Cost-effectiveness of cladribine tablets versus fingolimod in patients with highly active relapsing multiple sclerosis in Portugal

References

• Peixoto S, Abreu P. Magnetic resonance imaging conversion predictors of clinically isolated syndrome to multiple sclerosis. Acta Med Port. 2016;29(11):742–748.
   PubMed Web of Science ®Google Scholar
• World Health Organisation. Atlas of multiple sclerosis. Multiple Sclerosis International Federation, 2013.
   Google Scholar
• de Sá J, Alcalde-Cabero E, Almazan-Isla J, et al. Incidence of multiple sclerosis in Northern Lisbon, Portugal: 1998–2007. BMC Neurol. 2014;14(1):249.
   PubMedGoogle Scholar
• de Sá J. Captura-recaptura como método epidemiológico a aplicar à Esclerose Múltipla. Universidade de Lisboa: Lisboa. 2014b.
   Google Scholar
• Compston A, Coles A. Multiple sclerosis. Lancet. 2008;372(9648):1502–1517.
   PubMed Web of Science ®Google Scholar
• Harrison DM. Multiple sclerosis. Ann Intern Med. 2014;160(7):ITC4-2–ITC4-18.
   Web of Science ®Google Scholar
• Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278–286.
   PubMed Web of Science ®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
• Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777–788.
   PubMed Web of Science ®Google Scholar
• 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
• Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc. 2014;89(2):225–240.
   PubMed Web of Science ®Google Scholar
• Tsivgoulis G, Katsanos AH, Grigoriadis N, et al. The effect of disease modifying therapies on disease progression in patients with relapsing-remitting multiple sclerosis: a systematic review and meta-analysis. PLoS One. 2015;10(12):e0144538.
   PubMed Web of Science ®Google Scholar
• Goodin DS, Frohman EM, Garmany GP, Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002;58(2):169–178.
   PubMed Web of Science ®Google Scholar
• Infarmed. Orientações da Comissão Nacional de Farmácia e Terapêutica (CNFT). Utilização de fármacos para o tratamento da esclerose múltipla 2017 [updated 10 March 2017]. p. 1–3. Available from: http://www.infarmed.pt/documents/15786/1816213/4_CNFT_Esclerose+M%C3%BAltipla/69b03432-969c-4976-8ab0-7ed3f83f7940.
   Google Scholar
• European Medicines Agency. New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya: EMA/688187/2015. 18 December 2015. Available from: https://www.ema.europa.eu/en/news/new-recommendations-minimise-risks-rare-brain-infection-pml-type-skin-cancer-gilenya.
   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
• Giovannoni G, Cook S, Rammohan K, et al. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis. Lancet Neurol. 2011;10(4):329–337.
   PubMed Web of Science ®Google Scholar
• Giovannoni G, Soelberg Sorensen P, Cook S, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: results from the randomized extension trial of the CLARITY study. Mult Scler. 2018;24(12):1594–1604.
   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):522–522.
   PubMedGoogle Scholar
• Silva EA, Pinto CG, Sampaio C, et al. Orientações metodológicas para estudos de avaliação económica de medicamentos. Lisboa: Ministério da Saúde, Infarmed; 1998.
   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
• Ebers GC. Natural history of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2001;71(Suppl 2):ii16–ii19.
   PubMed Web of Science ®Google Scholar
• Warwick Evidence. Beta interferon and glatiramer acetate for treating multiple sclerosis (review of TA32) [ID809], 2016. Available from: https://www.nice.org.uk/guidance/GID-TAG529/documents/assessment-report.
   Google Scholar
• Instituto Nacional de Estatística (INE). Tábuas completas de mortalidade 2014-2016. 2017. Available from: https://www.ine.pt/xportal/xmain?xpgid=ine_main&xpid=INE&xlang=pt
   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
• Sadovnick AD, Ebers GC, Wilson RW, et al. Life expectancy in patients attending multiple sclerosis clinics. Neurology. 1992;42(5):991–994.
   PubMed Web of Science ®Google Scholar
• Pokorski RJ. Long-term survival experience of patients with multiple sclerosis. J Insur Med. 1997;29(2):101–106.
   PubMedGoogle 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. 2018;34(8):1361–1371.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya: EMA/688187/2015. 18 dezember 2015.
   Google Scholar
• Multiple Sclerosis Trust. Multiple Sclerosis Trust: Progressive multifocal leukoencephalopathy (PML). 2016. 2016.
   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
• National Institute for Health and Clinical Excellence (NICE). Technology appraisal guidance. Daclizumab for treating relapsing–remitting multiple sclerosis (TA441). [cited 2017 April 26]. Available from: https://www.nice.org.uk/guidance/ta441
   Google Scholar
• National Institute for Health and Clinical Excellence (NICE) Technology appraisal guidance. Dimethyl fumarate for treating relapsing-remitting multiple sclerosis (TA320). [cited 2014 Aug 27]. Available from: https://www.nice.org.uk/guidance/ta320.
   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
• 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(1):346.
   PubMedGoogle Scholar
• Mateus MdCC. Contributos para a avaliação económica de medicamentos em Portugal: Escola Nacional de Saúde Pública, Universidade Nova de Lisboa, Lisboa. 2010.
   Google Scholar
• Ministério da Saúde. Diário da República n° 153/2015 - Série I, Portaria n° 234 de 07 de agosto de 2015.
   Google Scholar
• Infarmed. Infomed databse [Infarmed website]; [cited 2017 Nov]. Available from: http://app7.infarmed.pt/infomed/
   Google Scholar
• Instituto Nacional Estatística (INE), Inquérito Nacional de Saúde 2014. 2016. Available from: https://www.ine.pt/xportal/xmain?xpid=INE&xpgid=ine_publicacoes&PUBLICACOESpub_boui=263714091&PUBLICACOESmodo=2&xlang=pt.
   Google Scholar
• Sá MJ, Kobelt G, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe: results for Portugal. Mult Scler. 2017;23(2_suppl):143–154.
   PubMed Web of Science ®Google Scholar
• Kobelt G, Thompson A, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017;23(8):1123–1136.
   Google Scholar
• Hawton A, Green C. Health Utilities for Multiple Sclerosis. Value Health. 2016;19:460–468.
   Google Scholar
• Mansouri S, Zayeri F. Global and regional trends of multiple sclerosis disability-adjusted life years rates: a 25-year assessment. Neuroepidemiology. 2019;52(1–2):17–24.
   PubMed Web of Science ®Google Scholar
• Lambe T, Duarte R, Mahon J, et al. Cladribine tablets for the first-line treatment of relapsing-remitting multiple sclerosis: an evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics. 2019;37:345–357.
   PubMed Web of Science ®Google Scholar