NICE health technology evaluation topic selection: the manual

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.

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.

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.

These are new active substances in their first indication or that have extensions to their marketing authorisation to add a significant new therapeutic indication (see the 2019 Department of Health and Social Care voluntary scheme for branded medicines pricing and access). Medicines which are expected to get appropriate regulatory approval within 24 months are eligible.

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 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.

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.

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.

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