Cost effectiveness of glatiramer acetate and natalizumab in relapsing-remitting multiple sclerosis
- First Online:
Disease-modifying drugs are a significant expenditure for treating multiple sclerosis. Natalizumab (NZ) has been shown to be effective in reducing relapses and disease progression. However, assessment of the cost effectiveness of NZ compared with other disease-modifying drugs in the presence of long-term data has been limited.
To assess the lifetime cost effectiveness from the US healthcare and societal perspectives of glatiramer acetate (GA) and NZ (both given with symptom management) relative to symptom management alone in patients with relapsing-remitting multiple sclerosis (RRMS) using evidence from long-term published studies.
A Markov model was developed with patients transitioning through health states based on Kurtzke’s expanded disability status scale (EDSS). Patients were ≥18 years of age with RRMS, EDSS <6.0 and receiving treatment. Treatment effects were obtained from clinical trials for years 1 and 2 of therapy and long-term clinical assessments thereafter. Transitions were adjusted for discontinuation and persistent NZ antibodies. Patients incurred drug, other medical and lost worker productivity costs. Patient quality of life was considered in the form of utilities, which were taken from assessments of patients with MS. Costs were valued in 2007 $US, and costs and outcomes were discounted at 3% per annum. Various parameters and assumptions were tested in one-way sensitivity analyses, and scenario-based analyses were also performed.
Remaining lifetime, direct medical costs for patients receiving GA or NZ versus symptom management were $US408 000, $US422208 and $US341 436, respectively. Patients receiving GA or NZ benefited from increased years in EDSS 0.0–5.5 (1.18 and 1.09, respectively), years relapse-free (1.30 and 1.18) and QALYs (0.1341 and 0.1332). The incremental cost per QALY for GA or NZ compared with symptom management was $US496 222 and $US606 228, respectively, excluding lost worker productivity costs. GA was associated with a cost saving compared with NZ. The incremental cost per QALY results were sensitive to changes in time horizon, disease progression and drug costs. Improved QALYs for NZ were sensitive to changes in the clinical effect of NZ on disease progression and discontinuation over time.
GA or NZ in RRMS patients is associated with increased benefits compared with symptom management, albeit at higher costs. Although year 1 and 2 disease progression and relapse rates were better for NZ than GA, long-term evidence may show GA to have similar, if not improved, clinical benefit.
- 2.National Multiple Sclerosis Society. National MS Society information sourcebook [online]. Available from URL: http://nationalmssociety.org/sourcebook.asp [Accessed 2007 Nov 1]
- 21.RxList.com. Tysabri® (natalizumab) product description [online]. Available from URL: http://www.rxlist.com/cgi/generic/tysabri.htm [Accessed 2007 Apr 2]
- 24.Biogen Idec. Natalizumab (Tysabri®) for the treatment of adults with highly active relapsing remitting multiple sclerosis. Biogen Idec single technology appraisal (STA) submission to the National Institute for Health and Clinical Excellence [online]. Available from URL: http://guidance.nice.org.uk/page.aspx?o=419040 [Accessed 2007 Apr 11]
- 25.Tappenden P, Chilcott J, O’Hagan T, et al. Cost-effectiveness of beta interferons and glatiramer acetate in the management of multiple sclerosis. Final report to the National Institute for Clinical Excellence. Centre for Bayesian Statistics in Health Economics. Sheffield: University of Sheffield, 2001 JulGoogle Scholar
- 26.Tappenden P, McCabe C, Simpson E, et al. The clinical and cost-effectiveness of beta interferons and glatiramer acetate in the management of relapsing/remitting and secondary-progressive multiple sclerosis. Report to the Centers for Medicare and Medicaid on behalf of the US Agency for Healthcare Research and Quality. Sheffield: University of Sheffield, 2005 DecGoogle Scholar
- 27.Oleen-Burkey M, Kobelt G, Borgstrom F. Costs and quality of life of patients with relapsing-remitting multiple sclerosis currently on immunomodulatory therapy in the United States [presentation]. International Committee on Databases in Multiple Sclerosis 2003 Conference; 2003 May 30; San Diego (CA)Google Scholar
- 35.Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsingremitting multiple sclerosis: results of a phase III multi-center, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45(7): 1268–76PubMedCrossRefGoogle Scholar
- 38.Gold M, Siegel JE, Russell LB, et al., editors. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996Google Scholar
- 44.US Department of Labor, Bureau of Labor Statistics. Consumer price index: all urban consumers (current series) [online]. Available from URL: http://data.bls.gov/PDQ/outside.jsp?survey=cu [Accessed 2007 Jun 13]
- 45.RxList.com. Copaxone (glatiramer acetate) product description [online]. Available from URL: http://www.rxlist.com/cgi/generic/glatiramer.htm [Accessed 2007 Apr 2]
- 46.Red Book for Windows [computer program]. Windows Version 61129, Vol. 44. Montvale (NJ): Thomson PDR, 2007Google Scholar
- 47.US Department of Health and Human Services. Tysabri® risk minimization action plan: summary of TOUCH [online]. Available from URL: http://www/fda/gov/cder/drug/infopage/natalizumab/RiskMAP.pdf [Accessed 2007 Apr 9]
- 48.US Department of Health and Human Services, Agency for Healthcare Research and Quality. HCUPnet [online]. Available from URL: http://hcupnet.ahrq.gov [Accessed 2007 May 31]
- 49.McCormmick M. Infusion billing update: 2006 opportunities to ensure proper reimbursement and program success [online]. Available from URL: http://www.aan.com/professionals/coding/pdfs/aan_infusion_billing_06.pdf [Accessed 2007 Apr 6]
- 50.Ingenix Inc. The 2007 essential RBRVS: a comprehensive listing of RBRVS values for CPT and HCPCS codes. Salt Lake City (UT): Ingenix, Inc, 2006Google Scholar
- 53.US Department of Labor, Bureau of Labor and Statistics. Employer costs for employee compensation, March 2007 [online]. Available from URL: http://www.bls.gov/ncs/ect/home.htm [Accessed 2007 Jun 21]
- 54.Hoyert DL, Heron MP, Murphy SL, et al. Deaths: final data for 2003. National Vital Statistics Reports Vol. 54, no. 13. Hyattsville (MD): National Center for Health Statistics, 2006Google Scholar
- 56.Weinstein MC. From cost-effectiveness ratios to resource allocation: where to draw the line. In: Sloan FA, editor. Valuing health care: costs, benefits, and effectiveness of pharmaceuticals and other medical technologies. New York: Cambridge University Press, 1995Google Scholar