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    NICE integrated topic prioritisation and strategic principles

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    7 Prioritisation framework stage 1 and stage 2

    7.1 Developing topic briefings for prioritisation

    If a new topic or an update is eligible for prioritisation at pre-stage 1, a topic briefing is developed to support decision making. NICE will keep its sponsor teams at the Department of Health and Social Care (DHSC) and NHS England (NHSE) updated on all proposed new topics and updates that will be assessed by the prioritisation board. The topic briefing will provide information on the new topic or update, and how the prioritisation framework stage 1 and stage 2 criteria are met or not met. The topic briefing summarises:

    • title of the new topic or update

    • context (including description of the technology if applicable)

    • related NICE guidance

    • potential impact on related NICE guidance.

    The topic briefing will provide information on how the new topic or update meets prioritisation framework stage 1 and stage 2 criteria. Where appropriate, input will be sought from a relevant regulator, committee, or other organisations (such as NHSE, NHSE Transformation Directorate, Department of Health and Social Care, Office for Health Improvement and Disparities, Health Innovation Networks, Office for Life Sciences and NHS Supply Chain), and relevant topic experts (such as patients, clinical and academic experts). The prioritisation framework uses a 2‑stage approach.

    7.2 Prioritisation framework stage 1 criteria

    The prioritisation framework stage 1 criteria are used to determine if a new topic is appropriate for NICE to address.

    7.2.1 Stage 1 criteria

    NICE's role

    What value will NICE add to the health and care system by producing guidance? For example, can NICE produce guidance that is useful and useable to users through:

    • evaluations of clinical and cost effectiveness

    • decision making by independent, multidisciplinary committees

    • robust methodology and processes

    • objective review of evidence.

    Health and care need

    Will the guidance address avoidable illness, harm or care burden, significant morbidity, premature mortality and reduced quality of life? Are there related national policies or targets that indicate that the topic is of national importance (for example, the Major Conditions Strategy, NHS Long Term Plan or annual NHS priority areas)?

    Evidence availability

    Is evidence available or expected to support further exploration of guidance products? The availability of evidence should be in the context of the relevant topic area; for example, rare conditions will frequently have less evidence than more common conditions.

    Availability and access

    Will the technologies, interventions or services under consideration be available for implementation in the health and care system? For example:

    • there is appropriate marketing authorisation or regulatory classification (for example, MHRA [Medicines and Healthcare products Regulatory Agency], CE or UKCA [UK Conformity Assessed] mark, DTAC [Digital Technology Assessment Criteria]) for the relevant pharmaceuticals or health technologies

    • current health and care structure or configurations can adopt or adapt and deliver the interventions or services.

    7.2.2 Omitting stage 1

    Stage 1 is omitted for:

    These topics will go directly to stage 2.

    7.3 Prioritisation framework stage 2 criteria

    If a new topic is deemed suitable at stage 1, or an update requires further ratification, a more detailed set of criteria is used to support decision making at stage 2. This will examine whether a topic or an update should be prioritised by NICE.

    7.3.1 Stage 2 criteria

    Budget impact

    The likely impact on health and care system budgets of implementing the potential topic guidance. This may be a disinvestment opportunity, be cost saving or cost neutral, or more expensive or cost incurring to the system.

    System impact

    The potential impact of the guidance on health and care infrastructure, and capacity and capability for implementation. For example, the guidance may:

    • address current system infrastructure or workforce capacity constraints or burden

    • have no or negligible impact on current system infrastructure or workforce capacity (for example, it could be incorporated into the existing care pathway)

    • be challenging to achieve because of infrastructure or workforce capacity constraints in the relevant public funded services.

    Population impact

    The size of the relevant target population, and the anticipated potential of guidance to improve patient or service user outcomes by addressing gaps or variations in current practice.

    Evidence quality

    Availability of evidence at the quality that meets NICE's requirement and addresses relevant clinical and service outcomes. Availability of accurate system intelligence that indicates gaps or variations in current practice, or where there is a need for NICE to inform best practice.

    Health inequalities

    The potential for the guidance or update to introduce, increase or reduce health inequalities, or have no health inequalities impact.

    Environmental sustainability

    The potential for the guidance or update to reduce the use of healthcare services through prevention of ill health, support disinvestment and reinvestment plans (for example, medicines or products prioritised for substitution or disinvestment in Delivering a net zero NHS report, Environmental principles policy statement or other subsequent statutory NHSE guidance related to the environmental duties in the Health and Care Act 2022).

    7.4 Assessment

    Each stage 2 criterion will be assessed as having a:

    • positive impact

    • negative impact

    • nil or neutral impact or

    • unknown or unclear impact.

    The NICE prioritisation board will discuss the topic in detail and vote to agree an overall final decision on the relative priority for NICE to develop guidance in that topic area.

    For positive final decisions, the NICE prioritisation board will further discuss routing considerations, based on all the information available from pre-stage 1 to stage 2. The final routing decision could include developing single guidance or multiple and integrated guidance products (see section 6.1.1).

    The NICE (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 require a direction from the Secretary of State formally referring the topic before NICE is able to make a technology (for example, a medicine, health or medical technology) appraisal or highly specialised technologies recommendation on a technology. NICE requests a Ministerial referral once a topic has been selected. The Ministerial referral does not specify whether the topic is routed to technology appraisal or highly specialised technologies guidance because routing is NICE's responsibility. For information on highly specialised technologies and the routing criteria, see appendix 3. For all other guidance, NICE develops this in accordance with the relevant legislation.

    7.5 Possible outcomes for a topic that has not been prioritised

    For a topic that has not been prioritised, the prioritisation board members will discuss possible outcomes that are more appropriate for addressing the topic or update. These may include:

    • revisiting the topic or update later, for example, when more evidence or system intelligence becomes available

    • producing an alternative NICE product such as a quality standard or clinical knowledge summary

    • developing research recommendations with engagement from potential research funders, such as the National Institute for Health and Care Research (NIHR), UK Research and Innovation (UKRI), and the Association of Medical Research Charities (AMRC)

    • cross-referencing to suitable guidance or guideline recommendations produced by other organisations

    • engaging with external bodies to explore appropriate solutions (for example, the Royal Colleges, specialist societies, other arms-length bodies, or NHSE)

    • no further action

    • standing down content (for updates only).