http://news.bbc.co.uk/hi/english/health/newsid_1627000/1627863.stm

Wednesday, 31 October, 2001, 00:38 GMT

Extended clinical trials of a controversial and expensive drug to treat multiple sclerosis have been proposed by the government.

The Department of Health wants to establish just how many MS patients would benefit from using beta-interferon.

Its own advisory body has warned that the treatment is not currently cost-effective, and should only be made widely available if a new way to improve value for money is found.

Under the scheme, up to 10,000 patients who meet the clinical criteria for therapy would be prescribed the treatment and monitored over a number of years.

The scheme will go ahead if the Department of Health can negotiate a deal to share the financial risk between the government and the drug companies.

A spokesman said: "If [the drug] was working, payments would continue. If not, payments to manufacturers would be reduced on a sliding scale."

£10,000 a year

Beta-interferon is not a cure for the degenerative disease but for it can increase the length of time between relapses in one type of the illness.

It costs about £10,000 a year for each patient, and the National Institute for Clinical Excellence had indicated that it was likely to block the NHS use of either beta-interferon or an alternative treatment glatiramer acetate (Copaxone).

In provisional guidance published on its website, NICE argued that neither drug had been proven to bring enough benefit to enough people.

It recommended the government and manufacturers look at ways in which the drugs could be more cost effective for the NHS.

Only hope

The MS Society welcomed the government's proposal, which would cover patients in England and Wales, as "sensible".

Chief executive Peter Cardie said: "We know this drug does not work for everybody, and that its benefits are limited.

"But if this trial takes place, then we should at the end of it know much more about who exactly the drug works for, and what its benefits are."

Shadow health secretary Dr Liam Fox said in a statement: "The government's promise was clear - under Labour nobody would be denied the treatment they required.

"These proposed trials are just a smokescreen to hide yet another broken promise."

Approximately 63,000 people are living with MS in England and Wales, and up to 10,000 have the form of the disease which might allow them to benefit from beta-interferon.

Currently only 2,000 receive the treatment - which has led to accusations of a "postcode lottery".

Many patients believe the drugs represent their only chance of holding back the progress of their disease.

However, some experts argue that there is little evidence that patients given the drug are any better off a few years later.

And many doctors favour ruling out the drugs - saying the money could be better spent on other aspects of MS care.

'Not that expensive'

The MS Society has always claimed that the methods used by NICE to assess the true value of the drug to the health service and society were flawed.

Dr Mohammed Sharief, a consultant neurologist at Guys and St Thomas' Hospital in London, said NICE's calculations did not take into account recent significant price cuts.

"Any decision to reject the drug on grounds of cost-effectiveness would be unfair and unscientific," he said.

"I am convinced of its worth from a practical point of view - I see patients before they take it, and after they take it.

"Compared to some cancer drugs and HIV drugs, it certainly isn't that expensive a drug for the NHS - and it does benefit patients."