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More MS news articles for June 2003

Shared scheme for assessing drugs for multiple sclerosis

Cost effective provision of effective treatments for multiple sclerosis

BMJ  2003;326:1212 (31 May)
Jacqueline C Napier, associate medical director - Schering Health Care, Burgess Hill, West Sussex RH15 9NE
Richard Francis, country manager United Kingdom and Ireland - Biogen, Maidenhead, Berkshire SL6 3UD
Glyn Wright, general manager - Teva Pharmaceuticals, High Wycombe, Buckinghamshire HP13 7SS

Sudlow and Counsell think that the UK government's risk sharing scheme for the provision of disease modifying drugs for multiple sclerosis (interferon beta and glatiramer acetate) may be flawed.1

Firstly, the risk sharing scheme was introduced to ensure that the disease modifying drugs in question are acquired by the NHS in a cost effective manner, which will be reviewed by the Department of Health at scheduled time points, with the required adjustments being made to ensure the agreed cost effectiveness threshold is maintained.

Secondly, pivotal, randomised, placebo controlled studies lasting for up to five years already show that these drugs are effective and well tolerated. The longer term outcome is less certain, although evidence both from observational studies and more than 15 years of clinical practice in the United States indicates that efficacy continues and there have been no unexpected safety issues.

We agree that additional robust long term data on lifetime cost effectiveness of treatments for multiple sclerosis need to be collected, and this is what the risk sharing scheme sets out to achieve. Crucially, cost effectiveness of treatments that delay disease progression can be measured properly only over the long term, 20 years or more. However, implying that this can only be done in a new placebo controlled study would be naive, unethical, and in practice unworkable.

Thirdly, we are surprised that unlicensed drugs or other forms of treatment are being suggested at this stage as alternatives to interferon beta or glatiramer. Azathioprine was not widely used before the disease modifying drugs were licensed, and, to our knowledge, no new data have been published in the past 10 years to suggest improved efficacy or risk-benefit profile in comparison to the licensed treatments being used in the risk sharing scheme.

Competing interests:

The authors are employees of pharmaceutical companies involved in multiple sclerosis research and the risk sharing scheme


  1. Sudlow CLM, Counsell CE. Problems with the UK government's risk sharing scheme for assessing drugs for sclerosis. BMJ 2003;326: 388-392. (15 February.)[Free Full Text]

© 2003 BMJ Publishing Group Ltd