NICE process and methods

4 Topic identification, prioritisation and selection

4 Topic identification, prioritisation and selection

4.1 Topic identification and prioritisation

The NICE topic selection programme is responsible for managing the process of topic identification, prioritisation and selection for ESUOMs. Topics will be selected where a demand for information has been identified.

There is no established horizon scanning service to identify potential topics for this work stream. A new approach to gathering this information is therefore required.

Topic identification, prioritisation and selection

Stage 1: Identifying potential topics

Partner organisations[3] are approached twice a year to suggest potential topics. They are asked to consider the exclusion criteria in Box 1 when suggesting topics. These criteria are designed to filter out topics unsuitable for development into an ESUOM and ensure each topic selected will add value.

Box 1 Long list: exclusion criteria

  • There is a clinically appropriate licensed alternative and use of the unlicensed or off-label medicine is being proposed on solely economic grounds

  • The topic is a variation in delivery route or a modification to a formulation already licensed

  • The topic covers population screening, immunisation or HIV treatment (as these are normally covered by other bodies)

  • High-quality reviews/guidance are already available from a NICE-accredited source

  • A marketing authorisation is being sought and expected to be granted within 2 years

The suggestions from the partner organisations and any other potential topics identified through NICE networks, are compiled to form a list of potential topics.

Stage 2: Filtration: applying the exclusion criteria

The NICE Topic Selection team and the Medicines and Prescribing Centre check the potential list of topics against the exclusion criteria (see box 1). Topics that meet the exclusion criteria are removed from the list and a long list for prioritisation is created.

Stage 3: Prioritisation: developing the short list

The UOM Prioritisation Panel (see section 3.5) meets twice a year to consider the priority for each topic on the long list. They advise NICE on the priority of each topic using the prioritisation criteria in Box 2.

Box 2 Short List: prioritisation criteria

  • High volume of requests from the NHS for information on the topic

  • Large variations in clinical practice, significant divergence of clinical opinion and/or reports of difficulty of access to the unlicensed or off-label medicine

  • Uncertainty on the risk:benefit balance of the unlicensed or off-label medicine

The advice from the UOM Prioritisation Panel is considered by NICE and used to produce the short list of topics that NICE intend to develop as ESUOMs.

Stage 4: Approval:

The short list of potential ESUOM topics is sent to the Director of the NICE Centre for Clinical Practice who confirms that NICE should proceed to develop ESUOMs on those topics.

Stage 5: Commissioning

NICE sends the final list to the external supplier and formally asks them to develop an ESUOM for each topic.


[3] Partner organisations are organisations with a particular interest in the unlicensed and off-label use of medicines. They include professional and patient bodies and trade organisations such as the Royal College of Paediatrics and Child Health, Rare Diseases UK, the Chief Pharmacists Network and the Association of the British Pharmaceutical Industry (ABPI). A list of partner organisations will be available on the NICE website, but is not be intended to be exhaustive, as we aim to engage with all who can help identify potentially suitable topics.