Cost-effectiveness of gastro-resistant risedronate tablets for the treatment of postmenopausal women with osteoporosis in France

M Hiligsmann, J-Y Reginster, M Hiligsmann, J-Y Reginster

Abstract

The use of gastro-resistant risedronate, a convenient dosing regimen for oral bisphosphonate therapy, seems a cost-effective strategy compared with weekly alendronate, generic risedronate, and no treatment for the treatment of postmenopausal women with osteoporosis in France.

Introduction: Gastro-resistant (GR) risedronate tablets are associated with improved persistence compared to common oral bisphosphonates but are slightly more expensive. This study assessed its cost-effectiveness compared to weekly alendronate and generic risedronate for the treatment of postmenopausal women with osteoporosis in France.

Methods: A previously validated Markov microsimulation model was used to estimate the lifetime costs (expressed in €2017) per quality-adjusted life-years (QALY) of GR risedronate compared with weekly alendronate, generic risedronate, and no treatment. Pooled efficacy data for bisphosphonates derived from a previous meta-analysis were used for all treatment options, and persistence data (up to 3 years) were obtained from a large Australian longitudinal study. Evaluation was done for high-risk women 60-80 years of age, with a bone mineral density (BMD) T-score ≤ - 2.5 and/or prevalent vertebral fractures.

Results: In all of the simulated populations, GR risedronate was cost-effective compared to alendronate, generic risedronate, and no treatment at a threshold of €60,000 per QALY gained. In women with a BMD T-score ≤ - 2.5 and prevalent vertebral fractures, the cost per QALY gained of GR risedronate compared to alendronate, generic risedronate, and no treatment falls below €20,000 per QALY gained. In women aged 75 years and older, GR risedronate was even shown to be dominant (more QALYs, less costs) compared to alendronate, generic risedronate, and no treatment.

Conclusion: This study provides the first economic results about GR risedronate, suggesting that it represents a cost-effective strategy compared with weekly alendronate and generic risedronate for the treatment of postmenopausal women with osteoporosis in France.

Keywords: Cost-effectiveness; Economic evaluation; Osteoporosis; Risedronate; Treatment.

Conflict of interest statement

MH has received research grant through institution from Amgen, Radius Health, and Teva and lecture fees from Radius. JYR has received consulting fees or paid advisory boards from IBSA-Genevrier, Mylan, Radius Health, Pierre Fabre, Teva; lecture fees when speaking at the invitation of sponsor: IBSA-Genevrier, Mylan, CNIEL, Dairy Research Council, Teva; and grant support from industry (all through institution) from IBSA-Genevrier, Mylan, CNIEL, Radius Health.

Figures

Fig. 1
Fig. 1
Persistence rates to oral bisphosphonates up to 3 years
Fig. 2
Fig. 2
Cost-effectiveness acceptability curves of GR risedronate versus generic risedronate (a), alendronate (b), and no treatment (c) in women aged 60, 70, and 80 years with prevalent vertebral fractures and a BMD T-score ≤ − 2.5

References

    1. Kanis JA, Burlet N, Cooper C, Delmas PD, Reginster JY, Borgstrom F, et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2008;19(4):399–428. doi: 10.1007/s00198-008-0560-z.
    1. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005;21(9):1453–1460. doi: 10.1185/030079905X61875.
    1. Hiligsmann M, Rabenda V, Gathon HJ, Ethgen O, Reginster JY. Potential clinical and economic impact of nonadherence with osteoporosis medications. Calcif Tissue Int. 2010;86(3):202–210. doi: 10.1007/s00223-009-9329-4.
    1. McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, et al. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012;23(1):267–276. doi: 10.1007/s00198-011-1791-y.
    1. McClung MR, Balske A, Burgio DE, Wenderoth D, Recker RR. Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years. Osteoporos Int. 2013;24(1):301–310. doi: 10.1007/s00198-012-2175-7.
    1. Hiligsmann M, Kanis JA, Compston J, Cooper C, Flamion B, Bergmann P, Body JJ, Boonen S, Bruyere O, Devogelaer JP, Goemaere S, Kaufman JM, Rozenberg S, Reginster JY. Health technology assessment in osteoporosis. Calcif Tissue Int. 2013;93(1):1–14. doi: 10.1007/s00223-013-9724-8.
    1. Hiligsmann M, Ethgen O, Bruyere O, Richy F, Gathon HJ, Reginster JY. Development and validation of a Markov microsimulation model for the economic evaluation of treatments in osteoporosis. Value Health. 2009;12(5):687–696. doi: 10.1111/j.1524-4733.2008.00497.x.
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E, CHEERS Task Force Consolidated health economic evaluation reporting standards (CHEERS) statement. Value Health. 2013;16(2):e1–e5. doi: 10.1016/j.jval.2013.02.010.
    1. 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. 2013;8:137. doi: 10.1007/s11657-013-0137-0.
    1. Briot K, Maravic M, Roux C. Changes in number and incidence of hip fractures over 12 years in France. Bone. 2015;81:131–137. doi: 10.1016/j.bone.2015.07.009.
    1. Bouee S, Lafuma A, Fagnani F, Meunier PJ, Reginster JY. Estimation of direct unit costs associated with non-vertebral osteoporotic fractures in five European countries. Rheumatol Int. 2006;26(12):1063–1072. doi: 10.1007/s00296-006-0180-x.
    1. Cotte FE, De Pouvourville G. Cost of non-persistence with oral bisphosphonates in post-menopausal osteoporosis treatment in France. BMC Health Serv Res. 2011;11:151. doi: 10.1186/1472-6963-11-151.
    1. Prigent A, Auraaen A, Kamendje-Tchokobou B, Durand-Zaleski I, Chevreul K. Health-related quality of life and utility scores in people with mental disorders: a comparison with the non-mentally ill general population. Int J Environ Res Public Health. 2014;11(3):2804–2817. doi: 10.3390/ijerph110302804.
    1. Svedbom A, Borgstom F, Hernlund E, Strom O, Alekna V, Bianchi ML, 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. 2018;29(3):557–566. doi: 10.1007/s00198-017-4317-4.
    1. National Institute for Clinical Excellence and Health (2008) Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women. Technology appraisal guidance [TA160]. Available from . Access 15 Jun 2017
    1. . Access 28 Feb 2018
    1. Hiligsmann M, Reginster JY. Cost effectiveness of denosumab compared with oral bisphosphonates in the treatment of post-menopausal osteoporotic women in Belgium. PharmacoEconomics. 2011;29(10):895–911. doi: 10.2165/11539980-000000000-00000.
    1. Hiligsmann M, Burlet N, Fardellone P, Al-Daghri N, Reginster JY. Public health impact and economic evaluation of vitamin D-fortified dairy products for fracture prevention in France. Osteoporos Int. 2017;28(3):833–840. doi: 10.1007/s00198-016-3786-1.
    1. Kanis JA, Johnell O, De Laet C, Johansson H, Oden A, Delmas P, et al. A meta-analysis of previous fracture and subsequent fracture risk. Bone. 2004;35(2):375–382. doi: 10.1016/j.bone.2004.03.024.
    1. Kanis JA, 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. 2000;27(5):585–590. doi: 10.1016/S8756-3282(00)00381-1.
    1. INSEE. Mortality table 2013–2015. Available from . Access 15 Jun 2017
    1. Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B. Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int. 2004;15(2):108–112. doi: 10.1007/s00198-003-1516-y.
    1. Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B, Oglesby AK. The components of excess mortality after hip fracture. Bone. 2003;32(5):468–473. doi: 10.1016/S8756-3282(03)00061-9.
    1. Drame M, Fierobe F, Lang PO, Jolly D, Boyer F, Mahmoudi R, et al. Predictors of institution admission in the year following acute hospitalisation of elderly people. J Nutr Health Aging. 2011;15(5):399–403. doi: 10.1007/s12603-011-0004-x.
    1. DGCS, CNSA, ATIH - enquête de coûts 2013 en établissements d’hébergement pour personnes âgées dépendantes (EHPAD), May 2015. Available from . Access 15 Jun 2017
    1. Weaver J, Sajjan S, Lewiecki EM, Harris ST, Marvos P. Prevalence and Cost of subsequent fractures among U.S. patients with an incident fracture. J Manag Care Spec Pharm. 2017;23(4):461–471.
    1. Hiligsmann M, Ethgen O, Richy F, Reginster JY. Utility values associated with osteoporotic fracture: a systematic review of the literature. Calcif Tissue Int. 2008;82(4):288–292. doi: 10.1007/s00223-008-9117-6.
    1. Davis S, Martyn-St James M, Sanderson J, Stevens J, Goka E, Rawdin A, Sadler S, Wong R, Campbell F, Stevenson M, Strong M, Selby P, Gittoes N. A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures. Health Technol Assess. 2016;20(78):1–406. doi: 10.3310/hta20780.
    1. National Institute for Clinical Excellence and Health (2017) Bisphosphonates for treating osteoporosis. Technology appraisal guidance [TA464]. Available from /. Access 15 Jun 2017
    1. Hiligsmann M, Evers SM, Ben Sedrine W, Kanis JA, Ramaekers B, Reginster JY, Silverman S, Wyers CE, Boonen A. A systematic review of cost-effectiveness analyses of drugs for postmenopausal osteoporosis. PharmacoEconomics. 2015;33(3):205–224. doi: 10.1007/s40273-014-0231-1.
    1. Strom O, Landfeldt E, Garellick G. Residual effect after oral bisphosphonate treatment and healthy adherer effects--the Swedish Adherence Register Analysis (SARA) Osteoporos Int. 2015;26(1):315–325. doi: 10.1007/s00198-014-2900-5.
    1. Hiligsmann M, McGowan B, Bennett K, Barry M, Reginster JY. The clinical and economic burden of poor adherence and persistence with osteoporosis medications in Ireland. Value Health. 2012;15(5):604–612. doi: 10.1016/j.jval.2012.02.001.
    1. Hiligsmann M, Rabenda V, Bruyere O, Reginster JY. The clinical and economic burden of non-adherence with oral bisphosphonates in osteoporotic patients. Health Policy. 2010;96(2):170–177. doi: 10.1016/j.healthpol.2010.01.014.
    1. Gallagher AM, Rietbrock S, Olson M, van Staa TP. Fracture outcomes related to persistence and compliance with oral bisphosphonates. J Bone Miner Res. 2008;23(10):1569–1575. doi: 10.1359/jbmr.080510.
    1. Kanis JA, Reginster JY, Kaufman JM, Ringe JD, Adachi JD, Hiligsmann M, Rizzoli R, Cooper C. A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos Int. 2012;23(1):213–221. doi: 10.1007/s00198-011-1796-6.
    1. Borgstrom F, Johnell O, Kanis JA, Jonsson B, Rehnberg C. At what hip fracture risk is it cost-effective to treat? International intervention thresholds for the treatment of osteoporosis. Osteoporos Int. 2006;17(10):1459–1471. doi: 10.1007/s00198-006-0107-0.
    1. Lippuner K, Johansson H, Borgstrom F, Kanis JA, Rizzoli R. Cost-effective intervention thresholds against osteoporotic fractures based on FRAX(R) in Switzerland. Osteoporos Int. 2012;23(11):2579–2589. doi: 10.1007/s00198-011-1869-6.
    1. Marques A, Lourenco O, Ortsater G, Borgstrom F, Kanis JA, da Silva JA. Cost-effectiveness of intervention thresholds for the treatment of osteoporosis based on FRAX((R)) in Portugal. Calcif Tissue Int. 2016;99(2):131–141. doi: 10.1007/s00223-016-0132-8.
    1. Briggs A, Claxton K, Sculpher M. Decision modelling for health economic evaluation. Oxford: Oxford University Press; 2006.
    1. Borgstrom F, Strom O, Coelho J, Johansson H, Oden A, McCloskey EV, et al. The cost-effectiveness of risedronate in the UK for the management of osteoporosis using the FRAX. Osteoporos Int. 2010;21(3):495–505. doi: 10.1007/s00198-009-0989-8.
    1. Hiligsmann M, Boonen A, Rabenda V, Reginster JY. The importance of integrating medication adherence into pharmacoeconomic analyses: the example of osteoporosis. Expert Rev Pharmacoecon Outcomes Res. 2012;12(2):159–166. doi: 10.1586/erp.12.8.
    1. IMS Brogan (2013) Ontario public drug plan longitudinal database
    1. Hiligsmann M, Reginster JY. The projected public health and economic impact of vitamin D fortified dairy products for fracture prevention in France. Expert Rev Pharmacoecon Outcomes Res. 2018;18(2):191–195. doi: 10.1080/14737167.2017.1375406.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅