Cost-effectiveness of sequential treatment with abaloparatide followed by alendronate vs alendronate monotherapy in women at increased risk of fracture: a US payer perspective
Cost-effectiveness of sequential treatment with abaloparatide followed by alendronate vs alendronate monotherapy in women at increased risk of fracture. a US payer perspective.pdf
[en] Objectives: Emerging evidence supports sequential therapy with anabolic followed by antiresorptive in patients at high-risk of fragility fractures. This study assessed the cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) [(ABL/ALN)] compared to ALN monotherapy and to sequential treatment starting with antiresorptive therapy (ALN/ABL/ALN).
Methods: A previously validated Markov microsimulation model was used to estimate the cost-effectiveness of sequential ABL/ALN compared to ALN monotherapy and to sequential ALN/ABL/ALN from a lifetime US payer perspective. In line with practice guidelines, patients were assumed to receive ABL for 18 months followed by 5 years of ALN, or ALN monotherapy for 5 years, or a sequence of ALN for 2 years followed by 18 months of ABL and then by 3 years ALN. Evaluation was conducted for patients aged 50 80 years old with a BMD T-score -3.5 and without a history of prior fracture, or with a T-score between -2.5 and -3.5 and a history of 1 osteoporotic fracture.
Results: Sequential ABL/ALN was cost-effective (threshold of US$150,000 per QALY) vs generic ALN monotherapy in women 60 years with a BMD T-score 3.5 and in women with BMD T-score between 2.5 and
3.5 and history of osteoporotic fracture. In all simulated populations, sequential ABL/ALN therapy was dominant (lower costs, more QALYs) compared with sequential ALN/ABL/ALN, resulting from limited effect of ABL in patients previously treated with an antiresorptive agent.
Conclusions: Sequential ABL/ALN therapy is cost-effective vs ALN monotherapy for US postmenopausal women aged 60 years at increased risk of fractures.
Disciplines :
Public health, health care sciences & services
Author, co-author :
Hiligsmann, Mickael
Williams, S.A.
Fitzpatrick, L.A.
Silverman, S.S.
Weiss, R.
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Language :
English
Title :
Cost-effectiveness of sequential treatment with abaloparatide followed by alendronate vs alendronate monotherapy in women at increased risk of fracture: a US payer perspective
Cosman, F., Nieves, J.W., Dempster, D.W., Treatment sequence matters: anabolic and antiresorptive therapy for osteoporosis. J Bone Miner Res 32:2 (2017), 198–202.
Leder, B.Z., Optimizing sequential and combined anabolic and antiresorptive osteoporosis therapy. JBMR Plus. 2:2 (2018), 62–68.
Lou, S., Lv, H., Wang, G., Li, Z., Li, M., Zhang, L., et al. The effect of sequential therapy for postmenopausal women with osteoporosis: a PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore), 95(49), 2016, e5496.
Bone, H.G., Cosman, F., Miller, P.D., Williams, G.C., Hattersley, G., Hu, M.Y., et al. ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis. J Clin Endocrinol Metab 103:8 (2018), 2949–2957.
Hiligsmann, M., Reginster, J.Y., Tosteson, A.N.A., Bukata, S.V., Saag, K.G., Gold, D.T., et al. 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. 30:1 (2019), 45–57.
Garrison, L.P. Jr., Neumann, P.J., Willke, R.J., Basu, A., Danzon, P.M., Doshi, J.A., et al. A health economics approach to us value assessment frameworks-summary and recommendations of the ISPOR special task force report. Value Health 21:2 (2018), 161–165.
Sculpher, M., ISPOR's initiative on us value assessment frameworks: seeking a role for health economics. Value Health 21:2 (2018), 171–172.
Hiligsmann, M., Williams, S.A., Fitzpatrick, L.A., Silverman, S.S., Weiss, R., Reginster, J.Y., Cost-effectiveness of sequential treatment with abaloparatide vs. teriparatide for United States women at increased risk of fracture. Semin Arthritis Rheum 49:2 (2019), 184–196.
Hiligsmann, M., Gathon, H.J., Bruyere, O., Ethgen, O., Rabenda, V., Reginster, J.Y., Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health 13:4 (2010), 394–401.
Hiligsmann, M., Reginster, J.Y., Cost effectiveness of denosumab compared with oral bisphosphonates in the treatment of post-menopausal osteoporotic women in Belgium. Pharmacoeconomics 29:10 (2011), 895–911.
Hiligsmann, M., Ethgen, O., Bruyere, O., Richy, F., Gathon, H.J., Reginster, J.Y., Development and validation of a Markov microsimulation model for the economic evaluation of treatments in osteoporosis. Value Health 12:5 (2009), 687–696.
Camacho, P.M., Petak, S.M., Binkley, N., Clarke, B.L., Harris, S.T., Hurley, D.L., et al. American association of clinical endocrinologists and American college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis - 2016–Executive summary. Endocrine Practice 22:9 (2016), 1111–1118.
Sanders, G.D., Neumann, P.J., Basu, A., Brock, D.W., Feeny, D., Krahn, M., et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA 316:10 (2016), 1093–1103.
Academy of Managed Care Pharmacy. The AMCP format for formulary submissions version 4.0. A Format for Submission of Clinical and Economic Evidence in Support of Formulary Consideration. April 2016. Access http://www.amcp.org/FormatV4/.
Husereau, D., Drummond, M., Petrou, S., Carswell, C., Moher, D., Greenberg, D., et al. Consolidated health economic evaluation reporting standards (CHEERS) statement. Value Health 16:2 (2013), e1–e5.
Svedbom, A., Hernlund, E., Ivergard, M., Compston, J., Cooper, C., Stenmark, J., et al. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos, 8, 2013, 137.
Ettinger, B., Black, D.M., Dawson-Hughes, B., Pressman, A.R., Melton, L.J. 3rd, Updated fracture incidence rates for the US version of Frax. Osteoporos Int 21:1 (2010), 25–33.
Burge, R., Dawson-Hughes, B., Solomon, D.H., Wong, J.B., King, A., Tosteson, A., Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. Journal of Bone and Mineral Research 22:3 (2007), 465–475.
Kanis, J.A., Johnell, O., De Laet, C., Johansson, H., Oden, A., Delmas, P., et al. A meta-analysis of previous fracture and subsequent fracture risk. Bone 35:2 (2004), 375–382.
Kanis, J.A., Johnell, O., Oden, A., Jonsson, B., De Laet, C., Dawson, A., Risk of hip fracture according to the world health organization criteria for osteopenia and osteoporosis. Bone 27:5 (2000), 585–590.
Klotzbuecher, C.M., Ross, P.D., Landsman, P.B., Abbott, T.A., Berger, M. 3rd, Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Mineral Res 15:4 (2000), 721–739.
Johansson, H., Siggeirsdottir, K., Harvey, N.C., Oden, A., Gudnason, V., McCloskey, E., et al. Imminent risk of fracture after fracture. Osteoporos Int 28:3 (2017), 775–780.
Hauber, A.B., Gonzalez, J.M., Groothuis-Oudshoorn, C.G., Prior, T., Marshall, D.A., Cunningham, C., et al. Statistical methods for the analysis of discrete choice experiments: a report of the ISPOR conjoint analysis good research practices task force. Value Health 19:4 (2016), 300–315.
Tran, T., Bliuc, D., van Geel, T., Adachi, J.D., Berger, C., van den Bergh, J., et al. Population-Wide impact of non-hip non-vertebral fractures on mortality. J Bone Mineral Res 32:9 (2017), 1802–1810.
Kanis, J.A., Oden, A., Johnell, O., De Laet, C., Jonsson, B., Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int 15:2 (2004), 108–112.
Kanis, J.A., Oden, A., Johnell, O., De Laet, C., Jonsson, B., Oglesby, A.K., The components of excess mortality after hip fracture. Bone 32:5 (2003), 468–473.
Leibson, C.L., Tosteson, A.N.A., Gabriel, S.E., Ransom, J.E., Melton, L.J., Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J Am Geriatr Soc 50:10 (2002), 1644–1650.
U.S. Bureau of Labor Statistics. Consumer price index for all urban consumers: medical care [CPIMEDSL], retrieved from FRED. 2017, Federal Reserve Bank of St, Louis https://fred.stlouisfed.org/series/CPIMEDSL November 2.
Bonafede, M., Shi, N., Viswanathan, H.N., Yurgin, N., Osteoporosis-Related fracture costs among female commercially insured and medicare patients. Value Health, 14(3), 2011 A125-A.
Tosteson, A.N., Melton, L.J. 3rd, Dawson-Hughes, B., Baim, S., Favus, M.J., Khosla, S., et al. Cost-effective osteoporosis treatment thresholds: the United States perspective. Osteoporos Int 19:4 (2008), 437–447.
Weaver, J., Sajjan, S., Lewiecki, E.M., Harris, S.T., Marvos, P., Prevalence and cost of subsequent fractures among U.S. Patients with an Incident Fracture. J Manag Care Spec Pharm 23:4 (2017), 461–471.
Genworth 2017 Cost of Care Survey, conducted by Carescout. long term care costs across the United States; June 2017. https://www.genworth.com/about-us/industry-expertise/cost-of-care.html.
WAC price, Online red book, December 2017.
Miller, P.D., Hattersley, G., Riis, B.J., Williams, G.C., Lau, E., Russo, L.A., et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 316:7 (2016), 722–733.
The Medicare Learning Network®, MLN connects®, and MLN matters®. The ABCs of the annual wellness visit (AWV). G0349 code.
Liu, H., Michaud, K., Nayak, S., Karpf, D.B., Owens, D.K., Garber, A.M., The cost-effectiveness of therapy with teriparatide and alendronate in women with severe osteoporosis. Arch. Intern. Med. 166:11 (2006), 1209–1217.
Hiligsmann, M., Dellaert, B.G., Watson, V., Boonen, A., Comment on: patients' preferences for anti-osteoporosis drug treatment: a cross-European discrete choice experiment: reply. Rheumatology (Oxford) 57:3 (2018), 584–585.
Parthan, A., Kruse, M., Yurgin, N., Huang, J., Viswanathan, H.N., Taylor, D., Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US. Appl Health Econ Health Policy 11:5 (2013), 485–497.
Hanmer, J., Lawrence, W.F., Anderson, J.P., Kaplan, R.M., Fryback, D.G., Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores. Med Decis Mak 26:4 (2006), 391–400.
Svedbom, A., Borgstom, F., Hernlund, E., Strom, O., Alekna, V., Bianchi, M.L., et al. Quality of life for up to 18 months after low-energy hip, vertebral, and distal forearm fractures-results from the ICUROS. Osteoporos Int 29:3 (2018), 557–566.
Hiligsmann, M., Ethgen, O., Richy, F., Reginster, J.Y., Utility values associated with osteoporotic fracture: a systematic review of the literature. Calcif. Tissue Int. 82:4 (2008), 288–292.
Bone, H.G., Cosman, F., Miller, P.D., Williams, G.C., Hattersley, G., Hu, M.Y., et al. ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis. J. Clin. Endocrinol. Metab. 103:8 (2018), 2949–2957 1.
Hiligsmann, M., Evers, S.M., Ben Sedrine, W., Kanis, J.A., Ramaekers, B., Reginster, J.Y., et al. A systematic review of cost-effectiveness analyses of drugs for postmenopausal osteoporosis. Pharmacoeconomics 33:3 (2015), 205–224.
Strom, O., Landfeldt, E., Garellick, G., Residual effect after oral bisphosphonate treatment and healthy adherer effects-the Swedish adherence register analysis (SARA). Osteoporosis Int 26:1 (2015), 315–325.
Neumann, P.J., Cohen, J.T., Weinstein, M.C., Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. NEngl J Med 371:9 (2014), 796–797.
Dubois, R., Cost–effectiveness thresholds in the USA: are they coming? Are they already here?. J. Comp. Eff. Res. 5:1 (2016), 9–11.
Briggs, A., Claxton, K., Sculpher, M., Decision modelling for health economic evaluation. 2006, Oxford University Press.
Eastell, R., Nickelsen, T., Marin, F., Barker, C., Hadji, P., Farrerons, J., et al. Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS). J Bone Miner Res 24:4 (2009), 726–736.
Ettinger, B., San Martin, J., Crans, G., Pavo, I., Differential effects of teriparatide on BMD after treatment with raloxifene or alendronate. J Bone Miner Res 19:5 (2004), 745–751.
Obermayer-Pietsch, B.M., Marin, F., McCloskey, E.V., Hadji, P., Farrerons, J., Boonen, S., et al. Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment. J Bone Miner Res 23:10 (2008), 1591–1600.
Kendler, D.L., Marin, F., Zerbini, C.A.F., Russo, L.A., Greenspan, S.L., Zikan, V., et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 391:10117 (2018), 230–240.
Saag, K.G., Petersen, J., Brandi, M.L., Karaplis, A.C., Lorentzon, M., Thomas, T., et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 377:15 (2017), 1417–1427.
Cosman, F., Crittenden, D.B., Adachi, J.D., Binkley, N., Czerwinski, E., Ferrari, S., et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 375:16 (2016), 1532–1543.
