Evidence summaries: new medicines – Interim process statement

1.1 Introduction to the interim process statement

This interim process statement has been produced to guide the development of 'Evidence summaries: new medicines' (ESNMs). 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.

This interim process statement of ESNMs will be superseded when the final process guide is issued later in 2012, following engagement and discussions with key groups.

1.2 Background to 'Evidence summaries: new medicines'

The National Institute for Health and Clinical Excellence (NICE) is part of the NHS. NICE's evidence-based guidance and other products help resolve uncertainty about which medicines, treatments, procedures, technologies and devices represent the best quality care and offer the best value for money for the NHS. 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 ESNMs.

ESNMs will provide a summary of the published evidence for selected new medicines that are considered to be of significance to the NHS. This will include new indications for existing medicines and new formulations of existing medicines. The strengths and weaknesses of the relevant evidence will be critically reviewed within this summary. Importantly, the ESNM product will not constitute formal NICE guidance and this will be 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 will also be 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 will 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 where different organisations are producing their own evidence summaries.

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

In both cases, topics will only be considered for an ESNM where a NICE technology appraisal (TA) is not planned or in progress.