Guide to the technology appraisal and highly specialised technologies appeal process

5.1 Initial scrutiny of the appeal

NICE will aim to acknowledge receipt of appeal letters within 2 working days. The lead non-executive director for appeals will usually write to the appellant within 5 working days from the end of the appeal period with their initial views on the appeal.

The lead non-executive director for appeals will respond to each appeal letter to indicate their preliminary view on the validity of each of the appellant's points. In doing so they may take legal advice. This response is known as the initial scrutiny letter.

To determine the validity of an appeal point, the lead non-executive director considers whether it is:

The reason for this step is to ensure the appeal process remains within its proper bounds, and to enable an appeal panel to use its time most effectively.

When deciding if a point is arguable, the lead non-executive director will consider factors such as whether the:

They will also consider whether the matter complained of has been previously considered and rejected by an appeal panel. NICE does not consider that past decisions of appeal panels are strictly binding on future appeals, but it does aspire to broad consistency of approach. If the lead non-executive director considers that past appeal decisions show a settled position on an issue, they may decide an appeal point is unarguable if it relies on a position that is contrary to and cannot be factually distinguished from that settled position.

The lead non-executive director may suggest or require that a point is considered under a different ground of appeal to that suggested by the appellant. For example, an appellant may say that the committee 'has ignored' some evidence and that is unfair. If the lead non-executive director considers that the evaluation documentation shows the committee did consider the evidence, they may either dismiss the appeal point as unarguable or request that it be considered instead under ground 2 (for example, that the committee's treatment of the evidence led to an unreasonable recommendation).

If the lead non-executive director for appeals is minded to reject 1 or more grounds of appeal they will give reasons for this in the initial scrutiny letter and will invite further information or clarification.

If an appeal is to proceed, the scrutiny letter will usually say whether the lead non-executive director for appeals considers that the appeal should be held orally or in writing. In exceptional circumstances, 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 after consultation with the appellant(s).

Appellants are given 10 working days to respond to the initial scrutiny letter. Responses to this letter must not contain new points of appeal. Responses must deal only with requested clarifications, or arguments or comments about the lead non-executive director for appeals' initial view that an appeal point is not valid. Responses received after the deadline will not be considered.

The appellant's response to the initial scrutiny letter will usually be the last opportunity to elaborate or provide clarification to their appeal points, unless they are specifically invited to submit material by the lead non-executive director for appeals. Any uninvited material submitted after the response to the initial scrutiny letter will be rejected.

5.2 What happens after initial scrutiny?

If the initial scrutiny letter indicates that there are valid appeal points, NICE informs the appellant(s) of the date of the appeal and who will be on the appeal panel as soon as possible. In the case of an oral appeal, NICE also informs the appellant(s) who will attend from NICE, the committee and external advisers. In the case of an oral appeal, the appellant is asked to provide the names and job titles of the representatives who will be representing their organisation at the appeal (see section 8.2). In the case of a written appeal, NICE informs the appellant(s) that it will proceed as a written appeal, the date of the appeal and who will be on the appeal panel.

NICE informs stakeholders that an appeal has been received, whether the appeal will be oral or written, the name of the appellant(s) organisation, and the date of the appeal hearing. At least 2 working days after stakeholders are informed of the date of the appeal, NICE publishes a notice on its website announcing that an appeal will be held.

5.3 Final scrutiny of the validity of the appeal points

Within 5 working days of receiving an appellant's response to the initial scrutiny letter, the lead non-executive director for appeals will write to the appellant with their final decision on the validity of the appeal points raised. This is known as the final scrutiny letter. A further response cannot be submitted by the appellant. The letter outlines all appeal points that will be considered at the appeal and may also make specific directions for the conduct of an appeal.

Exceptionally, scrutiny letters may suggest that one or more appeal points could be further explored in writing before the appeal hearing or written appeal. Typically, this will be when a legal point has been raised and it will be unhelpful for the appeal panel's preparation for that point to be detailed for the first time in the hearing itself. In that case, the lead non-executive director for appeals will provide directions for how the point should be dealt with, usually by preparing written arguments in advance.

The final scrutiny letter may also contain advice or suggestions intended to support the conduct of the appeal. For example, drawing attention to a past decision when it appears likely that the appeal panel may have this in mind, or suggesting a grouping of appeal points. Any such advice will always be subject to the appeal panel chair's right to conduct the hearing as they think best.

If there is more than one appellant, each appellant will be sent a copy of the other appellants' appeal letters at this stage. If the appeal letter or responses to scrutiny contain confidential information, the appellant must ensure they have provided a version with this information redacted. When possible, appellants should coordinate when preparing their appeal presentations to avoid duplication, although NICE appreciates there may be valid reasons why this is not always appropriate.

A decision that an appeal point is not valid may be challenged by way of judicial review. NICE's position is that: