Treatment thresholds for osteoporosis and reimbursability criteria: perspectives associated with fracture risk-assessment tools.

The definition of osteoporosis was based for several years on bone mineral density values, which were used by most guidelines for defining treatment thresholds. The availability of tools for the estimation of fracture risk, such as FRAX™ or its adapted Italian version, DeFRA, is providing a way to grade osteoporosis severity. By applying these new tools, the criteria identified in Italy for treatment reimbursability (e.g., "Nota 79") are confirmed as extremely conservative. The new fracture risk-assessment tools provide continuous risk values that can be used by health authorities (or "payers") for identifying treatment thresholds. FRAX estimates the risk for "major osteoporotic fractures," which are not counted in registered fracture trials. Here, we elaborate an algorithm to convert vertebral and nonvertebral fractures to the "major fractures" of FRAX, and this allows a cost-effectiveness assessment for each drug.