UK's NICE turns nasty, rejecting Glaxo Wellcome's anti-flu drug Relenza

In its first action, the UK's recently-created National Institute forClinical Excellence, which has basically been set up as a second channel to the Medicines Control Agency to assess the safety and efficacy of medicines available on the National Health Service (Marketletters passim), has said that Glaxo Wellcome's new influenza drug, the neuraminidase inhibitor Relenza (zanamivir), should not be prescribed on the NHS. The NICE's rapid assessment committee had been fast-tracking Relenza, which costs around L24 ($39.72) for a course of treatment, so that it might be available in time for the flu season.

The committee's negative stance is based on what it sees as insufficient evidence of the drug's efficacy in the people most vulnerable to the impact of flu, mostly the elderly and asthmatics. Clinical testing of the drug was undertaken in 6,000 patients worldwide, but the company admits that only a few were asthma suffers or elderly people, since such patients are difficult to recruit into trials. It argues, however, that it is only in general practice that the full benefits for these patient populations can be demonstrated.

The NICE has no statutory powers and only makes recommendations to the Secretary of State for Health. As the Marketletter was going to press, there had been no response from Health Secretary Frank Dobson.