| The National Institute for Clinical Excellence has rejected an appeal by Glaxo Wellcome against a recommendation that its influenza drug zanamivir (Relenza) should not be made available for prescription on the National Health Service.
According to leaked reports, NICE's rapid assessment committee decided last week that there is not enough research evidence to recommend the inhaled antiviral for people most vulnerable to influenza, such as the elderly. Subsequently, the company appealed to the institute's board, which rejected the appeal on October 4. The NICE recommendation was forwarded to the Secretary of State for Health (Mr Frank Dobson), who is expected to make a decision shortly, probably within the next two weeks. Observers believe he is unlikely to reject the recommendation, which is the institute's first. If Mr Dobson endorses the NICE stance, regulations will be laid to exclude Relenza from NHS prescription. |
A five-day course of treatment with Relenza, which is formulated as a dry powder inhaler, has a net UK cost of £24 |
The institute has carried out its appraisal of zanamivir under a fast-track procedure developed for use in circumstances where the NHS requires guidance on a new drug at short notice (see panel). This process was chosen for zanamivir, the institute says, because of the nature of the drug and "because of the fact that 'flu will again burden patients and the NHS" this autumn and winter.
The drug will undergo the full appraisal procedure, which takes around eight months, in the new year, as will oseltamivir (Tamiflu), an oral product from Roche, which is expected to be licensed soon.
Glaxo Wellcome has protested that the rapid assessment process is unfair. It says that the institute demanded data on Relenza that the company did not have because it could only be obtained from widespread use of the product. The company also says that the rapid assessment timetable did not allow proper preparation of the appeal.
The company's chairman (Sir Richard Sykes) has told the Government that a decision to ban the use of Relenza would damage the entire British pharmaceutical industry. He has also hinted that Glaxo Wellcome might quit the UK, claiming that the NICE decision "calls into question the suitability of the UK as a base for multinational pharmaceutical operations".
Glaxo Wellcome is reported to be considering seeking a judicial review of the NICE decision. The company fears that the decision could set a precedent for regulators world-wide.
Allegations have been made that news of the NICE decision was leaked during the Labour Party conference last week - with at least one report (Times, October 5) claiming that Mr Dobson was the source of the leak. Glaxo is said to be concerned that the news had been broadcast round the world before it had had a chance to lodge an appeal.
Relenza was launched in the UK on September 6 (PJ, September 11, p374). Its net price is £24 for a five-day course of treatment. Glaxo Wellcome has estimated its annual cost to the NHS at £10-15m, based on the number of patients who might consult a general practitioner within the first two days of symptoms. A National Prescribing Centre estimate of £115m was based on significant usage for both treatment and prophylaxis in an epidemic year, although zanamivir is not currently licensed for prophylaxis.
Glaxo Wellcome says that in clinical trials zanamivir reduced the severity of major symptoms by up to 44 per cent and shortened the duration of illness by a median of 1.5 days. Some high risk patients (eg, the elderly and asthma patients) were included in the trials and appeared to have no major safety problems while taking zanamivir, but efficacy data for these patients were limited.