Intervention thresholds for denosumab in the UK using a FRAX®-based cost-effectiveness analysis
The objective was to undertake a health economic analysis of denosumab for the treatment of osteoporosis in women from the UK, using the FRAX® tool. Denosumab was cost-effective in women with a risk of major osteoporotic fracture meeting or exceeding approximately 20 % who are unable to take, comply with or tolerate generic alendronate.
Denosumab is a novel biologic agent developed for the treatment of osteoporosis, which has been shown to reduce the risk of fractures in a phase-III trial. The objective of the present study was to undertake a health economic analysis of denosumab in women from the UK. Ten-year probabilities of a major osteoporotic fracture at which denosumab is a cost-effective alternative to no treatment, generic alendronate, risedronate and strontium ranelate were estimated.
A previously published Markov model was adapted to incorporate fracture and mortality risk assessments based on absolute fracture probability, as estimated by FRAX®. The model included treatment persistence and residual effect after discontinuation.
At a willingness-to-pay (WTP) of £30,000 per quality-adjusted life year and a 10-year fracture probability equivalent to a woman with a prior fragility fracture, denosumab was cost-effective compared to no treatment from the age of 70 years. At the same WTP, denosumab was—irrespective of age—cost-effective compared to no treatment at a major osteoporotic fracture probability of approximately 20 %. Denosumab was estimated to cost-effectively replace strontium, risedronate and generic alendronate at 10-year probabilities exceeding 11, 19 and 32 %, respectively.
FRAX® facilitates the estimation of cost-effectiveness-based intervention thresholds applicable to patients with different combinations of clinical risk factors, which more closely matches the situation in clinical practice. Denosumab is cost-effective in patients with major osteoporotic fracture probabilities meeting or exceeding approximately 20 % who are unable to take, comply with or tolerate generic alendronate.
KeywordsCost-effectiveness Denosumab Fracture FRAX Osteoporosis
- 1.Kanis J (2008) Assessment of osteoporosis at the primary health-care level. Technical Report. WHO Collaborating Centre, University of Sheffield, UKGoogle Scholar
- 5.Association Suisse contre l‘Osteoporose (2011) Osteoporose: Recommandations 2010. BernGoogle Scholar
- 7.Grossman JM et al (2010) American College of Rheumatology 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care Res (Hoboken) 62:15–26Google Scholar
- 8.NOF (2008) Physician's guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DCGoogle Scholar
- 9.Socialstyrelsen (2010) Nationella riktlinjer för rörelseorganens sjukdomar 2012. Osteoporos, artros, inflammatorisk ryggsjukdom och ankyloserande spondylit, psoriasisartrit och reumatoid artrit. Stöd för styrning och ledning. 1-116. PubliceradGoogle Scholar
- 11.U.S. Preventive Services Task Force (2011) Screening for osteoporosis: U.S. preventive services task force recommendation statement. Ann Intern Med 154(5):356–364Google Scholar
- 15.National Osteoporosis Foundation (2008) Clinician's guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington, DCGoogle Scholar
- 16.National Institute for Health and Clinical Excellence (2010) Final appraisal determination 160. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women. National Institute for Health and Clinical Excellence, LondonGoogle Scholar
- 17.National Institute for Health and Clinical Excellence (2010) Final appraisal determination 161. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. National Institute for Health and Clinical Excellence, LondonGoogle Scholar
- 18.National Institute for Health and Clinical Excellence (2010) Technology appraisals TA204: Osteoporotic fractures—denosumab. Accessed 5 June 2011; http://guidance.nice.org.uk/TA204
- 19.Kanis J et al (2010) An evaluation of the NICE guidance for the prevention of osteoporotic fragility fractures in postmenopausal women. Arch Osteoporos. doi:10.1007/s11657-010-0045-5
- 24.Li L et al (2010) Non-persistence to anti-osteoporosis medications in the UK using the general practice research database (GPRD) Rheumatology 49 Supplement 1 (OP54)Google Scholar
- 28.NICE (2008) Guide to the methods of technology appraisal. http://www.nice.org.uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf. Accessed 18 Jan 2012
- 34.National Institute for Health and Clinical Excellence (2008) Systematic reviews of clinical effectiveness prepared for the guideline osteoporosis: “assessment of fracture risk and the prevention of osteoporotic fractures in individuals at high risk”. http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11621. Accessed 12 March 2011
- 36.Stevenson M, Davis S (2006) Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide. Accessed 13 May 2008; http://www.nice.org.uk/page.aspx?o=370643
- 41.National Statistics: The official UK statistics site. www.statistics.gov.uk. Accessed 14 January 2011
- 47.Curtis L (2010) Unit Costs of Health and Social Care. http://www.pssru.ac.uk/pdf/uc/uc2010/uc2010.pdf. Accessed 1 Dec 2010
- 49.Swedish National Inpatient Register and Causes of Death Register, The Swedish National Board of Health Centre - The Epidemiological Centre, http://www.sos.se/epc/epceng.htm. Accessed 1 Dec 2011
- 57.Stevenson M, Davis S (2006) Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide (NICE). The University of Sheffield, School of Health and Related Research, SheffieldGoogle Scholar
- 67.Kanis JA et al (2011) A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos IntGoogle Scholar
- 70.McCloskey EV, Johansson H, Oden A, (2012) Denosumab reduces the risk of all osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX®. J Bone Miner Res. doi:10.1002/jbmr.1606