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    NICE integrated topic prioritisation and strategic principles

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    6 Prioritisation framework: eligibility criteria

    6.1 New topics eligible to be considered at pre-stage 1

    New topics identified may be suitable for individual NICE guidance, or multiple pieces of NICE guidance (combined or integrated topics). Eligibility criteria outlined in section 6.3 will be applied to facilitate the prioritisation process and routing decisions.

    6.1.1 Types of NICE guidance for review using the pre-stage 1 eligibility criteria

    6.2 New topics not routinely eligible for consideration

    Medicines that will not receive regulatory approval for use in the UK within 24 months

    The appropriate regulatory approval for medicines is usually a marketing authorisation. Medicines outside a 24-month timeframe for regulatory approval are not eligible for consideration.

    Established interventional procedures

    These are procedures in standard clinical practice with a well‑known efficacy and safety profile. This is unless there is new information on safety, efficacy or cost that needs to be reviewed, or the procedure has changed, which might affect its safety, efficacy or cost.

    Health technologies that will not receive regulatory approval in the UK within 12 months

    The appropriate regulatory approval is usually a UK Conformity Assessed (UKCA) or CE mark, but other regulatory processes or quality procedures can apply instead of, or in addition to, these. For example, the Human Tissue Authority regulates human tissue transplants, the United Kingdom Accreditation Service regulates in-house diagnostic tests, and the Care Quality Commission (CQC) regulates services. In some cases, it can be unclear if the technology is a device, medicine or other product such as a cosmetic. These are considered 'borderline products' (Medicines and Healthcare products Regulatory Agency [MHRA] guidance explains the borderlines between medical devices and medicines or other products). Devices, diagnostics, digital technologies and other topics without regulatory approval for use in the UK are not eligible to be considered for topic selection if approval is more than 12 months away. These topics are eligible to be considered if they are expected to secure regulatory approval within 12 months.

    New topics that involve use of an unlicensed technology

    These are unlicensed technologies that require regulatory approval for their use outside of research in the UK, but approval is not expected within the next 24 months.

    New topics that involve use of an off-label medicine or technology

    Off-label technologies have UK regulatory approval but are being used differently to how the manufacturer has instructed. Off-label technologies will not be considered unless new regulatory approval has been sought. Off-label medicine topics may be addressed within an existing relevant guideline.

    Digital health technologies in tier A or B of NICE's evidence standards framework

    NICE's evidence standards framework for digital health technologies classifies digital health technologies by function and places them into evidence tiers. Digital health technologies listed in tier A or B are not normally eligible to be considered. Examples include communication platforms or productivity tools that optimise patient flow through clinics or help assign staff rotas.

    Antimicrobials (antibiotics, antiparasitics, antifungals)

    NICE is developing innovative models with NHS England (NHSE) for the evaluation and purchase of antimicrobials to inform future policy.

    Topics intended for use in national, proactive population-based screening

    These are considered by the UK National Screening Committee. Some technologies have more than 1 intended use. For example, a test used to screen for cancer is not eligible to be considered for its use in a proactive national cancer screening programme, but the same test can be considered for its use outside of screening programmes (for example, when used by a clinician to diagnose cancer in people presenting with symptoms).

    Prophylactic vaccinations

    These are considered by the Joint Committee on Vaccination and Immunisation.

    Other topics

    Substances such as food, drinks, nutritional supplements, cosmetics, toiletries and personal protective equipment are not eligible to be considered. This includes topics that are not regulated (or seeking regulation) as medical devices or medicines, consumer apps that are not regulated by Software as a Medical Device (SaMD) or those that do not have direct patient benefits (such as scheduling tools).

    Topics with special circumstances

    In some exceptional circumstances, topics that are not usually eligible may be considered. This might be done to support policy or another organisation's decision making, or to address an equality or sustainability issue.

    6.3 Pre-stage 1 eligibility criteria for new topics

    New topics are assessed against the pre-stage 1 eligibility criteria outlined in sections 6.3.1 to 6.3.4. New topics that meet the pre-stage 1 eligibility criteria will progress to stage 1 of the prioritisation process. In some circumstances, new topics may be routed directly to guidance production without being assessed by the integrated topic prioritisation process. These are highlighted below in sections 6.3.2 to 6.3.4. The amount and quality of information available on an identified new topic can vary. Companies or other relevant 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 pre-stage 1 eligibility criteria, it is not progressed further. The new topic can be reconsidered when NICE is alerted that further information is available.

    6.3.1 Pre-stage 1 eligibility criteria for new guidelines or guideline topics

    A new guideline or guideline topic may be selected for pre-stage 1 prioritisation 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.

    6.3.2 Pre-stage 1 eligibility criteria for new interventional procedure topics

    An interventional procedure may be selected 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.

    Selected interventional procedures are directly routed to interventional procedures guidance for an assessment of the safety and efficacy evidence. The prioritisation board will be notified of these topics.

    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 the prioritisation framework stage 1 and stage 2 (see section 7).

    6.3.3 Eligibility criteria for new medicine topics

    Medicines that meet the eligibility criteria (as stated in the 2024 Department of Health and Social Care voluntary scheme for branded medicines, pricing, access and growth) will be selected, except when there is a clear reason not to. For example:

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

    • when 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 receive the technology for NICE guidance to be developed).

    The NICE (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 (including health or medical technology) appraisal or highly specialised technology recommendation on a topic.

    Selected medicines are directly routed to technology appraisals guidance.

    In some circumstances when new medicines meet the criteria for routing to highly specialised technologies guidance, or require further ratification by the NICE prioritisation board (see appendix 3), a topic briefing will be developed for the NICE prioritisation board and will go straight to prioritisation framework stage 2 (see section 7.2.2).

    6.3.4 Eligibility criteria for all other new health technology topics

    A device, diagnostic, digital, or any other topic with direct patient benefits, may be selected 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 the selection thresholds may be considered, for example, special referrals by the Secretary of State to assess health technologies using NICE technology appraisal methodology.

    For selected topics, a topic briefing will be developed to proceed through stage 1 and stage 2 (see section 7) of the prioritisation framework. 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 health technology topic may bypass the prioritisation process, for example, special referral by the Secretary of State.

    All other health technology topics may be routed to the following NICE guidance outputs by the prioritisation board, which may include:

    Guideline recommendations within an existing guideline pathway

    A health technology topic may also be addressed as a topic area within an existing guideline where the technology is well placed in a guideline 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 technology that meets all the highly specialised technologies criteria (see appendix 3).

    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).

    6.4 Pre-stage 1 eligibility criteria for updates

    This manual covers updates to all NICE guidance outlined in section 6.1.1.

    Proposed updates to NICE guidance will be assessed using the following pre-stage 1 eligibility criteria. Updates that meet these criteria will not be assessed by the 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).

    • The update is 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 an incorporated technology appraisal).

    • The update is innovative and does not need guidance development team resources (for example, incorporation of NICE guidance into guideline recommendations, consolidation of the portfolio [see section 5 of appendix M in Developing NICE guidelines: the manual]).

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