NICE health technology evaluation topic selection: the manual

The topic selection oversight panel is mainly responsible for making the following decisions about topics that have been considered by the NICE team:

• selecting devices, diagnostics and digital health technologies for medtech innovation briefings (see section 5.2) and selecting and routing topics to any type of NICE guidance (see section 8.2)

• ratifying the NICE team's decision not to select a topic for interventional procedures guidance (see section 8.3)

• selecting and routing medicines to technology appraisal or highly specialised technologies guidance (see section 8.4).

The topic selection oversight panel considers the briefing (if available, the medtech innovation briefing is used) and apply the selection and routing considerations to make their selection and routing decision (see section 6).

The topic selection oversight panel is informed about any topics that are not selected for interventional procedures guidance and is responsible for ratifying the NICE team's decision.

The topic selection oversight panel may be required to make a selection and routing decision on eligible interventional procedure topics if:

• the clinical and cost effectiveness of the interventional procedure also needs assessing, or

• another eligible topic is used within the procedure, such as a device, diagnostic or medicine.

The topic selection oversight panel applies the selection and routing considerations (see section 6) to decide whether to select the interventional procedure or other eligible topic for NICE guidance. If the topic is selected, multiple routing decisions may apply (see section 8.5).

The topic selection oversight panel is responsible for making selection and routing decisions on eligible medicine topics if:

• the medicine meets the highly specialised technologies routing criteria, or there are uncertainties about whether the criteria are met (see section 7.1)

• there are uncertainties about whether the medicine fulfils the medicines selection considerations

• the medicine fulfils the medicines selection considerations, but there is uncertainty about whether issuing technology appraisal guidance would add value (for example, because a new or existing policy allows people to have the medicine).
  
  All other topics that fulfil the medicines considerations are automatically selected and routed to technology appraisal guidance by the NICE team.

The topic selection oversight panel considers the topic briefing and applies the medicines and highly specialised technologies criteria to decide whether to route the medicine to technology appraisal or highly specialised technologies guidance, or to deselect the topic. Deselected topics may be referred to another organisation (such as NHS England and NHS Improvement) or considered for another output such as a NICE guideline, for which separate topic selection processes apply.

The NICE (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 require NICE to seek approval from the government before starting the development of technology appraisal or highly specialised technologies guidance. NICE does this by seeking a ministerial referral once a topic has been selected.

The ministerial referral does not specify whether to route the topic to technology appraisal or highly specialised technologies guidance because routing is NICE's responsibility.

Some topics may need more than 1 type of NICE guidance, for example interventional procedures that use a technology. NICE guidance may be needed to both assess the safety and efficacy of the procedure and the clinical and cost evidence of the technology used within the procedure.

The topic selection oversight panel considers topics that need more than 1 type of NICE guidance and whether they should be developed:

• in parallel, where NICE will publish 2 separate pieces of guidance on the topic at the same time

• in sequence, where NICE will publish 2 separate pieces of guidance at different times

• through a modified guidance development process where NICE will publish 1 piece of guidance that explicitly assesses the safety and efficacy of the procedure and the clinical and cost evidence of the technology.