Estimated to have cost around £50m annually, the researchers point out that, if an assessment had been completed two years after the scheme began, the NHS could by now have saved around £250 million. Only in 2009 -- seven years after the scheme was set up -- was the first analysis of the data undertaken and, although this revealed that patient outcomes were much worse than predicted, the scheme’s scientific advisory group judged that it was premature to reduce prices without further analysis.
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.
Health economist Christopher McCabe, and colleagues at the University of Leeds, 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 DoH. 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, he said. However, for the NHS it can be judged only as ‘a costly failure’. According to the professor, ‘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.’
However, Alastair Compston, Professor of Neurology at the University of Cambridge argued 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.
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.’
Neil Scolding, Professor of Clinical Neurosciences at the University of Bristol and Frenchay Hospital, described the scheme as a clever achievement, which despite being flawed, has had unintended beneficial consequences. He argues that the scheme has spawned an extremely successful infrastructure of specialist MS care in the UK and that the drugs prescribed will have prevented thousands of relapses. He also said: ‘It leaves a platform for introducing new treatments and executing clinical research that is second to none in the world.’