NICE process and methods

4 Making an appeal

4.1 Who can appeal?

Only consultees involved in a technology appraisal or a highly specialised technology can appeal against final recommendations. A consultee is referred to as an appellant once an appeal has been lodged.

4.2 How to lodge an appeal?

A consultee may appeal to NICE within 15 working days from the day the final draft guidance is issued to consultees and commentators. This is the appeal period. The letter from NICE that accompanies the final draft guidance states this deadline for appeal.

Consultees must lodge appeals in writing with the appeal project manager within the appeal period.

4.3 What is the scope of an appeal?

Generally the Appeal Panel will not rehear evidence or be persuaded by repetition of points previously made by the appellant and considered by the advisory committee unless it can be shown that 1 or more of the 2 grounds of appeal referred to in section 1 are also valid.

An appeal may relate only to the final draft guidance for technology appraisals and HSTs, or the way in which the guidance process was conducted. An appeal cannot be lodged against other documents produced during the process (for example, the preliminary draft guidance, overview or scope).

Requests for corrections of minor factual or typographical errors are not normally considered at an appeal and will be looked at separately. If factual errors are submitted at the same time as an appeal is lodged, the lead non-executive director for appeals, who initially considers the appeal, will be informed. For full details of correction of factual errors, see NICE's technology appraisal process guides.

4.4 The grounds of appeal

Ground 1 (a) – NICE has failed to act fairly

NICE is committed to following a fair process throughout the technology appraisal and HST processes. An appellant who believes that they have not been treated fairly by NICE or the advisory committee because the published process has not been followed may appeal on this ground. This ground relates only to the fairness of the process followed and not to the content of the final draft guidance. It should be noted that the final draft guidance with which an appellant does not agree is not unfair for that reason. For example, although it would be unfair to exclude a relevant data set from the appraisal or HST process, it would not be unfair if the committee considered the relevant data set and reached a view with which the appellant did not agree.

This ground of appeal does not cover unfairness in the colloquial sense, for instance that it is 'unfair' to patients not to provide a treatment.

Unsubstantiated allegations of general unfairness, for example the alleged inability to understand a conclusion, will not be accepted as a valid appeal point. Details and evidence must be provided in every case. For example, if it is claimed that an appellant cannot understand the reasons for a conclusion, and so could not respond to a consultation, the appellant must first set out the range of possible reasons that they considered may have applied, then explain why they are unable to distinguish which was the correct reason, and finally indicate why that has affected their ability to participate fairly in the consultation.

NICE requires appellants to explain what steps they took to resolve any unfairness promptly at the time it arose, for example if the same issue was present in both the consultation draft of the guidance and in the final version and the point was not raised by the appellant at the earlier consultation stage. The Appeal Panel may interpret the absence of any such steps, without sufficient reason, as evidence that there was in fact no such unfairness.

Ground 1 (b) – NICE has exceeded its powers

NICE is a public body. It undertakes its work in accordance with public law, the statutory instruments under which it was established and the directions and guidance issued by the Secretary of State for Health. An appellant may appeal on the ground that NICE has acted outside its remit or has acted unlawfully.

Ground 2 – The recommendation is unreasonable in light of the evidence submitted to NICE

NICE will not accept an appeal simply because a consultee disagrees with the views or conclusions in the final draft guidance. However, a consultee may appeal if they consider that the recommendations in the final draft guidance cannot reasonably be justified from the evidence presented to the committee. This ground means that the guidance is obviously and unarguably wrong, illogical, or so absurd that a reasonable advisory committee could not have reached such conclusions. The Appeal Panel will not make new judgements about the technology, but will review the advisory committee's decisions to see if they can reasonably be justified, based on the evidence that was available to the advisory committee. It should be noted that it is possible that 2 different committees could reach different conclusions based on the same evidence without acting unreasonably.

4.5 What must the appeal letter contain?

The appeal letter is the appellant's first opportunity to present the points they wish to appeal on. It is important that the appeal letter is submitted correctly, is presented clearly and contains the necessary information, as explained below. If the letter received is not appropriate (for example, the letter does not have sufficient supporting information or the relevance of the appeal points is unclear), there is a possibility that the appeal will be dismissed as 'not valid' because it does not fall within 1 or more of the grounds of appeal. The appeal letter requirements are stated in this section.

The appeal letter must contain an introductory statement clearly indicating the final draft guidance that is to be appealed and on which of the permitted grounds the appeal is being made. For complex appeals, or if a notice of appeal is longer than 5 A4 pages, appellants are asked to produce an executive summary of the appeal. This should be no longer than 1 page of A4.

The appeal letter must clearly and succinctly set out the appellant's points of appeal in detail. Appeal points must be made in order of the ground to which they relate, that is, all appeal points made under ground 1 must be made first, followed by all points made under ground 2. Appeal letters must be sufficiently comprehensive that the Appeal Panel can understand all points being raised.

Each point must be headed with the appeal ground to which it relates, and a 1‑sentence description of the appeal point. For example:

Ground 1 (a): the change from a positive to negative recommendation following an ACD without further consultation is unfair

Appellants who wish to appeal under ground 1 must refer to the relevant NICE process document (including the specific paragraph number) that has allegedly been contravened. If arguments are for a final draft guidance being procedurally unfair, the arguments should be clearly outlined in the appeal letter.

Each appeal point must be numbered so that the first appeal point under ground 1(a) is numbered 1(a).1 with subsequent ground 1 points numbered 1(a).2, 1(a).3, and so on. The same numbering will apply for ground 1(b) and ground 2 points, for example: 1(b).1, 2.1 and so on. It is not necessary to number individual paragraphs in the appeal letter, but if the appellant considers that this aids clarity, they should simply number every paragraph in the appeal letter sequentially, and use the numbered headings described above for appeal points to break up the text.

The Appeal Panel only considers the exact grounds and arguments as set out in the appeal letter, and appellants should prepare their appeal letters accordingly. The grounds for appeal are quite distinct and are set out in section 1. Appellants are therefore advised to consider carefully which ground of appeal any given complaint relates to. In particular, it is unhelpful to submit complaints that are essentially about the substance of guidance (that is, that the conclusion is unreasonable in light of the evidence) under ground 1(a). If the context for different appeal points overlaps, it is not necessary to repeat the same points under more than 1 appeal point, but appellants must set out the argument they wish to make under each ground in detail. They must not refer the Appeal Panel to earlier text without clearly indicating how that text relates to the current appeal point. For instance, it is not acceptable to state under ground 2: 'The appellant repeats the points made under point 1(a).1 above'. But it is acceptable to state: 'The appellant argues that the points set out in 1(a).1 above also demonstrate that the guidance cannot reasonably be justified in the light of the evidence submitted in that...'.

Appeals will not be considered unless the grounds for appeal are clearly identified, fall within 1 or more of the grounds set out in section 1, and are arguable.

If the appeal letter contains commercial-in-confidence or academic-in-confidence information, the appellant will be responsible for ensuring that this information is clearly labelled and a second version of the appeal letter is submitted with the commercial-in-confidence or academic-in-confidence information redacted.

The letter must conclude with a final statement indicating whether the appellant wishes to be heard at an oral or a written appeal, should one take place. The lead non-executive director for appeals will make this decision at their discretion; however, the appellant's preference will be taken into account.

In summary the appeal letter must include the following information:

  • the ground(s) of appeal

  • the aspect(s) of the final draft guidance or technology appraisal/HST process being appealed against

  • the reasons why the aspect(s) of the final draft guidance or technology appraisal/HST process being appealed against fall within the specified ground(s) of appeal, in enough detail to demonstrate an arguable case

  • the concluding statement indicating whether the appellant wishes to be heard at an oral or written appeal.

Only the original appeal letter submitted by an appellant for scrutiny will be considered. Revised versions of the appeal letter submitted after the appeal period and during the scrutiny stage will not be accepted.

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. This response is known as an initial scrutiny letter, which is set out in section 5.1.

4.6 Patient access schemes and flexible pricing in the technology appraisal programme

Appeals following the rapid review of guidance after the submission of a new patient access scheme will only be accepted on points relating to the new patient access scheme. The Appeal Panel will not consider points previously raised unless they are directly concerned with the impact of the patient access scheme on clinical or cost effectiveness.

Appeals will be accepted only on points relating to the flexible pricing scheme proposal. The appeal will not consider points previously raised unless they are directly concerned with the impact of the flexible pricing proposal on clinical or cost effectiveness

4.7 Can new data be submitted to the Appeal Panel?

All data that consultees consider relevant to the guidance topic should be submitted to the advisory committee as part of the technology appraisal or HST process as described in the NICE process guides. New evidence or information that was not presented to the Committee, or re-analysis of existing evidence or information, must not be presented in the appeal letter or at the hearing, and will not be considered by the Appeal Panel.

An appeal is not an opportunity to reopen arguments and issues that the advisory committee has decided on. It is not possible to appeal against the final draft guidance because a consultee does not agree with it.

Generally the Appeal Panel will not rehear evidence or be persuaded by repetition of points previously made by the appellant and considered by the advisory committee unless it can be shown that 1 or more of the 2 grounds of appeal in section 1 is also valid.