Evidence summaries: unlicensed/off-label medicines summarise the best available evidence for selected unlicensed and off-label medicines.
Unlicensed and off-label medicines have a valuable role in the care of certain patients when there are no suitable licensed medicines available which meet their needs. However, information for healthcare professionals and patients to decide whether these medicines are safe and effective, and when they are most likely to yield good patient outcomes, can be difficult to find. It is estimated that around 1000 specific requests for off-label drug use are made to NHS commissioners in England every year.
The summaries are the first nationally-available source of information for healthcare professionals and patients. They allow evidence-based prioritisation, treatment and funding decisions to be made where there are no clinically-appropriate licensed alternatives.
The strengths and weaknesses of the relevant evidence are critically reviewed, but the summaries do not constitute formal NICE guidance.
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