[en] [en] BACKGROUND: Osteoporotic-related fractures represent an increasing burden to patients, health care systems and society.
AIMS: This study estimated cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) compared to relevant alternative strategies in US men and women aged 50 to 80 years at very high fracture risk (bone mineral density T-score ≤ - 2.5 and a recent fracture).
METHODS: A lifetime Markov-based microsimulation model was used to estimate healthcare costs and quality-adjusted life years (QALYs). Comparators were sequential treatment with unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Analyses were conducted based on initial fracture site (hip, vertebral, or any fracture) and treatment efficacy data (derived from clinical trials or a recent network meta-analysis).
RESULTS: From all analyses completed, sequential ABL/ALN demonstrated more QALYs for lower healthcare costs versus unbranded TPTD/ALN. No treatment was dominated (higher costs for less QALYs) versus ALN monotherapy. Sequential ABL/ALN resulted in favorable cost-effectiveness (at US threshold of $150,000/QALY) versus generic ALN monotherapy in men aged ≥ 50 years with any fracture type, women aged ≥ 65 years with any fracture type, and women aged ≥ 55 years having a hip or vertebral fracture.
DISCUSSION: Similar cost-effectiveness of sequential ABL/ALN versus unbranded TPTD/ALN, ALN monotherapy, and no treatment was observed in both US men and women at very high fracture risk, with a moderate improvement in cost-effectiveness in men versus women and in patients with a hip or vertebral fracture.
CONCLUSIONS: Sequential therapy with ABL/ALN was cost-effective in US men and women at very high risk of fractures.
Disciplines :
Public health, health care sciences & services
Author, co-author :
Hiligsmann, Mickaël ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé ; Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. m.hiligsmann@maastrichtuniversity.nl
Silverman, Stuart L ; Cedars-Sinai Medical Center, Los Angeles and the OMC Clinical Research Center, Beverly Hills, CA, USA
Singer, Andrea J ; MedStar Georgetown University Hospital and Georgetown University Medical Center, Washington, DC, USA
Pearman, Leny ; Radius Health, Inc., Boston, MA, USA
Wang, Yamei ; Radius Health, Inc., Boston, MA, USA
Caminis, John ; Radius Health, Inc., Boston, MA, USA
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique ; World Health Organization Collaborating Center for Epidemiology of Musculoskeletal Health and Aging, Liège, Belgium
Language :
English
Title :
Comparison of the cost-effectiveness of sequential treatment with abaloparatide in US men and women at very high risk of fractures.
Publication date :
30 January 2024
Journal title :
Aging Clinical and Experimental Research
ISSN :
1594-0667
eISSN :
1720-8319
Publisher :
Springer Science and Business Media Deutschland GmbH, Germany
All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. The sponsor, Radius Health, Inc., was involved in the design of the study, review of the protocol, and review and author approval of the manuscript. The sponsor had no role in the final selection of data and assumptions, execution and analysis of the model, and the interpretation of the results. Medical editorial support and graphic services were provided by AOIC, LLC and were funded by Radius. Artificial intelligence (AI) technologies such as Language Learning Models, chatbots, and image creators were not used in the production of this work.
National Osteoporosis Foundation (2011) The man’s guide to osteoporosis. Bone Health and Osteoporosis Foundation. https://www.bonehealthandosteoporosis.org/wp-content/uploads/2016/02/Mans-Guide-to-Osteoporosis.pdf. Accessed 5 Oct 2023.
Office of the Surgeon General (US) (2004) Bone health and osteoporosis: a report of the surgeon general. Office of the Surgeon General (US), Rockville (MD). http://www.ncbi.nlm.nih.gov/books/NBK45513/. Accessed 16 Aug 2023.
Hansen D, Pelizzari PM, Pyenson BS (2021) Medicare cost of osteoporotic fractures: 2021 updated report. https://www.milliman.com/en/insight/medicare-cost-of-osteoporotic-fractures-2021-updated-report. Accessed 1 Oct 2023.
Kanis JA, Norton N, Harvey NC et al (2021) SCOPE 2021: a new scorecard for osteoporosis in Europe. Arch Osteoporos 16:82. 10.1007/s11657-020-00871-9 DOI: 10.1007/s11657-020-00871-9
Soreskog E, Strom O, Spangeus A et al (2020) Risk of major osteoporotic fracture after first, second and third fracture in Swedish women aged 50 years and older. Bone 134:115286. 10.1016/j.bone.2020.115286 DOI: 10.1016/j.bone.2020.115286
Camacho PM, Petak SM, Binkley N et al (2020) American association of clinical endocrinologists/American college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update. Endocr Pract 26:1–46. 10.4158/gl-2020-0524suppl DOI: 10.4158/gl-2020-0524suppl
Eastell R, Rosen CJ, Black DM et al (2019) Pharmacological management of osteoporosis in postmenopausal women: an endocrine society* clinical practice guideline. J Clin Endocrinol Metab 104:1595–1622. 10.1210/jc.2019-00221 DOI: 10.1210/jc.2019-00221
Curtis EM, Reginster J-Y, Al-Daghri N et al (2022) Management of patients at very high risk of osteoporotic fractures through sequential treatments. Aging Clin Exp Res 34:695–714. 10.1007/s40520-022-02100-4 DOI: 10.1007/s40520-022-02100-4
Kim SC, Kim MS, Sanfelix-Gimeno G et al (2015) Use of osteoporosis medications after hospitalization for hip fracture: a cross-national study. Am J Med 128:519–26 e1. 10.1016/j.amjmed.2015.01.014 DOI: 10.1016/j.amjmed.2015.01.014
Bone HG, Cosman F, Miller PD et al (2018) ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis. J Clin Endocrinol Metab 103:2949–2957. 10.1210/jc.2018-00163 DOI: 10.1210/jc.2018-00163
Yang D, Tan J, Long Y et al (2023) Sequential treatment of teriparatide and alendronate versus alendronate alone for elevation of bone mineral density and prevention of refracture after percutaneous vertebroplasty in osteoporosis: a prospective study. Aging Clin Exp Res 35:531–539. 10.1007/s40520-023-02342-w DOI: 10.1007/s40520-023-02342-w
Hiligsmann M, Silverman SS, Singer AJ et al (2023) Cost-effectiveness of sequential abaloparatide/alendronate in men at high risk of fractures in the United States. Pharmacoeconomics 41:819–830. 10.1007/s40273-023-01270-x DOI: 10.1007/s40273-023-01270-x
Yu G, Tong S, Liu J et al (2023) A systematic review of cost-effectiveness analyses of sequential treatment for osteoporosis. Osteoporos Int 34:641–658. 10.1007/s00198-022-06626-1 DOI: 10.1007/s00198-022-06626-1
Li N, Beaudart C, Cauley JA et al (2023) Cost effectiveness analyses of interventions for osteoporosis in men: a systematic literature review. Pharmacoeconomics 41:363–391. 10.1007/s40273-022-01239-2 DOI: 10.1007/s40273-022-01239-2
Hiligsmann M, Williams SA, Fitzpatrick LA et al (2019) Cost-effectiveness of sequential treatment with abaloparatide vs. teriparatide for United States women at increased risk of fracture. Semin Arthritis Rheum 49:184–196. 10.1016/j.semarthrit.2019.01.006 DOI: 10.1016/j.semarthrit.2019.01.006
Hiligsmann M, Williams SA, Fitzpatrick LA et al (2020) Cost-effectiveness of sequential treatment with abaloparatide followed by alendronate vs. alendronate monotherapy in women at increased risk of fracture: a US payer perspective. Semin Arthritis Rheum 50:394–400. 10.1016/j.semarthrit.2020.02.004 DOI: 10.1016/j.semarthrit.2020.02.004
Hiligsmann M, Boonen A, Rabenda V et al (2012) The importance of integrating medication adherence into pharmacoeconomic analyses: the example of osteoporosis. Expert Rev Pharmacoecon Outcomes Res 12:159–166. 10.1586/erp.12.8 DOI: 10.1586/erp.12.8
AMCP (2023) AMCP Format for formulary submissions—guidance on submission of pre-approval and post-approval clinical and economic information and evidence, version 4.1. AMCP. https://www.amcp.org/Resource-Center/format-formulary-submissions/AMCP-Format-for-Formulary-Submissions-4.1. Accessed 16 Aug 2023.
Ettinger B, Black DM, Dawson-Hughes B et al (2010) Updated fracture incidence rates for the US version of FRAX. Osteoporos Int 21:25–33. 10.1007/s00198-009-1032-9 DOI: 10.1007/s00198-009-1032-9
Luo C, Qin SX, Wang QY et al (2023) Cost-effectiveness analysis of five drugs for treating postmenopausal women in the United States with osteoporosis and a very high fracture risk. J Endocrinol Invest 46:367–379. 10.1007/s40618-022-01910-7 DOI: 10.1007/s40618-022-01910-7
Kanis JA, Johnell O, Oden A et al (2000) Risk of hip fracture according to the World Health Organization criteria for osteopenia and osteoporosis. Bone 27:585–590. 10.1016/s8756-3282(00)00381-1 DOI: 10.1016/s8756-3282(00)00381-1
Looker AC, Wahner HW, Dunn WL et al (1998) Updated data on proximal femur bone mineral levels of US adults. Osteoporos Int 8:468–489. 10.1007/s001980050093 DOI: 10.1007/s001980050093
Center JR, Bliuc D, Nguyen TV et al (2007) Risk of subsequent fracture after low-trauma fracture in men and women. JAMA 297:387–394. 10.1001/jama.297.4.387 DOI: 10.1001/jama.297.4.387
Liu H, Michaud K, Nayak S et al (2006) The cost-effectiveness of therapy with teriparatide and alendronate in women with severe osteoporosis. Arch Intern Med 166:1209–1217. 10.1001/archinte.166.11.1209 DOI: 10.1001/archinte.166.11.1209
Cheng LI, Durden E, Limone B et al (2015) Persistance and compliance with osteroporosis therapies among women in a commercially insured population in the United States. J Manag Care Spec Pharm 21:824–833. 10.18553/jmcp.2015.21.9.824 DOI: 10.18553/jmcp.2015.21.9.824
NICE (2017) Bisphosphonates for treating osteoporosis: technology appraisal guidance [TA464]. https://www.nice.org.uk/guidance/ta464. Accessed 16 Aug 2023.
Willems D, Javaid MK, Pinedo-Villanueva R et al (2022) Importance of time point-specific indirect treatment comparisons of osteoporosis treatments: a systematic literature review and network meta-analyses. Clin Ther 44:81–97. 10.1016/j.clinthera.2021.11.015 DOI: 10.1016/j.clinthera.2021.11.015
Czerwinski E, Cardona J, Plebanski R et al (2022) The efficacy and safety of abaloparatide-SC in men with osteoporosis: a randomized clinical trial. J Bone Miner Res 37:2435–2442. 10.1002/jbmr.4719 DOI: 10.1002/jbmr.4719
Miller PD, Hattersley G, Riis BJ et al (2016) Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 316:722–733. 10.1001/jama.2016.11136 DOI: 10.1001/jama.2016.11136
Tran T, Bliuc D, van Geel T et al (2017) Population-wide impact of non-hip non-vertebral fractures on mortality. J Bone Miner Res 32:1802–1810. 10.1002/jbmr.3118 DOI: 10.1002/jbmr.3118
Hiligsmann M, Reginster J-Y, Tosteson ANA et al (2019) Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts’ consensus meeting organized by the European society for clinical and economic aspects of osteoporosis, osteoarthritis and musculoskeletal diseases (ESCEO) and the US branch of the International Osteoporosis Foundation. Osteoporos Int 30:45–57. 10.1007/s00198-018-4744-x DOI: 10.1007/s00198-018-4744-x
Tran O, Silverman S, Xu X et al (2021) Long-term direct and indirect economic burden associated with osteoporotic fracture in US postmenopausal women. Osteoporos Int 32:1195–1205. 10.1007/s00198-020-05769-3 DOI: 10.1007/s00198-020-05769-3
Weaver J, Sajjan S, Lewiecki EM et al (2017) Prevalence and cost of subsequent fractures among US patients with an incident fracture. J Manag Care Spec Pharm 23:461–471. 10.18553/jmcp.2017.23.4.461 DOI: 10.18553/jmcp.2017.23.4.461
Williams SA, Chastek B, Sundquist K et al (2020) Economic burden of osteoporotic fractures in US managed care enrollees. Am J Manag Care 26:e142–e149. 10.37765/ajmc.2020.43156 DOI: 10.37765/ajmc.2020.43156
Hanmer J, Lawrence WF, Anderson JP et al (2006) Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores. Med Decis Making 26:391–400. 10.1177/0272989x06290497 DOI: 10.1177/0272989x06290497
Gold T, Williams SA, Weiss RJ et al (2019) Impact of fractures on quality of life in patients with osteoporosis: a US cross-sectional survey. J Drug Assess 8:175–183. 10.1080/21556660.2019.1677674 DOI: 10.1080/21556660.2019.1677674
Svedbom A, Borgstöm F, Hernlund E et al (2018) Quality of life for up to 18 months after low-energy hip, vertebral, and distal forearm fractures-results from the ICUROS. Osteoporos Int 29:557–566. 10.1007/s00198-017-4317-4 DOI: 10.1007/s00198-017-4317-4
Kanis JA, Johansson H, Odén A et al (2018) Characteristics of recurrent fractures. Osteoporos Int 29:1747–1757. 10.1007/s00198-018-4502-0 DOI: 10.1007/s00198-018-4502-0
Talevski J, Sanders KM, Watts JJ et al (2022) Sex differences in recovery of quality of life 12 months post-fracture in community-dwelling older adults: analyses of the Australian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study (AusICUROS). Osteoporos Int 33:67–75. 10.1007/s00198-021-06058-3 DOI: 10.1007/s00198-021-06058-3
Dubois RW (2016) Cost-effectiveness thresholds in the USA: are they coming? Are they already here? J Comp Eff Res 5:9–11. 10.2217/cer.15.50 DOI: 10.2217/cer.15.50
Husereau D, Drummond M, Augustovski F et al (2022) Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Pharmacoeconomics 40:601–609. 10.1016/j.jval.2021.11.1351 DOI: 10.1016/j.jval.2021.11.1351
Hiligsmann M, Cornelissen D, Vrijens B et al (2019) Determinants, consequences and potential solutions to poor adherence to anti-osteoporosis treatment: results of an expert group meeting organized by the European society for clinical and economic aspects of osteoporosis, osteoarthritis and musculoskeletal diseases (ESCEO) and the International Osteoporosis Foundation (IOF). Osteoporos Int 30:2155–2165. 10.1007/s00198-019-05104-5 DOI: 10.1007/s00198-019-05104-5
Li N, Hiligsmann M, Boonen A et al (2021) The impact of fracture liaison services on subsequent fractures and mortality: a systematic literature review and meta-analysis. Osteoporos Int 32:1517–1530. 10.1007/s00198-021-05911-9 DOI: 10.1007/s00198-021-05911-9
Wu C-H, Kao I-J, Hung W-C et al (2018) Economic impact and cost-effectiveness of fracture liaison services: a systematic review of the literature. Osteoporos Int 29:1227–1242. 10.1007/s00198-018-4411-2 DOI: 10.1007/s00198-018-4411-2
Beaudart C, Demonceau S, Sabico S et al (2023) Efficacy of osteoporosis pharmacological treatments in men: a systematic review and meta-analysis. Aging Clin Exp Res 35:1789–1806. 10.1007/s40520-023-02478-9 DOI: 10.1007/s40520-023-02478-9
Yeam CT, Chia S, Tan HCC et al (2018) A systematic review of factors affecting medication adherence among patients with osteoporosis. Osteoporos Int 29:2623–2637. 10.1007/s00198-018-4759-3 DOI: 10.1007/s00198-018-4759-3
Cosman F, Cooper C, Wang Y et al (2022) Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: a US administrative claims database study. Osteoporos Int 33:1703–1714. 10.1007/s00198-022-06413-y DOI: 10.1007/s00198-022-06413-y
Bao Y, Xu Y, Li Z et al (2023) Racial and ethnic difference in the risk of fractures in the United States: a systematic review and meta-analysis. Sci Rep 13:9481. 10.1038/s41598-023-32776-1 DOI: 10.1038/s41598-023-32776-1
Noel SE, Santos MP, Wright NC (2021) Racial and ethnic disparities in bone health and outcomes in the United States. J Bone Miner Res 36:1881–1905. 10.1002/jbmr.4417 DOI: 10.1002/jbmr.4417
Institute for Clinical and Economic Review. The QALY: rewarding the care that most improves patients’ lives. December 2018. https://icer.org/wp-content/uploads/2020/12/QALY_evLYG_FINAL.pdf. Accessed 25 Aug 2023.
Haentjens P, Magaziner J, Colon-Emeric CS et al (2010) Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med 152:380–390. 10.7326/0003-4819-152-6-201003160-00008 DOI: 10.7326/0003-4819-152-6-201003160-00008
