Mickael Hiligsmann1, Stuart Silverman2, Andrea J Singer3, Leny Pearman4, jake Mathew4, Yamei Wang4, John Caminis4 and Jean-Yves Reginster5, 1Maastricht University, Maastricht, Netherlands, 2Cedar-Sinai Medical Center and UCLA School of Medicine, Los Angeles, CA, 3MedStar Georgetown University Hospital, Washington, DC, 4Radius Health, Inc., Waltham, MA, 5University of Liège, Liège, Belgium
Background/Purpose: Previous cost-effectiveness analyses in postmenopausal women (PmW) with osteoporosis (OP) demonstrated that sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) resulted in lower healthcare costs and more favorable outcomes than sequential treatment with teriparatide (TPTD) followed by ALN. ABL/ALN was also more cost-effective compared to ALN monotherapy in women aged ≥60. Recently, the ATOM study demonstrated that ABL significantly increased bone mineral density (BMD) at the lumbar spine and hip in men with osteoporosis similarly to those reported in PmW with OP from the ACTIVE study. Differences in the incidence and consequences of fractures between men and women potentially influences cost-effectiveness of treatment. This study assessed the cost-effectiveness of sequential ABL/ALN compared to alternative treatments in men at high risk of fractures in the United States (US).
Methods: A validated Markov microsimulation model was adapted to estimate the cost-effectiveness from a lifetime US payer perspective of sequential ABL/ALN in men aged 50-80 years old with a recent fracture and a BMD T-score ≤-2.5. Comparators were no treatment, sequential generic TPTD/ALN and generic ALN monotherapy. Patients were assumed to receive 18 months ABL or generic TPTD followed by 5 years ALN, or 5 years ALN monotherapy. Because of similar gains in BMD in men and women in the ACTIVE and ATOM trials, respectively, the effects of ABL/ALN on fracture risk were derived from the ACTIVExtend trial conducted in PmW with OP. The model also accounted for time-specific risk of subsequent fracture in patients with a recent fracture, incorporated incremental costs following fractures up to 5 years and used US male-specific data when available. To assess the increased relative risk of fractures due to low BMD, two scenarios were modelled using female and male standards for BMD T-scores, respectively.
Results: Sequential ABL/ALN was shown to be dominant (lower costs for more quality-adjusted life years (QALYs)) compared with sequential generic TPTD/ALN over the full age range. Sequential ABL/ALN was also cost-effective compared with no treatment, with cost per QALY gained lower than $100,000 from the age of 50 years, and below $50,000 in men aged ≥70 years. Using male standard for BMD T-score, the cost per QALY gained of sequential ABL/ALN compared to ALN monotherapy was between $155,000 and $165,000 in men aged 60 and 65 years, and below $150,000 in men aged ≥70 years. The cost-effectiveness of sequential ABL/ALN improved when using female standard for BMD T-scores with cost per QALY gained falling under $150,000 beginning at 60 years of age.
Conclusion: This study suggests that sequential ABL/ALN is cost-effective compared to generic TPTD/ALN and no treatment in US men aged ≥50 years at high risk of fractures. It suggests that sequential ABL/ALN is cost-effective (at a threshold of $150,000) compared to generic ALN monotherapy in men aged ≥60 years using female standard for BMD T-scores, as currently recommended and implemented in clinical practice. In addition, the results suggest similar cost-effectiveness of sequential ABL/ALN in both men and women in the US.
Disclosures: M. Hiligsmann, Radius Health; S. Silverman, Radius Health; A. Singer, Radius Health, UCB Pharma, AgNovos, Amgen; L. Pearman, Radius Health; j. Mathew, Radius Health; Y. Wang, Radius Health; J. Caminis, Radius Health; J. Reginster, ISBA Pharma, Mylan, Radius Health, Pierre Fabre, Faes Farma, Rejuvenate Biomed, Samumad, Teva, Theramex, Pfizer Inc., Mithra Pharmaceuticals, Cniel, Dairy Research Council, Nutricia, Danone, Agnovos, TRB Pharma.
