Denosumab (Prolia) Common Drug Review Request for Advice /

The CADTH Common Drug Review (CDR)-participating drug plans are requesting advice with respect to the alignment of the recommendations issued for the postmenopausal osteoporosis indication in women with the osteoporosis indication in men, particularly with regard to: Request for Advice Questions the age criterion for women the context in regard to defining bisphosphonate failure; and the usa [...] This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] October 2016 CDR REQUEST FOR ADVICE FOR PROLIA 3. CDR APPROACH TO THE REQUEST FOR ADVICE In order to address the RFA questions, the CDR review team updated the systematic review in the clinical report for the postmenopausal osteoporosis indication to include clinical data published since the original review in 2011, and similarly updated the review for the indication in men from September 2015, wi [...] The evidence presented above supports the removal of the clinical criterion of age in the recommendation for the reimbursement of denosumab in postmenopausal women with osteoporosis. [...] The Osteoporosis Canada 2010 guidelines signified a paradigm shift in the prevention and treatment of osteoporotic fractures, moving the focus from treating low BMD to better identifying the risk of fragility fractures in patients.7 Two tools are available in Canada for estimating the 10-year risk of a major osteoporotic fracture:7 the updated tool of the CAROC the FRAX tool of the World Healt