Process and methods
The topics for 'Evidence summaries: new medicines' (ESNMs) are selected in collaboration with the existing NICE topic selection programme. Two types of topics are 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 are only considered for an ESNM if a NICE technology appraisal (TA) is not planned or in progress, unless the technology appraisal programme will not publish an appraisal consultation document (ACD) within 6 months of the medicine's launch.
The NICE topic selection process is the primary route to identify significant new medicines. Potential topics for an ESNM can be identified at several points during the topic selection and technology appraisal process and they can include:
topics that are not prioritised for development into technology appraisal guidance
topics referred to the technology appraisal programme if the appraisal consultation document (ACD) will not be published within 6 months of the medicine's launch
terminated technology appraisals
other topics from the National Institute for Health Research Horizon Scanning Centre (NIHR HSC).
The NICE topic selection prioritisation criteria include the size of population affected, severity of disease, potential resource impact and claimed therapeutic benefit.
The NICE Medicines and Prescribing Centre presents a list of medicines identified in stage 1 to NICE Medicines and Prescribing Associates 5 times a year. The Medicines and Prescribing Associates 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.
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 NICE Medicines and Prescribing Associates network. The Director of the NICE Centre for Clinical Practice reviews the list and gives approval to the topics on which NICE should proceed to develop ESNMs. Once approved, the manufacturers of the medicines are 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 ESNM page of the 'Medicines and prescribing' section of the NICE website.