LONDON, December 2 /PRNewswire/ -- 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      MS, published 6 years ago is now chronically out of date

"This is a deeply frustrating situation. The 4 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.

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.

Notes to Editors:

1) Questions concerning this matter have been raised in the UK Parliament Paul Burstow MP Nos. 638,639 and 640:

http://www.publications.parliament.uk/pa/cm200910/cmordbk1/91123w01.htm

James Gray MP Nos. 84, 85 and 86:

http://www.publications.parliament.uk/pa/cm200910/cmordbk1/91124w01.htm

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.

2) The specific response to the Tysabri question demonstrates a post-code lottery;

    
    - You are six times (5.7) more likely to be prescribed Tysabri in
      London than in the East Midlands region.
    - You are eleven times (11.0) more likely to be prescribed Tysabri
      in London than in the South East Coast region.
    - All SHAs (apart from London and the North East) are prescribing
      below the national average (0.059).

3) James Gray MP, Chair of the All Party Parliamentary Group on MS, announced his intention (23/11/09) to call for an Adjournment Debate on this matter and will be inviting the minister for health to the next APPG to outline the Governments' intentions regarding this moving forward.

    
    - The MS Society (http://www.mssociety.org.uk) is the UK's largest
      charity dedicated to supporting everyone whose life is touched by
      multiple sclerosis (MS), providing respite care, an award-winning
      freephone helpline (0808-800-8000), specialist MS nurses and funding 
      more than 80 vital MS research projects in the UK.
    - MS is the most common disabling neurological condition affecting
      young adults and an estimated 100,000 people in the UK have MS.
    - MS is the result of damage to myelin - the protective sheath
      surrounding nerve fibres of the central nervous system - which 
      interferes with messages between the brain and the body.
    - For some people, MS is characterised by periods of relapse and
      remission while for others it has a progressive pattern.
    - Symptoms range from loss of sight and mobility, fatigue,
      depression and cognitive problems. There is no cure and few effective
      treatments.