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Canadian Drug Review Reimbursement Decision

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Generic Denosumab
Company Amgen Canada Inc.
Indication osteoporosis
Condition Musculoskeletal
Submission Type
Patient Population Denosumab is indicated by Health Canada for the treatment of postmenopausal women at high risk for osteoporotic (fragility) 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. Denosumab is a fully human monoclonal antibody that inhibits osteoclast-mediated bone resorption. Health Canada recommends that denosumab be administered as a single subcutaneous (SC) injection of 60 mg once every six months. Denosumab 60 mg/mL solution for injection is available as a 1.0 mL single use vial and a 1.0 mL prefilled syringe.
Status Complete
Date of Recommendation 2011-03-30
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that denosumab be listed for women with postmenopausal osteoporosis who would otherwise be eligible for jurisdictional funding for oral bisphosphonates, but for whom bisphosphonates are contraindicated due to hypersensitivity or abnormalities of the esophagus (e.g., esophageal stricture or achalasia), and have at least two of the following: • age >75 years • a prior fragility fracture • a bone mineral density (BMD) T-score ≤ -2.5.
Reason for Recommendation In one double-blind randomized controlled trial comparing denosumab with placebo in postmenopausal women with low BMD T-scores, denosumab achieved a statistically significantly greater reduction in the incidence of new vertebral and hip fractures, in both the total patient population and a predefined high risk subgroup. A cost-utility analysis based on the high risk subgroup resulted in a cost per quality-adjusted life-year (QALY) of $29,000 for denosumab compared with no treatment. The cost per QALY was higher when the total patient population was considered. Of Note: The Committee considered the clinical basis for the manufacturer’s economic evaluation of denosumab compared with raloxifene, but had concerns regarding the comparability of the patient populations in the clinical trials that were used to inform the economic evaluation.
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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