Document Leak: NICE Says No to MS - Pharmaceutical Executive

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Document Leak: NICE Says No to MS


Pharmaceutical Executive

London-Schering and Biogen have both expressed anger over the leak of a National Institute of Clinical Excellence (NICE) document suggesting that doctors stop prescribing beta-interferon to new multiple sclerosis (MS) patients.

NICE was forced to release the contents of the document, known as a provisional appraisal determination (PAD), on its website after the information was leaked to the press. It concluded that, on the basis of clinical or cost-effectiveness, neither glatiramer acetate nor beta-interferon should be recommended for use in England and Wales.

A Schering spokesperson called the content of the PAD "flawed" and said the company is preparing a response to submit before the consultation’s September 11 deadline. She also says clinical data, although it would not be new, would support the response.

After noting that the United Kingdom spends ?970 per person on health each year, whereas in France the figure is ?1,400 and in Germany ?1,700, the spokesperson said, "In Europe, we have the worst survival rates 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."

A Biogen spokesperson says there is overwhelming evidence for the effectiveness of beta-interferon and called the leak "part of a cynical exercise of deflecting attention away from National Health Service (NHS) rationing."

Biogen rejects claims made in a radio interview by Professor David Barnett, chairman of the NICE appraisal committee, that the committee has examined all the available evidence. "In fact," the Biogen spokesperson continued, "NICE rejected the opportunity to consider the whole range of clinical evidence arising from the MS trials."

Press reports of the leak caused alarm by suggesting that the PAD represented a final decision rather than preliminary findings. Schering is now urging consultant neurologists to extend prescriptions of beta-interferon to all MS patients who will benefit from treatment.

Andrew Dillon, NICE chief executive, said the agency considers its provisional conclusions to be "robust" but added, "It is important that the national patient and professional organizations, manufacturers, and other consultees have the opportunity to comment both on our interpretation of the evidence and on our conclusions."

Evidence that NICE is more concerned about cost-effectiveness than clinical effectiveness can be found in its suggestion that NHS, the National Assembly for Wales, and manufacturers should consider actions to secure MS medicines for patients in a cost-effective way.

Peter Cardy, chief executive of the MS Society, says NICE’s preliminary conclusions suggest to patients that "these drugs are not worth prescribing because you’re not worth treating."

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