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

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. As a result, the Department of Health and the manufacturers developed a “risk sharing scheme” aimed at providing these drugs more cost effectively. 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) 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.