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The unintended consequences of NICE
  1. Gavin Giovannoni
  1. Barts and The London School of Medicine and Dentistry, Blizard Institute, Queen Mary University London, London E1 2AT, UK
  1. Correspondence to Dr Gavin Giovannoni, Barts and The London School of Medicine and Dentistry, Blizard Institute, Queen Mary University London, London E1 2AT, UK; g.giovannoni{at}

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Will the latest risk-sharing scheme results cure the doubting Thomases of their scepticism about the real-life efficacy of disease-modifying therapies for the treatment of MS?

The UK Department of Health’s (DoH) risk-sharing scheme (RSS) was set up as a political solution to protect NICE (National Institute for Health and Care Excellence) from a legal challenge. Interferon-β (IFN-β), and subsequently glatiramer acetate (GA), had been licensed by the European Medicines Evaluation Agency (now the European Medicines Agency) for the treatment of relapsing-remitting multiple sclerosis (MS). The costs of these disease-modifying therapies (DMTs) were very high and most local National Health Service (NHS) payers or primary care trusts (PCTs) were not prepared to fund these new treatments. On the other hand some PCTs, which have subsequently been disbanded, had allowed the prescribing of these DMTs. This resulted in the so-called ‘postcode prescribing’ and the ‘NHS lottery’ fiasco with access to treatments based on where you lived.

Around this time NICE formerly called the National Institute for Clinical Excellence, and subsequently renamed the National Institute for Health and Care Excellence, had just been formed with the specific aim to create consistent guidelines and end rationing of treatment by postcode across the UK. One of the first technology appraisals they did was to assess the cost-effectiveness of three IFN-β preparations (Betaferon, Avonex and Rebif) and GA (Copaxone). Not unexpectedly, NICE ruled that these …

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  • Contributors I have personally written this commentary.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests In the last 5 years Professor GG has received compensation for participating on Advisory Boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees from: Abbvie, Actelion, Atara Bio, Biogen, Celgene, Genzyme-Sanofi, Genentech, GSK, Merck-Serono, Novartis, Roche, Synthon BV and Teva.

  • Patient consent Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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