UK Department of Health's 'money back' deal for MS drugs questioned; failing people with the disease

In 2002, the UK's 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 set up an observational study called the Risk Sharing Scheme.

The aim of the study was to observe the effects of these drugs (over a 10-year period) and if the four 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 National Health Service. The scheme promised to make these drugs available to all those with MS who fitted the study criteria.

After the NICE rejected the drugs Avonex (interferon beta-1a, Biogen), Betaferon (interferon beta-1b, Bayer Schering), Rebif (interferon beta-1a, Merck Serono) and Copaxone (glatiramer acetate, Teva) as poor value for money in 2002, the drug makers offered discounts on their products of between £5,800 and £8,000 ($9,600 and $13,326) on condition that the price could change again after as little as two years if results were 20% more or less effective than claimed.

Seven years into the scheme; the first two-year analysis of the project, was belatedly published in the British Medical Journal on-line on December 2. It highlights a series of methodological difficulties with the scheme, which if not addressed will result in its failure.

The findings of the research, led by Mike Boggild, a consultant neurologist from the Walton Centre in Liverpool, raise questions about the growing number of other pharmaceutical risk-sharing schemes subsequently agreed between drug companies and government. However, D Boggild did admit it was hard to assess the cost-effectiveness of multiple sclerosis drugs because of the difficulties in comparison with lack of treatment and because their effect can only be observed over long periods. 'There would have been easier diseases to study with this sort of study,' he said, reported by the Financial Times.

MS charity has more concerns

The UK-based charity, the MS Society, says it has an additional list of concerns regarding this scheme, noting that:

' Prescribing rates for MS drugs in Britain are amongst the very lowest in Europe;
' There is evidence that the four 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 (natalizumab), is subject to a massive post-code lottery, and confusion exists amongst commissioners regarding entitlement to this drug which is not part of the scheme; and
' The 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.

"This is a deeply frustrating situation. The four drugs involved are not the issue and many have benefitted from taking them - it is the way the scheme has been run that is the problem. People with MS and taxpayers deserve much better. Government's approach towards the treatment of 100,000 people with MS across the UK doesn't give them, or their families, confidence for the future,' the MS Society claims.

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 of the MS Society.

Questions raised in Parliament

According to the Society, questions concerning this matter have been raised in the UK Parliament by Paul Burstow, MP. However, the UK Parliament answers make it clear that no assessment has been made of the scheme's impact on access to drugs. Questions have also been laid in the Scottish Parliament by Ross Finnie MSP and the Welsh Assembly by Peter Black AM. With prescribing rates in the UK amongst the very lowest in Europe, to continue to run the scheme without such an assessment represents a serious omission, the MS Society argues.