NICE issues guidance on zanamivir (Relenza) for influenza

NICE 2000/ 047
Issued: 21 November 2000

Press Release

NICE issues guidance on zanamivir (Relenza) for influenza

The National Institute for Clinical Excellence (NICE) has today issued its guidance on the use of the zanamivir (Relenza) for the treatment of influenza. This guidance replaces the Institute's guidance on zanamivir issued in October 1999.

NICE has recommended that:

• The NHS should not use zanamivir to treat flu in people who are otherwise healthy. These patients are advised not to visit the GP; but you are advised to stay at home and take medicines from the chemist (pharmacist) to relieve the symptoms.
• When flu is circulating in the community zanamivir may be used to treat at-risk adults, who are able to begin their treatment within 48 hours of the start of their symptoms. In the clinical trials that were conducted on zanamivir at-risk adults were defined as people who are in one or more of the following groups:

- age 65 years or over

- have chronic respiratory disease that requires regular medication - including chronic obstructive pulmonary disease (COPD) and asthma.

- have significant cardiovascular disease - this does not mean people with hypertension (high blood pressure).

- have a lowered resistance to disease - this means that they are immunocompromised

- have diabetes mellitus

Professor Sir Michael Rawlins, Chair of the Institute said "If you are in one or more of the at-risk categories then you should ensure that you have had your 'flu-jab' this is your first line of defence against the flu. If however you do develop flu-like symptoms you should contact your GP surgery or telephone NHS Direct on 0845 46 47 for advice. You should do this within 36 hours of the symptoms starting."

Andrew Dillon, the Institute's Chief Executive said: "This new guidance on zanamivir demonstrates the Institute's commitment to ensuring that guidance for treating patients is based soundly in the evidence. When we reviewed zanamivir last year the data did not show that this product would significantly support the NHS's management of patients with flu. New evidence submitted by Glaxo Wellcome for this appraisal demonstrates benefits in using this product for people at risk of serious complications of flu"

Ends

Notes for Editors Background- Flu & zanamivir

1.

Influenza is more commonly known as flu. Flu is a common condition that can affect anyone. It is a respiratory illness caused by infection with a flu virus (there are three viruses - A, B and C). When patients catch flu the virus spreads in the lungs and airways. Flu is usually associated with the following symptoms - quickly developing a high temperature as well as general aches and pains, a loss of appetite, nausea, vomiting and usually a harsh cough that doesn't bring anything up. For most people these symptoms get better within 6-8 days and they don't experience any other problems ( these problems are known as complications). However for some people who have certain medical conditions flu can potentially lead to complications and result in serious illness, hospitalisation or even (in rare cases) death. This group of people are therefore referred to as being at-risk.

2. Infections with flu virus A occur most years during the winter. Normally less than 50 out of every 100,000 people visit their GP with flu-like symptoms every week. This can rise to between 50 and 400 out of 100,000 people per week. A flu outbreak is called an epidemic when more than 400 people in every 100,000 visit their GP with flu symptoms each week.

3. People who visit their GP with the flu-like symptoms described above may not in fact be suffering from flu. This is because a variety of other illnesses caused by viruses can result in similar symptoms.

4. People who are otherwise healthy and have flu-like symptoms are advised not to visit their GP, instead they are advised to stay at home and take medicines from the chemist (pharmacist) to relieve their symptoms.

5. The NHS advises people who are considered at-risk of complications from flu to be immunised against the flu virus (often referred to as having a 'flu-jab').

6. Zanamivir (sold as Relenza) is one of the medicines that can be used in the treatment of flu. It is called an anti-viral agent and it helps prevent the spread of the virus in the lungs and airways. It is licensed in the UK for treating people aged 12 and over who present with flu symptoms when flu is circulating in the community. The drug is taken twice a day for 5 days using a device similar to an inhaler. When the patient breathes in using the inhaler device it ensures that medication is delivered to the lungs. The drug should be started as soon as possible after the symptoms of flu were first seen, and it has to be started within the first 48 hours.

Nice guidance

7. NICE has issued its guidance to the NHS in England and Wales, copies of the guidance have been sent to all GPs.

8. The Department of Health and the National Assembly for Wales have issued their own guidance for the management of influenza and zanamivir. This is available at: http://www.doh.gov.uk/zanamivirguidance

9. The NICE guidance does not cover the circumstances of a pandemic or widespread epidemic of a new strain of influenza for which there is little or no community resistance.

10. This guidance will be reviewed in June 2002.

Evidence:
For all adults:

11. The duration of symptoms of influenza is reduced by 1 day from about 6 to 5 days in the intention-to-treat population (ITTP).

12. Support for the finding of a reduction in duration of symptoms comes from the observation that the duration of fever appears to be reduced from about 2.5 days to about 2 days. Less convincing, but largely in the same direction, is the suggestion of a reduction in the time to return to normal activities of 0.5 days from about 7.0 to 6.5 days for the ITTP. For at-risk adults

13. The evidence-base for at-risk adults (some 800 individuals) is based both on sub-group analysis of individuals in eight all-adult trials and the recently completed NAI30008 trial.

14. In the overall pooled analysis of at-risk individuals, the duration of symptoms of influenza is reduced by 1.2 days from about 6 to 5 days in the ITTP, and Overall zanamivir reduced the absolute risk of complications requiring antibiotics in the ITTP by 6%.

15. No reliable data are available as to the impact of the use of zanamivir on hospitalisation rates or mortality.

Impact for NHS

16. It is estimated that this guidance will result in between 97,000 and 487,000 at-risk individuals being prescribed zanamivir in the influenza season, at a cost of between £2.3m and £11.7m, in England and Wales. These estimates are based on drug costs alone. Increased primary care activity and potential decreases in hospitalisations will influence actual costs.

17. The impact on primary care of the availability of zanamivir for the at-risk groups is difficult to calculate. This is partly because it is not possible accurately estimate how many people in the at-risk groups already consult their general practitioner for influenza like illness (ILI) during the influenza season. On the basis that there are 29,000 general practitioners in England and Wales, and that measures to target zanamivir to patients in the at risk groups are effective, the number patients eligible to receive zanamivir and seeking a consultation would be between 3 and 17 per general practitioner.

18. The present NHS policy of active influenza immunisation provides the opportunity for a targeted approach to the use of zanamivir in the at-risk population. Information about the availability and appropriate use of the medicine could be incorporated into local and national influenza prevention and treatment campaigns.

19. NICE recognise that this guidance could have a considerable impact on primary health care services - both during the day and out of hours. Health authorities and primary care organisations should use practice data to estimate the possible range of demand from the local at-risk population. Handling strategies should be developed which take into account local prescribing arrangements including the use of patient group directions. Such plans should form part of integrated winter planning arrangements.

20. In considering local implementation arrangements, health authorities and primary care organisations will wish to take account of advice from the Department of Health and the National Assembly for Wales. Local action might include some or all of the following:

• Telephone triaging by practice nurse or other health professional working to a protocol and standard diagnostic questions
• Patient group directions for direct supply by nurses and community pharmacists, including those working from NHS Walk-in Centres (England only)
• NHS prescriptions issued by GPs in the normal way following consultations or home visit

General Information

21. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 12pm (lunchtime) on Tuesday 21st November

22. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

23. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. That is we use a team of experts to produce guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes around 12 months to complete and involves the manufacturers of the technology, patient groups and professional organisations.

24. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.

25. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.