Multiple sclerosis cost-effectiveness of therapy
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Fahimeh Shojaei, M.D., Julinka Auta Fernandes
Overview
Multiple sclerosis is associated with substantial lifelong direct medical, direct non-medical, and indirect costs. Important cost drivers include disease-modifying therapies, other health and social care, reduced employment and productivity, and paid or unpaid caregiving. Costs generally increase as disability accumulates.[1][2][3]
The cost-effectiveness of therapy depends on the population, comparator, jurisdiction, analytic perspective, treatment costs, time horizon, expected benefits and harms, and willingness-to-pay threshold. Cost-effectiveness, health-system budget impact, and patient affordability are distinct considerations.[4][5]
The American Academy of Neurology recommends considering patients' cost-related preferences alongside efficacy, safety, tolerability, route of administration, and lifestyle when selecting a disease-modifying therapy.[6]
Cost effectiveness
Methods and interpretation
- A cost-effectiveness analysis compares the incremental costs and health outcomes of an intervention with a relevant alternative. Cost-utility analyses commonly report an incremental cost per quality-adjusted life year (QALY) gained.[4][5]
- Relevant costs may include acquisition, administration, monitoring, treatment-related adverse events, relapse management, disability-related care, rehabilitation, equipment, and long-term support. A societal analysis may additionally include lost productivity, informal caregiving, and other non-medical costs.[5][3]
- Interpretation requires the population, comparator, perspective, currency and price year, time horizon, discount rate, assumptions, uncertainty, funding, and conflicts of interest to be reported transparently. The Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement provides reporting guidance; it is not a treatment recommendation or a measure of methodological quality.[5]
- Net acquisition prices, administration costs, and commercial arrangements affect economic results; comparisons using public list prices may not reflect the prices paid by a health system.[4]
- Budget impact addresses whether a health system can afford adoption at the expected population scale; a therapy can be cost-effective but have a large budget impact, or have a modest budget impact without being cost-effective.[4]
Economic burden and cost drivers
- In the United States, the total economic burden attributable to MS in 2019 was estimated at US$85.4 billion: US$63.3 billion in direct medical costs and US$22.1 billion in indirect and non-medical costs. These historical estimates describe annual societal burden, not lifetime treatment expenditure for an individual.[1]
- A study published in 2017 covering 16 European countries reported mean annual societal costs per person of approximately €22,800 in mild disease, €37,100 in moderate disease, and €57,500 in severe disease, expressed in 2015 euros adjusted for purchasing-power parity. The results demonstrate the association between disability and cost; they are not current national treatment prices.[2]
- A 2026 review of recent cost-of-illness studies identified disease-modifying medicine expenditure and productivity loss as major direct and indirect cost drivers, respectively, while also emphasizing variation among countries and the frequent underestimation of non-medical and caregiver costs.[3]
- Relapses increase healthcare use and productivity loss, while disability contributes substantially to long-term costs. Preventing these outcomes may reduce downstream expenditure, but does not necessarily make a therapy cost-saving or cost-effective once treatment costs and harms are included.[2][4]
Disease-modifying therapies
Economic conclusions about disease-modifying therapies are specific to the population, comparator, prices, and assumptions evaluated. A change in generic or biosimilar availability, negotiated prices, or treatment sequence can alter the result.[4]
United States
The Institute for Clinical and Economic Review (ICER), an independent US health-technology-assessment organization, assessed therapies for relapsing MS in 2023. At the modeled prices, natalizumab, ocrelizumab, ofatumumab, and ublituximab each exceeded US$150,000 per QALY gained compared with generic dimethyl fumarate. These are historical model results, not a current ranking of the therapies.[7]
Across these therapies, annual QALY-based threshold prices spanned US$16,500–32,700 at willingness-to-pay thresholds of US$100,000–150,000 per QALY gained. The report's broader US$16,500–34,900 benchmark also incorporated equal-value life-year analyses. These modeled prices are not current market prices or patient out-of-pocket costs.[7]
ICER reports provide independent economic assessments rather than federal prescribing guidelines or coverage mandates.[7]
Europe
The joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)/European Academy of Neurology (EAN) clinical guideline provides European pharmacological-treatment recommendations but does not replace country-specific regulation, reimbursement, or health-technology assessment. Consequently, a therapy considered cost-effective in one European health system should not automatically be described as cost-effective in another.[8]
In England, National Institute for Health and Care Excellence (NICE) makes product-, indication-, and comparator-specific recommendations, often incorporating commercial arrangements:
- NICE technology appraisal TA527 supported specified interferon beta-1a, interferon beta-1b, and glatiramer acetate products for defined populations under commercial arrangements. Interferon beta-1b marketed as Betaferon was not considered cost-effective under the appraisal's assumptions. These findings are product- and setting-specific.[9]
- NICE technology appraisal TA1126 reached different recommendations for originator and biosimilar natalizumab and for intravenous and subcutaneous presentations in a defined population. This illustrates why cost-effectiveness conclusions may differ among presentations and originator or biosimilar products.[10]
Conclusions
MS-related costs vary with disability, disease course, health system, calendar year, and the components included in an analysis. A single lifetime-cost figure is therefore not generalizable to all patients or settings.[1][3]
Population-level cost-effectiveness does not establish affordability for an individual patient. Economic evidence complements assessment of clinical benefit, safety, access, and patient preferences.[6][7]
References
- ↑ 1.0 1.1 1.2 Bebo B, Cintina I, LaRocca N, Ritter L, Talente B, Hartung D, Ngorsuraches S, Wallin M, Yang G (3 May 2022). "Economic Burden of Multiple Sclerosis in the United States: Estimate of Direct and Indirect Costs". Neurology. 98 (18): e1810–e1817. doi:10.1212/WNL.0000000000200150. PMC 9109149 Check
|pmc=value (help). PMID 35418457 Check|pmid=value (help). - ↑ 2.0 2.1 2.2 Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J (July 2017). "New insights into the burden and costs of multiple sclerosis in Europe". Mult Scler. 23 (8): 1123–1136. doi:10.1177/1352458517694432. PMC 5476197. PMID 28273775.
- ↑ 3.0 3.1 3.2 3.3 Lanza-León P, Cantarero-Prieto D, Coca de Pablo D, Colón López de Dicastillo A, Tarquini Rodríguez L, Riancho J (3 March 2026). "An updated review of the economic burden of multiple sclerosis: direct and indirect costs". Front Immunol. 17: 1678055. doi:10.3389/fimmu.2026.1678055. PMC 12992015 Check
|pmc=value (help). - ↑ 4.0 4.1 4.2 4.3 4.4 4.5 National Institute for Health and Care Excellence (31 January 2022). "NICE technology appraisal and highly specialised technologies guidance: the manual—economic evaluation". Process and methods [PMG36]. National Institute for Health and Care Excellence. Retrieved 31 August 2026.
- ↑ 5.0 5.1 5.2 5.3 Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S (January 2022). "Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations". BMJ. 376: e067975. doi:10.1136/bmj-2021-067975. PMC 8749494 Check
|pmc=value (help). PMID 35017145 Check|pmid=value (help). - ↑ 6.0 6.1 Rae-Grant A, Day GS, Marrie RA, et al. (April 2018). "Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis". Neurology. 90 (17): 777–788. doi:10.1212/WNL.0000000000005347. PMID 29686116.
- ↑ 7.0 7.1 7.2 7.3 Lin GA, Whittington MD, Nikitin D, Agboola F, McKenna A, Herron-Smith S, Pearson SD, Campbell J (21 February 2023). "Oral and Monoclonal Antibody Treatments for Relapsing Forms of Multiple Sclerosis: Effectiveness and Value—Final Evidence Report" (PDF). Status update 15 May 2024. Institute for Clinical and Economic Review. Retrieved 1 September 2026.
- ↑ Montalban X, Gold R, Thompson AJ, et al. (February 2018). "ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis". Mult Scler. 24 (2): 96–120. doi:10.1177/1352458517751049. PMID 29353550.
- ↑ National Institute for Health and Care Excellence (27 June 2018). "Beta interferons and glatiramer acetate for treating multiple sclerosis". Technology appraisal guidance [TA527]. National Institute for Health and Care Excellence. Retrieved 31 August 2026.
- ↑ National Institute for Health and Care Excellence (28 January 2026). "Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy". Technology appraisal guidance [TA1126]. National Institute for Health and Care Excellence. Retrieved 31 August 2026.