NICE process and methods

4 Making an appeal

4.1 How to lodge an appeal?

A consultee may appeal to NICE within the appeal period. The appeal period starts when the final draft guidance is issued to stakeholders and ends 15 working days later at 5pm. The letter from NICE that accompanies the final draft guidance states this deadline for appeal. Appeals must be submitted in writing to See section 12 for accessibility and adjustments.

4.2 What is the scope of an appeal?

An appeal is not a rehearing of the evaluation. The appeal panel will only consider arguments about valid grounds of appeal as listed in section 2. It will not rehear evidence or consider points previously made by the appellant that do not fall within a valid ground of appeal.

An appeal can only relate to final draft guidance for a technology appraisal or highly specialised technologies evaluation, or the way that the evaluation was done. An appeal cannot be lodged against other documents produced during the process (for example, the draft guidance or scope), although the content of those documents may be relevant and referred to in an appeal. This is because an appeal must be brought against a 'recommendation', and only final draft guidance can be considered a recommendation.

NICE also considers the following as 'recommendations' for the purpose of the appeal process:

  • all parts of final draft guidance that explain the recommendations

  • the evidence considered

  • the committee's reasoning or wording in the final draft guidance that otherwise could influence the use of a product within the NHS.

Any other part of the final draft guidance may not be the subject of an appeal.

Requests for corrections of minor factual or typographical errors in final draft guidance are not normally considered at an appeal but will be looked at separately by the NICE team responsible for the guidance. 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 and receive a copy of the factual error submissions for information. The NICE team responsible for the guidance will usually consider such requests for amendments after the appeal decision.

4.3 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 highly specialised technologies process. An appellant who believes that an evaluation was not fair 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 if an appellant does not agree with final draft guidance this does not make it unfair. For example, although it is unfair to exclude relevant data from the technology appraisal and highly specialised technologies evaluation process, it is not unfair to consider the relevant data but then reach a view with which the appellant did not agree.

This ground of appeal does not cover an argument that it is 'unfair' in a general sense, for example, that it is 'unfair' to patients not to recommend a treatment.

Unspecific allegations of unfairness, for example, an alleged inability to understand a conclusion, will not be accepted as a valid appeal point. Details and evidence must be provided in every case.

NICE requires appellants to explain what steps they took to promptly resolve any unfairness when they first became aware of it. The appeal panel may interpret the absence of any such steps, without sufficient reason, as evidence that there was in fact no such unfairness, or potentially as a reason not to refer guidance back to the committee or to request changes to guidance.

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 and Social Care. An appellant may appeal on the ground that NICE has acted outside its remit or has acted unlawfully. This ground of appeal would also include allegations that either the process used to generate guidance or the guidance itself are contrary to equality legislation.

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

Draft guidance is produced after a formal evaluation process that includes structured evidence gathering, consultation, expert input and consideration by a broad-based committee. The appeal process cannot replicate those steps. Therefore, the properly exercised and reasonable judgement of a committee must be respected and 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 'does not add up'. The appeal panel will not make its own judgements about the technology, but it will review the committee's decisions to see if they can reasonably be justified, based on the evidence that was available to the committee.

4.4 Appeals against recommendations revised because of commercial arrangements

NICE may review published guidance recommendations either through a rapid review after submission of a new patient access scheme or a review after submission of a commercial access agreement.

Appeals against the reviewed recommendations are limited to appeal points that relate to consideration of the new patient access scheme or commercial access proposal. This is because there would have been an unrestricted opportunity to appeal the guidance before it was originally published.

4.5 Second appeals

Revised guidance produced after a successful appeal may itself be the subject of an appeal. In such cases, appeal points that were rejected at the first appeal, and which relate to elements of the guidance that have not been changed, may not be raised again at the second appeal.

4.6 What must the appeal letter contain?

The appeal letter is the appellant's first opportunity to present the points they wish to lodge an appeal on. It must be submitted by 5pm of the deadline for receipt of appeals and requests for corrections. It is important that the appeal letter is submitted correctly, is presented clearly and contains the necessary information (see appeal letter requirements). If the submitted letter is not appropriate (for example, it does not have enough 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 or appears unarguable. The appeal letter requirements are stated in this section and an appeal letter template is available on the NICE technology appraisal and highly specialised technologies appeal webpage.

Appeal letter requirements

The appeal letter must contain an introductory statement clearly specifying 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 an appeal letter is longer than 5 A4 pages, appellants should produce an executive summary of the appeal. The executive summary should be no longer than 1 A4 page.

The appeal letter must clearly and concisely 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(a) must be made first, followed by all points made under ground 1(b) and then all appeal points made under ground 2. Appeal letters must provide enough information for the appeal panel to 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).1: the change from a positive to negative recommendation following draft guidance without further consultation is unfair'.

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(a) 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, 1(b).2, 2.1 and so on.

It is not necessary to number individual paragraphs in the appeal letter. If the appellant considers that this aids clarity, they should simply number every paragraph in the appeal letter sequentially, and use the numbered headings for the 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 of appeal are quite distinct (see section 4.3). So, appellants should consider carefully which ground of appeal any given concern 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), which is concerned with process.

If the context for different appeal points overlaps (for example, if an alleged unfairness is also said to have produced a recommendation that cannot reasonably be justified) it is acceptable to cross refer. But appellants must set out the argument they wish to make under each ground in detail. They should specify how earlier 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 of appeal are clearly identified, fall within 1 or more of the grounds set out in section 4.3, and are arguable.

If the appeal letter contains commercial-in-confidence information (in-confidence material which cannot be shared in public), the appellant will be responsible for clearly labelling this information and for submitting a second version of the appeal with this information redacted.

Appeal letters and other information supplied as part of the appeals process will be published on the NICE website. To help ensure content is accessible to everyone including users with impairments to vision, hearing, mobility, thinking and understanding, appeal letters (and the responses to scrutiny) should be submitted as Microsoft Word documents.

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 but 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 or highly specialised technologies evaluation process, being appealed against

  • the reasons why the aspect(s) of the final draft guidance, or technology appraisal or highly specialised technologies evaluation 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 only be accepted in exceptional circumstances and when these relate to factual corrections.

The lead non-executive director for appeals will respond to each appeal letter to indicate their preliminary view of the 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.

4.7 Can new data be submitted to the appeal panel?

All data that consultees consider relevant to the guidance topic should have been submitted to the committee as part of the technology appraisal or highly specialised technologies evaluation process (as described in the relevant NICE process guide that applied when the evaluation started, see section 1). 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. Stakeholders who consider that new data casts doubt on a recommendation should seek a review of the guidance, rather than appeal it.

The appeal panel will have access to the key material reviewed by the committee.

The appeal panel cannot accept late or ad hoc submissions, because this affects preparations for the appeal. If in exceptional circumstances appellants or representatives of NICE or the committee feel there is unsubmitted written material they wish to rely on during the appeal hearing they must inform the NICE appeal team as soon as possible about what the material is, why it is desirable to submit it, and when it will be available. The appeal panel chair will then decide if the information can be provided, and if so, the appeals team will provide a deadline for submission. The material must then be submitted to the NICE appeals team by the given deadline.