1 Introduction

This is not the current process. From February 2017, evidence summaries were developed using the evidence summaries: process guide.

1.1 Introduction to integrated process statement

This integrated process statement has been produced to explain how 'Evidence summaries: unlicensed and off-label medicines' (ESUOMs) are developed. It provides an overview of the key process principles and describes all stages of development for ESUOMs. These procedures are designed to ensure that a robust, quality-assured commentary is developed for the NHS in an open, transparent and timely way, with appropriate input from key groups.

1.2 Background to Evidence summaries: unlicensed and off-label medicines

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. Further information about NICE and its work is available on the NICE website.

The NICE Medicines and Prescribing Centre provides advice and support for delivering safety, efficiency and effectiveness in the use of medicines. The Medicines and Prescribing Centre is responsible for developing the ESUOMs.

ESUOMs provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, usually when there is no licensed medicine for the condition requiring treatment or no licensed medicines are appropriate for a significant proportion of people requiring treatment. ESUOMs should not be considered to promote the use of unlicensed medicines solely for economic reasons.

ESUOMs provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies. The strengths and weaknesses of the relevant evidence are critically reviewed within each ESUOM. Importantly, an ESUOM does not constitute formal NICE guidance and this is clearly stated on each publication. This information from NICE helps to avoid potential duplication of effort and the need for different NHS organisations to produce similar products for their own local use.

The topics for ESUOMs are selected in collaboration with the existing NICE topic selection programme. Two types of topics are considered:

  • An unlicensed medicine; that is, a medicine that does not have a UK marketing authorisation and is not expected to do so in the next 2¬†years.

  • An off-label medicine; that is, a medicine with an existing UK marketing authorisation that is:

    • used outside the terms of its marketing authorisation, for example, by indication, dose, route or patient population and

    • it is not expected that the existing UK marketing authorisation will be extended to cover this use in the next 2¬†years.

Previous inclusion of an unlicensed or off-label medicine in a NICE clinical guideline is not necessarily a reason for it not to be selected for an ESUOM. ESUOMs do not constitute NICE guidance and do not include recommendations, but they do provide a dedicated summary of the evidence relating to the use of particular medicine in a particular condition within the context of the rest of the NICE guidance. They may include new evidence which has been published since the NICE clinical guideline was last updated. As such, they support local decision-making and implementation of the clinical guideline, and may influence the development of guidance or updates of guidance.