Comparative cost-effectiveness of bazedoxifene and raloxifene in the treatment of postmenopausal osteoporosis in Europe, using the FRAX algorithm

Osteoporosis International

Volumn 25, Issue 1, 2014, Pages 325-337

  Kim, K ^a   Svedbom, A ^a,b   Luo, X ^c   Sutradhar, S ^c   Kanis, J A ^d  

^a OptumInsight   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

^c PFIZER INC   (United States)

^d UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Bazedoxifene; Cost effectiveness; Fracture; FRAX; Osteoporosis; Raloxifene

Indexed keywords

BAZEDOXIFENE; RALOXIFENE;

ALGORITHM; ARTICLE; BELGIUM; BONE DENSITY; CLINICAL ASSESSMENT TOOL; COMPUTER; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; EUROPE; FRAGILITY FRACTURE; FRANCE; GERMANY; HEALTH CARE; HIGH RISK PATIENT; HUMAN; IRELAND; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; QUALITY OF LIFE; RISK FACTOR; SENSITIVITY ANALYSIS; SIMULATION; SPAIN; SPINE FRACTURE; SWEDEN; UNITED KINGDOM;

AGED; ALGORITHMS; BONE DENSITY CONSERVATION AGENTS; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; DOSE-RESPONSE RELATIONSHIP, DRUG; EUROPE; FEMALE; HEALTH CARE COSTS; HEALTH SERVICES RESEARCH; HUMANS; INDOLES; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; OSTEOPOROTIC FRACTURES; QUALITY OF LIFE; RALOXIFENE; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY;

EID: 84891864811     PISSN: 0937941X     EISSN: 14332965     Source Type: Journal    
DOI: 10.1007/s00198-013-2521-4     Document Type: Article

References (85)

1. Cooper C (1999) Epidemiology of osteoporosis. Osteoporos Int 9(Suppl 2):S2-S8 (Pubitemid 29231749)
2. Hernlund E, Svedbom A, Ivergard M, Compston J, Joonsson B, Kanis J (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. Archives of Osteoporosis (in press)
3. Stone KL, Seeley DG, Lui LY, Cauley JA, Ensrud K, Browner WS, Nevitt MC, Cummings SR (2003) BMD at multiple sites and risk of fracture of multiple types: long-term results from the study of osteoporotic fractures. J Bone Miner Res 18:1947-1954. doi: 10.1359/jbmr.2003.18.11.1947 (Pubitemid 37377443)
4. Pasco JA, Sanders KM, Hoekstra FM, Henry MJ, Nicholson GC, Kotowicz MA (2005) The human cost of fracture. Osteoporos Int 16:2046-2052. doi: 10.1007/s00198-005-1997-y (Pubitemid 41790926)
5. Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR (1998) The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 128:793-800 (Pubitemid 28267711)
6. Johnell O, Kanis JA (2004) An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int 15:897-902 (Pubitemid 39506456)
7. Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17:1726-1733 (Pubitemid 44607392)
8. Delmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, Draper M, Christiansen C (1997) Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 337:1641-1647 (Pubitemid 27510100)
9. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Gluer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. Jama 282:637-645 (Pubitemid 29384151)
10. Silverman SL, Christiansen C, Genant HK, Vukicevic S, Zanchetta JR, de Villiers TJ, Constantine GD, Chines AA (2008) Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res 23:1923-1934
11. Kanis JA, Johansson H, Oden A, McCloskey EV (2009) Bazedoxifene reduces vertebral and clinical fractures in postmenopausal women at high risk assessed with FRAX. Bone 44:1049-1054
12. Silverman SL, Chines AA, Kendler DL, Kung AW, Teglbjaerg CS, Felsenberg D, Mairon N, Constantine GD, Adachi JD (2011) Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporos Int 23:351-363. doi: 10.1007/s00198-011-1691-1
13. Tremollieres FA, Pouilles JM, Drewniak N, Laparra J, Ribot CA, Dargent-Molina P (2010) Fracture risk prediction using BMD and clinical risk factors in early postmenopausal women: sensitivity of the WHO FRAX tool. J Bone Miner Res 25:1002-1009. doi: 10.1002/jbmr.12
14. Kanis JA, Hans D, Cooper C, Baim S, Bilezikian JP, Binkley N, Cauley JA, Compston JE, Dawson-Hughes B, El-Hajj FG, Johansson H, Leslie WD, Lewiecki EM, Luckey M, Oden A, Papapoulos SE, Poiana C, Rizzoli R, Wahl DA, McCloskey EV (2011) Interpretation and use of FRAX in clinical practice. Osteoporos Int 22:2395-2411
15. Committee for Medicinal Products for Human Use (2006) Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis. Ref CPMP/EWP/552/95Rev.2. CHMP, London
16. Kanis JA, Johansson H, Oden A, McCloskey EV (2010) A meta-analysis of the efficacy of raloxifene on all clinical and vertebral fractures and its dependency on FRAX. BONE 47:729-735
17. Kanis JA, Johansson H, Oden A, McCloskey EV (2011) A meta-analysis of the effect of strontium ranelate on the risk of vertebral and non-vertebral fracture in postmenopausal osteoporosis and the interaction with FRAX((R)). Osteoporos Int 22:2347-2355. doi: 10.1007/s00198-010-1474-0
18. McCloskey EV, Johansson H, Oden A, Vasireddy S, Kayan K, Pande K, Jalava T, Kanis JA (2009) Ten-year fracture probability identifies women who will benefit from clodronate therapy - additional results from a double-blind, placebo-controlled randomised study. Osteoporos Int 20:811-817
19. McCloskey EV, Johansson H, Oden A, Austin M, Siris E, Wang A, Lewiecki EM, Lorenc R, Libanati C, Kanis JA (2012) Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res 27:1480-1486. doi: 10.1002/jbmr.1606
20. Borgstrom F, Strom O, Kleman M, McCloskey E, Johansson H, Oden A, Kanis JA (2010) Cost-effectiveness of bazedoxifene incorporating the FRAX(R) algorithm in a European perspective. Osteoporos Int 22:955-965. doi: 10.1007/s00198-010- 1291-5
21. Huybrechts KF, Ishak KJ, Caro JJ (2006) Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. BONE 38:922-928 (Pubitemid 44498580)
22. Seeman E, Compston J, Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, Jonsson B, Pols H, Cramer JA (2007) Non-compliance: the Achilles' heel of anti-fracture efficacy. Osteoporos Int 18:711-719. doi: 10.1007/s00198-006-0294- 8 (Pubitemid 46684777)
23. The Belgian Health Care Knowledge Centre (2008) Guidelines for pharmacoeconomic evaluations in Belgium: KCE reports 78C. The Belgian Health Care Knowledge Centre (KCE), Brussels
24. NICE (2008) Guide to the methods of technology appraisal. http://www.nice.org/uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf. Accessed June 2008
25. Lopez BJ, Oliva J, Antonanzas F, Garcia-Altes A, Gisbert R, Mar J, Puig-Junoy J (2010) A proposed guideline for economic evaluation of health technologies. Gac Sanit 24:154-170
26. Health Information and Quality Authority (2010) Guidelines for the economic evaluation of health technologies in Ireland. Health Information and Quality Authority, Cork
27. Capri S, Ceci A, Terranova L, Merlo F, Mantovani L (2001) Guidelines for economics evaluations in Italy: recommendations from the Italian group of pharmacoeconomic stuides. Drug Inf J 35:189-201 (Pubitemid 32198569)
28. Sorenson C, Drummond M, Kanavos P (2008) Ensuring value for money in health care: the role of health technology assessment in the European Union. European Observatory on Health Systems and Policies. Observatory Studies Series No.11
29. Kanis JA, Jonsson B (2002) Economic evaluation of interventions for osteoporosis. Osteoporos Int 13:765-767 (Pubitemid 36336720)
30. Cox DR, Oakes D (1984) Analysis of survival data. Monographs on statistics and applied probability 21. Chapman & Hall, London
31. Kanis JA, Borgstrom F, Johnell O, Oden A, Sykes D, Jonsson B (2005) Cost-effectiveness of raloxifene in the UK: an economic evaluation based on the MORE study. Osteoporos Int 16:15-25 (Pubitemid 40193215)
32. Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756-765
33. Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, Nevitt MC, Suryawanshi S, Cummings SR (2000) Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 85:4118-4124 (Pubitemid 32055362)
34. EMEA (2009). Committe for medicinal products for human use - summary of positive opinion for Conbriza. EMEA, London, 19 February 2009
35. Federaal Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu. Bestuur van de gezondheidszorgen. Commissie voor toezicht op en evaluatie van statistische gegevens die verband houden met de medische activiteiten in de ziekenhuizen. Rijksadministratif centrum. Brussel. Upon written request
36. Dodds MK, Codd MB, Looney A, Mulhall KJ (2009) Incidence of hip fracture in the Republic of Ireland and future projections: a population-based study. Osteoporos Int 20:2105-2110. doi: 10.1007/s00198-009-0922-1
37. Kanis JA, Oden A, Johnell O, Jonsson B, de Laet C, Dawson A (2001) The burden of osteoporotic fractures: a method for setting intervention thresholds. Osteoporos Int 12:417-427 (Pubitemid 32606468)
38. Kanis J (2008) Assessment of osteoporosis at the primary health-care level. Technical report. WHO Collaborating Centre, University of Sheffield, UK
39. IARC (2008). GLOBOCAN 2008. Cancer incidence, mortality and prevalence worldwide in 2008. International Agency for Research on Cancer, Lyon. http://globocan.iarc.fr/
40. Wilmoth JR, Shkolnikov V (2012). The human mortality database (HMD). Online source http://www.mortality.org/
41. Oden A, Dawson A, Dere W, Johnell O, Jonsson B, Kanis JA (1998) Lifetime risk of hip fractures is underestimated. Osteoporos Int 8:599-603 (Pubitemid 28566977)
42. Johnell O, Kanis JA, Oden A, Sernbo I, Redlund-Johnell I, Petterson C, de Laet C, Jonsson B (2004) Mortality after osteoporotic fractures. Osteoporos Int 15:38-42 (Pubitemid 38252438)
43. Poor G, Atkinson EJ, O'Fallon WM, Melton LJ III (1995) Determinants of reduced survival following hip fractures in men. Clin Orthop 319:260-265.
44. Kanis JA, Oden A, Johnell O, de Laet C, Jonsson B (2004) Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int 15:108-112 (Pubitemid 38252423)
45. Parker MJ, Anand JK (1991) What is the true mortality of hip fractures? Public Health 105:443-446
46. Kanis JA, Oden A, Johnell O, de Laet C, Jonsson B, Oglesby AK (2003) The components of excess mortality after hip fracture. BONE 32:468-473 (Pubitemid 39665705)
47. Strom O, Borgstrom F, Sen SS, Boonen S, Haentjens P, Johnell O, Kanis JA (2007) Cost-effectiveness of alendronate in the treatment of postmenopausal women in 9 European countries - an economic evaluation based on the fracture intervention trial. Osteoporos Int 18:1047-1061 (Pubitemid 47020004)
48. Borgstrom F, Carlsson A, Sintonen H, Boonen S, Haentjens P, Burge R, Johnell O, Jonsson B, Kanis JA (2006) The cost-effectiveness of risedronate in the treatment of osteoporosis: an international perspective. Osteoporos Int 17:996-1007 (Pubitemid 43864853)
49. NICE (2008) Osteoporosis - secondary prevention including strontium ranelate: appraisal consultation document. www.nice.org.uk
50. Kearon C (2003) Natural history of venous thromboembolism. Circulation 107:I22-I30
51. Azhar A, Lim C, Kelly E, O'Rourke K, Dudeney S, Hurson B, Quinlan W (2008) Cost induced by hip fractures. Ir Med J 101:213-215
52. Bouee S, Lafuma A, Fagnani F, Meunier PJ, Reginster JY (2006) Estimation of direct unit costs associated with non-vertebral osteoporotic fractures in five European countries. Rheumatol Int 26: 1063-1072. doi. 10.1007/s00296-006- 0180-x (Pubitemid 44450839)
53. Jonsson B, Christiansen C, Johnell O, Hedbrandt J, Karlsson G (1996) Cost-effectiveness of fracture prevention in established osteoporosis. Scand J Rheumatol Suppl 103:30-38 (Pubitemid 126716948)
54. Kanis J (2001). Epidemiology and costs of fractures in the UK - background document for male osteoporosis model. Personal communication 2001
55. Borgstrom F, Jonsson B, Strom O, Kanis JA (2006) An economic evaluation of strontium ranelate in the treatment of osteoporosis in a Swedish setting: based on the results of the SOTI and TROPOS trials. Osteoporos Int 17:1781-1793 (Pubitemid 44607399)
56. Broekx S, Den HE, Torfs R, Remacle A, Mertens R, D'Hooghe T, Neven P, Christiaens MR, Simoens S (2011) The costs of breast cancer prior to and following diagnosis. Eur J Health Econ 12:311-317
57. The World Bank (2010). Global purchasing power parities and real expenditures. The World Bank Database 2010. http://data.worldbank.org/. Accessed Dec 2011
58. Statistics Belgium (2012) www.statbel.fgov.be. Accessed Oct 2012
59. Stevenson M, Davis S (2006). Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide. NICE, London
60. Brecht JG, Kruse HP, Mohrke W, Oestreich A, Huppertz E (2004) Health-economic comparison of three recommended drugs for the treatment of osteoporosis. Int J Clin Pharmacol Res 24:1-10 (Pubitemid 39535379)
61. Visentin P, Ciravegna R, Fabris F (1997) Estimating the cost per avoided hip fracture by osteoporosis treatment in Italy. Maturitas 26:185-192. doi:S0378512296010997 (Pubitemid 27209950)
62. Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Lunsjo K, Thorngren KG, Sernbo I, Rehnberg C, Jonsson B (2006) Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int 17:637-650. doi: 10.1007/s00198-010-1291-5
63. Zethraeus N, Strom O, Borgstrom F (2006) What is the risk of institutionalization after hip fracture? Osteoporos Int 17(Suppl 1):57-58
64. Gordois A, Posnett J, Borris L, Bossuyt P, Jonsson B, Levy E, de Pouvourville G (2003) The cost-effectiveness of fondaparinux compared with enoxaparin as prophylaxis against thromboembolism following major orthopedic surgery. J Thromb Haemost 1:2167-2174
65. The National Board of Health and Welfare in Sweden (2010). http://www.socialstyrelsen.se. Accessed Dec 2010
66. Gillespie P, O'Shea E, Murphy AW, Byrne MC, Byrne M, Smith SM, Cupples ME (2010) The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease. Int J Technol Assess Health Care 26:263-271
67. Autier P, Haentjens P, Bentin J, Baillon JM, Grivegnee AR, Closon MC, Boonen S (2000) Costs induced by hip fractures: a prospective controlled study in Belgium. Belgian Hip Fracture Study Group. Osteoporos Int 11:373-380 (Pubitemid 30450118)
68. Kobelt G, Berg J, Lindgren P, Izquierdo G, Sanchez-Solino O, Perez-Miranda J, Casado MA (2006) Costs and quality of life of multiple sclerosis in Spain. Eur J Health Econ 7(Suppl 2):S65-S74. doi: 10.1007/s10198-006-0381-y
69. Stadsledningskontoret. Stockholms stads budgetavräkning. 2003
70. Burstrom K, Johannesson M, Diderichsen F (2001) Swedish population health-related quality of life results using the EQ-5D. Qual Life Res 10:621-635 (Pubitemid 34056332)
71. Kind P, Dolan P, Gudex C, Williams A (1998) Variations in population health status: results from a United Kingdom national questionnaire survey. Br Med J 316:736-741 (Pubitemid 28121072)
72. Foundation NO (1998) Osteoporosis: review of the evidence for prevention, diagnosis and treatment and cost-effective analysis. Osteoorosis Int 8:1-88
73. Sobocki P, Lekander I, Borgstrom F, Strom O, Runeson B (2007) The economic burden of depression in Sweden from 1997 to 2005. Eur Psychiatry 22:146-152 (Pubitemid 46507737)
74. Zethraeus N, Borgstrom F, Jonsson B, Kanis J (2005) Reassessment of the cost-effectiveness of hormone replacement therapy in Sweden: results based on the Women's Health Initiative randomized controlled trial. Int J Technol Assess Health Care 21:433-441 (Pubitemid 41642834)
75. Ström O, Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Ceder L, Thorngren KG, Sernbo I, Jonsson B (2008) Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden. Acta Orthop 79:269-280. doi: 10.1080/17453670710015094 (Pubitemid 351878360)
76. Kanis JA, Oden A, Johnell O, Johansson H, de Laet C, Brown J, Burckhardt P, Cooper C, Christiansen C, Cummings S, Eisman JA, Fujiwara S, Gluer C, Goltzman D, Hans D, Krieg MA, La Croix A, McCloskey E, Mellstrom D, Melton LJ III, Pols H, Reeve J, Sanders K, Schott AM, Silman A, Torgerson D, van Staa T, Watts NB, Yoshimura N (2007) The use of clinical risk factors enhances the performance of BMD in the prediction of hip and osteoporotic fractures in men and women. Osteoporos Int 18:1033-1046 (Pubitemid 47020000)
77. Borgstrom F, Strom O, Coelho J, Johansson H, Oden A, McCloskey EV, Kanis JA (2010) The cost-effectiveness of risedronate in the UK for the management of osteoporosis using the FRAX. Osteoporos Int 21:495-505. doi: 10.1007/s00198-009-0989-8
78. Borgstrom F, Strom O, Coelho J, Johansson H, Oden A, McCloskey E, Kanis JA (2010) The cost-effectiveness of strontium ranelate in the UK for the management of osteoporosis. Osteoporos Int 21:339-349. doi: 10.1007/s00198-009- 0971-5
79. Ström O, Borgstrom F, Kleman M, McCloskey E, Odén A, Johansson H, Kanis J (2010). FRAX® and its applications in health economics. Cost-effectiveness and intervention thresholds. BONE 47:430-437
80. Hiligsmann M, Sedrine WB, Reginster JY (2012). Cost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women. J Bone Miner Res. doi: 10.1002/jbmr.1819
81. Darba J, Perez N, Kaskens L, Racketa J, Rejas J (2011). A cost-effectiveness model of bazedoxifene versus raloxifene for the prevention of fractures in Spanish postmenopausal women. European Congress on Osteoporosis and Osteoarthritis (ECCEO11-IOF) 2011, Valencia (Spain)
82. van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C (2000) Oral corticosteroids and fracture risk: relationship to daily and cumulative doses. Rheumatology (Oxford) 39:1383-1389 (Pubitemid 32045866)
83. Kanis JA, Johansson H, Johnell O, Oden A, de Laet C, Eisman JA, Pols H, Tenenhouse A (2005) Alcohol intake as a risk factor for fracture. Osteoporos Int 16:737-742 (Pubitemid 40933589)
84. National Services Scotland (2009). The patient journey post hip fracture: what constitutes rehabilitation? - A report from the Scottish hip fracture audit. Scottish Hip Fracture Audit 2009. http://www.shfa.scot.nhs.uk/
85. Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK (2006) Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 355:125-137. doi: 10.1056/NEJMoa062462 (Pubitemid 44050394)