Process and methods

3 Who is involved in producing Evidence summaries: unlicensed and off-label 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: unlicensed and off-label medicines' (ESUOMs), senior members of the medicines evidence and medicines education teams within the Medicines Prescribing Centre are responsible for:

  • developing and reviewing processes and methods for producing ESUOMs

  • identifying potential topics for ESUOMs in collaboration with the NICE topic selection team

  • developing and preparing ESUOMs for publication in line with the agreed process and standards

  • identifying external specialist commentators to help ensure the content is relevant and useful

  • providing quality assurance of the content of ESUOMs

  • ensuring timelines and quality assurance standards are followed

  • reviewing and updating content of published ESUOMs, when required.

3.2 The NICE Public Involvement Programme

The Public Involvement Programme (PIP) provides NICE with advice on involving patients, carers and members of the public. The role of the PIP team in the ESUOM programme is to provide editorial input into the information for the public as well as helping to identify expert patients, or commentators from patient organisations or groups[1], to input into the topic selection and content of the information for the public.

3.3 Other NICE teams

In addition to the PIP, the Medicines and Prescribing Centre works closely with members of other NICE teams to develop ESUOMs. These include:

  • Topic Selection, to assist in topic identification and prioritisation

  • Technology Appraisals, to ensure that there is no conflict or overlap with published, planned or proposed NICE technology appraisals

  • 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

  • Communications, to carry out an editorial review, then to publish and promote the final versions

  • Guidance Information Services, to assist at the topic selection stage with checking the topics against the exclusion criteria.

3.4 Unlicensed and Off-label Medicines (UOM) Prioritisation Panel

The UOM Prioritisation Panel has a standing membership, which advises NICE on topics that should be prioritised for development as an ESUOM. Members of the panel include lay members, representatives from the Association of the British Pharmaceutical Industry (ABPI), Royal College of Paediatrics and Child Health (RCPCH), and NHS secondary and tertiary care pharmacists. The membership of the panel and UOM Prioritisation Panel minutes are published on the NICE website.

3.5 External specialist commentators

The specialist commentator(s) are identified to review draft ESUOMs before publication. They are practitioners who have significant expertise in the therapeutic area for which the unlicensed or off-label medicine is to be used. Their role is to clarify any issues about the reviewed evidence and the practical implications of the information contained in the ESUOM. Suggestions for appropriate external specialist commentators come from existing NICE networks, national professional organisations and NICE Medicines and Prescribing Associates (see section 3.8).

3.6 Manufacturers

When a topic is selected for the ESUOM programme, NICE informs the manufacturer[2] 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 ESUOM.

3.7 The Medicines and Healthcare products Regulatory Agency (MHRA)

The NICE Medicines and Prescribing Centre contacts the MHRA (or the European Medicines Agency [EMA], as appropriate) to ask for any evidence on the topic held on file that is not confidential. It is invited to comment on a draft of the ESUOM within an agreed time frame. The role of the MHRA or EMA is to comment on regulatory and safety issues within the topic covered by the ESUOM.

3.8 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 identification of topics (see section 4.1), and help to identify external specialist commentators.

3.9 Conflicts of interest

NICE staff, members of the UOM Prioritisation Panel, 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.

[1] NICE uses the terms 'patient organisation' and 'patient group' to include patients, carers, and community and other lay organisations, including those representing people from groups protected by equalities legislation.

[2] For some unlicensed or off-label medicines, more than 1 manufacturer may be involved in the development of the drug. On these occasions, all relevant manufacturers based in the UK are contacted for information.