Process and methods

1 Introduction

1.1 Introduction to process guide

This process guide provides an overview of the key principles used for developing evidence summaries. Each stage ensures 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

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.

NICE's medicines and technologies programme (MTP) provides advice and support for delivering safety, efficiency and effectiveness in the use of medicines. The MTP is responsible for developing evidence summaries. The NHS Constitution gives patients the right to expect that decisions about the funding of medicines and treatments will be made rationally, following proper consideration of the evidence. Evidence summaries provide consistent access to the best available information on a medicine to guide decision-making, nationally within NHS England and locally, for example within a clinical commissioning group, an NHS trust, or across a local health economy.

What are evidence summaries?

Evidence summaries provide a summary of the best available evidence for selected medicines[1] that are considered to be of significance to the NHS including:

  • new medicines

    • a medicine that has recently been granted a marketing authorisation or recently launched in the UK (normally within the past 6 months)

    • a medicine with an existing UK marketing authorisation that has been recently licensed for a new indication (normally within the past 6 months)

    • a new formulation of an existing licensed medicine recently granted a marketing authorisation or launched in the UK (normally within the past 6 months)

  • off-label use of licensed medicines

    • a medicine that is used outside of its marketing authorisation (off-label use of medicines)

  • unlicensed medicines

    • a medicine that is used when there is no licensed medicine for a condition

    • a medicine that is used when there is no licensed medicine appropriate for a significant proportion of people needing treatment for a condition.

Full systematic reviews, meta-analysis and cost-effectiveness reviews are not carried out when producing evidence summaries. Topics are considered for an evidence summary if a NICE technology appraisal is not planned or in progress, or the technology appraisal programme will not publish an appraisal consultation document within 6 months of a medicine's launch. Previous inclusion of an unlicensed or off-label medicine in a NICE guideline is not necessarily a reason for it not to be selected for an evidence summary.

The strengths and weaknesses of the relevant evidence are critically reviewed within each evidence summary. Importantly, an evidence summary does not include recommendations and does not constitute formal NICE guidance.

Evidence summaries should not be considered to promote the use of unlicensed medicines solely for economic reasons.

[1] NHS England may commission an evidence summary for any medicine to inform a commissioning policy for that topic area.