NICE process and methods

6 Selection and routing considerations

6 Selection and routing considerations

Topics identified as eligible to be considered are assessed against the selection and routing considerations (see sections 6.1 to 6.3).

The amount and quality of information available on an identified topic can vary. Companies or other relevant organisations, or people, may be contacted to provide additional information.

When there is not enough information to assess a topic against the selection considerations, it is not progressed further. The topic can be reconsidered when NICE is made aware that further information is available.

Table 1 shows the technology types and the type of guidance that may be developed.

Table 1. Technology types and the type of guidance that may be developed

Technology types

Type of guidance developed

Diagnostics

Diagnostics

Devices (cost-saving and cost-neutral technologies)

Medical technologies

Devices (cost-incurring technologies)

Medicines

Technology appraisal

Interventional procedures only

Interventional procedures

Medicines only

Highly specialised technologies

6.1 Selection and routing considerations for interventional procedure topics

6.1.1 An interventional procedure is likely to be selected if it is:

  • a new or significantly modified interventional procedure that is available to the NHS or independent sector, or about to be used outside of formal research, or

  • an existing interventional procedure that needs its safety, efficacy or costs reviewing.

Interventional procedures guidance

6.1.2 Selected interventional procedures are routed to interventional procedures guidance for an assessment of the safety and efficacy evidence. Topics are considered and selected as quickly as possible because guidance is important for protecting the safety of patients.

6.1.3 If a device, diagnostic, digital, combination or integrated technology, or any other technology with direct patient benefits is used within a new or significantly modified interventional procedure and an assessment of the procedure's safety and efficacy is needed, the procedure is routed to interventional procedures guidance. If the clinical and cost evidence also needs assessing, multiple routing decisions may apply (see section 8.5).

6.2 Selection and routing considerations for medicine topics

6.2.1 Medicines that meet the eligibility criteria will be selected, except when there is a clear rationale not to do so. For example, when:

  • changes to the dose, formulation or administration will not significantly affect the clinical and cost effectiveness of the medicine, or

  • appropriate access to the medicine is provided by an existing policy (such as NHS England's policy on commissioning medicines for children in specialised services) or when a new policy can be developed (for example, when not enough people are eligible to have the technology and NICE guidance would not provide value for the NHS)

  • it is appropriate to assess the medicine within a NICE guideline (for example, a new medicine within an existing class).

6.2.2 Selected medicines are routed to technology appraisal guidance unless they meet the criteria for routing to highly specialised technologies guidance (see section 7).

Highly specialised technologies guidance

6.2.3 This guidance is for any medicine that meets all the highly specialised technologies criteria (see section 7).

6.3 Selection and routing considerations for all other topics

6.3.1 A device, diagnostic, digital, combination or integrated topic is likely to be selected if the following apply:

  • a systematic assessment of the cost and effects on the health system is needed

  • there is an unmet clinical need or an unmet health system need

  • it has benefits that are likely to be highly disruptive or lead to a stepwise change to a care pathway in the UK, and

  • the benefits are supported by:

    • evidence (such as randomised controlled trials, pre- or post‑marketing studies, cohort studies, diagnostic test accuracy studies or other study designs; this includes evidence generated outside the UK that can be generalised to UK practice) showing the technology's effectiveness compared with current practice in the UK health and care system or an appropriate reference standard, and

    • information about the expected resource impact of adopting the technology that is directly applicable to the UK health and care system, and

    • advice from experts (such as patients, carers, clinicians and commissioners) that confirms the potential benefits are meaningful and likely to be realised when adopted in the UK health and care system.

Diagnostics guidance

6.3.2 This guidance is for all diagnostic topics.

Medical technologies guidance

6.3.3 This guidance is for therapeutic devices and procedures that need a cost-minimisation analysis.

Technology appraisal guidance

6.3.4 This guidance is for medicines, and any other technologies that need a multiple technology assessment or a cost-utility analysis.

6.3.5 In some exceptional circumstances, topics that do not fulfil the selection considerations may be considered. This might be done to stop an ineffective activity happening, to address a particular issue of safety, to stimulate appropriate research or when system support is required.