Guide to the technology appraisal and highly specialised technologies appeal process (pre June 2023)

5.1 Initial scrutiny of the appeal

NICE will acknowledge receipt of appeals 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.

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

The 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, 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). If the notice of appeal does not present an arguable case under 1 or more of the grounds of appeal, the lead non-executive director for appeals will give reasons for this and may request further information or clarification in the initial scrutiny letter. Appeals are only referred to an Appeal Panel if, after giving the appellant an opportunity to elaborate or clarify the grounds of appeal, the lead non-executive director for appeals is satisfied that the appeal falls into one or more of the grounds and is arguable. The lead non-executive director for appeals has the discretion to allow the appeal to go ahead on one or more grounds presented in any appeal letter but not others.

In determining the prospects of success of appeal points, the lead non-executive director for appeals has regard to and is guided by past decisions of the Appeal Panel, but is not strictly bound by them. The lead non-executive director for appeals gives greater weight to past decisions on legal or quasi‑legal issues, and less weight to decisions on factual issues. For example, a finding that guidance should consider any significant groups of patients with disabilities who may be unable to take a treatment being recommended is likely to be given weight in future appeals. This is a finding on a legal issue. A finding that some specific aspect of guidance was or was not reasonably justified is unlikely to be given much weight in a future appeal. This is only a finding about the facts of 1 appraisal or highly specialised technology topic.

The lead non-executive director for appeals may suggest reallocating grounds of appeal if the issues raised seem weak under the nominated ground, and may be stronger under a different ground.

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' concern that an appeal point raised has no reasonable prospect of success, is unsupported by evidence, or is outside the scope for an appeal. Existing appeal points may be elaborated and further evidence in support of existing appeal points may be given. Responses received after the deadline may not be considered, and a final decision may be taken without their being taken into account. There may be occasions when further clarification is needed and more than 1 scrutiny letter may be sent.

The appellant must not submit a revised appeal letter in response to comments in the initial scrutiny letter unless invited to do so. For example, the appellant must not move and renumber appeal points to clarify what appeal points were being made if the original letter was insufficiently clear. The response to the initial scrutiny letter must only address the points raised by the lead non-executive director for appeals.

If, exceptionally, the appellant is invited to submit a revised appeal letter, it must not contain new grounds of appeal. The numbering of the original letter should be preserved as far as possible or clearly indicate when an appeal point has changed number (for example, "2.1 [formerly 1(a).3]", if an appeal point changes from ground 1(a) to ground 2) or held to have no reasonable prospect of success (for example, 2.3 [not now used]).

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, who will be on the Appeal Panel, and in the case of an oral appeal, who will attend from NICE and its advisory committee and external advisors, as soon as possible. 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. It may be necessary to limit the number of representatives attending the appeal.

In the case of a written appeal, NICE confirms with the appellant(s) that the appeal will proceed as a written appeal, the date of the appeal, and who will be on the Appeal Panel.

NICE informs consultees and commentators that an appeal has been received, whether the appeal will be held orally or be on the papers, the name of the appellant(s) organisation, and the date of the appeal hearing. NICE publishes a notice on its website announcing that an appeal will take place at least 2 working days after consultees and commentators are informed of the date of the appeal.

5.3 Final scrutiny of the appeal

The lead non-executive director for appeals writes to the appellant with the final decision on the admissibility of the appeal points raised within 5 working days of considering the appellant's response to the initial scrutiny letter. This is known as the final scrutiny letter.

The final scrutiny letter is the lead non-executive director for appeals' final word and a further response cannot be submitted by the appellant. That letter will outline all of the appeal points that will be considered at the appeal and may also make specific directions for the conduct of an appeal, if necessary.