Health watchdog relents on flu drug

Most flu sufferers will not be prescribed Relenza on the NHS

LONDON, England (Reuters) -- The National Institute of Clinical Excellence on Tuesday backtracked on an earlier blanket rejection of the flu drug Relenza, ruling it could be given to the elderly and other high risk groups.

The decision by the watchdog body -- which determines which treatments should be reimbursed on the state health service -- means the medicine will be available during the 2000/01 influenza season.

Patients qualifying for Glaxo Wellcome Plc's drug will include people aged 65 years or over, as well as those suffering from respiratory problems, cardiovascular disease, diabetes or a weakened immune system.

NICE estimates that 100,000 to 500,000 people could now be prescribed Relenza at a cost to the National Health Service of 2.3-11.7 million pounds ($3.3-16.7 million).

The product will only be prescribed when flu is circulating in the community.

The organisation initially rejected the controversial drug in October 1999, arguing it had not been shown to offer sufficient benefits to merit dispensing on the NHS, a move which led to a furious confrontation with drugmaker Glaxo.

Glaxo and other drug companies sent a joint letter to Prime Minister Tony Blair in response, saying the intervention of NICE could seriously threaten the British drugs industry.

The body's revised recommendation follows a further review in the light of new clinical data.

"New evidence submitted by Glaxo Welcome for this appraisal demonstrates benefits in using this product for people at risk of serious complications of flu," said NICE Chief Executive Andrew Dillon.

NICE said, however, that Relenza should not be used to treat otherwise healthy patients and stressed that the flu vaccine should be the first line of defence.

Glaxo, which sold 19 million pounds worth of Relenza world-wide in the first half of 2000, welcomed the decision.

Industry analysts said the direct financial impact of the move would be limited, given that the UK accounts for just three percent of world pharmaceuticals sales -- but the NICE verdict could have wider ramifications.

"NICE's earlier decision had a negative knock-on effect in a lot of other European markets and the fact that they have reconsidered that position could now improve the reimbursement climate elsewhere," said Susan Haylock of Deutsche Bank.

The chairman of the British Medical Association's general practitioners' Committee, John Chisholm, said the NICE had made "the right decision" but warned that demand for the medicine could put enormous strains on surgeries if there was a flu epidemic.

Health Minister John Denham said the government was taking steps to minimise the burden on GPs, including drawing up agreements to enable nurses and pharmacists to supply Relenza.

Up to 4,000 people die from flu-related illnesses every winter in Britain.

Relenza, which costs 24 pounds ($34) for a course of treatment, is delivered via an inhaler and must be taken 48 hours after the first signs of flu.

It was discovered by Melbourne-based Biota Holdings and is one of a new group of products addressing the underlying mechanism of the disease.

It competes in the key United States marketplace with Roche Holding AG's tablet Tamiflu which was approved on Monday by the U.S. Food and Drug Administration for flu prevention as well as treatment.

Tamiflu is not yet available in Britain.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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National Institute of Clinical Excellence

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