Professor Christopher McCabe, a health economist at the University of Leeds, and colleagues argue that the biggest losers are the other NHS patients who would otherwise have benefited from the money spent on the scheme, estimated to be around £50m per year since it was set up in 2002.
They also point out that, if an assessment had been completed after the first two years, the NHS could have already saved around £250m.
The risk sharing scheme was set up by the Department of Health to make sure disease-modifying drugs were available on the NHS after the National Institute of Health and Clinical Excellence (NICE) ruled that they were not cost effective.
Under the terms of the scheme, the government agreed to provide these drugs on the NHS while research was carried out to assess their long term cost effectiveness. The NHS 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.
Prof McCabe and his co-authors argue that none of the reasons for delaying the price review withstand critical assessment. They raise concerns about the independence of the group, which includes representatives from the drug manufacturers, patient groups, clinicians and the Department of Health. The delay in the publication of the first results is a further cause for concern, they add.
James Raftery, Professor of health technology assessment at Southampton University, supports these concerns and raises further questions about the independence of the advisory group, and the overall governance of the scheme.
The scheme was a success for the drug companies, who sold at close to full price to the NHS, says Raftery. For the NHS, however, it can be judged only “a costly failure,” he writes. “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 concludes.”
McCabe and colleagues add: “When the key uncertainty in the evidence base for a new product relates to its effectiveness, a randomised controlled trial is likely to be the quickest, most efficient, and most ethical strategy.”
But in an accompanying commentary, Alastair Compston, Professor of Neurology at the University of Cambridge argues that the scheme has benefited patients, though he acknowledges that its governance was inadequate and that 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.
And in a second commentary, George Ebers, Professor of Clinical Neurology at the University of Oxford, believes that the outcome measures used in the scheme were flawed. He also says that the scheme’s findings raise questions about industrial-academic relationships and their governance. “The scheme may have been well intentioned, but perhaps the public interest would be served by an independent inquiry,” he writes.
And in an editorial, Neil Scolding, Professor of Clinical Neurosciences at the University of Bristol and Frenchay Hospital, describes the scheme as a clever achievement, which despite being flawed, has had unintended beneficial consequences.
Scolding argues that the scheme has spawned an extremely successful infrastructure of specialist multiple sclerosis care in the UK and that the drugs prescribed will have prevented thousands of relapses. He also says that “it leaves a platform for introducing new treatments and executing clinical research that is second to none in the world.”
Original press release from the BMJ.
View the media coverage of the story by following the links below
For more information
A full copy of Prof McCabe’s article, entitled ‘Continuing the multiple sclerosis risk sharing scheme is unjustified’ can be viewed here.
Contact the University of Leeds media relations team on 0113 343 4031