinal cord compression, radiation therapy to bone or surgery to bone. • 3 Good performance status is defined as patients that are ambulatory, capable of self care and up and about more than 50 per cent of waking hours. • For the treatment of patients with symptoms due to bony metastases secondary to breast cancer or multiple myeloma who have failed or are intolerant to pamidronate. • Consideration for patients who are symptomatic due to bony metastases secondary to other types of solid tumours or cancers will be considered on a case-by-case basis. The physician is asked to include information describing the patient’s bone pain and use of other therapies including the use of bisphosphonates. The use of other non- pharmacologic treatment modalities such as surgery or radiation that have been tried should be provided in the request. 399 Zoledronic Acid Brand(s): Zometa Concentrate DOSAGE FORM/ STRENGTH: 4 mg/ 5 mL Vial Duration of Approval: 6 Months Renewals will be considered for patients who are responding to therapy and is still deemed to require treatment. Duration of Approval: 6 Months 400  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 399, record 228, 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 ↗)

Zometa Concentrate · DIN 02248296 Manufacturer: Novartis Pharma Canada Inc.; listing date 2014-04-30 Health Canada: Marketed since 2004-10-14 · brand ZOMETA CONCENTRATE · ATC M05BA08 ZOLEDRONIC ACID · form Solution · route Intravenous · ingredients ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG/5ML · company Novartis pharmaceuticals canada inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02248296). DIN 02248296: Zometa Concentrate Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000575; group id 991; item number 2326; lccId None; manufacturer id NOV Source form: Inj Sol-5mL Pk (Preservative-Free); strength: 4mg/5mL 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=02248296 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=72636

Interchangeable products

Jamp-Zoledronic Acid · DIN 02482525 · $415.5600 Taro-Zoledronic Acid Concentrate · DIN 02415186 · $415.5600 Zoledronic Acid for Inj. Concentrate · DIN 02413701 · $415.0000 Zoledronic Acid for Inj. Concentrate · DIN 02422425 · $415.5600 Zoledronic Acid for Injection · DIN 02407639 · $415.5600 Zoledronic Acid for Injection · DIN 02434458 · $415.5600 Zoledronic Acid for Injection · DIN 02444739 · $415.5600 Zoledronic Acid for Injection · DIN 02472805 · $415.5600 Zoledronic Acid-Z · DIN 02401606 · $415.5600

Shortage status: not checked (no credentials)