Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain

References

• Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96–120.
   PubMed Web of Science ®Google Scholar
• MSSSI: Ministerio de Sanidad, Servicios Sociales e Igualdad. Estrategia en Enfermedades Neurodegenerativas del Sistema Nacional de Salud; 2016 [cited 2018 Jun]. Available from: http://www.msps.es/organizacion/sns/planCalidadSNS/pdf/Est_Neurodegenerativas_APROBADA_C_INTERTERRITORIAL.pdf
   Google Scholar
• Bártulos M, Marzo ME, Estrella LA, et al. Estudio epidemiológico de la esclerosis múltiple en La Rioja. Neurología. 2015;30(9):552–560.
   PubMedGoogle Scholar
• Izquierdo G, Venegas A, Sanabria C, et al. Long-term epidemiology of multiple sclerosis in the Northern Seville District. Acta Neurol Scand. 2015;132(2):111–117.
   PubMed Web of Science ®Google Scholar
• Carreón-Guarnizo E, Andreu-Reinón E, Cerdán-Sánchez M, et al. Prevalencia de la esclerosis múltiple en la Región de Murcia. Rev Neurol. 2016;62(9):396–402.
   PubMed Web of Science ®Google Scholar
• Oreja-Guevara C, Kobelt G, Berg J, et al. The European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe: results for Spain. Mult Scler J. 2017;23(2S):166–178.
   PubMedGoogle Scholar
• Fernández O, Calleja-Hernández MA, Meca-Lallana J, et al. Estimate of the cost of multiple sclerosis in Spain by literature review. Expert Rev Pharmacoecon Outcomes Res. 2017;17(4):321–333.
   PubMed Web of Science ®Google Scholar
• Weinshenker BG, Bass B, Rice GP, et al. The natural history of multiple sclerosis: A geographically based study. I. Clinical course and disability. Brain. 1989;112(Pt1):133–146.
   PubMedGoogle Scholar
• Confavreux C, Vukusic S. Natural history of multiple sclerosis: A unifying concept. Brain. 2006;129(Pt3):606–616.
   PubMedGoogle Scholar
• Gilenya 0,5 mg cápsulas duras. Ficha técnica o Resumen de características del producto; [cited 2018 Apr 13]. Available from: https://cima.aemps.es/cima/dochtml/ft/11677005/FT_11677005.html
   Google Scholar
• Mavenclad 10 mg comprimidos. Ficha técnica o Resumen de características del producto; [cited 2018 Apr 13]. Available from: https://cima.aemps.es/cima/pdfs/es/ft/1171212001/FT_1171212001.pdf
   Google Scholar
• Hettle R, Harty G, Wong SL. Cost-effectiveness of cladribine tablets, alemtuzumab and natalizumab in the treatment of relapsing-remitting multiple sclerosis with high disease activity in England. J Med Econ. 2018;21(7):676–686.
   PubMed Web of Science ®Google Scholar
• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444–1452.
   PubMed Web of Science ®Google Scholar
• Palace J, Duddy M, Bregenzer T, et al. Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK multiple sclerosis risk sharing scheme at 6 years: a clinical cohort study with natural history comparator. Lancet Neurol. 2015;14(5):497–505.
   PubMed Web of Science ®Google Scholar
• Siddiqui MK, Khurana IS, Budhia S, et al. Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2017;34(8):1361–1371.
   PubMed Web of Science ®Google Scholar
• Palace J, Bregenzer T, Tremlett H, et al. UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model. BMJ Open. 2014;4(1):e004073.
   PubMed Web of Science ®Google Scholar
• 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(1):54–60.
   PubMed Web of Science ®Google Scholar
• Tan K, Roda R, Ostrow L, et al. PML-IRIS in patients with HIV infection: clinical manifestations and treatment with steroids. Neurology. 2009;72(17):1458–1464.
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comii G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402–415.
   PubMed Web of Science ®Google Scholar
• Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):416–426.
   PubMed Web of Science ®Google Scholar
• Kappos L, Radue EW, Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. New Engl J Med. 2010;362(5):387–401.
   PubMed Web of Science ®Google Scholar
• Gubieras L, Casado V, Romero-Pinel L, et al. Cost of the relapse of multiple sclerosis in Spain. Value Health. 2011;14(5):A320.
   Web of Science ®Google Scholar
• Karampampa K, Gustavsson A, Miltenburger C, et al. Treatment experience, burden and unmet needs (TRIBUNE) in MS study: results from Spain. Mult Scler. 2012;18(2 Suppl):35–39.
   PubMed Web of Science ®Google Scholar
• Saida T, Kikuchi S, Itoyama Y, et al. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012;18(9):1269–1277.
   PubMed Web of Science ®Google Scholar
• Acaster S, Perard R, Chauhan D, et al. A forgotten aspect of the NICE reference case: an observational study of the health related quality of life impact on caregivers of people with multiple sclerosis. BMC Health Serv Res. 2013;13:346.
   PubMed Web of Science ®Google Scholar
• Calabresi PA, Radue EW, Goodin D, et al. Safety and efficacy of in patients with relapsing-remittingmultiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(6):545–556.
   PubMed Web of Science ®Google Scholar
• Pakpoor J, Disanto G, Altmann DR, et al. No evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine. Neurol Neuroimmunol Neuroinflamm. 2015;2(6):e158.
   PubMed Web of Science ®Google Scholar
• Shingler S, Fordham B, Evans M, et al. Utilities for treatment-related adverse events in type 2 diabetes. J Med Econ. 2015;18(1):45–55.
   PubMed Web of Science ®Google Scholar
• Hawton A, Green C. Health utilities for multiple sclerosis. Value Health. 2016;19(4):460–468.
   PubMed Web of Science ®Google Scholar
• Trogdon JG, Ekwueme DU, Chamiec-Case L, et al. Breast cancer in young women: health State utility impacts by race/ethnicity. Am J Prev Med. 2016;50(2):262–269.
   PubMed Web of Science ®Google Scholar
• e-salud. Base de datos de costes sanitarios en España; 2017 [cited 2017 Nov]. Available from: http://www.oblikue.com/bddcostes
   Google Scholar
• BotPlus 2.0. Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF); 2018 [cited 2018 Jan 11]. Available from: www.portalfarma.com
   Google Scholar
• NICE TA312. National Institute for Health and Clinical Excellence (NICE). Alemtuzumab for treating relapsing-remitting multiple sclerosis. NICE technology appraisal guidance 312; 2014 [cited 2016 Nov]. Available from: https://www.nice.org.uk/guidance/ta312?unlid=106213045220161014202829
   Google Scholar
• Llaneza MA Epidemiología de la esclerosis múltiple en el Área sanitaria de Ferrol. Tesis doctoral Universidad de la Coruña, 2016[cited 2017 Sep 14] . Available from: http://hdl.handle.net/2183/17565
   Google Scholar
• Scolding N, Barnes D, Cader S, et al. Association of British Neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis. Pract Neurol. 2015;15(4):273–279.
   PubMedGoogle Scholar
• López-Bastida J, Oliva J, Antoñanzas F, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias. Gac Sanit. 2010;24(2):154–170.
   PubMedGoogle Scholar
• The human mortality database; [ cited 11 de abril de 2018]. Available from: http://www.mortality.org/
   Google Scholar
• Rodríguez-Antigüedad Zarranz A, Mendibe Bilbao M, Llarena González C, et al. Mortality and cause of death in multiple sclerosis: findings from a prospective population-based cohort in Bizkaia, Basque Country, Spain. Neuroepidemiology. 2014;42(4):219–225.
   PubMed Web of Science ®Google Scholar
• Real Decreto-ley 8/2010, de 20 de mayo, por el que se adoptan medidas extraordinarias para la reducción del déficit público. BOE Nº 126, Lunes 24 de mayo de 2010: 45070.
   Google Scholar
• Resolución de adjudicación. Suministro de productos y equipos necesarios para la realización de pruebas mediante Enzimoinmunoanálisis en el Laboratorio Central de la OSI Araba; [cited 2018 Sep 5]. Available from: http://www.contratacion.euskadi.eus/w32-1084/en/v79aWar/comunJSP/v79aObtenerFichero.do;jsessionid=fSLO1l59MGryeVEuGZ4GUYTIAj3qlo8pipVaKmOlpQOCubFtKA-E!-2033055975!-1619630890?identificador=140721&idTabla=007&R01HNoPortal=true
   Google Scholar
• Brazier J, Roberts J, Tsuchiya A, et al. A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ. 2004;13(9):873–884.
   PubMed Web of Science ®Google Scholar
• Horsman J, Furlong W, Feeny D, et al. The Health Utilities Index (HUI): concepts, measurement properties and applications. Health Qual Life Outcomes. 2003;1:54.
   PubMedGoogle Scholar
• Walters SJ, Brazier JE. What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health Qual Life Outcomes. 2003;1:4.
   PubMedGoogle Scholar
• Wee H-L, Machin D, Loke W-C, et al. Assessing differences in utility scores: a comparison of four widely used preference-based instruments. Value Health. 2007;10(4):256–265.
   PubMed Web of Science ®Google Scholar
• Tappenden P, Chilcott J, O’Hagan T, et al., [Internet]. Cost-effectiveness of beta interferons and glatiramer acetate in the management of multiple sclerosis: final report to the National Institute for Clinical Excellence; 2001 [cited 2018 Jan 31]. Available from: http://www.academia.edu/8908699/Cost_effectiveness_of_beta_interferons_and_glatiramer_acetate_in_the_management_of_multiple_sclerosis
   Google Scholar
• Tappenden P, McCabe C, Chilcott J, et al. Cost-effectiveness of disease-modifying therapies in the management of multiple sclerosis for the Medicare population. Value Health. 2009;12(5):657–665.
   PubMed Web of Science ®Google Scholar
• Peninsula Technology Assessment Group (PenTAG) [Internet]. The effectiveness and cost-effectiveness of natalizumab for multiple sclerosis: an evidence review of the submission from Biogen; 2007 [cited 2018 Jan 31]. Available from: https://www.nice.org.uk/guidance/ta127/resources/multiple-sclerosis-natalizumabevaluation-report-evidence-review-group-report2
   Google Scholar
• Gani R, Giovannoni G, Bates D, et al. Cost-effectiveness analyses of natalizumab (Tysabri) compared with other disease-modifying therapies for people with highly active relapsing-remitting multiple sclerosis in the UK. PharmacoEconomics. 2008;26(7):617–627.
   PubMed Web of Science ®Google Scholar
• Chilcott J, McCabe C, Tappenden P, et al. Modelling the cost-effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis. Commentary: evaluating disease modifying treatments in multiple sclerosis. BMJ. 2003;326(7388):522.
   PubMedGoogle Scholar