Since 2002, the scheme has enabled the NHS to prescribe the drugs while their cost-effectiveness was evaluated.

But the charity argues the study is flawed, and fears the scheme is hindering access to other therapies. "The scheme has been so badly run, so badly administered and has so many problems with the methodology and the data collection that's there's nothing meaningful coming out of it."

The government insists the scheme has significantly improved the overall care and support available to MS patients.

The Government has spent around 350m pounds on drugs for people with Multiple Sclerosis despite the drug watchdog NICE ruling they weren’t cost effective. Eight years after a compromise agreement was reached with the pharmaceutical industry to make disease modifying drugs available, the UK's largest MS charity is calling for the risk-sharing scheme that made it possible to be scrapped.

The Donal MacIntyre programme investigated the scheme’s progress and heard serious concerns about the clinical study designed to test how well the drugs work.

You can listen to programme by clicking the link below:

Donal MacIntyre programme 21/02/10

Objective To generate evidence on the longer term cost effectiveness of disease modifying treatments in patients with relapsing-remitting multiple sclerosis.
Design Prospective cohort study with historical comparator.

Setting Specialist multiple sclerosis clinics in 70 centres in the United Kingdom.

Participants Patients with relapsing-remitting multiple sclerosis who started treatment from May 2002 to April 2005 under the UK risk sharing scheme.

Interventions Treatment with interferon beta or glatiramer acetate in accordance with guidelines of the UK Association of British Neurologists.

Main outcome measures Observed utility weighted progression in disability at two years’ follow-up assessed on the expanded disability status scale (EDSS) compared with that expected by applying the progression rates in a comparator dataset, modified for patients receiving treatment by multiplying by the hazard ratio derived separately for each disease modifying treatment from the randomised trials.

Results In the primary per protocol analysis, progression in disability was worse than that predicted and worse than that in the untreated comparator dataset ("deviation score" of 113%; excess in mean disability status scale 0.28). In sensitivity analyses, however, the deviation score varied from –72% (using raw baseline disability status scale scores, rather than applying a "no improvement" algorithm) to 156% (imputing missing data for year two from progression rates for year one).

Conclusions It is too early to reach any conclusion about the cost effectiveness of disease modifying treatments from this first interim analysis. Important methodological issues, including the need for additional comparator datasets, the potential bias from missing data, and the impact of the "no improvement" rule, will need to be addressed and long term follow-up of all patients is essential to secure meaningful results. Future analyses of the cohort are likely to be more informative, not least because they will be less sensitive to short term fluctuations in disability.

Mike Boggild, consultant neurologist¹, Jackie Palace, consultant neurologist², Pelham Barton, senior lecturer in mathematical modelling³, Yoav Ben-Shlomo, professor of clinical epidemiology⁴, Thomas Bregenzer, director, biostatistics⁵, Charles Dobson, senior projects officer⁶, Richard Gray, director⁷

¹ The Walton Centre, Liverpool L9 7LJ, ² John Radcliffe Hospital, Oxford OX3 9DU, ³ Health Economics Unit, University of Birmingham, Birmingham B15 2TT, ⁴ Department of Social Medicine, Canynge Hall, Bristol BS8 2PS, ⁵ Biostatistics Unit, Parexel International, 14050 Berlin, Germany, ⁶ Department of Health, Quarry House, Leeds LS2 7UE, ⁷ University of Birmingham Clinical Trials Unit, Birmingham B15 2TT

Source: BMJ © 2009 BMJ Publishing Group Ltd.  (02/12/09)

The risk-sharing scheme between the government and pharmaceutical companies to supply Beta-interferon to patients is going more slowly than was hoped and may not be completed during the 18 month period.

The findings, made by the MS Trust and the MS Society, have been presented to the Department of Health. Although progress is being made in many respects, fundamental issues surrounding funding and resources remain.

The research was carried out among MS Lead Officials in Strategic Health Authorities and Health Authorities/Health Boards in England, Scotland and Wales. The aim was to gain an accurate picture of health bodies' progress in implementing the risk-sharing scheme and to explore some of pharmaceutical companies to the issues surrounding take-up.

On the positive side, the scheme appears to have been widely accepted and is seen as compulsory. As a result, it is being implemented across England, Scotland and Wales and all participants were hopeful that they would have the scheme fully in place by the end of 2003.

However, inadequate funding is still a key issue. Some areas state that sufficient funds have yet to be allocated, although the start of the new financial year should help resolve this problem.

A lack of suitably trained staff is also hampering progress. This is leading to lengthy waiting times for patients to be assessed and treated.

An estimated 1,600 Scots with multiple sclerosis are set to benefit from a deal to make Beta-interferon available to all those who may be helped by the drug. MS patients north of the border have welcomed the agreement between the government and drug manufacturers.

Not all Scottish health boards have been able to afford the drug, which can slow down the progress of the disease in some patients.

But under the risk-sharing scheme announced on Monday, the National Health Service will pay for beta interferon and other similar drugs where they prove effective.

"I congratulate everyone who has played a part, including those who worked for the recent record-breaking petition to the Scottish Parliament" said  Mark Hazelwood, MS Society for Scotland However, the industry will have to foot a proportion of the bill where they are not successful.

Neurologists will now begin the process of assessing patients.

An estimated 10,500 people in Scotland have from MS, a disease of the nervous system for which there is no cure. It is thought that some 1,600 Scottish MS patients will be deemed suitable to receive the drugs over the next 18 months.

The Multiple Sclerosis Society for Scotland said the move was a major victory for people with MS.

Source: BBC News Copywrie BBC MMII (04/02/02)

The National Institute of Clinical Excellence (NICE) have made their final decision, that Betainterferon and Copaxone (glatiramer acetate) are not to be made available on the NHS to people with MS who are not already getting them. NICE argued that neither drug had been proven to bring enough benefit to enough people.

However, extended clinical trials to study the effectiveness of these drugs in treating MS have been proposed by the government.

Under the scheme, up to 10,000 patients who meet the clinical criteria for therapy would be prescribed the treatment and monitored over a number of years. The Department of Health wants to establish just how many MS patients would benefit from using these drugs.

Its' own advisory body has warned that both treatments are not currently cost-effective, and should only be made widely available if a new way to improve value for money is found.

The scheme will go ahead if the Department of Health can negotiate a deal to share the financial risk between the government and the drug companies. Chief executive of the MS Society, Peter Cardy, welcomed the proposed trials saying: "We know this drug does not work for everybody, and that its benefits are limited. But if this trial takes place, then we should at the end of it know much more about who exactly the drug works for, and what its benefits are."

Source:  BBC News Copywrite BBC MMII (04/02/02)

Following the Department of Health's announcement today (Monday, 4
February 2002), a statement was issued jointly by the Association of British Neurologists, the Multiple Sclerosis Society, the MS Trust and the UK MS Specialist Nurses Association:

"We warmly welcome the Department of Health's scheme. While NICE has been evaluating the new disease modifying treatments for MS over more than two years, we have advocated that these drugs should be available to patients in the UK.

We intend now to work closely with the Department to help ensure the scheme is effectively implemented. This will be a major undertaking.

There will be heavy demand on health authorities and primary care trusts to fund the treatments. That must not compromise services to other NHS patients, including those with MS for whom the drugs are not suitable.

The new scheme will mean that as many as 20 to 30,000 MS patients may need to be assessed to identify around 10,000 expected to be eligible under the ABN guidelines.

To avoid causing distressing delays to patients, this will require major expansion of neurological services. Additional sessions will be needed
for neurologists, MS specialist nurses, medical secretaries and other support staff. We understand the funding to do this has been agreed nationally and will be implemented locally to allow neurologists to assess all potentially eligible patients, treat those who are eligible, and then follow them up over the next 10 years to assess their progress.

We know that the Department intends to ensure that the required additional therapies and infrastructure are provided through health authorities and primary care trusts without compromising existing
services. Neurological services are already very stretched, with outpatient waiting times more than six months in many areas and double that in some.

Our organisations will co-operate fully in the scheme and expect to play an active role in monitoring and feeding back information through regular meetings with the Department."