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NICE-wide topic prioritisation: the manual

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Annex A: Topic selection for HealthTech using NICE's technology appraisal process (National HealthTech Access Programme) NICE prioritisation board proposals for selection

Purpose

The NICE prioritisation board makes decisions as to which new guidance topics and updates to existing NICE guidance will be prioritised and selected, including topics that involve use of new HealthTech.

The purpose of this annex is to provide further details on the approach to further consideration of a subset of HealthTech topics that have already been prioritised by the NICE prioritisation board for guidance, to be proposed to the Department of Health and Social Care (DHSC) and the Secretary of State for decisions as to whether they should be developed using NICE's technology appraisal process (see NICE's technology appraisal and highly specialised technologies guidance manual).

Selection approach

Summary of the NICE prioritisation board consideration process for HealthTech using NICE's technology appraisal process

All HealthTech topics including proposed updates will go through the prioritisation process as laid out in NICE-wide topic prioritisation: the manual. All HealthTech topics that are prioritised by the NICE prioritisation board for routine-use guidance development are eligible for consideration for guidance development using NICE's technology appraisal process. The consideration process for HealthTech using NICE's technology appraisal process involves the following (also see figure 1):

  • after HealthTech topics are prioritised by the NICE prioritisation board for routine-use guidance development, the topics will be put forward to a subgroup of the NICE prioritisation board, the NICE health technology funding decision group (HTFG), for consideration. This can happen before or during scoping of the topic, depending on the availability of the information required for the HTFG to make a selection proposal.

  • the NICE HTFG (subgroup of the NICE prioritisation board) will make proposals through deliberations and discussion on the factors in section 2.3. The proposals will then be put forward to the full NICE prioritisation board for final proposal decisions.

  • HealthTech topics that are proposed for guidance development using NICE's technology appraisal process will require a formal ministerial (Secretary of State) decision and referral for a technology appraisal. NICE will seek formal ministerial decision and referral after the NICE HTFG has made the proposal.

  • HealthTech topics that are not proposed for guidance development using NICE's technology appraisal process will be routed to the NICE HealthTech programme for standard guidance development (for example, routine-use HealthTech guidance).

  • all proposals and brief rationales will be published on the NICE website.

For the methods and processes used to develop guidance on HealthTech products, see the manuals on:

NICE health technology funding decision group

The membership of this group will reflect the expertise required to apply the selection considerations.

The role of the funding decision group

The funding decision group will:

  • identify topics suitable for guidance development using NICE's technology appraisal process

  • ensure consistency in the deliberations of proposal considerations

  • maintain alignment with related initiatives that inform proposal considerations

  • ensure that HealthTech funding resource limitations (should they exist) are taken into account

  • make proposals to the NICE prioritisation board for consideration

  • support a transparent approach by publishing proposals and rationales on the NICE website.

Factors to be considered and discussed for the proposals for HealthTech topics using NICE's technology appraisal process

Information from the topic briefing (see section 8 of NICE-wide topic prioritisation: the manual) prepared for the NICE prioritisation board will be used to inform the proposal considerations. Where required, additional information will be sought to allow deliberations.

The following factors will be used to assess the suitability of a HealthTech topic for guidance development using NICE's technology appraisal process.

Factor 1: indicative cost impact and engagement

The HealthTech would benefit from a funding mandate to enable faster and fairer roll-out to the NHS. There will be a commercial intelligence briefing (CIB) that provides information on:

  • the indicative cost impact to the NHS to implement the technology

  • additional intelligence about the use case and feasibility through:

    • industry engagement

    • patient and user engagement

    • system (for example, NHS or integrated care board) engagement

  • the routes to reimbursement.

The CIB will be completed by NHS England for consideration by the NICE HTFG.

Factor 2: evidence

There is sufficient evidence on the HealthTech topic to have an acceptable opportunity of getting a routine recommendation for use, or a recommendation to not use, through NICE technology appraisal evaluation as described in NICE's technology appraisal and highly specialised technologies guidance manual. HealthTech topics with insufficient evidence that are being considered for NICE early-use assessment are not eligible.

Factor 3: transformation of clinical pathways and services

The HealthTech should support the transformation of clinical pathways and services. For example:

  • the HealthTech has the potential to necessitate far-reaching changes in clinical practice and services, such as reducing the need for outpatient appointments or radically reshaping diagnostic approaches, or

  • the HealthTech has the potential to drive profound and innovative service redesign with real benefits for patients, and it aligns with system priorities as set out in the 10 Year Health Plan for England.

Assessment, deliberation and decision making

Each factor will be discussed and deliberated by the HTFG until consensus is reached. The rationale for the decision on each factor will be transparently documented. The HTFG will need to be satisfied on all 3 factors for the topic to be considered for proposal to the Secretary of State for guidance development using NICE's technology appraisal process. The proposals will then be taken to the NICE prioritisation board for final consideration. The final prioritisation board decision, together with the rationales, will be published on the NICE website. NICE will seek formal ministerial decision and referral for all topics that are proposed for guidance development using NICE's technology appraisal process.

HealthTech topics that are not proposed to NHAP will be routed to the NICE HealthTech programme for standard HealthTech guidance development (for example, routine-use HealthTech guidance) (see NICE's HealthTech programme manual [PMG48]).

For communicating decisions, please see section 10 of NICE-wide topic prioritisation: the manual.

Clarification process

The aim of the clarification process is to explain NICE's reason for its selection or proposal decision(s) that are queried by stakeholders. Requests for clarification do not usually offer an opportunity to revisit or overturn the NICE prioritisation board's decision. For the clarification process, please section 11 of NICE-wide topic prioritisation: the manual.

Figure 1:NICE proposals to NHAP guidance