NICE process and methods

7 Eligibility criteria for using the prioritisation framework and direct routing to guidance development

7 Eligibility criteria for using the prioritisation framework and direct routing to guidance development

7.1 Eligibility criteria for new topics

New topics are assessed against the eligibility criteria outlined in sections 7.1.1 to 7.1.4.

The amount and quality of information available on an identified new topic can vary. Companies or other relevant organisations or people may be contacted to provide more information. Any commercial in confidence information will be handled according to NICE internal commercial in confidence policies.

When there is not enough information to assess a new topic against the eligibility criteria, it is not progressed further. The new topic can be reconsidered when NICE is alerted that further information is available.

7.1.1 New guidelines or guideline topics

A new guideline or guideline topic may be selected for assessment using the prioritisation framework if:

  • it is within NICE's remit to address, not the remit of, for example, the Joint Committee on Vaccination and Immunisation (JCVI), National Screening Committee (NSC), UK Health Security Agency (UKHSA), Care Quality Commission (CQC) and

  • there is a gap in the existing NICE guidance portfolio or

  • there is significant and unwarranted variation in practice.

7.1.2 Topics that involve use of new interventional procedures

An interventional procedure may be selected for assessment by the interventional procedures programme if it is:

  • new or significantly modified and available to the NHS or independent sector or

  • about to be used outside of formal research or

  • an existing procedure that warrants review in relation to safety, efficacy or cost.

All selected interventional procedures are directly routed to interventional procedures guidance for an assessment of the safety, efficacy evidence or cost. All these topics will be shared with the NICE prioritisation board so it will have the oversight of the whole NICE guidance portfolio.

In some circumstances, where there is uncertainty on a new topic that needs ratification or further routing decision from the NICE prioritisation board, a topic briefing will be developed for use with the prioritisation framework (see section 9).

7.1.3 Topics that involve use of new medicines

New medicines that meet the criteria stated in the 2024 voluntary scheme for branded medicines, pricing, access and growth will be selected for assessment by the technology appraisal programme, except when there is a clear rationale not to do so. For example, when:

  • changes to the dose, formulation or administration that will not significantly affect the clinical and cost effectiveness of the medicine or

  • appropriate access to the medicine is provided by an existing policy (such as NHSE's policy on commissioning medicines for children in specialised services) or when a new policy can be developed (for example, when not enough people are eligible to have the technology and NICE guidance would not provide value for the NHS)

  • it is appropriate to assess the medicine within a NICE guideline (for example, a new medicine within an existing class).

All medicines that meet the criteria in the 2024 voluntary scheme for branded medicines, pricing, access and growth are directly routed to technology appraisal guidance without using the NICE-wide topic prioritisation process. These topics will be shared with the NICE prioritisation board so it will have the oversight of the whole NICE guidance portfolio.

Where the criteria in the 2024 voluntary scheme for branded medicines, pricing, access and growth are not met, that is, when there is a clear rationale not to select a topic for technology appraisal guidance, NICE will directly seek support for a non-selection decision from NHSE. All selection and non-selection decisions will be reported to the NICE prioritisation board.

When new medicines meet the criteria for routing to highly specialised technologies guidance (see appendix 1 for the vision for the HST programme and the routing criteria to HST guidance), a separate topic overview will be developed for the NICE prioritisation board for routing decision using the HST criteria.

The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 require a direction from the Secretary of State before NICE is able to make a technology appraisal or highly specialised technology recommendation on a topic (medicines and health technologies).

7.1.4 Topics that involve use of new health technologies

A medical device, diagnostic, digital, or other health technology with direct patient benefits, may be selected for assessment using the prioritisation framework if:

  • a systematic assessment of the cost and effects on the system is needed (for example, because there is uncertainty or because the topic is expected to be significantly cost incurring or cost saving)

  • it has benefits that are likely to be highly disruptive or lead to a stepwise change to a care pathway in the UK, and the benefits are supported by:

    • evidence (such as randomised controlled trials, before and after studies, cohort studies, diagnostic test accuracy studies or other study designs; this includes evidence generated outside the UK that can be generalised to UK practice) showing the technology's effectiveness compared with current practice in the UK health and care system or an appropriate reference standard

    • information about the expected resource impact of adopting the technology that is directly applicable to the UK health and care system

    • advice from experts (such as patients, carers, clinicians and commissioners) that confirms that benefits are meaningful and likely to be realised when adopted in the UK health and care system.

In exceptional circumstances, topics that do not fulfil these criteria may be considered by NICE, for example, special referrals by the Secretary of State to assess health technologies using NICE technology appraisal methodology.

For topics that meet the criteria in this section of the manual, a topic briefing will be developed for use with the prioritisation framework (see section 9). Stage 1 will usually be omitted where the topic is a direct formal notification from NHSE or the Department of Health and Social Care (DHSC).

In some circumstances, a topic that involves use of a health technology may bypass the topic prioritisation process, for example, special referral by the Secretary of State.

Topics that involve use of health technologies may be routed to the following NICE guidance outputs by the prioritisation board:

Guideline recommendations within an existing care pathway

A topic that involves use of a health technology may be addressed as a topic area within an existing guideline where the technology is or can be part of an existing care pathway.

Health technologies guidance

This may include guidance on diagnostics, devices, digital technologies or interventional procedures.

Highly specialised technologies guidance

This guidance is for any health technology that meets all the highly specialised technologies criteria (see appendix 1 for the vision for the HST programme and the routing criteria to HST guidance).

Technology appraisal guidance

This guidance is for technologies, procedures and any other topic that requires a multiple technology assessment or a cost‑utility health economic approach (diagnostic technologies are only considered in exceptional circumstances).

7.2 Eligibility criteria for updates of existing guidance

This manual covers updates to all NICE guidance.

Proposed updates to NICE guidance will be assessed using the following eligibility criteria. Updates that meet the following criteria will not be assessed by the NICE prioritisation board. They will be allocated directly to guidance development teams for progression where the update is:

  • related to a safety alert that NICE must respond to (for example, MHRA drug safety update, Health Services Safety Investigations Body report, coroner's Regulation 28 report or others).

  • an alignment of guidance related to content that has already been approved by the prioritisation board (for example, the update of a quality standard related to updated guideline recommendations, or the update of guideline recommendations as a consequence of an update to incorporated technology appraisal recommendations)

  • innovative (see appendix N of the manual on developing NICE guidelines) and does not need significant guidance development team resources (for example, incorporation of other NICE guidance into guideline recommendations, and consolidation of the guidelines portfolio (see section 5 of appendix M of the manual on developing NICE guidelines).

Only updates that need ratification or a routing decision will be considered by the prioritisation board. In these circumstances, a topic briefing will be developed for use with stage 2 of the prioritisation framework, omitting stage 1.