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  • Question on Document

    Do you agree NICE should focus on guidance production and maintenance on priority areas (section 5) and these should be reviewed periodically to ensure NICE is supporting what the health and care system needs? If you disagree, please give reason and rationale.
  • Question on Document

    Do you agree that NICE should be transparent about its remit (section 3.12, section 6.1.1 and 6.2)? If you disagree, please give reason and rationale.
  • Question on Document

    Do you think the new process and consideration factors for NICE to propose topics to the Secretary of State for NHAP are robust and transparent (section 4 and Annex A)? If you disagree, please give reason and rationale. Are there any other factors NICE should include to consider?
  • Question on Document

    Do you think the new merged single-stage prioritisation framework is more streamlined and efficient for topic selection? If you disagree, please give reason and rationale.

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.

When necessary, this manual distinguishes 'health technologies' as being medicines or HealthTech. If not indicated otherwise, health technologies refers to both medicines and HealthTech.

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

2.1 Topics for guidelines or guideline recommendations

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

2.2 Topics that involve use of HealthTech

HealthTech includes non-medicine technologies. This means diagnostics, medical devices, digital technologies including artificial intelligence, and interventional procedures.

Examples include technologies, techniques, strategies and pathways that help diagnose, monitor, prognose, predict or symptomatically screen for health conditions, and those that treat, manage or prevent a health condition (including digital HealthTech listed in tier C of NICE's evidence standards framework for digital health technologies). HealthTech topics (including interventional procedures) can be assessed for 'early use', 'routine use' or 'existing use' (see NICE's HealthTech programme manual).

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 guidance topic (either the different guidance being developed sequentially or simultaneously) to achieve integrated guidance production. Examples include:

  • a NICE guideline with HealthTech guidance to cover a diagnostic pathway

  • using several medicines with distinct mechanisms of action to form a combination regimen

  • using a medical device that integrates a monitor

  • genetically-guided treatment that includes genetic testing

  • 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 some high-dose vitamins that are regulated as a medicine because they are used to prevent or treat a specific condition.