Product Details

Prolia

Denosumab
60 mg/mL
Solution for Subcutaneous Injection
1-mL Single-Use Prefilled Syringe (Preservative-Free)

DIN/PIN/NPN

02343541

Manufacturer

Amgen Canada Inc.

Formulary Listing Date

2026-08-31

Unit Price

440.1000

Amount MOH Pays

440.1000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:00:00 Unclassified Therapeutic Agents

Therapeutic Note

NO

ATC Code

M05BX04

Interchangeable Products

NO

LU Clinical Criteria

NO

Requirements

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Oncology – Supportive Management	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: 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. ¹Progressive 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. ²Note: 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 EAP Drug Request Form: Standard Form for EAP Drug Requests
Unclassified EAP Drugs	These drugs are not currently listed in the Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs – January 1, 2025 Edition Physicians may wish to contact the EAP directly by phone at 416-327-8109 or 1-866-811-9893 or by email at EAPFeedback.MOH@ontario.ca to see if an unlisted drug product and/or indication may be considered for EAP funding.

Product Monograph