NICE process and methods

9 Prioritisation framework stage 1 and stage 2

9 Prioritisation framework stage 1 and stage 2

9.1 Developing topic briefings for prioritisation

If a new topic or an update is eligible for assessment using the prioritisation framework (see section 7), a topic briefing is developed to support decision making.

NICE will keep its sponsor teams at the DHSC and 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/or stage 2 criteria are met or not met. The topic briefing summarises:

  • title of the new topic or update

  • context (including description of the health technology, if applicable)

  • related NICE guidance

  • potential impact on related NICE guidance.

Where appropriate, input will be sought from a relevant regulator, committee, or other organisations (such as NHSE, NHSE Transformation Directorate, Greener NHS, DHSC, 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 for most new topics.

The NICE strategic principles to public health, social care and rare diseases will be applied alongside the prioritisation framework, where appropriate, particularly when considering health and care need, population impact, and health inequalities.

9.2 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. Information in the topic briefing will be used to assess each criterion qualitatively with an initial judgement of a yes or no.

The NICE prioritisation board will conclude an overall final decision whether the new topic should proceed to stage 2 or not, with clear rationales on the trade-off among the 4 criteria specific to the topic of interest.

New topics that do not proceed to stage 2 may be revisited later if new information or intelligence become available.

9.2.1 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 health and care need by reducing:

  • avoidable illness

  • harm or care burden

  • significant morbidity

  • premature mortality

  • low 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?

Is there:

  • sufficient volume of evidence

  • limited evidence

  • lack of, or no, evidence?

The assessment of the availability of evidence should be proportionate within the context of the relevant topic area, for example, there will often be less or limited evidence for rare diseases, compared with more common conditions. The assessment should be contextual with an equitable focus in relation to the topic area.

Availability and access

Will the health 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, CE or UKCA mark, or digital technology assessment criteria (DTAC) for the relevant medicines or health technologies

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

9.2.2 Omitting stage 1

Stage 1 is omitted for:

These topics will go directly to stage 2. For routing decisions on technology appraisals or highly specialised technologies, the HST criteria (see appendix 1 for the routing criteria to HST guidance) will be used by the NICE prioritisation board instead of the prioritisation framework stage 2 criteria.

9.3 Prioritisation framework stage 2 criteria

If a new topic is deemed suitable at stage 1, or an update requires further ratification or a routing decision, 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.

9.3.1 Stage 2 criteria

Budget impact

The likely impact on health and care system budgets of implementing the new or updated guidance. This may be:

  • a disinvestment opportunity

  • cost saving or cost neutral

  • more expensive or cost incurring to the system.

A topic area that is more expensive or cost incurring to the system does not necessarily mean it will be disadvantaged during consideration. The decision from the NICE prioritisation board is based on a deliberation of the trade-offs across all criteria.

System impact

The potential impact of the new or updated 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 potential impact of the new or updated guidance on the target population, for example:

  • the size of the target population

  • the anticipated potential of guidance to improve patient or service user outcomes by addressing gaps or variations in current practice.

Consideration of population impact will not merely focus on the prevalence of the condition, but will also consider whether the target population is experiencing severely life-limiting or debilitating diseases (for example, rare diseases) with a lack of, or no, treatment options.

Evidence quality and system intelligence

Availability of:

  • evidence that meets NICE's quality requirements and addresses relevant clinical and service outcomes

  • accurate system intelligence that indicates gaps or variations in current practice, or where there is a need for NICE to inform best practice.

The assessment of the quality of available evidence will be contextual to the topic area, acknowledging that some topic areas are not suitable or ethical to be addressed by randomised controlled trials, for example, topic areas in rare diseases, children and young people, and the effectiveness of invasive surgical procedures.

Health inequalities

The potential for the new or updated guidance to:

  • introduce, increase or reduce health inequalities

  • have no health inequalities impact

  • address one of the Core20Plus5 priority areas.

As different health inequalities may be simultaneously impacted to different degrees and in opposing ways in different sub-populations, a breakdown of the criterion to sub-criteria to indicate opposing impact may be appropriate during the assessment.

Where there is appropriate evidence or intelligence, the impact of the wider determinants of health (such as social, economic and environmental factors) on health outcomes will also be considered during the deliberations of the NICE prioritisation board.

Environmental sustainability

The potential for the new or updated guidance to reduce avoidable production and consumption of healthcare through:

  • the prevention of ill health and the future need for services

  • appropriate disinvestment and/or

  • the existence of a link between the guidance and a medicine or product prioritised for substitution/disinvestment in the Delivering a Net Zero NHS report or subsequent statutory NHSE guidance related to environmental duties in the Health and Care Act 2022.

9.3.2 Assessment, deliberation and decision making

Each stage 2 criterion will be assessed as having a:

  • positive impact or

  • negative impact or

  • nil or neutral impact or

  • unknown or unclear impact.

A fixed scoring and weighting approach will not be applied to the criteria because individual criterion will have different levels of impact based on the topic area of interest. For example, there should not be a fixed numerical score or weighting for population impact as a criterion when assessing the priority of high prevalence but self-limiting upper respiratory tract infections, in comparison to low prevalence but debilitating conditions such as motor neurone disease.

The decision-making approach is a combination of the framework and the NICE prioritisation board members' deliberations and discussions about the trade-offs between the different criteria specific to the topic area of interest.

After the deliberations, the NICE prioritisation board members will conduct a formal voting, each choosing one of the 4 ratings (-2 = very low priority, -1 = low priority, +1 = high priority, +2 = very high priority). An average positive score indicates an overall 'yes' decision on the relative priority for NICE to develop guidance in that topic area, while an average negative score indicates an overall 'no' decision. The rationales for the trade-offs and the deliberations by the NICE prioritisation board will be documented transparently and published on the NICE website.

For positive final decisions, the NICE prioritisation board will further discuss routing considerations, based on all the information available. The final routing decision could include developing single guidance or combination of guidance products.

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 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, for example, 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 1 for the vision for the HST programme and the routing criteria to HST guidance. For all other guidance, NICE develops this in accordance with the relevant legislation.

9.3.3 Possible outcomes for a topic that has not been prioritised

For a topic that has not been prioritised at stage 2, 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 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).