Denosumab: a cost-effective alternative for older men with osteoporosis from a Swedish payer perspective.

To assess the cost-effectiveness of denosumab versus other treatments in men with osteoporosis who are ≥75years old from a payer perspective in Sweden. A lifetime cohort Markov model was developed with seven health states: well, hip fracture, vertebral fracture, other osteoporotic fracture, post-hip fracture, post-vertebral fracture, and dead. During each cycle, patients could have a fracture, remain healthy, remain in a post-fracture state or die. Background fracture risks, mortality rates, persistence rates, utilities, medical and drug costs were derived using published sources. Estimates of fracture efficacy were drawn from available studies in post-menopausal osteoporotic (PMO) women as BMD improvements have been shown to be similar across male osteoporosis (MOP) and PMO populations, and a recent clinical trial suggested that the fracture risk reduction from bisphosphonate therapy in men is similar to that seen in women in comparable studies. Lifetime expected costs and quality-adjusted life-years (QALYs) were estimated for denosumab, generic alendronate, generic risedronate, ibandronate, zoledronate, strontium ranelate and teriparatide. On average, patients in the model were 78years old, with bone mineral density T-score at the femoral neck of -2.12. Prevalent vertebral fractures were present in 23% of patients. In the base-case, the model assumed that patients would experience treatment-related effects up to 2years after discontinuation. Costs and QALYs were discounted at 3% annually. Extensive sensitivity analyses were conducted. Total lifetime costs for denosumab, alendronate, strontium ranelate, zoledronate, risedronate, ibandronate and teriparatide were €31,004, €33,731, €34,788, €34,796, €34,826, €35,983 and €37,461, respectively. Total QALYs were 5.23, 5.15, 5.15, 5.17, 5.13, 5.12 and 5.22, respectively. Compared to other treatments, denosumab had the lowest costs and highest QALYs. In the one-way sensitivity analyses, when compared to alendronate (next least expensive strategy), the ICER for denosumab was most sensitive to the relative risk of hip fracture on denosumab. The probability of denosumab being cost-effective compared to the other treatments at a threshold of €66,000/QALY was 96.1%. Denosumab dominated all comparators, including generic bisphosphonates, in the treatment of osteoporosis in men who were ≥75years old in Sweden.

Parthan A ，Kruse M ，Agodoa I ，Silverman S ，Orwoll E ... -  《-》

Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US.

Parthan A ，Kruse M ，Yurgin N ，Huang J ，Viswanathan HN ，Taylor D ... -  《-》

Cost-effectiveness of denosumab in the treatment of postmenopausal osteoporosis in Canada.

Chau D ，Becker DL ，Coombes ME ，Ioannidis G ，Adachi JD ，Goeree R ... -  《-》

Cost effectiveness of denosumab compared with oral bisphosphonates in the treatment of post-menopausal osteoporotic women in Belgium.

Hiligsmann M ，Reginster JY 《-》

Potential cost-effectiveness of denosumab for the treatment of postmenopausal osteoporotic women.

Denosumab has recently been shown to be safe and to significantly reduce the risk of vertebral, hip and non-vertebral fractures in the "Fracture REduction Evaluation of Denosumab in Osteoporosis every 6Months" (FREEDOM) Trial. Besides the clinical profile of a new drug, it becomes increasingly important to assess whether the drug represents good value for money. This study aims to examine the potential cost-effectiveness of denosumab in the treatment of postmenopausal osteoporotic women. An updated version of a validated Markov microsimulation model was used to estimate the cost (euro2009) per quality-adjusted life-year (QALY) gained of a 3-year denosumab treatment compared with no treatment. The model was populated with cost and epidemiological data for Belgium from a health-care perspective and the base-case population was defined from the FREEDOM Trial. The effect of denosumab after treatment cessation was conservatively assumed to decline linearly over 1year. Uncertainty was investigated using one-way and probabilistic sensitivity analyses. In particular, additional analyses were performed in populations (over 60 years) where osteoporosis medications are currently reimbursed in many European countries, i.e. with bone mineral density (BMD) T-score < or = -2.5 or prevalent vertebral fracture. In the base-case analysis, the cost per QALY gained of denosumab compared with no treatment was estimated at euro28,441. This value decreased to euro15,532 and to euro11,603 for women with a BMD T-score of -2.5 or prevalent vertebral fracture, respectively. Additional analyses showed that the cost-effectiveness of denosumab fall below commonly accepted threshold of euro 30,000per QALY gained for women with a BMD T-score < or = -2.5 or prevalent vertebral fracture, over the entire age range examined (60-80 years). The results were robust under a wide range of plausible assumptions. In conclusion, this study suggests, on the basis of currently available data, that denosumab is cost-effective compared with no treatment for postmenopausal Belgian women with low bone mass and who are similar to patients included in the FREEDOM Trial. In addition, denosumab was found to be cost-effective in population currently reimbursed in Europe with T-score < or = -2.5 or prevalent vertebral fracture, aged 60 years and above. Additional data are needed on the relative cost-effectiveness compared with other anti-osteoporotic agents and on the long-term safety of denosumab.

Hiligsmann M ，Reginster JY 《-》