References
- Mackenzie IS, Morant SV, Bloomfield GA, et al. Incidence and prevalence of multiple sclerosis in the UK 1990–2010: a descriptive study in the General Practice Research Database. J Neurol Neurosurg Psychiatry 2014;85:76-84
- Hooper K. Managing progressive MS. National Multiple Sclerosis Society. Available at: https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Managing-Progressive-MS.pdf [Last accessed 12 March 2018]
- Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology 1996;46:907-11
- Tremlett H, Zhu F, Petkau J, et al. Natural, innate improvements in multiple sclerosis disability. Mult Scler 2012;18:1412-21
- National Institute for Health and Care Excellence. TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis. Available at: http://www.nice.org.uk/guidance/ta303/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA312: Alemtuzumab for treating relapsing–remitting multiple sclerosis. Available at: http://www.nice.org.uk/guidance/ta312/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis. Available at: http://www.nice.org.uk/guidance/ta127/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA320: Dimethyl fumarate for treating relapsing–remitting multiple sclerosis. Available at: http://www.nice.org.uk/guidance/ta320/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA254: Fingolimod for the treatment of adults with highly active relapsing–remitting multiple sclerosis. Available at: http://www.nice.org.uk/guidance/ta254/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA32: Beta interferon and glatiramer acetate for the treatment of multiple sclerosis. Available at: https://www.nice.org.uk/guidance/TA320/documents/multiple-sclerosis-relapsingremitting-dimethyl-fumarate-evaluation-report2 [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA493: Cladribine tablets for treatment of relapsing–remitting multiple sclerosis. Available at: https://www.nice.org.uk/guidance/ta493 [Last accessed 12 March 2018]
- European Medicines Agency. Gilenya 0.5 mg hard capsules. Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Informa-tion/human/002202/WC500104528.pdf [Last accessed 12 March 2018]
- Caro JJ, Briggs AH, Siebert U, et al. Modeling good research practices – overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1. Value Health 2012;15:796-803
- Guo S, Pelligra C, Saint-Laurent Thibault C, et al. Cost-effectiveness analyses in multiple sclerosis: a review of modelling approaches. PharmacoEconomics 2014;32:559-72
- Brennan A, Chick SE, Davies R. A taxonomy of model structures for economic evaluation of health technologies. Health Econ 2006;15:1295-310
- National Institute for Health and Care Excellence. TSD 13: Identifying and reviewing evidence to inform the conceptualisation and population of cost-effectiveness models. Available at: http://nicedsu.org.uk/technical-support-documents/reviewing-model-parameters-tsd/ [Last accessed 12 March 2018]
- Institute for Clinical and Economic Review. Multiple Sclerosis: Evidence Report. Available at: https://icer-review.org/material/ms-evidence-report/ [Last accessed 12 March 2018]
- Barton P, Bryan S, Robinson S. Modelling in the economic evaluation of health care: selecting the appropriate approach. J Health Serv Res Policy 2004;9:110-18
- Briggs A, Sculpher M. An introduction to Markov modelling for economic evaluation. Pharmacoeconomics 1998;13:397-409
- Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993;13:322-38
- Allen F, Montgomery S, Maruszczak M, et al. Convergence yet continued complexity: a systematic review and critique of health economic models of relapsing–remitting multiple sclerosis in the United Kingdom. Value Health 2015;18:925-38
- Maruszczak MJ, Montgomery SM, Griffiths MJ, et al. Cost-utility of fingolimod compared with dimethyl fumarate in highly active relapsing–remitting multiple sclerosis (RRMS) in England. J Med Econ 2015;18:874-85
- Montgomery SM, Maruszczak MJ, Slater D, et al. A discrete event simulation to model the cost-utility of fingolimod and natalizumab in rapidly evolving severe relapsing–remitting multiple sclerosis in the UK. J Med Econ 2017;20:474-82
- Montgomery SM, Kusel J, Nicholas R, et al. Costs and effectiveness of fingolimod versus alemtuzumab in the treatment of highly active relapsing–remitting multiple sclerosis in the UK: re-treatment, discount, and disutility. J Med Econ 2017;20:962-73
- Caro JJ, Moller J. Advantages and disadvantages of discrete-event simulation for health economic analyses. Expert Rev Pharmacoecon Outcomes Res 2016;16:327-9
- Novartis Pharmaceuticals UK Ltd. Fingolimod for the treatment of relapsing–remitting multiple sclerosis in adults. Manufacturer submission of evidence to NICE. Available at: https://www.nice.org.uk/guidance/ta254/documents/manufacturer-submission-from-novartis2 [Last accessed 12 March 2018]
- Scottish Medicines Consortium (SMC). ID 992/14: fingolimod (Gilenya) – Detailed Advice. Available at: https://www.scottishmedicines.org.uk/files/advice/fingolimod_Gilenya_FINAL_August_2014_Amended_03.09.14_for_website.pdf [Last accessed 12 March 2018]
- All Wales Medicines Strategy Group. Fingolimod (Gilenya) 3135 ASAR. Available at: http://www.awmsg.org/awmsgonline/grabber;jsessionid=47406cb3dcacc349d2e16a69d976?resId=2479 [Last accessed 12 March 2018]
- Scottish Medicines Consortium (SMC). ID 1038/15: fingolimod (Gilenya) Detailed Advice. Available at: https://www.scottishmedicines.org.uk/files/advice/fingolimod__Gilenya__FINAL_March_2015_Amended_070415_for_website.pdf [Last accessed 12 March 2018]
- Khatri BO, Garland J, Berger J, et al. The effect of dimethyl fumarate (Tecfidera) on lymphocyte counts: A potential contributor to progressive multifocal leukoencephalopathy risk. Mult Scler Relat Disord 2015;4:377-9
- Putzki N. Characteristics of PML cases in multiple sclerosis patients switching to fingolimod from natalizumab. Presented at the 6th Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis, Boston, MA, 10–13 September 2014
- European Medicines Agency. Lemtrada 12 mg concentrate for solution for infusion. Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf [Last accessed 12 March 2018]
- Coles AJ, Arnold D, Cohen JA, et al. Patients with active RRMS and an inadequate response to prior therapy demonstrate durable improvements in relapse and disability following treatment with alemtuzumab: 5-year follow-up of the CARE-MS II study. Presented at the 68th Annual Meeting of the American Academy of Neurology, Vancouver, BC, Canada, 15–21 April 2016
- Genzyme. Alemtuzumab for the treatment of relapsing remitting multiple sclerosis in adults. Manufacturer submission of evidence to NICE. Available at: https://www.nice.org.uk/guidance/ta312/documents/multiple-sclerosis-relapsingremitting-alemtuzumab-evaluation-report4 [Last accessed 12 March 2018]
- Tuohy O, Costelloe L, Hill-Cawthorne G, et al. Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J Neurol Neurosurg Psychiatry 2015;86:208-15
- Kappos L, Radue EW, O’Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401
- Calabresi PA, Radue EW, Goodin D, et al. Safety and efficacy of fingolimod in patients with relapsing–remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol 2014;13:545-56
- Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
- 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;112:133-46
- European Medicines Agency. Tecfidera: EPAR – Public assessment report. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002601/WC500162070.pdf [Last accessed 12 March 2018]
- Derfuss T, Bergvall NK, Sfikas N, et al. Efficacy of fingolimod in patients with highly active relapsing–remitting multiple sclerosis. Curr Med Res Opin 2015;31:1687-91
- Hutchinson M, Kappos L, Calabresi PA, et al. The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. J Neurol 2009;256:405-15
- National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. Available at: https://www.nice.org.uk/process/pmg9/ [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. List of technologies with approved Patient Access Schemes. Available at: https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit/list-of-technologies-with-approved-patient-access-schemes [Last accessed 12 March 2018]
- National Health Service. National tariff payment system 2016/17. Available at: https://www.gov.uk/government/publications/nhs-national-tariff-payment-system-201617 [Last accessed 12 March 2018]
- Biogen Idec Ltd. Natalizumab (Tysabri) for the Treatment of Adults with Highly Active Relapsing Remitting Multiple Sclerosis. Manufacturer submission of evidence to NICE. Available at: https://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 12 March 2018]
- Biogen Idec Ltd. Dimethyl fumarate for the treatment of adult patients with relapsing remitting multiple sclerosis. Manufacturer submission of evidence to NICE. Available at: https://www.nice.org.uk/guidance/ta320/documents/multiple-sclerosis-relapsingremitting-dimethyl-fumarate-evaluation-report2 [Last accessed 12 March 2018]
- All Wales Medicines Strategy Group. Reference No. 3135, fingolimod (Gilenya). Available at: http://www.awmsg.org/awmsgonline/app/appraisalinfo/3135 [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA494: Naltrexone–bupropion for managing overweight and obesity. Available at: https://www.nice.org.uk/guidance/TA494 [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed. Updated technology assessment report. Available at: https://www.nice.org.uk/guidance/TA375/documents/rheumatoid-arthritis-adalimumab-etanercept-infliximab-certolizumab-pegol-gol-imumab-abatacept-and-tocilizumab-review-appendix-1-updated-assessment-report2 [Last accessed 12 March 2018]
- National Institute for Health and Care Excellence. TA415: Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor. Evidence review report. Available at: https://www.nice.org.uk/guidance/TA415/documents/committee-papers [Last accessed 12 March 2018]
- Karnon J, Haji Ali Afzali H. When to use discrete event simulation (DES) for the economic evaluation of health technologies? A review and critique of the costs and benefits of DES. PharmacoEconomics 2014;32:547-58
- Bergvall N, Sfikas N, Chin P, et al. Efficacy of fingolimod in pre-treated patients with disease activity: pooled analyses of FREEDOMS and FREEDOMS II (P3.174). Neurology 2014;82:P3.174
- Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012;380:1829-39
- Curtis L, Burns A. Unit Costs of Health and Social Care 2016. Available at: http://www.pssru.ac.uk/project-pages/unit-costs/2016/index.php?file=full [Last accessed 18 April 2017]
- Dong-Si T, Gheuens S, Gangadharan A, et al. Predictors of survival and functional outcomes in natalizumab-associated progressive multifocal leukoencephalopathy. J Neurovirol 2015;21:637-44
- NHS England. NHS standard contract for adult kidney transplant service. Schedule 2 – The Services A. Service Specifications. Available at: https://www.england.nhs.uk/wp-content/uploads/2014/04/a07-renal-transpl-ad-0414.pdf [Last accessed 12 March 2018]
- The National Kidney Federation. Transplantation Cost Effectiveness. Available at: http://www.kidney.org.uk/archives/news-archive-2/campaigns-transplantation-trans-cost-effect/ [Last accessed 25 January 2016]
- McGuigan C, Craner M, Guadagno J, et al. Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group. J Neurol Neurosurg Psychiatry 2016;87:117-25
- 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
- Petrou S, Hockley C. An investigation into the empirical validity of the EQ-5D and SF-6D based on hypothetical preferences in a general population. Health Econ 2005;14:1169-89
- Currie CJ, McEwan P, Peters JR, et al. The routine collation of health outcomes data from hospital treated subjects in the Health Outcomes Data Repository (HODaR): descriptive analysis from the first 20,000 subjects. Value Health 2005;8:581-90
- Biogen Idec Ltd. Reactive presentation for healthcare professionals (approval number: TY-PAN-0683(2) Date: September 2015). Available at: http://multiple-sclerosis-research.blogspot.com/2015/12/clinicspeak-natalizumab-pml-risk-update.html [Last accessed 23 March 2018]
- Havrdova E, Horakova D, Kovarova I. Alemtuzumab in the treatment of multiple sclerosis: key clinical trial results and considerations for use. Ther Adv Neurol Disord 2015;8:31-45
- Twyman C, Oyuela P, Palmer J, et al. Thyroid autoimmune adverse events in patients treated with alemtuzumab for relapsing–remitting multiple sclerosis: four-year follow-up of the CARE-MS studies (P2.199). Neurology 2014;82
- Gordois A, Nobes M, Toohey M, et al. Cost-effectiveness of sirolimus therapy with early cyclosporin withdrawal vs. long-term cyclosporin therapy in Australia. Clin Transplant 2006;20:526-36
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107
- Lloyd A, Nafees B, Narewska J, et al. Health state utilities for metastatic breast cancer. Br J Cancer 2006;95:683-90