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ZOLEDRONIC ACID

All injection strengths: not a benefit

Other products in the same Health Canada class (M05B, M05BA) — coverage varies; not interchangeable

  • Alendronate (Fosamax): general benefit, Not a benefit
  • Risedronate (Actonel DR): general benefit, Not a benefit
  • Clodronate (Ostac): limited Use 280, 358, 359, Not a benefit
  • Etidronate (Didronel): limited Use 236, 237, Not a benefit
  • Pamidronate (Aredia): not a benefit
  • Alendronate + cholecalciferol (Fosavance): general benefit

1 more in the class list below

Zoledronic Acid-Z · DIN 02401606 · 4mg/5mL · injection solution-5mL Pk (Preservative-Free)

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
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
Brand vs generic price
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 ↗)
1 brand, same coverage
Zoledronic Acid-Z · DIN 02401606 Manufacturer: Sandoz Canada Inc.; listing date 2014-04-30 Health Canada: Marketed since 2014-01-15 · brand ZOLEDRONIC ACID - Z · ATC M05BA08 ZOLEDRONIC ACID · form Solution · route Intravenous · ingredients ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4 MG/5ML · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Zoledronic Acid-Z: Formulary list price $415.5600/unit (unit not stated in source; not the patient's cost)

Ministry pays: $415.5600 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88649 · Verify on the e-Formulary ↗ (DIN 02401606)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02401606). DIN 02401606: Zoledronic Acid-Z Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000575; group id 991; item number 2326; lccId None; manufacturer id SDZ 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): $415.5600; ministry $415.5600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02401606 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88649
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 Zometa Concentrate · DIN 02248296 · not recorded
Shortage status: To be discontinued; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02401606
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

RISEDRONATE SODIUM

· 23 products · General benefit (20), Listed, not a benefit (3) · strengths: 35mg, 5mg, 30mg, 150mg · DR Tab, Tab

CLODRONATE DISODIUM

· 2 products · Listed, not a benefit (1), Limited Use, codes 280, 358, 359 (1) · strengths: 400mg · Cap

ETIDRONATE DISODIUM

· 2 products · Listed, not a benefit (1), Limited Use, codes 236, 237 (1) · strengths: 200mg · Tab

PAMIDRONATE DISODIUM

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 3mg/mL, 6mg/mL, 9mg/mL · Inj Sol-10mL Vial

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

DENOSUMAB

· 8 products · Limited Use, codes 687, 688 (4), Limited Use, codes 686 (4) · strengths: 60mg/mL, 120mg/1.7mL · Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-Pref Syr, Inj Sol-Pref Syr (Preservative-Free), Inj Sol-Vial Pk, Inj Sol-Vial Pk (Preservative-Free)

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Tumour-Induced Hypercalcaemia (TIH) ZOMETA® (zoledronic acid for injection) is indicated for the treatment of Tumour-Induced Hypercalcaemia, defined as albumin-corrected serum calcium (cCa) ≥ 12.0 mg/dL (3.0 mmol/L), following adequate saline rehydration. Prior to treatment with ZOMETA, renal excretion of excess calcium should be promoted by restoring and maintaining adequate fluid balance and urine output. Bone Metastases of Solid Tumours and Osteolytic Lesions of Multiple Myeloma ZOMETA (zoledronic acid for injection) is indicated for the treatment of patients with documented bone metastases from solid tumours (including prostate cancer, breast cancer, lung cancer, renal cell carcinoma and other solid tumours) and patients with osteolytic lesions of multiple myeloma in conjunction with standard care in order to prevent or delay potential complications from the bone lesions (see WARNINGS AND PRECAUTIONS, Deterioration in renal function). ZOMETA must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. https://pdf.hres.ca/dpd_pm/00038968.PDF PM date: April 13, 2017 Source product: ZOMETA CONCENTRATE; DIN 02248296; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Zoledronic Acid-Z · DIN 02401606 Shortage status: To be discontinued; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02401606

Check this DIN again

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
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 |
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.
Source; updated September 15, 2026

Zoledronic Acid (Zometa Concentrate)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: 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

Ministry criteria corpus 2025-01-01; page 399

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

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Other review policies

For Zoledronic Acid-Z: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026