NICE-wide topic prioritisation: the manual

3.1 Medicines that will not receive regulatory approval (marketing authorisation) 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 obtaining a regulatory approval (marketing authorisation) in the UK are not considered by NICE.

3.2 Established interventional procedures

Interventional procedures that are standard clinical practice and have a well‑known efficacy and safety profile (including robotic delivery of an established interventional procedure) are not considered by NICE unless:

3.3 HealthTech that does not have regulatory approval in the UK

Medical devices, diagnostics and digital technologies (including those qualified as software as a medical device [SaMD], and artificial intelligence as a medical device [AIaMD]) without appropriate regulatory approval for use in the UK are not considered by NICE. HealthTech topics are only considered if:

All medical devices marketed in the UK, including SaMD and AIaMD, must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and comply with the UK Medical Devices Regulations (UK MDR 2002). For information about UK Conformity Assessed (UKCA) and CE marking (the EU equivalent) please see information on the UKCA mark and conformity assessment bodies. The MHRA may apply different regulation procedures to certain products, such as in-house tests. For more information, please see the MHRA webpage on regulating medical devices in the UK and the MHRA webpage on registering medical devices to place on the market.

HealthTech topics without appropriate regulatory approval may be reconsidered once appropriate regulatory approval is obtained.

3.4 Digital HealthTech listed in tier A or B of NICE's evidence standards framework

NICE's evidence standards framework for digital health technologies classifies digital HealthTech by function and places them into evidence tiers. Digital HealthTech listed in tier A or B are not normally considered by NICE. Examples include productivity tools that target appointment communications or help assign staff rotas.

3.5 New topics that involve use of an unlicensed medicine

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

3.6 New topics that involve use of an off-label medicine

Off-label medicines have UK regulatory approval but are being used differently to how the manufacturer has instructed. Off-label medicines will not be considered by NICE's medicines evaluation programme unless new regulatory approval has been sought for significant indications as stated in the 2024 voluntary scheme for branded medicines pricing, access and growth. Off-label medicines may be addressed within an existing relevant guideline.

3.7 New generic or biosimilar medicines if the branded version is recommended in NICE guidance

If the branded medicine is recommended in NICE technology appraisal or highly specialised technologies guidance (see the European Medicines Agency's definitions of generic medicine and biosimilar medicine), the generic version or biosimilar will not be not considered by NICE. This is because the recommendation usually applies to the generic or biosimilar medicine. Under exceptional circumstances, generics or biosimilars could be considered by the NICE prioritisation board for guidance development in any NICE programme, to optimise treatment recommendations for patients. For example, when multiple biosimilars or generics have become available since guidance on the originator product was published, and the biosimilars or generics have significant price variations.

If the branded version or originator product is not recommended by NICE technology appraisal or highly specialised technologies guidance (that is, it has a negative recommendation), or does not have any guidance in NICE's guidance portfolio, the new generic or biosimilar can be considered by the NICE prioritisation board for an update of the related NICE technology appraisal or highly specialised technologies guidance (to update the negative recommendation, for example), or for inclusion in an update of related NICE guidelines.

3.8 Antimicrobials (antibiotics, antiparasitics, antifungals)

NICE and NHS England (NHSE) have developed a separate innovative Antimicrobial Products Subscription Model for the evaluation and purchase of antimicrobials.

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

These are considered by the UK National Screening Committee (NSC). Some HealthTech products have more than 1 intended use. For example, a test used to screen for cancer is not considered by NICE 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 healthcare professional to diagnose cancer in people presenting with symptoms).

3.10 Prophylactic vaccinations

These are considered by the Joint Committee on Vaccination and Immunisation (JCVI). However, therapeutic vaccinations (for example, for treating cancer or another condition) are considered by NICE.

3.11 Other topics not considered by NICE

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

3.12 Topics that are outside of NICE's remit to produce guidance

NICE will not consider guidance development for topic areas that are the remit of other government or arms-length bodies, for example:

Topic areas more appropriate to royal colleges and specialist societies will also not be considered by NICE, for example, professional standards, training and education.

3.13 Topics with special circumstances

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