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Canadian Drug Review Reimbursement Decision


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  XGEVA
Generic denosumab
Company Amgen Canada Inc.
Indication prostate cancer
Condition Musculoskeletal
Submission Type
Patient Population Xgeva has a Health Canada indication for reducing the risk of developing SREs in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. It is available as a 120 mg single use, subcutaneous injection and the Health Canada recommended dose is 120 mg every four weeks.
Status Complete
Date of Recommendation 2011-11-16
Recommendation Summary List with criteria/condition
Recommendation Notes This document was originally issued on November 16, 2011. It was corrected on December 5, 2011. First on-study SRE results were clarified in the first bullet, under the heading "Efficacy" on page 3.
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that denosumab be listed for the prevention of skeletal-related events (SREs) in patients with castrate-resistant prostate cancer (CRPC) with one or more documented bony metastases and good performance status (ECOG performance status score of 0, 1, or 2), in jurisdictions that list zoledronic acid for the same indication.
Reason for Recommendation In three double-blind randomized controlled trials (RCTs) in patients with bony metastases secondary to solid tumours, denosumab was superior (study 103 and study 136) or noninferior (study 244) to zoledronic acid for outcomes related to SREs (composite of fracture, spinal cord compression, and the need for surgery or radiation therapy of symptomatic bone metastases). 2. Based on the manufacturer’s cost-utility analysis, denosumab is cost effective in comparison with zoledronic acid in CRPC, resulting in lower incremental costs and greater incremental quality-adjusted life-years (QALYs). The cost-effectiveness of denosumab in other solid tumours is not known. 3. The incremental cost per QALY for denosumab compared with no treatment in CRPC is $111,000.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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