NICE process and methods

9 The written appeal process

9.1 What is the timescale for an appeal?

If the lead non-executive director for appeals has agreed to proceed with a written appeal, the appeal panel will aim to meet within 10 weeks of an appeal being lodged.

9.2 How is the written appeal process done?

All communication for written appeals is done through an exchange of letters by email.

The lead non-executive director for appeals scrutinises the appeal letter and composes the initial scrutiny letter, usually within 5 working days of receiving the notice of appeal, requesting clarification on the appeal points, if necessary, and proposing that the appeal proceeds as a written appeal. The appellant has 10 working days to respond to the initial scrutiny letter and respond to the proposal that it will be a written appeal.

In exceptional circumstances, when the validity of the appeal points are uncertain at initial scrutiny, the lead non-executive director for appeals may wait to decide whether to proceed with an oral hearing or propose a written appeal, until the appeal points are confirmed at final scrutiny.

A written appeal process will only be adopted after consultation with appellant(s), however, the final decision rests with the lead non-executive director for appeals.

Once the grounds of appeal have been determined and the written appeal confirmed, the correspondence is forwarded to the committee chair and NICE's director for medicines evaluation, who have the opportunity to respond in writing to each appellant, within 10 working days, with respect to the grounds agreed in the scrutiny letter(s). This response is sent to the appellant, who is given the opportunity to respond in writing to the comments made by the committee chair and NICE's director for medicines evaluation. The appellant(s) also has 10 working days to respond. If there are multiple appellants, the comments made by the committee chair and NICE's director for medicines evaluation, along with any response to those comments, are shared with the other appellants.

All correspondence, along with the relevant documents from the evaluation, are then provided to the appeal panel. The appeal panel then meet to consider each appellant's appeal points and the submissions received.

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

As set out in section 8.2, 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 NICE appeals team will invite another member of the appeal panel (of the same category) to attend. They will ensure there are no conflicts of interest with the evaluation being appealed. If it is not possible to replace the member at short notice, the appeal panel chair 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 lay representative, and that one of the health service or lay representatives is the panel chair. This agreement to proceed will be noted in the appeal panel decision.

9.3 Who may attend the appeal?

The appeal panel meets to discuss the appeal points accepted at the scrutiny stage, the committee chair's and NICE team's response, and the appellant's response to this. This meeting may be held in person or virtually. The appeal panel may take legal advice if necessary. No appellants, committee members, NICE staff (other than the appeals team), press or public will attend this meeting.

During the meeting, the appeal panel will discuss and agree their decision on each appeal point. The appeal decision will summarise the issues discussed at the hearing, the panel's decision on each appeal point and their rationale.