NICE process and methods

2 Evidence summaries: unlicensed and off-label medicines

2 Evidence summaries: unlicensed and off-label medicines

2.1 Aims

The aim of an ESUOM is to provide information about an unlicensed or off-label medicine that is being considered for use in circumstances where there are no clinically appropriate licensed alternatives. The ESUOM helps inform decision-making by clinicians and patients and supports the construction and updating of local formularies.

2.2 Key audiences

ESUOMs are produced specifically for:

  • clinicians, to inform their decision-making

  • patients and the public, to inform their decision-making

  • local decision-making groups involved in commissioning, policy development, or individual funding requests (IFRs), for example, within a Clinical Commissioning Group (CCG) or NHS Trust.

2.3 Key activities

The key activities involved in the production of each ESUOM are:

  • identifying, prioritising and selecting the topic

  • summarising the published evidence

  • critically reviewing the strengths and weaknesses of the evidence

  • placing the evidence in the context of the wider evidence base, for the management of the condition for which the unlicensed or off-label use is being considered, particularly NICE guidance, where available

  • highlighting any potential implications for local decision-making or clinical practice

  • producing a summary for patients for each ESUOM

  • identifying any new evidence relevant to published ESUOMs through scanning the literature, reviewing and, if necessary, updating or withdrawing an ESUOM (see section 6).

NICE holds a contract with an external supplier to produce ESUOMs to an agreed process and standard (see section 3.2).