Wednesday October 31, 6:30 AM EST
By Ben Hirschler, European Pharmaceuticals
Correspondent
LONDON, Oct 31 (Reuters) - Thousands of Britons suffering from multiple sclerosis could receive beta-interferon under an extended trial scheme, despite a health watchdog's view that the drug is not cost-effective, officials said on Wednesday.
Under the scheme -- details of which are being hammered out with drug firms -- up to 10,000 UK patients who meet clinical criteria for therapy would receive the costly treatment on the state health service and be monitored over a number of years.
The Department of Health said it wanted to see how the drugs worked for different patients and was considering a "risk-sharing" price mechanism, under which payments to companies would be scaled back if the drugs failed to help sufferers.
Plans for such a large study were first proposed by the UK Multiple Sclerosis Society in August in a bid to defuse a row over access to MS drugs, after the National Institute for Clinical Excellence (NICE) provisionally proposed that beta-interferon and glatiramer acetate should not be paid for by the state-funded National Health Service (NHS).
"This is very much in line with the proposal from the society... it does appear to be a very encouraging development," said David Harrison, a spokesman for the society.
Anne-Toni Rodgers, communications director at NICE, said final guidance on the use of MS drugs would not be available before December, but the body's provisional view was they should not be prescribed on the NHS, except for existing patients.
One of the problems identified by NICE is that there is considerable uncertainty over which patients benefit from the therapy and for how long.
The multi-year trial, offering treatment to patients with the "relapsing-remitting" version of the disease, would aim to resolve these doubts.
The drugs cannot cure MS, a debilitating disease that causes the body's immune system to destroy a sheath protecting nerve cells in the brain and spinal cord, causing paralysis, pain and tremors. But many neurologists believe they are effective in reducing the frequency of relapses.
SLIDING SCALE
Beta-interferon -- which costs 7,000-10,000
pounds ($10,200-14,570) per patient a year -- is made by Germany's Schering
AG (SCHG), Switzerland's Serono SA (SEOZ) and Biogen Inc (BGEN) of the
United States, while Israel's Teva Pharmaceutical Industries (TEVA) markets
glatiramer acetate.
The government is now discussing
with the four companies how the cost of medicines might be capped under
the trial programme.
"After a period of time an assessment
would be made of whether the drug was working for patients," a Department
of Health spokesman said. "If it was, payments would continue. If not,
payments to manufacturers would be reduced on a sliding scale."
Philip Wood, medical director at
Teva UK, said firms had held preliminary discussions with government on
the issue but there was still a "considerable amount of work to be done".
Currently, less than three percent
of Britain's 85,000 MS sufferers receive beta-interferon, compared with
12 percent in Italy, France and Germany, and even more in North America.
NICE's stance on MS has fuelled controversy
over the role of the drugs watchdog, which was set up two years ago to
assess the cost-effectiveness of treatment. The body has been slammed by
industry and some patient groups as a rationing agent.
Trevor Jones, director-general of
the Association of the British Pharmaceutical Industry, welcomed the MS
drug plan.
"It means that the Department of
Health is not prepared to accept the NICE view and wants to find a way
of making this drug available on the NHS, which says many things about
the role of NICE," he said.
©2001 Reuters Limited