The government/industry cost-sharing scheme for four multiple sclerosis (MS) drugs, begun in 2002 after NICE rejected them on cost-effectiveness grounds, has failed so far to show whether or not they represent value for money, says a new study.

The research, results of which were published last week in the British Medical Journal (BMJ) by neurologist Mike Boggild of The Walton Centre, Liverpool, and colleagues, sought to generate evidence on the longer-term cost-effectiveness of disease modifying-treatments in patients with relapsing-remitting MS. However, the researchers say that it is too early to reach any conclusion, that important methodological issues will need to be addressed and that long-term follow-up of all patients is essential.

Patient group the MS Society has condemned the fact that, seven years into the scheme, the first two-year analysis has only just now been published, and warns that the methodological difficulties uncovered by the researchers will, if not addressed, cause it to fail.

The risk-sharing scheme was set up by the Department of Health, following NICE’s negative evaluation, to observe the effects of Biogen’s Avonex and Merck KGaA’s Rebif both (interferon beta-1a), Bayer’s Betaferon (beta interferon 1b) and Teva’s Copaxone (glatiramer acetate) over a 10 year-period.

MS Society chief executive Simon Gillespie emphasizes that the four drugs are not the issue, and that it is the way the scheme has been run that is the problem.

“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 (Elan/Biogen Idec’s natalizumab, the only MS drug recommended by NICE) for people with severe MS,” he said, and warned: “unless the shortcomings of the scheme are addressed rapidly, the introduction of other new therapies for MS is also likely to be delayed.”

The Society adds that it has an additional list of concerns regarding the MS risk-sharing scheme, namely: - UK prescribing rates for MS drugs are among the lowest in Europe; - there is evidence that the four drugs are still subject to a post-code lottery, despite the scheme, and that Tysabri is subject to a “massive post-code lottery,” because of confusion amongst commissioners regarding entitlement to it because it is not part of the scheme.

NICE will not update guidance on the drugs pending the outcome of the scheme, and the “inertia this has created means that the NICE guideline on MS, published six years ago, is now chronically out of date,” says the Society, which adds that, as a result, it has withdrawn its support for the scheme.