The Canadian Agency for Drugs and Technologies in Health (CADTH) has received a request for advice for denosumab (Prolia®). The request for advice comes from their participating drug plans, and can result in a revised Canadian Drug Expert Committee (CDEC) recommendation or a CDEC Record of Advice.
CADTH is interested in learning:
- How should fracture risk be best described?
- Is there a place for age (>75 years) or bone density scores, or are these adequately captured within fracture risk?
- How should bisphosphonate failure be best described?
- How should bisphosphonate intolerance be best described?
Advice is sought regarding the alignment of the CDEC recommendations for women (2011) and for men (2015).
In 2011, CDEC recommended 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.
In 2015, CDEC recommended that denosumab also be listed to increase bone mass in men with osteoporosis who are at a high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy, with a condition of a reduced price and if the following clinical criteria are met:
- High fracture risk defined as either: a moderate 10 year fracture risk (10% to 20%) with a prior fragility fracture; or a high 10 year fracture risk (?20%) as defined by either the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the World Health Organization’s Fracture Risk Assessment (FRAX) tool.
- Contraindication to oral bisphosphonates
Please email your input to email@example.com by Friday, December 11, 2015.