The Value and Sustainability of Ocrelizumab in Relapsing Multiple Sclerosis: A Cost-Effectiveness and Budget Impact Analysis

Paolo Angelo Cortesi, Damiano Paolicelli, Marco Capobianco, Paolo Cozzolino, Lorenzo Giovanni Mantovani

DOI: https://doi.org/10.7175/fe.v20i1.1435

Abstract

INTRODUCTION: The availability of ocrelizumab for the relapsing forms of multiple sclerosis (MS) in the Italian markets raised some questions about its economic impact and value compared to the alternative treatment options available.

AIM: To assess the cost-effectiveness and budget impact of ocrelizumab compared to the most used second line disease modifying therapies (DMTs) in Italy.

METHODS: The study was divided in two phases: Phase 1 – based on the development of a decision analytical Markov model to assess the cost-effectiveness of ocrelizumab compared to natalizumab and fingolimod, and Phase 2 – based on the development of a budget impact model to assess the economic impact of ocrelizumab in Italy. Both models used the National Health System perspective; a lifetime horizon was applied in the cost-effectiveness analysis and a 3-year time horizon in the budget impact. The cost-effectiveness analysis results were reported as incremental cost-effectiveness ratio (ICER) expressed as € per Quality Adjusted Life Year (QALY) gained, the budget impact analysis results were reported as difference in the overall budget (€) between a scenario with and without ocrelizumab.

RESULTS: The two analyses reported ocrelizumab as a cost-effective option compared to natalizumab and fingolimod with a positive impact on the overall NHS budget. In the base-case analysis, the ICER was € 2,023 for ocrelizumab compared to fingolimod; while ocrelizumab resulted cost-saving compared to natalizumab. The sensitivity analysis confirmed the base-case analysis results. Further, the use of ocrelizumab was associated to a budget decrease of € 21 million (-2.6%) in a 3-year time horizon.

CONCLUSION: The results of our cost-effectiveness and budget impact models reported ocrelizumab as an effective and efficient treatment in patients with relapsing forms of MS who failed a first line DMTs from the Italian NHS perspective.

Keywords

Disease Modifying Therapies; Relapsing Multiple Sclerosis; Cost-effectiveness

Full Text

HTML PDF

References

  • GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol 2017; 16: 877-97; https://doi.org/10.1016/S1474-4422(17)30299-5
  • Brownlee WJ, Hardy TA, Fazekas F, et al. Diagnosis of multiple sclerosis: progress and challenges. Lancet 2017; 389: 1336-46; https://doi.org/10.1016/S0140-6736(16)30959-X
  • Reich DS, Lucchinetti CF, Calabresi PA. Multiple Sclerosis. N Engl J Med 2018; 378: 169-80; https://doi.org/10.1056/NEJMra1401483
  • Adelman G, Rane SG, Villa KF. The cost burden of multiple sclerosis in the United States: a systematic review of the literature. J Med Econ 2013; 16: 639-47; https://doi.org/10.3111/13696998.2013.778268
  • Kobelt G, Thompson A, Berg J, et al.; MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler 2017; 23: 1123-36; https://doi.org/10.1177/1352458517694432
  • Kobelt G, Berg J, Lindgren P, et al. Costs and quality of life of patients with multiple sclerosis in Europe. J Neurol Neurosurg Psychiatry 2006; 77: 918-26; https://doi.org/10.1136/jnnp.2006.090365
  • Capra R, Cordioli C, Rasia S, et al. Assessing long-term prognosis improvement as a consequence of treatment pattern changes in MS. Mult Scler 2017; 23: 1757-61; https://doi.org/10.1177/1352458516687402
  • Hauser SL, Bar-Or A, Comi G, et al.; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med 2017; 376: 221-34; https://doi.org/10.1056/NEJMoa1601277
  • Iannazzo S, Iliza AC, Perrault L. Disease-Modifying Therapies for Multiple Sclerosis: A Systematic Literature Review of Cost-Effectiveness Studies. Pharmacoeconomics 2018; 36: 189-204; https://doi.org/10.1007/s40273-017-0577-2
  • Sanders GD, Neumann PJ, Basu A, et al. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA 2016; 316: 1093-103; https://doi.org/10.1001/jama.2016.12195
  • Cortesi PA, Belli LS, Facchetti R, et al.; European Liver and Intestine Transplant Association (ELITA). The optimal timing of hepatitis C therapy in liver transplant-eligible patients: Cost-effectiveness analysis of new opportunities. J Viral Hepat 2018; 25: 791-801; https://doi.org/10.1111/jvh.12877
  • Cottrell DA, Kremenchutzky M, Rice GP, et al. The natural history of multiple sclerosis: a geographically based study. 5. The clinical features and natural history of primary progressive multiple sclerosis. Brain 1999; 122: 625-39; https://doi.org/10.1093/brain/122.4.641
  • Kremenchutzky M, Rice GP, Baskerville J, et al. The natural history of multiple sclerosis: a geographically based study 9: observations on the progressive phase of the disease. Brain 2006; 129: 584-94; https://doi.org/10.1093/brain/awh721
  • Scalfari A, Neuhaus A, Degenhardt A, et al. The natural history of multiple sclerosis, a geographically based study 10: relapses and long-term disability. Brain 2010; 133: 1914-29; https://doi.org/10.1093/brain/awq118
  • Patzold U, Pocklington PR. Course of multiple sclerosis. First results of a prospective study carried out of 102 MS patients from 1976-1980. Acta Neurol Scand 1982; 65: 248-66; https://doi.org/10.1111/j.1600-0404.1982.tb03084.x
  • Weinshenker BG, Bass B, Rice GP, et al. The natural history of multiple sclerosis: a geographically based study. 2. Predictive value of the early clinical course. Brain 1989; 112: 1419-28; https://doi.org/10.1093/brain/112.6.1419
  • Orme M, Kerrigan J, Tyas D, et al. The effect of disease, functional status, and relapses on the utility of people with multiple sclerosis in the UK. Value Health 2007; 10: 54-60; https://doi.org/10.1111/j.1524-4733.2006.00144.x
  • National Institute For Health And Clinical Excellence – NICE. Fingolimod for the Treatment of Relapsing-Remitting Multiple Sclerosis in Adults. Revised in line with ERG responses, and updated indication, in line with CHMP opinion: Submitted 18 March 2011. Available at https://www.nice.org.uk/guidance/TA254/documents/manufacturer-submission-from-novartis2 (last accessed November 2018)
  • Pokorski RJ. Long-term survival experience of patients with multiple sclerosis. J Insur Med 1997; 29: 101-6
  • Palace J1, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, Duddy M, Dobson C. UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model. BMJ Open 2014; 4: e004073
  • Battaglia M, Kobelt G, Ponzio M, et al.; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe: Results for Italy. Mult Scler 2017; 23: 104-16; https://doi.org/10.1177/1352458517708176
  • Cozzolino P, Cortesi PA, Cesana G, et al. The Economic Burden of Different Multiple Sclerosis Phenotypes. Value in Health 2017; 20: A721; https://doi.org/10.1016/j.jval.2017.08.1934. Poster available at: https://tools.ispor.org/RESEARCH_STUDY_DIGEST/research_index.asp (last accessed July 2019)
  • Istituto Nazionale di Statistica – ISTAT. Mortality Tables 2015. Available at http://demo.istat.it/index.html (last accessed November 2018)
  • McCool R, Wilson K, Arber M, et al. Systematic review and network meta-analysis comparing ocrelizumab with other treatments for relapsing multiple sclerosis. Mult Scler Relat Disord 2019; 29: 55-61; https://doi.org/10.1016/j.msard.2018.12.040
  • Biogen Idec Ltd, Heron Evidence Development. 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. London: NICE; 2007. URL: www.nice.org.uk/guidance/TA127/documents/multiple-sclerosis-natalizumab-manufacturer-submissions-biogen-idec-uk-and-elan-pharma-international-ltd-joint-development-agreement-confidential-information-removed2 (last accessed November 2018)
  • National Institute For Health And Clinical Excellence – NICE. Alemtuzumab for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance TA312. London: NICE, 2014. Available at www.nice.org.uk/guidance/ta312 (last accessed November 2018)
  • Istituto Nazionale di Statistica – ISTAT. Calcolo delle rivalutazioni monetarie. Available at http://rivaluta.istat.it/Rivaluta/ (last accessed November 2018)
  • Agenzia Italiana del Farmaco – AIFA. Tabelle farmaci di classe A e H al 17/12/2018. Available at http://www.aifa.gov.it/content/tabelle-farmaci-di-classe-e-h-al-17122018 (last accessed December 2018)
  • AGEnzia NAzionale per i Servizi Sanitari Regionali – AGENAS. Prestazioni specialistiche ambulatoriali. Confronto tra le tariffe nazionali ex DM 18.10.2012 e le tariffe regionali vigenti al 31.10.2014. Available at http://www.agenas.it/images/agenas/monitoraggio/spesa_sanitaria/tariffe/specialistica_ambulatoriale_tariffe.pdf (last accessed November 2018)
  • Regione Emilia-Romagna. Assessorato Politiche per la Salute. Percorso regionale di diagnosi e terapia della sclerosi multipla. Maggio 2011. Available at http://www.saluter.it/documentazione/ptr/elaborati/128_sclerosi_multipla.pdf (last accessed November 2018)
  • Regione Emilia-Romagna. Assessorato Politiche per la Salute. Indicazioni per erogazione del fingolimod presso i centri sclerosi multipla dell’Emilia Romagna. Maggio 2012. Available at http://salute.regione.emilia-romagna.it/documentazione/ptr/elaborati/159_fingolimod.pdf/at_download/file/159_fingolimod.pdf (last accessed November 2018)
  • Associazione Italiana Sclerosi Multipla – AISM. Barometro della sclerosi multipla 2018
  • Atlas of MS 2013: Mapping Multiple Sclerosis Around the World. London: Multiple Sclerosis International Federation; 2013. Available at: http://www.msif.org/about-ms/publications-and-resources/ (last accessed November 2018)
  • Jick SS, Li L, Falcone GJ, et al. Mortality of patients with multiple sclerosis: a cohort study in UK primary care. J Neurol 2014; 261: 1508-17, https://doi.org/10.1007/s00415-014-7370-3
  • Istituto Nazionale di Statistica – ISTAT. Popolazione Residente per età, sesso e stato civile. Available at http://demo.istat.it/ (last accessed November 2018)
  • Cortesi PA, Cozzolino P, Cesana G, et al. The Prevalence and Treatment Status of Different Multiple Sclerosis Phenotypes in a Italian Reference Center. Value in Health 2017; 20: A720; https://doi.org/10.1016/j.jval.2017.08.1928
  • Ciaccio A, Cortesi PA, Bellelli G, et al. Direct-acting antivirals combination for elderly patients with chronic hepatitis C: A cost-effectiveness analysis. Liver Int 2017; 37: 982-94; https://doi.org/10.1111/liv.13339
  • Scottish Medicine Consortium – SMC. Ocrelizumab 300 mg concentrate for solution for infusion (Ocrevus®). Advice, November 2018. Available at https://www.scottishmedicines.org.uk/medicines-advice/ocrelizumab-ocrevus-resubmission-smc2121/ (last accessed February 2019)
  • Canadian Agency for Drugs and Technologies in Health – CADTH. Pharmacoeconomic Review Report Ocrelizumab (OCREVUS). December 2017. Available at https://www.cadth.ca/ocrelizumab (last accessed February 2019)
  • Chirikov V, Ma I, Joshi N, et al. Cost-Effectiveness of Alemtuzumab in the Treatment of Relapsing Forms of Multiple Sclerosis in the United States. Value Health 2019; 22: 168-76; https://doi.org/10.1016/j.jval.2018.08.011
  • Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting Indirect-Treatment-Comparison and Network-Meta-Analysis Studies: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices-Part 2. Value Health 2011; 14: 429-37; https://doi.org/10.1016/j.jval.2011.01.011
  • Fox EJ, Arnold DL, Cohen JA, et al. Durable efficacy of alemtuzumab on clinical outcomes over 5 years in CARE-MS II with most patients free from treatment for 4 years. Poster presented at ECTRIMS 2015.Barcelona, Spain, October 7-10, 2015
  • Havrdova E, Arnold DL, Cohen JA, et al.; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology 2017; 89: 1107-16; https://doi.org/10.1212/WNL.0000000000004313
  • Coles AJ, Habek M, Bass AD, et al. Durable efficacy of alemtuzumab over 10 years: long-term follow-up of patients with RRMS from the CAMMS223 Study. Neurology 2016; 78: P3.053
  • Tappenden P, McCabe C, Chilcott J, et al. Cost-effectiveness of diseasemodifying therapies in the management of multiple sclerosis for the Medicare population. Value Health 2009; 12: 657e65; https://doi.org/10.1111/j.1524-4733.2008.00485.x

Statistics

Abstract: 68 views
HTML: 9 views
PDF: 29 views

Refbacks

  • There are currently no refbacks.




© SEEd srl