NICE process and methods
3 Who is involved in producing 'Evidence summaries: new medicines'?
3 Who is involved in producing 'Evidence summaries: new medicines'?
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 'Evidence summaries: new medicines' (ESNMs), senior members of the medicines evidence and medicines education teams within the Medicines and Prescribing Centre are responsible for:
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developing and reviewing processes and methods for producing ESNMs
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identifying potential topics for ESNMs in collaboration with the NICE topic selection team
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preparing ESNMs for publication, including selecting and critically appraising the evidence
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identifying and liaising with external specialist commentators to help ensure the content is relevant and useful
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providing quality assurance of the content of ESNMs
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ensuring timelines and quality assurance standards are followed
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reviewing and updating content of published ESNMs when required.
3.2 Other NICE teams
In developing ESNMs, the Medicines and Prescribing Centre works closely with members of other NICE teams. These include
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Topic Selection, to assist in topic identification and prioritisation
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Technology Appraisals, to ensure that there is no conflict or overlap with published, planned or proposed NICE technology appraisals
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Clinical Guidelines, to suggest topics for prioritisation and ensure that there is synergy with published or planned NICE clinical guidelines, including the review and updating of NICE clinical guidelines
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Communications, to carry out an editorial review then to publish and promote the final versions
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Guidance Information Services, to assist at the topic selection stage and to conduct literature searches for the development of ESNMs.
3.3 External specialist commentators
Specialist commentator(s) and/or specialist agencies (for example, the Health Protection Agency for an infectious disease topic) are identified through suggestions from NICE staff, national professional organisations and NICE Medicines and Prescribing Associates (see section 3.5), to review the ESNMs before publication. Specialists are identified early in the production process and provide comments within an agreed timeframe. 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.
3.4 Manufacturers
When a topic is selected for the ESNM programme, NICE informs the manufacturer of the medicine of its intention to produce an evidence summary and the expected time frame for production. NICE invites them to provide relevant information to support the production of the evidence summary.
The manufacturer is also invited to comment on a draft of the evidence summary, and provides comments within an agreed time frame. The manufacturer has the opportunity to comment on matters of factual accuracy, and respond to any specific questions from NICE about the information they submitted to inform the development of the ESNM.
3.5 The NICE Medicines and Prescribing Associates programme
NICE Medicines and Prescribing Associates are a network of health professionals for whom influencing medicines and prescribing strategy in the NHS is a significant part of their job. They work within their own NHS organisation, health board or service and in their wider local health economy to support high-quality, cost-effective prescribing and medicines optimisation. Details of current Associates are published on the NICE website. NICE Medicines and Prescribing Associates assist with the prioritisation of topics for ESNMs (see section 4.1), and help to identify external specialist commentators.
3.6 Conflicts of interest
NICE staff, NICE Medicines and Prescribing Associates and specialist commentators are 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.