1,134
Views
16
CrossRef citations to date
0
Altmetric
Neurology

A discrete event simulation to model the cost-utility of fingolimod and natalizumab in rapidly evolving severe relapsing-remitting multiple sclerosis in the UK

, , , , &
Pages 474-482 | Received 01 Nov 2016, Accepted 20 Dec 2016, Published online: 23 Jan 2017

References

  • Summary of Product Characteristics: Gilenya 0.5 mg hard capsules. London: European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf. Accessed October 30, 2015
  • Summary of Product Characteristics: Tysabri 300 mg concentrate for solution for infusion. London: European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000603/WC500044686.pdf. Accessed October 30, 2015
  • 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
  • Kingwell E, Marriott JJ, Jette N, et al. Incidence and prevalence of multiple sclerosis in Europe: a systematic review. BMC Neurol 2013;13:128
  • Miller D, Barkhof F, Montalban X, et al. Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history, pathogenesis, diagnosis, and prognosis. Lancet Neurol 2005;4:281-8
  • Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology 2014;83:278-86
  • Gani R, Nixon RM, Hughes S, et al. Estimating the rates of disability progression in people with active relapsing-remitting multiple sclerosis. J Med Econ 2007;10:79-89
  • McCrone P, Heslin M, Knapp M, et al. Multiple sclerosis in the UK: service use, costs, quality of life and disability. Pharmacoeconomics 2008;26:847-60
  • Montgomery S, Kusel J, Allen F, et al. Paucity and inconsistency: a systematic review and critique of budget impact analyses of disease-modifying therapies for multiple sclerosis in the UK and the implications for policy in the UK. Appl Health Econ Health Policy 2016;14:545-58
  • National Institute for Health and Care Excellence. Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis (TA127). London, UK: NICE; 2007
  • Scottish Medicines Consortium. Natalizumab 300 mg concentrate for solution for infusion (Tysabri). NHS Scotland: Glasgow; 2007
  • Scottish Medicines Consortium. Fingolimod (Gilenya). NHS Scotland: Glasgow; 2014
  • Polman CH, O’Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006;354:899-910
  • Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354:911-23
  • 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
  • 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
  • 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
  • National Institute for Health and Care Excellence. Alemtuzumab for treating relapsing-remitting multiple sclerosis (TA312). London, UK: NICE; 2014
  • Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012;380:1819-28
  • 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
  • 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
  • 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
  • Caro JJ, Moller J. Advantages and disadvantages of discrete-event simulation for health economic analyses. Expert Rev Pharmacoecon Outcomes Res 2016;16:327-9
  • 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
  • National Institute for Health and Care Excellence. Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis (TA254). London, UK: NICE; 2012
  • National Institute for Health and Care Excellence. Teriflunomide for treating relapsing-remitting multiple sclerosis (TA303). London, UK: NICE; 2014
  • National Institute for Health and Care Excellence. Dimethyl fumarate for treating relapsing-remitting multiple sclerosis (TA320). London, UK: NICE; 2014
  • National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. London: National Institute for Health and Care Excellence, 2015; http://www.nice.org.uk/article/pmg9/. Accessed October 30, 2015
  • Association of British Neurologists. Guidelines for prescribing in multiple sclerosis. London, UK: Association of British Neurologists; 2009
  • 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):133-46
  • 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
  • European Medicines Agency. Gilenya: EPAR - Assessment Report; 2011. London, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002202/WC500104529.pdf Accessed October 30, 2015
  • Novartis. Data on file: HR vs placebo for 3-month confirmed disability progression (with the definition of progression adjusted to match that from the AFFIRM trial), pooled FREEDOMS + FREEDOMS II RES sub-group, Camberley, Surrey 2016
  • NHS. National Schedule of Reference Costs 2014–15 for NHS trusts and NHS foundation trusts. London, UK: NHS; 2015
  • NHS. NHS Tariff 2014–15. London, UK: NHS; 2015
  • Biogen Idec Ltd. Natalizumab (Tysabri(r)) for the treatment of adults with highly active relapsing remitting multiple sclerosis. Manufacturer submission of evidence to NICE. London, UK: National Institute for Health and Clinical Excellence: TA127; 2007
  • National Institute for Health and Care Excellence. List of technologies with approved Patient Access Schemes. London: National Institute for Health and Care Excellence, https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit/list-of-technologies-with-approved-patient-access-schemes. Accessed November 30, 2016
  • Curtis L, Burns A. Unit costs of health and social care 2015. Canterbury,Kent: University of Kent, 2015
  • Genzyme. Alemtuzumab for the treatment of relapsing remitting multiple sclerosis in adults. Manufacturer submission of evidence. London, UK: National Institute for Health and Care Excellence: TA312; 2013
  • 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
  • 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
  • Genzyme. Teriflunomide for the treatment of relapsing-remitting multiple sclerosis in adults. Manufacturer submission of evidence. London, UK: National Institute for Health and Care Excellence: TA303; 2013
  • Novartis Pharmaceuticals UK Ltd. Fingolimod for the treatment of relapsing remitting multiple sclerosis in adults. Manufacturer submission of evidence. London, UK: National Institute for Health and Clinical Excellence: TA254; 2011
  • Espallargues M, Czoski-Murray CJ, Bansback NJ, et al. The impact of age-related macular degeneration on health status utility values. Invest Ophthalmol Vis Sci 2005;46:4016-23
  • 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
  • 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, September 10–13, 2014, Boston, MA
  • Biogen Idec. TYSABRI (natalizumab) Benefit/risk update & PML risk stratification. Reactive presentation for healthcare professionals (approval number: TY-PAN-0683(2) Date: September 2015). Cambridge: Massachusetts http://www.slideshare.net/gavingiovannoni/tysabri-benefit-risk-update-q3-2015/. Accessed May 20, 2016
  • Raffel J, Gafson AR, Malik O, et al. Anti-JC virus antibody titres increase over time with natalizumab treatment. Mult Scler 2015;21:1833-8
  • 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:e004073
  • Kusel J, Maruszczak M, Adlard N. Cost-utility of fingolimod compared with dimethyl fumarate (Dmf) in highly active relapsing remitting multiple sclerosis (Rrms) in England: comparison of a Markov and discrete event simulation model. Value Health 2015;18:A759
  • Coles AJ, Arnold DL, 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, April 15–21, 2016, Vancouver, BC, Canada
  • 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

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.