Evidence summaries: new medicines – Interim process statement

3.1 The Medicines and Prescribing Centre

The Medicines and Prescribing Centre is part of NICE's Centre for Clinical Practice (CCP). The Medicines and Prescribing Centre consists of a programme director, associate directors and clinical, technical, project and administrative staff. For ESNMs, senior members of the medicines evidence team within the Medicines and Prescribing Centre are responsible for:

3.2 Other NICE teams

In developing ESNMs, the Medicines and Prescribing Centre works closely with members of other NICE teams, including Technology Appraisals, Clinical Guidelines, Publishing, Evidence Information Services and Guidance Information Services. Their roles will be specifically defined in the final version of the process guide.

3.3 External specialist commentators

Specialist commentator(s) and/or specialist agencies (for example, the Health Protection Agency for an infectious disease topic) will be identified to review the ESNMs ahead of publication. Specialists will be identified early in the production process and, using advance notice and careful scheduling, will provide comments within a short time frame, usually 1 week. Specialist commentators are practitioners who have significant expertise in the therapeutic area for which the new medicine is to be used. Their role is to clarify issues about the reviewed evidence and the practical implications of the information contained in the ESNM. Suggestions for reviewers come from NICE, national professional organisations and the New Medicines Community of Practice.

3.4 Manufacturers

When a topic is selected for the ESNMs programme, NICE will inform the manufacturer of the medicine of its intention to produce an evidence summary and the expected timeframe. NICE will contact the manufacturer to invite them to provide data to support the production of the evidence summary.

The manufacturer will be invited to comment on an early draft of the evidence summary, and, using advance notice and careful scheduling will provide comments within a short time frame, usually within 1 week. The manufacturer has the opportunity to comment on matters of factual accuracy, and respond to any specific questions from NICE about any information they submitted to inform the summary.

3.5 The NICE Medicines and Prescribing 'New Medicines Community of Practice'

The New Medicines Community of Practice is a group consisting of about 300 healthcare professionals who are actively involved in local decision making bodies such as area prescribing committees. The group was established by the Medicines and Prescribing Centre to support those NHS staff who have a role in managing the introduction of new medicines within health communities. Their aim is to facilitate the sharing of information, knowledge and wisdom around new medicines to assist local decision making.

The New Medicines Community of Practice is facilitated in 2 ways: via an electronic discussion group and by invitation to 3 face-to-face meetings each year. These meetings consider the available technical data on new medicines in development, as well as matters of process and implementation.

The New Medicines Community of Practice advise the prioritisation of topics for ESNMs (see section 4.1), and – in conjunction with the NICE technology appraisals team – identify external specialist commentators, who may come from the Community of Practice itself.

3.6 Conflicts of interest

NICE staff, members of the New Medicines Community of Practice and specialist commentators will be required to comply with the NICE code of conduct on conflicts of interest. For more information about how NICE deals with conflicts of interest, please see 'A code of practice for declaring and dealing with conflicts of interest'