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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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DENOSUMAB

All injection strengths: Limited Use (codes 687, 688)

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

  • Alendronate (Fosamax): general benefit, Not a benefit
  • Alendronate + cholecalciferol (Fosavance): general 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
  • Zoledronic acid (Aclasta): limited Use 319, 436, 523, Not a benefit

1 more in the class list below

Stoboclo · DIN 02560917 · 60mg/mL · injection solution-1.0mL pre-filled syringe Pk (Preservative-Free)

Limited Use — Reason for Use code 687, 688 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 687, 688 required
Write on scriptLU code 687, 688 (patient must meet the criteria below)
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

Ontario Limited Use criteria — code 687, 688
Reason for Use code 687 To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 688 To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision
No interchangeable product listed in the Ontario extract
Stoboclo · DIN 02560917 Manufacturer: Celltrion Inc.; listing date 2025-11-28 Health Canada: Marketed since 2025-10-30 · brand STOBOCLO · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 60 MG/ML · company Celltrion inc. · schedule Schedule d, Prescription
Check this DIN again · Health Canada product record

Stoboclo: Formulary list price $194.7000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $194.7000 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=106393 · Verify on the e-Formulary ↗ (DIN 02560917)

Source record
DIN 02560917: Stoboclo Raw flags: sec12=Y, sec3=Y Item: 920000804; group id 909; item number 2176; lccId 00397; manufacturer id CEI Source form: Inj Sol-1.0mL Pref Syr Pk (Preservative-Free); strength: 60mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $194.7000; ministry $194.7000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02560917 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106393
Shortage status: not checked (no credentials)
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

ALENDRONATE & CHOLECALCIFEROL

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

ZOLEDRONIC ACID

· 12 products · Limited Use, codes 319, 436, 523 (2), Off-Formulary Interchangeable, not an ODB benefit (10) · strengths: 5mg/100mL, 4mg/5mL · Inj Sol-100mL Pk (Preservative-Free), Inj Sol-5mL Pk (Preservative-Free)

PAMIDRONATE DISODIUM

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

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
1 INDICATIONS Indications have been granted on the basis of similarity between JUBBONTI and the reference biologic drug PROLIA®. JUBBONTI (denosumab injection) is indicated: • Postmenopausal Osteoporosis for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, JUBBONTI reduces the incidence of vertebral, nonvertebral and hip fractures (see 14 CLINICAL TRIALS). • Treatment to Increase Bone Mass in Men with Osteoporosis at High Risk for Fracture as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis the rapy (see 14 CLINICAL TRIALS). • Treatment to Increase Bone Mass in Men with Nonmetastatic Prostate Cancer receiving Androgen Deprivation Therapy (ADT), who are at high risk for fracture as a trea… https://pdf.hres.ca/dpd_pm/00074781.PDF PM date: FEB 16, 2024 Source product: JUBBONTI; DIN 02545411; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

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

Denosumab (Xgeva)

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 in patients with hormone refractory prostate cancer.

Ministry criteria corpus 2025-01-01; page 392

Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024
Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption.
For the treatment of bony metastases in patients with hormone refractory prostate cancer.
Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic.
Hormone refractory prostate cancer is determined using the following criteria:
i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone
scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum
testosterone level in the request submission.
Approved Dosing. 120 mg subcutaneously every four (4) weeks
Duration of Approval: 1 Year
Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment.
Duration of Approval: 1 Year
392

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