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NICE-wide topic prioritisation: the manual

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

6.1 Eligibility criteria for new topics

New topics are initially assessed against the eligibility criteria outlined in this section. New topics that do not meet the initial eligibility assessment will not proceed to the prioritisation framework. The NICE prioritisation board will determine whether the new topics meet the eligibility criteria or not.

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.

6.1.1 Eligibility criteria for new guidelines and new HealthTech topics

Guidelines and HealthTech (excluding interventional procedures)

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

  • the new topic is within NICE's remit to address (see section 3.12)

  • the new topic is identified as a priority area.

If the new topic is not identified as a priority area, it could still be considered by the NICE prioritisation board if it has the potential to,

  • significantly improve the quality of life for target population(s)

  • change clinical pathways to improve efficiency for the health and care system.

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

For new topics that meet the eligibility criteria in this section of the manual, a topic briefing will be developed for use with the prioritisation framework (see section 8).

In some circumstances, a new topic may bypass the topic prioritisation process, for example, special referral by the Secretary of State.

New topics that involve the use of HealthTech may be routed to the following NICE guidance outputs by the NICE prioritisation board:

  • Guideline recommendations within an existing pathway. A new topic that involves the use of HealthTech may be addressed as a topic area within an existing guideline where the HealthTech is, or can be, part of an existing care pathway.

  • HealthTech guidance. This could be early-use, routine-use or existing-use guidance (see NICE's HealthTech programme manual). After prioritisation of the HealthTech topic(s), the NICE prioritisation board can also make further proposals to the Secretary of State for routine use HealthTech using NICE technology appraisal methods and processes (please see Annex A).

  • Highly specialised technologies guidance. This is for any medicine or HealthTech that meets all the highly specialised technologies: NICE prioritisation board routing criteria.

New interventional procedures

An interventional procedure may be selected for assessment 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 HealthTech programme 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, when there is uncertainty on a new topic that needs ratification or further routing decisions from the NICE prioritisation board, a topic briefing will be developed for use with the prioritisation framework (see section 9).

6.1.2 Eligibility criteria for 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 will not significantly affect the clinical and cost effectiveness of the medicine or

  • NICE receives a clear signal that a new commissioning policy will be developed or

  • 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 oversight of the whole NICE guidance portfolio.

When 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 NHS England. All selection and non-selection decisions will be reported to the NICE prioritisation board for ratification. When there is uncertainty whether the criteria in the 2024 voluntary scheme for branded medicines, pricing, access and growth are met or not met, the NICE prioritisation board is responsible for making the final decision.

When new medicines meet the highly specialised technologies: NICE prioritisation board routing criteria, a separate topic overview will be developed for the NICE prioritisation board for a routing decision using the highly specialised technologies 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 new guidance on a topic (medicines, HealthTech and guidelines).

6.2 Eligibility criteria for updates of existing NICE guidance

This manual covers prioritisation for updates to all NICE guidance.

Updates will be allocated directly to guidance development teams for progression if the reason for the proposed update is one of the following:

  • an update 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 result of an update to incorporated technology appraisal recommendations)

  • for guidelines, small and medium updates from topic suites will not be considered by the NICE prioritisation board, and instead a decision will be made by the Centre for Guidelines' (CfG) Guidelines Oversight and Delivery Group.

Other proposed updates to NICE guidance will be assessed using the prioritisation framework if the proposed update is identified as a priority area.

If the proposed update is not identified as a priority area, it could still be considered by the NICE prioritisation board if the update has the potential to:

  • significantly improve the quality of life of target population(s)

  • change clinical pathways to improve efficiency for the health and care system.

For the re-evaluation of early-use HealthTech guidance to routine-use HealthTech guidance, the guidance development teams will proceed without NICE prioritisation board consideration. This is because the early-use HealthTech guidance will have already been prioritised by the NICE prioritisation board. The re-evaluation will be put forward to the NICE prioritisation board for further prioritisation consideration if:

  • the early-use HealthTech guidance is not covered by current NICE priority areas (see section 5), or no longer meet the NICE prioritisation framework criteria (see section 8), or

  • the early-use HealthTech guidance is a potential topic for HealthTech using NICE's technology appraisal process (see Annex A on the National HealthTech Access Programme).

6.3 Update of existing NICE guidance routing decisions

If the proposed update to an existing guidance product is prioritised by the NICE prioritisation board, the board will also make a routing decision on the update. An update can be routed as technology appraisal or HealthTech guidance (including routine-use, existing-use or interventional procedures guidance), or into guidelines.