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Process for rapid assessment of zanamivir (Relenza)

Process for Rapid Assessment of zanamivir (Relenza)

1. Introduction:
A full appraisal by NICE takes around 8 months, however the Institute recognises that in certain circumstances the NHS may need guidance at shorter notice, and therefore it has developed a Rapid Assessment Procedure.

Because of the nature of zanamivir (Relenza), and the fact that this autumn and winter, flu will again burden patients and the NHS, the Institute will use this Rapid Assessment Procedure to produce preliminary guidance for the NHS in the early autumn.

Both zanamivir (Relenza) and ostelamivir (a similar product from Roche, which is expected to be licenced soon) will undergo the full appraisal procedure in the New Year.

2. Committee :
The process the National Institute of Clinical Excellence (NICE) will follow involves the formation of a Rapid Assessment Committee, which Andrew Dillon (Chief Executive of the Institute) will chair and which will have the following membership:

  • Chief Executive
  • Head of Appraisal
  • Clinical Director
  • public health physician
  • clinical pharmacologist
  • chest physician
  • geriatrician
  • microbiologist
  • general practitioner
  • health authority chief executive
  • health economist

3. Meetings :
There are two meetings of the Committee planned , and these will take place during September. These meetings will be held in private and GlaxoWellcome, the manufacturer of Zanamavir (Relenza) will be invited to attend the second.

4. Submissions:
The Manufacturer and other interested bodies were invited to make a submission on the 6 August 1999, to be received at the beginning of September.

5. Process:
The process the Institute will follow begins with a review of the manufacturer's (GlaxoWellcome) submission by the Head of Appraisal. The Head of Appraisal will, as required, seek clarification of submissions from those who provided them.

The Head of Appraisal will prepare an Assessment Report and draft the Interim Guidance for circulation to the Committee prior to their first meeting.

The Committee will give preliminary consideration to both documents at its first meeting and amend the draft Interim Guidance.

The manufacturer will see the Assessment Report and the draft Interim Guidance at the time it is circulated to the Committee and will be invited to comment on it when they attend to make a presentation to the second meeting.

There will be an opportunity for the manufacturer to appeal to the Board of the Institute prior to the Interim Guidance being submitted to the Secretary of State.

6. When will the Guidance be submitted to the Department of Health.
The Committee aims to submit its Interim Guidance to the Secretary of Health in early Autumn. There will be an opportunity for the manufacturer to appeal to the Board of the Institute prior to the Interim Guidance being submitted to the Secretary of State.

7. Content of Submissions:
The manufacturer and those interested parties submitting data have been free to determine the precise format of their submissions, but they will been guided by the fact that the Institute will wish to see evidence of the clinical and cost effectiveness of the technology, and any assessment which has made of its wider implications for the NHS.

The manufacturer has been invited to take account of the relevant sections from the Institute's Guidance for Manufacturers and Sponsors. This is the document which is used to inform the Institute's full appraisal process.

8. Full Appraisal of zanamivir.
GlaxoWellcome has been advised that the Institute will conduct a full appraisal of zanamivir following the rapid assessment.

Both zanamivir (Relenza) and ostelamivir (a similar product from Roche, which is expected to be licenced soon) will undergo the full appraisal procedure in the New Year (2000).