MS drugs scheme fails to deliver results

The MS scheme was the first implemented Risk Sharing scheme in the UK, the article highlights nicely the difficulties with perforance based schemes in difficult disease areas..

from the Financial Times

By Andrew Jack
Published: December 3 2009 01:56 | Last updated: December 3 2009 01:56

A pioneering scheme designed by the government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched.
In an article published on Wednesday in the British Medical Journal, a team of medical academics concluded there was no evidence to date that five drugs given since 2002 to multiple sclerosis patients were cost-effective.
The long-awaited study was the first public analysis of a “risk-sharing” programme established by the Department of Health and a series of pharmaceutical companies after the government’s medicines watchdog advised against use of their products by the National Health Service.
The findings of the research, led by Mike Boggild, a consultant neurologist from the Walton Centre in Liverpool, raise questions about the growing number of other pharmaceutical risk-sharing schemes subsequently agreed between drug companies and government.
They also stirred further criticism of the National Institute for Health and Clinical Excellence , which assesses the cost effectiveness of new drugs, and the willingness of the NHS to follow its recommendations.
After Nice rejected the drugs Avonex, Betaferon, Rebif and Copaxone as poor value for money in 2002, the drug companies discounted their products to between £5,800 and £8,000 ($9,600 and $13,326) on condition that the price could change again after as little as two years if results were 20 per cent more or less effective than claimed.
However, it took until 2005 before the 5,500 multiple sclerosis patients necessary to assess the drugs had been recruited, and the data was only finally released this week, more than two years after the first evaluation period ended in 2007.
Echoing criticisms raised when the scheme was first launched, Dr Boggild said it was hard to assess the cost-effectiveness of multiple sclerosis drugs because of the difficulties in comparison with lack of treatment and because their effect can only be observed over long periods.
“There would have been easier diseases to study with this sort of study,” he said.
The Multiple Sclerosis Society, a patient group, criticised the “belated” publication of the data, called the scheme “ineffective” and highlighted that the ability to gain access to the drugs varied widely across the UK, and was among the lowest levels in Europe.
“This is a deeply frustrating situation,” said Simon Gillespie, chief executive.