Report from National Institute of Clinical Excellence

Dear Colleague,

1. Zanamivir (Relenza) in the management and treatment of Influenza
   1.1 The National Institute for Clinical Excellence has been asked, by the Department of Health and the National Assembly for Wales, to prepare guidance for use within the NHS of zanamivir (Relenza) for the treatment of influenza, during the forthcoming winter. This guidance will be reviewed, in advance of the 2000/20~ influenza season. New guidance will then be issued to cover both zanamivir (Relenza) and oseltamivir (Tamiflu), which is expected to be licensed next year.

2. The Status of this Guidance
   2.1 Zanamivir (Relenza) is authorised in the United Kingdom as a prescription only medicine for the treatment of influenza A and B in adults and adolescents, 12 years of age and over with symptoms typical of influenza when when influenza is circulating in the community.
   2.2 Zanamivir (Relenza) is accordingly now available for prescribing on the NHS. Individual health professionals have a responsibility to exercise their clinical judgement in determining what treatments are appropriate and necessary for patients with influenza-like symptoms. This guidance does not override that individual responsibility. It is intended to assist health professionals with advice on the appropriate use of zanamivir (Relenza) alongside current best practice. The guidance represents the view of the Institute's Rapid Appraisal Committee (the membership of which is set out in Annex A), arrived at after careful consideration of the available evidence. Health professionals are expected to take it fully into account

3. Summary
   3.1 Influenza is an acute respiratory illness caused by infection with influenza viruses x A), arrived at after careful consideration of the available evidence. Health professionals are expected to take it fully into account when exercising their clinicalyrexia associated with general aches and pains, anorexia, nausea, vomiting and usually a harsh unproductive cough. Most patients do not develop complications and acute symptoms subside within 3-5 days. Patients with underlying morbidity are exposed to complications, which may result in senous illness and death.
   3.2 The combined evidence from the relevant clinical trials indicates that the use of zanamivir (Relenza), within 48 hours of the onset of symptoms of influenza, reduces the duration of the illness, by one day, from a median of 6 to 5 days.
   3.3 Due to the limited numbers of 'high risk' patients (particularly the elderly and those with cardiovascular disease, asthma, chronic obstructive pulmonary disease, or immunosuppression) that have been treated with zanamivir (Relenza) in clinical trials, the Institute has not found it possible to conclude that the product reduces the frequency of serious secondary complications in these groups of patients.
   3.4 On the basis of its findings and conclusions, the Institute advises that health professionals should not prescribe zanamivir (Relenza) during the 1999/2000 influenza season. The NHS should encourage, and where possible, support the manufacturer in the conduct of the four additional clinical trials which are currently underway.

4. Action
   4.1 Chief Executives are asked to bring this guidance to the attention of health professionals with responsibility for prescribing to patients who present with influenza-like symptoms.
   4.2 Directors of Public Health should ensure that arrangements are in place to implement the influenza vaccination programme as set out in the Chief Medical Officer's Update issued on 23 August 1999 (page 6)
   4.3 Health professionals should be aware that existing advice on the symptomatic management of patients presenting with influenza-like symptoms remains in force.

5. Process
   5.1 The Department of Health and the National Assembly for Wales asked the Institute to recommend to Health Ministers and the Health Secretary the circumstances under which zanamivir (Relenza) should be used, within the National Health Service, during the 1999/2000 influenza season.
   5.2 Because of the need for the Institute to provide its advice quickly, it was not possible to utilise its normal appraisal procedure. With the agreement of the Department of Health, the National Assembly for Wales, and the manufacturer (Glaxo Wellcome) the Institute adopted a rapid appraisal procedure. The procedure is described in Annex A.

National Institute for Clinical Excellence

Guidance to the NHS on zanamivir (Relenza)

Issue date: October 1999

Review date: September 2000

8 October 1999

Health Authority Chief Executives

MIS Trust Chief Executives

PCG Chief Executives

Local Health Group General Managers

Special Health Authority Chief Executives

MISE Regional Dfrectors

Chief Officers of Community Health Councils

How to contact NICE:

National Institute for Clinical Excellence

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