Last Updated: 2001-08-07 13:50:14 EDT (Reuters Health)

By Richard Woodman

LONDON (Reuters Health) – Britain's National Institute for Clinical Excellence (NICE) said on Tuesday its appraisal committee had provisionally concluded that two drugs for multiple sclerosis (MS) should not be paid for by the state-funded National Health Service (NHS).

"On the balance of their clinical and cost effectiveness neither beta interferon nor glatiramer acetate is recommended for the treatment of multiple sclerosis in the NHS in England and Wales," NICE said in a statement.

The decision represents a setback for the three manufacturers of beta interferon–Germany's Schering, Switzerland's Serono SA and America's Biogen–as well as for Israel's Teva Pharmaceuticals, which markets glatiramer acetate.

Patient groups have campaigned for wider use of beta interferon, arguing it can dramatically improve the lives of some MS sufferers.

Schering's UK subsidiary condemned NICE's provisional determination as "flawed" and accused the UK government of treating people with MS with disdain. The firm said it hoped that doctors would seize the opportunity to start prescribing MS drugs before NICE issues final guidance to the National Health Service.

"Each year the health service spends £970 per person in Britain compared to £1400 in France and £1700 in Germany," the firm said. "We have the worst survival rates in Europe from cancer and heart disease, so it comes as little surprise that the Government is prepared to treat people with MS with the same level of disdain by denying them proven effective treatment."

Schering said its Betaferon is supported by a wealth of trial data and up to 12 years of clinical experience across the world. "It has continuously shown benefits in reducing the number of relapses [and] the severity of relapses and has also shown strong data for slowing the progression of this disabling disease," the firm claimed. "Since its launch in 1995 around 85,000 patients have been treated worldwide and in all western European countries beta interferon is a fully reimbursable treatment for MS."

The company pointed out that NICE's assessment is still a provisional draft and that current guidance to the NHS is that appropriate patients should have access to beta-interferon. "It is hoped that consultant neurologists will view this as an appropriate time to extend prescription of beta-interferon to all those people with multiple sclerosis who will benefit from treatment," Schering added.

Meanwhile, NICE's appraisal committee called on the Department of Health and manufacturers to find a way for any of the four MS drugs to be secured for NHS patients "in a manner which could be considered to be cost effective."

In a document published on the NICE Web site, the committee indicated this would almost certainly require a significant reduction in the total cost of acquiring the drugs by the NHS in England and Wales.

Hinting at the need for further clinical trials, it added: "The uncertainty surrounding the definition of which patients benefit and to what extent are factors which could be considered relevant in any discussions between the Department of Health and manufacturers on ways in which these medicines could be acquired cost effectively."

The committee's provisional determination document says the current annual cost per patient of the beta interferons in the UK is £7,259 for Schering's Betaferon, £9,061 for Biogen's Avonex and £9,088 to £12,068 for Serono's Rebif. Teva's Copaxone costs £6,650.

The document said clinical trials showed the drugs reduce relapse frequency by about 30%, which is equivalent to one relapse avoided every 2.5 years in people with relapsing remitting MS. However, longterm effects of treatment on disability could not be predicted reliably, the committee said.

It noted that mathematical models of the drugs' cost-effectiveness had come to widely differing conclusions–ranging from a manufacturer's estimate of £10,000 per quality adjusted life year to an American research group's estimate of more than £3 million.

Subsequent modelling had produced estimates ranging from £40,000 to £200,000 per QALY when drugs were discounted over 20 years, but as high as £190,000 to 425,000 over 10 years and £380,000 to £780,000 over 5 years. The committee concluded on the basis of this evidence that the drugs were not cost effective.

NICE said it had decided to publish the document because of media speculation. Companies and other stakeholders have until September 11 to comment on the provisional determination, after which NICE will prepare a final determination and stakeholders may still appeal.

Biogen maintained in a statement that the evidence for the effectiveness of beta interferons in MS is now overwhelming. It added that the drugs are widely used in the treatment of MS in every developed country except the United Kingdom.