NICE process and methods

4 Topic identification, prioritisation and scoping

4 Topic identification, prioritisation and scoping

4.1 Topic identification and prioritisation

The topics for ESNMs will be selected in collaboration with the existing NICE topic selection programme. Two types of topics will be considered:

  • a medicine recently marketed in the UK

  • a medicine that may be marketed in the UK within the next 6–12 months.

In both cases, topics will only be considered for an ESNM where a NICE technology appraisal (TA) is not planned or in progress.

Stage 1: Identify potential topics

The NICE topic selection process is the primary route for the identification of significant new medicines. Potential topics for a NICE ESNM are being identified at various points during the topic selection and technology appraisal process and can come from:

  • the National Institute for Health Research Horizon Scanning Centre (NHSC) non-prioritised list[2]

  • topics that are not prioritised for development into technology appraisal guidance

  • topics referred to the technology appraisal programme that will not publish an appraisal consultation document (ACD) within 6 months of launch

  • terminated technology appraisals.

The NICE topic selection prioritisation criteria include the size of population affected, severity of disease, potential resource impact and claimed therapeutic benefit.

Stage 2: Prioritise topics

Three times each year, the NICE Medicines and Prescribing Centre will present a list of those medicines identified in stage 1 to members of the New Medicines Community of Practice. Members will advise NICE on the likely clinical and service impact of these new medicines. The purpose of this stage is to engage with those who have a role in managing the introduction of new medicines within health communities, with their advice informing stage 3 of this topic selection process.

Stage 3: Formal approval of topic for review

A final, prioritised list of topics is then compiled by the NICE Medicines and Prescribing Centre using the NICE topic selection prioritisation criteria (based on the size of population affected, severity of disease, potential resource impact and claimed therapeutic benefit), taking into account the advice from the New Medicines Community of Practice. The CCP Director is asked to formally approve the shortlist. Once approved, the manufacturers of the medicines will be informed of the intention to produce these ESNMs and the topics are added to the NICE Forward Planner, as well as being added to the 'Coming soon' section of the Medicines and prescribing page on the NICE website.

4.2 Scoping of individual topics

The NICE Medicines and Prescribing Centre will hold an internal scoping meeting for each ESNM topic to:

  • confirm key contacts at the pharmaceutical manufacturer

  • identify specialist commentators (via the New Medicines Community of Practice and other existing NICE networks)

  • identify terms for a literature search to identify published clinical trial data that reflect the possible indication for the medicines, usually phase III trials.

  • confirm arrangements for identifying:

    • proposed or likely indication

    • relevant published trials or other data to support the (possible) indication

    • likely licensing and marketing timeline

    • proposed cost and course of treatment

    • evidence of clinical effectiveness

    • safety issues

    • treatment alternatives

    • likely place in therapy

    • incidence and prevalence of (likely) indication (to inform an estimation of use).


[2] This is a list of topics identified by the NHSC that are not considered significant enough to consider as a potential technology appraisal.