NICE process and methods

2 Types of topics the manual covers

This section covers the types of topics considered by NICE. Section 3 lists topics that we do not usually consider for guidance development.

'Topic prioritisation' covers prioritisation of new topics and updates to existing NICE guidance.

For the methods and processes used to develop specific types of guidance, see the manuals on:

2.1 Topics for guidelines or guideline recommendations

A guideline usually includes recommendations on topic areas in clinical care (primary, secondary and community care), social care and public health.

2.2 Topics that involve use of health technologies

Health technologies cover diagnostics, medical devices, digital technologies and interventional procedures.

Examples of diagnostics and medical devices include technologies, techniques, strategies and pathways that help diagnose, prognose, predict or symptomatically screen for health conditions, and 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).

Interventional procedures topics cover new or significantly modified procedures that involve making an incision, a puncture or entry into a body cavity, or using ionising, electromagnetic or acoustic energy. They sometimes cover established procedures where safety, efficacy or costs need to be reviewed.

2.3 Topics that involve use of medicines

These cover new active substances in their first indication or that have extensions to their marketing authorisation to add a significant new therapeutic indication (see the Department of Health and Social Care's 2024 voluntary scheme for branded medicines, pricing, access and growth).

2.4 Combination topics

These are combinations of more than 1 type of medicine and/or health 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.

2.5 Other topics that have direct patient benefits

Other topics are eligible to be considered for guidance if they are regulated (or seeking regulation) (also see section 3) as a medicine or medical device or have direct patient benefits with assurance for safety and performance. Examples include human tissue products (for example, donor organs), interventions delivered by healthcare professionals (for example, self-care technology) and vitamins that are regulated as a medicine because they are used to prevent or treat a specific condition.