Denosumab: a cost-effective alternative for older men with osteoporosis from a Swedish payer perspective.
OBJECTIVE
To assess the cost-effectiveness of denosumab versus other treatments in men with osteoporosis who are ≥75years old from a payer perspective in Sweden.


METHODS
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.


RESULTS
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%.


CONCLUSIONS
Denosumab dominated all comparators, including generic bisphosphonates, in the treatment of osteoporosis in men who were ≥75years old in Sweden.
OptumInsight, One Main Street, Cambridge, MA 02142, USA. Electronic address: anju.parthan@optum.com.
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Parthan
OptumInsight, One Main Street, Cambridge, MA 02142, USA. Electronic address: morgan.kruse@optum.com.
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Kruse
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: iagodoa@amgen.com.
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Agodoa
Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA. Electronic address: stuarts@slsdss.net.
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Silverman
Oregon Health & Science University, 3181 SW Sam Jackson Park Road, L607, Portland, OR 97239, USA. Electronic address: orwoll@ohsu.edu.
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Orwoll
D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D000069448:Denosumab; D004164:Diphosphonates / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007093:Imidazoles / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008390:Markov Chains; D010024:Osteoporosis / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D058866:Osteoporotic Fractures / Q000139:chemically induced / Q000453:epidemiology; D012307:Risk Factors; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome; D000077211:Zoledronic Acid
D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000069448:Denosumab; D000077211:Zoledronic Acid; D000077557:Ibandronic Acid
A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of DenosumAb 60mg every six months versus placebo in Males with Osteoporosis; ADAMO; BMD; Bone mineral density; Cost-effectiveness; DAPS; Denosumab; Denosumab Adherence Preference Satisfaction; EMA; EQ-5D; EuroQOL-5 Dimension; European Medical Agency; FIT; FREEDOM; Fracture; Fracture Intervention Trial; Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6Months; HALT; Hormone Ablation Bone Loss Trial; ICER; IV; Incremental cost-effectiveness ratio; Intravenous; LTC; LY; Life-year; Long-term care institution; MOP; Male osteoporosis; NICE; National Institute for Health and Care Excellence; PMO; PSA; Post-menopausal osteoporosis; Probabilistic sensitivity analysis; QALY; Quality-adjusted life-year; Sweden