NICE process and methods

3 Topics that are not usually considered by NICE

3 Topics that are not usually considered by NICE

3.1 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 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:

  • there is new information that requires the safety, efficacy or cost of the procedure to be reviewed, or

  • the procedure has changed, which might affect its safety, efficacy or cost.

3.3 Medical devices, diagnostics and digital technologies that will not receive regulatory approval in the UK within 12 months

Medical devices, diagnostics and digital technologies without appropriate regulatory approval for use in the UK are not considered by NICE if approval is more than 12 months away. These topics are considered if they are expected to secure regulatory approval within 12 months. The appropriate regulatory approval is usually a UK Conformity Assessed (UKCA) or CE mark (as a medical device), but the Medicines and Healthcare products Regulatory Agency (MHRA) may apply different regulation procedures to certain products, such as in-house tests.

3.4 Digital technologies listed 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 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 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.

3.8 Antimicrobials (antibiotics, antiparasitics, antifungals)

NICE and NHS England (NHSE) have developed an innovative 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. Some technologies 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 clinician 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 cancer or another condition) are considered by NICE.

3.11 Other topics

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 Software as a Medical Device (SaMD) or those that do not have direct patient benefits (such as scheduling tools).

3.12 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.