Evidence summaries: new medicines – Integrated process statement

1.1 Introduction to integrated process statement

This integrated process statement has been produced to explain how 'Evidence summaries: new medicines' (ESNMs) are developed. It provides an overview of the key process principles and describes all stages of the development of ESNMs. 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: new 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 ESNMs.

ESNMs provide a summary of the published evidence for selected new medicines that are considered to be of significance to the NHS. This includes new indications for existing medicines and new formulations of existing medicines. The strengths and weaknesses of the relevant evidence are critically reviewed within each ESNM. Importantly, an ESNM does not constitute formal NICE guidance and this is clearly stated on each publication.

The context of the rest of the evidence informing the management of the licensed indication(s) or anticipated licensed indication(s) for the new medicine is also summarised to assist local decision-making.

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. ESNMs help provide consistent access to the best available information on a medicine to guide local decision-making, for example within a Clinical Commissioning Group (CCG), an NHS Trust, or across a local health economy. This information from NICE will help to avoid potential duplication of effort when different organisations are producing their own evidence summaries.

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

In both cases, topics are considered for an ESNM only if a NICE technology appraisal (TA) is not planned or in progress, unless the technology appraisal programme will not publish an appraisal consultation document (ACD) within 6 months of the medicine's launch.