The multiple sclerosis (MS) drug cost-sharing scheme set up by the Department of Health and drugmakers in 2002 has been a success for the industry but a “costly failure” for the NHS and should not be continued, according to experts writing in the British Medical Journal (BMJ).

They add that the biggest losers have been the other NHS patients who would otherwise have benefited from the £50 million a year spent on the MS scheme.

The cost-sharing initiative was agreed in order to ensure that MS patients could receive four disease-modifying drugs (DMDs) on the NHS after the National Institute of Health and Clinical Excellence (NICE) ruled that the treatments - beta interferons and glatiramer acetate - were not cost-effective. Under the terms of the scheme, the government agreed to provide the drugs on the NHS while research was carried out to assess their long-term cost-effectiveness. The Service would then gradually stop paying for the drugs if patients did not appear to be benefiting.

In 2009, seven years after the scheme was set up, the first analysis of the data showed that patient outcomes were much worse than predicted, but the scheme’s scientific advisory group judged that it was premature to reduce prices without further analysis. 5,583 patients had received at least one of the MS treatments during the time, at a total cost of around £350 million.

Writing in the BMJ, University of Leeds health economist Christopher McCabe and colleagues argue that none of the reasons for delaying the price review stand up to scrutiny. They raise concerns about the independence of the advisory group, which includes representatives of the drug manufacturers, patient groups, clinicians and the Department of Health, pointing out that “all these bodies have a vested interest in maintaining the status quo. The budget holders, who pay for these drugs, with responsibility for the health of populations served by the NHS, are not represented on the scientific advisory group, and as a result there is no countervailing influence on the group’s decision-making.”

The delay in publication of the first results is a further cause for concern, add the researchers, who estimate that the NHS could have already saved around £250 million if an assessment of the scheme had been completed after the first two years.

Their concerns are supported by James Raftery, professor of health technology assessment at Southampton University, who also raises further questions about the independence of the advisory group and the scheme’s overall governance.

While the scheme was a success for the drug companies, who sold at close to full price to the NHS, for the Service it can be judged only “a costly failure,” writes Prof Raftery. “Monitoring and evaluation of outcomes in future patient access schemes must be independent of the companies involved. Transparency is essential, involving annual reports, access to data and rights to publish. Any of these might have helped avoid the current fiasco,” he says.

The report in the BMJ is accompanied by a number of commentaries, including one by Alastair Compston, professor of neurology at the University of Cambridge, who argues that the scheme has benefited patients, although he agrees that its governance was inadequate and its terms of reference were not delivered. He also warns that attempts to force the drug companies to repay costs would be likely to trigger complex legal arguments.

A further commentary by George Ebers, professor of clinical neurology at the University of Oxford, says that the outcome measures used in the scheme were flawed and that the scheme’s findings raise questions about industrial-academic relationships, suggesting that “perhaps the public interest would be served by an independent inquiry.”

Finally, an editorial by Neil Scolding, professor of clinical neurosciences at the University of Bristol and Frenchay Hospital, agrees that the scheme is flawed but adds that it has had unintended beneficial consequences.

It has spawned an extremely successful infrastructure of specialist multiple sclerosis care in the UK and the drugs prescribed will have prevented thousands of relapses, says Prof Scolding, who adds that the scheme “leaves a platform for introducing new treatments and executing clinical research that is second to none in the world.”

Commenting on the BMJ reports, the MS Society says that it withdrew its support for the scheme last December after repeatedly raising concerns with the Department over a four-year period, "to no avail."

While the scheme has given many people access to MS drugs, it is stuck in the past and has failed to take account of the most up-to-date evidence and practices, said the Society's chief executive, Simon Gillespie. He urges the new government to ensure that people with MS across the UK have equity of access to the right drug at the right time in line with current evidence, adding: "this cannot be achieved through the current scheme."