Process and methods
4 Topic identification, prioritisation and selection
The NICE Medicines and Prescribing Centre is responsible for managing the process of topic identification, prioritisation and selection for 'Evidence summaries: unlicensed and off-label medicines' (ESUOMs). Topics are 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.
Figure 1 The main steps in the process for topic identification, prioritisation and selection for ESUOMs
Stage 1: Identifying potential topics
Partner organisations are approached up to 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. Previous inclusion of an unlicensed or off-label medicine in a NICE clinical guideline is not necessarily an exclusion criterion for its selection for an ESUOM (see section 1.2).
Box 1 Long list: exclusion criteria
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 Medicines and Prescribing Centre check the potential list of topics against the exclusion criteria (see box 1). Topics that do not meet the criteria are removed from the list and a long list for prioritisation is created.
Stage 3: Prioritisation: developing the short list
The Unlicensed and Off-label Medicines (UOM) Prioritisation Panel (see section 3.4) 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
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 Director of the NICE Centre for Clinical Practice reviews the short list of potential ESUOM topics and gives approval of the topics on which NICE should proceed to develop ESUOMs. Once topics are approved, the manufacturers of the medicines are informed of the intention to produce these ESUOMs and the topics are added to the NICE Forward Planner, as well as being added to the ESUOM page of the Medicines and prescribing section of the NICE website
Stage 5: Development
The NICE Medicines and Prescribing Centre develops an ESUOM for each of the approved topics.
 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). In addition, the NICE Medicines and Prescribing Associates may also suggest topics. A list of partner organisations is available on the NICE website, but is not intended to be exhaustive, as we aim to engage with all who can help identify potentially suitable topics.
 For some unlicensed or off-label medicines, more than 1 manufacturer may be involved in the development of the drug. On these occasions, all relevant manufacturers based in the UK are contacted for information.