Interim methods and processes statement for including NICE technology appraisal recommendations in guideline topic areas

NICE guideline recommendations are subject to surveillance processes set out in the developing NICE guidelines manual. NICE technology appraisal guidance that has been incorporated or integrated into a guideline topic area will be subject to surveillance processes as set out in appendix O of the developing NICE guidelines manual.

Scoping is carried out in line with the methods and processes outlined in the developing NICE guidelines manual. The scope or topic suite hub webpage will set out when NICE technology appraisal recommendations will be integrated.

NICE will ensure that all the stakeholder organisations that participated in the NICE technology appraisal are registered as stakeholders for the guideline. Consultees on the original NICE technology appraisal will retain that status.

Consultees are outlined using the stakeholder list (or matrix) published as part of the original NICE technology appraisal guidance development. During guideline development, stakeholders will be able to ask to become consultees. NICE will approve updates to the consultee list when they reflect changes over time and are aligned with the current definitions of consultees outlined in section 1.2.18 of the NICE health technology evaluations manual.

In line with the developing NICE guidelines manual, the best available evidence will be used to inform NICE technology appraisal integration decisions. This may include specific calls for evidence and using real-world data, as outlined in the developing NICE guidelines manual and the NICE real-world evidence framework.

As part of integration, NICE will request consent from relevant parties to share with Centre for Guidelines' development teams confidential data (including the economic model) that was submitted as part of the NICE technology appraisal evaluation.

VAT will be excluded from the integration decision space for NICE technology appraisal and non-technology appraisal guidance, as described in the NICE health technology evaluations manual.

Users will have the ability to include and exclude VAT in the resource impact assessment tools that publish alongside the guidance.

The application of relevant quantitative decision modifiers introduced by the Centre for Health Technology Evaluation for NICE technology appraisal guidance will be considered by the guideline committee as part of integration. This is to enable consistent decision making across NICE guidelines and technology appraisals.

When a technology appraisal is being integrated, the guideline committee will consider the application of relevant quantitative modifiers to that decision space. When severity considerations apply, this is set out in the NICE health technology evaluations manual.

In cases when quantitative decision modifiers were used in the NICE technology appraisal guidance but are no longer considered applicable during integration, the guideline committee will be mindful of how this might influence decisions on cost effectiveness. It will specifically consider whether health outcomes would be significantly reduced if a technology was removed as an option. In these circumstances, the committee may make recommendations applying greater flexibility around the range of acceptable cost-effectiveness estimates.

As outlined in the NICE principles, NICE considers value for money of interventions by assessing the incremental cost-effectiveness ratio (ICER). Interventions with an ICER of less than £20,000 per quality-adjusted life year (QALY) gained are generally considered to be cost effective. Decisions must consider the evidence underpinning an evaluation, population need and the 'opportunity cost' of recommending 1 intervention instead of another. NICE recommendations also take into account other factors beyond the evidence of costs and benefit alone. NICE's methods manuals explain when it is acceptable to recommend an intervention with a higher cost-effectiveness estimate than £20,000 per QALY gained.

The NICE health technology evaluations manual makes specific reference to decisions made for technologies when the most plausible ICER is between £20,000 to £30,000 per QALY gained, or over £30,000 per QALY gained.

When a NICE technology appraisal is integrated into a guideline, decisions on continued adoption of that technology by the NHS will consider if this is an effective use of NHS resources with specific reference to the above range. Because cost effectiveness is not the only basis for decisions, the committee will consider technologies in relation to the range of ICERs, and the influence of other factors on the decision to recommend a technology.

A guideline committee may consider 1 or more NICE technology appraisals for integration into a guideline topic area. In such cases, it may choose to make recommendations about preferred sequences or hierarchies, based on an assessment of clinical and cost effectiveness. Whether options are presented as sequences or hierarchies will depend on:

• how options are used to treat the condition in clinical practice

• the marketing authorisations for the technologies.

The evidence may show that the technology provides appropriate benefits and value for money, beyond the population that is covered by the NICE technology appraisal. In such cases, the guideline committee may make recommendations that expand its use from the population covered by the NICE technology appraisal. The committee may also make recommendations for a narrower use of the technology, for example, that it:

• can only be used in a particular condition for people who meet specific clinical eligibility criteria

• can only be offered to a specific subgroup

• must be given by staff with certain training or in a particular care setting.

The guideline committee may agree that, for the entire population outlined in the original NICE technology appraisal guidance, the technology is no longer likely to be a good use of NHS resources given full consideration of evidence. In such cases, the technology will be given a negative recommendation and the NICE technology appraisal guidance will be withdrawn.

The funding requirement associated with a positive NICE technology appraisal recommendation will remain unchanged whenever the technology is included in a guideline as a recommended option. This is the case even if that recommended use is narrower than that in the original NICE technology appraisal guidance. The funding requirement will no longer apply if the NICE technology appraisal guidance is withdrawn.

There will be a single opportunity to revise an existing simple discount patient access scheme at each of the following stages:

• during or after stakeholder consultation, and

• in response to the final draft recommendations after stakeholder consultation.

There will be an opportunity to review and potentially revise an existing, or engage in discussion about a new, commercial access agreement. This will be in response to the final draft recommendations (as outlined in the section on the validation process for draft guidelines) after stakeholder consultation, when NHS England confirms whether it is willing to engage in such discussions.

All commercial activities will be in line with the NHS commercial framework for new medicines.

The validation process, and finalising and publishing the guideline recommendations, will follow the methods and processes set out in the developing NICE guidelines manual. In addition, when final draft recommendations are made, these are released to companies. This is to make sure that all opportunities for engagement are fulfilled.

If NICE technology appraisal guidance is withdrawn after integration into a guideline, consultees outlined in the stakeholder list can appeal:

• the guidance withdrawal and accompanying guideline recommendation, or

• the process followed,
  
  using an amended NICE technology appraisal appeal process.

The NICE technology appraisal appeals process will only be amended to reflect:

• the methods and processes used for integrating NICE technology appraisals into a NICE guideline, and

• that a NICE guideline committee made the recommendations rather than a NICE appraisals committee.

Only consultees can lodge an appeal. Consultees will not be able to appeal any points from the original NICE technology appraisal development process or appeal process.