Guide to the technology appraisal and highly specialised technologies appeal process

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 This ground relates only to the fairness of the process followed and not to the content of the final draft guidance. It should be noted that if an appellant does not agree with final draft guidance this does not make it unfair.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Draft guidance is produced after a formal evaluation process that includes structured evidence gathering, consultation, expert input and consideration by a broad-based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.

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:

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.