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Canadian Drug Review Reimbursement Decision


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  Aclasta
Generic Zoledronic acid
Company Novartis Pharmaceuticals Canada Inc.
Indication osteoporosis
Condition Musculoskeletal
Submission Type
Patient Population Zoledronic acid (marketed as Aclasta) has a Health Canada indication for: • Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures • Treatment to increase BMD in men with osteoporosis • Treatment and prevention of glucocorticoid-induced osteoporosis, to increase BMD Prevention of postmenopausal osteoporosis in women with osteopenia • Treatment of Paget’s disease. Zoledronic acid (Aclasta) is available as a 5 mg/100 mL solution for intravenous infusion. The dose recommended by Health Canada for treatment of postmenopausal osteoporosis is 5 mg by intravenous infusion once a year.
Status Complete
Date of Recommendation 2011-11-16
Recommendation Summary List with criteria/condition
Recommendation Notes This recommendation supersedes the CEDAC recommendation for this drug and indication dated June 25, 2008.
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that zoledronic acid be listed for women with postmenopausal osteoporosis who would otherwise be eligible for jurisdictional funding for oral bisphosphonates, but for whom oral bisphosphonates are contraindicated due to 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 1. There is insufficient evidence that zoledronic acid offers a therapeutic advantage over oral bisphosphonates, including alendronate. 2. The cost of zoledronic acid is approximately five times that of generic alendronate. 3. The Committee recognized that there may be a small proportion of women who are otherwise eligible for jurisdictional funding of oral bisphosphonates but who are unable to take oral bisphosphonates and who may benefit from annual intravenous (IV) bisphosphonate therapy.
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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