NICE process and methods

8 The written appeal process

8.1 What is the timescale for an appeal?

Assuming that the appeal is valid, the Appeal Panel will aim to hold a written appeal within 10 weeks of an appeal being lodged.

8.2 How is the written appeal process conducted?

All communication for written appeals is done through an exchange of letters. The lead non-executive director for appeals scrutinises the appeal letter and composes the initial scrutiny letter, requesting clarification on the appeal points, if necessary, and proposing that the appeal proceeds as a written appeal usually within 5 working days of receiving the notice of appeal. The appellant has the opportunity to respond to the initial scrutiny letter to clarify and confirm the grounds to be considered at the appeal and respond to the written appeal proposal within 10 working days.

In exceptional circumstances, where the validity of the appeal points are uncertain at initial scrutiny, the lead non-executive director for appeals may defer deciding whether to proceed with an oral hearing or proposing that there should be a written appeal, until the appeal points are confirmed at final scrutiny. A written appeal process will only be adopted following consultation with appellant(s).

Once the grounds for appeal have been determined and the written appeal agreed, the correspondence is forwarded to the Chair of the advisory committee and the NICE Centre for Health Technology Evaluation Director (Centre Director), who have the opportunity to respond in writing to the appeal letter(s), within 10 working days, with respect to the grounds agreed in the scrutiny letter. This response is sent to the appellant(s), who is given the opportunity to respond in writing to the comments made by the advisory committee Chair and the Centre Director. The appellant(s) also has 10 working days to respond.

All correspondence, along with the technology appraisal or highly specialised technology documents, is then provided to the Appeal Panel. The Appeal Panel meet to consider each appellant's appeal points and the submissions received.

On the morning of the appeal, the appeal letter, the scrutiny letters and responses to these letters are placed on the NICE website. Any confidential information and personal data are removed before publication on the website.

All 5 members of the Appeal Panel must be present for the appeal. However, if a member is unable to attend or has to stand down at short notice, the Chair of the Appeal Panel will consult with the appellant(s) and NICE representatives. If all parties agree, the appeal will continue with only 4 members of the Appeal Panel, provided that there is still at least 1 representative of the life sciences industry, 1 health service representative, and 1 patient representative, and that one of the health service or patient representatives is the panel chair. This agreement to proceed will be noted in the Appeal Panel decision.

8.3 Who may attend the appeal?

The Appeal Panel convenes to discuss the appeal lodged, and the advisory committee Chair's and appellant(s) response. This meeting may be in person or via teleconference. The Appeal Panel may take legal advice if necessary. No appellants, advisory committee members, NICE staff, press or public will be in attendance at this meeting.

Figure 2 Summary of the written appeal process