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Reason for Use code 319 For the treatment of Paget's disease. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 436 For the treatment of osteoporosis in postmenopausal females who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where a patient's 10-year fracture risk based on the CAROC or FRAX tool, is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 523 For the treatment of osteoporosis in males who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where the patient's 10-year fracture risk is below 10% based on the CAROC or FRAX tool, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors. Coverage limit: LU Authorization Period: Indefinite Coverage limit: In all cases, patients receiving Aclasta should not be receiving concomitant bisphosphonate therapy. The recommended dose of Aclasta (zoledronic acid) is a single IV injection of 5mg, once yearly. Exceptional Access criteria on record are for Brand(s): Zometa Concentrate; DOSAGE FORM/ STRENGTH: 4 mg/ 5 mL Vial — not this product; no criteria on record for this product in this block. 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

Zoledronic Acid Injection · DIN 02422433 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2014-09-25 Health Canada: Marketed since 2014-05-28 · brand ZOLEDRONIC ACID INJECTION · ATC M05BA08 ZOLEDRONIC ACID · form Solution · route Intravenous · ingredients ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5 MG/100ML · company Dr reddy's laboratories ltd · schedule Prescription

DIN 02422433: Zoledronic Acid Injection Raw flags: sec12=Y, sec3=Y Item: 920000536; group id 990; item number 2325; lccId 00195; manufacturer id DRR Source form: Inj Sol-100mL Pk (Preservative-Free); strength: 5mg/100mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $391.6110; ministry $391.6110 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02422433 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90712

Interchangeable products

Aclasta · DIN 02269198 · $391.6110

Shortage status: not checked (no credentials)