Education And Debate

Problems with UK government's risk sharing scheme for assessing drugs for multiple sclerosis

BMJ 2003; 326 doi: (Published 15 February 2003) Cite this as: BMJ 2003;326:388
  1. Cathie L M Sudlow (, Wellcome clinician scientista,
  2. Carl E Counsell, senior lecturerb
  1. a Department of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU,
  2. b Department of Neurology, Aberdeen Royal Infirmary, Aberdeen AB25 2ZN
  1. Correspondence to: C L M Sudlow
  • Accepted 21 October 2002

The government plans to make interferon beta and glatiramer available to patients with multiple sclerosis through a risk sharing scheme, despite lack of evidence of cost effectiveness. Sudlow and colleagues argue that the money would be better spent on independent research

The National Institute for Clinical Excellence (NICE) recently announced that interferon beta and glatiramer acetate were not cost effective treatments for multiple sclerosis and could not be recommended for NHS funding.1 As a result, the Department of Health and the manufacturers developed a “risk sharing scheme” aimed at providing these drugs more cost effectively. 2 3 Treatment will be provided to ambulating patients with two or more disabling relapses in the past two years (about 15% of all patients with multiple sclerosis)4 and their progress monitored over 10 years. However, the scheme has several scientific and practical problems that we believe limit its ability to improve the care of patients in the long term. In this paper, we review the quality of the evidence on which NICE and the Department of Health reached their decisions, consider some of the problems of the risk sharing scheme, and suggest an alternative approach.

Summary points

NICE has announced that neither interferon beta nor glatiramer can be recommended for multiple sclerosis in the NHS

The Department of Health plans to make these drugs available through a risk sharing scheme that is scientifically unsound and impractical

Randomised trials suggest that azathioprine (which is 20 times cheaper) may be just as effective

The long term effectiveness of these drugs is unknown

Government money would be better spent on a long term randomised trial comparing interferon beta or glatiramer with azathioprine and no treatment


We identified randomised trials of disease modifying drugs in patients with multiple sclerosis from systematic reviews, 57 the Cochrane controlled …

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