Process and methods

1 Introduction

1 Introduction

This guide gives an overview of the process for developing evidence summaries. Evidence summaries provide advice but do not include recommendations and are not formal NICE guidance.

Evidence summaries help inform national and local decision making about medicines. They summarise the best available evidence for medicines with significant implications for the NHS. Each evidence summary is underpinned by a detailed evidence review (see section 6.6 and section 6.7).

Note that evidence summaries commissioned to inform an NHS England specialised commissioning policy follow an NHS England process.

1.1 Background

Evidence summaries are developed by NICE and provide advice and support for the safe, efficient and effective use of medicines. See the NICE website guidance and advice list for published evidence summaries.

When are evidence summaries developed?

An evidence summary may be developed if a NICE technology appraisal is not planned or in progress for the topic, or if an appraisal consultation document will not be published within 6 months of a medicine's launch. Topics can be:

  • new medicines and significant licence extensions:

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

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

    • new formulations 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:

    • medicines that are used outside of their marketing authorisation.

  • unlicensed medicines:

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

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