In 2002 the National Institute for Clinical Excellence (NICE) ruled that certain drugs for the treatment of Multiple Sclerosis were not cost effective. In response, the Department of Health (DH) set up an observational study called the Risk Sharing Scheme. The aim of the study was to observe the effects of these drugs (over a10 year period) and if the 4 drugs in question failed to perform as promised then the manufacturers would share the risk of any potential negative outcomes by subsidising their future cost to the NHS. The scheme promised to make these drugs available to all those with MS who fitted the study criteria.

Seven years into the scheme; the first 2 year analysis of the scheme, has been belatedly published in the BMJ online today. It highlights a series of methodological difficulties with the scheme, which if not addressed will result in its failure.

The MS Society has an additional list of concerns regarding this scheme

– Prescribing rates for MS drugs are amongst the very lowest in Europe.

– There is evidence that the 4 drugs in question are still subject to a
post-code lottery despite the scheme

– There is evidence that the only NICE approved drug for MS, Tysabri, is
subject to a massive post-code lottery. Confusion exists amongst
commissioners regarding entitlement to this drug which is not part of
the scheme.

– NICE will not update guidance on the drugs pending the outcome of the
scheme. The inertia this has created means that the NICE guideline on
MS, published 6 years ago is now chronically out of date

We already have evidence that the ineffective operation of the scheme has exacerbated the post code lottery in treatments, for example in prescribing the newer drug Tysabri for people with severe MS. Unless the shortcomings of the scheme are addressed rapidly, the introduction of other new therapies for MS is also likely to be delayed.

MS is a complex condition for which there is no cure. Most people live with their MS for many decades, and it is imperative that people with MS receive the correct treatment at the right time. Anything short of this would be a grave injustice to all those with MS, as well as ultimately costing society more for hospital stays and care that could be avoided” says Simon Gillespie, Chief Executive MS Society.

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