NICE process and methods

4 Eligibility criteria

4.1 Topics that are eligible to be considered

Devices

4.1.1

These are technologies that treat or prevent a health condition (including digital health technologies listed in tier C of NICE's evidence standards framework for digital health technologies). This includes those using artificial intelligence with fixed or adaptive algorithms. Examples include types of radiotherapy, implanted neuromodulators, and apps or software used to deliver cognitive behaviour therapy through a smartphone. Devices which are expected to get appropriate regulatory approval within 12 months are eligible.

Diagnostics

4.1.2

These are technologies, techniques, strategies and pathways used for an investigative medical purpose. This includes those to help detect, diagnose, monitor, prognose, predict or screen for health conditions (including digital health technologies listed in tier C of the evidence standards framework for digital health technologies). The term 'diagnostic' is used throughout this manual to indicate all such technologies. This includes in-house and companion diagnostics, and those using artificial intelligence with fixed or adaptive algorithms. For example, pathology tests, imaging technologies and software (such as CT scanners or dermatoscopes), measuring technologies (such as ECG (electrocardiogram) and bioimpedance devices), and apps or software for remote monitoring of a condition. Diagnostics which are expected to get appropriate regulatory approval within 12 months are eligible.

Interventional procedures

4.1.3

These are new or significantly modified procedures that use ionising, electromagnetic or acoustic energy, or involve making an incision, a puncture or entry into a body cavity. These also include established procedures where safety, efficacy or costs need to be reviewed. Examples include inserting a tube into a blood vessel, doing treatment inside the body with an instrument inserted through the mouth and using a laser to treat eye problems.

Medicines

Combination or integrated technologies

4.1.5

These are combinations of more than 1 type of technology (either sequentially or simultaneously) to achieve or enhance the intended effect. Examples include using several medicines with distinct mechanisms of action to form a combination regimen and using a medical device that integrates a monitor, an algorithm and a medicine to deliver treatment.

Other technologies that have direct patient benefits

4.1.6

Other technologies are eligible to be considered if they are regulated (or seeking regulation) as a medicine or medical device, or have direct patient benefits. Examples include human tissue products (for example donor organs), interventions delivered by healthcare professionals (for example a self-care technology) and vitamins that are regulated as a medicine because they are used to prevent or treat a specific condition.

4.1.7

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 issue.

4.2 Topics that are not usually eligible to be considered

Devices, diagnostics, digital technologies

Technologies that will not get appropriate regulatory approval in the UK within 12 months
4.2.1

Devices, diagnostics and digital technologies without appropriate regulatory approval for use in the UK are not eligible to be considered for topic selection if approval is more than 12 months away.

4.2.2

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.

Technologies listed in tier A or B of the evidence standards framework
4.2.3

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 productivity tools that target appointment communications or help assign staff rotas.

Established interventional procedures

4.2.4

These are procedures that are standard clinical practice and have a well‑known efficacy and safety profile (including robotic delivery of an established interventional procedure). This is unless:

  • there is new information and safety, efficacy or cost needs to be reviewed, or

  • the procedure has changed, which might affect the safety, efficacy or cost profile of the established procedure.

Medicines

Medicines that will not get appropriate regulatory approval in the UK within 24 months
4.2.5

The appropriate regulatory approval for medicines is usually a marketing authorisation. Medicines without regulatory approval for use in the UK are not eligible to be considered for topic selection if approval is more than 24 months away.

Unlicensed medicines
4.2.6

These are unlicensed technologies that require regulatory approval for their use outside of research in the UK but are not expecting to get approval within 24 months.

Off-label medicines
4.2.7

These have UK regulatory approval but are being used differently to how the company has instructed.

New generic or biosimilar medicines
4.2.8

Generic or biosimilar medicines are not eligible to be considered if the branded version is recommended in NICE technology appraisal or highly specialised technologies guidance (see the European Medicines Agency's definitions of generic medicines and biosimilar medicine). This is because the recommendation usually applies to the generic or biosimilar medicine. If the branded version is not recommended, does not have NICE guidance or is not recommended in a NICE guideline, the new generic or biosimilar can be considered for a rapid update of NICE technology appraisal or highly specialised technologies guidance by request, emailing topic.selection@nice.org.uk or contacting the NIHR Innovation Observatory.

Other topics and technologies

4.2.9

Items like foods, drinks, nutritional supplements, cosmetics, toiletries, personal protective equipment and general equipment are not eligible to be considered.

Antimicrobials
Technologies that are intended to be used for national, proactive population-based screening
4.2.11

These are considered by the UK National Screening Committee. Some technologies have more than one 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 GP to screen for cancer in people presenting with symptoms).

Prophylactic vaccinations
4.2.12

Prophylactic vaccinations are not eligible for consideration because this is the role of the Joint Committee on Vaccination and Immunisation. However, therapeutic vaccinations (for example for cancer or another condition) are eligible for consideration.