Evidence summaries: unlicensed and off-label 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 ESUOMs, senior members of the Medicines Evidence team within the Medicines Prescribing Centre are responsible for:

3.2 External supplier

Following a tendering process conducted in early 2012, NICE holds a contract with an external supplier to write ESUOMs to an agreed process and standard. The Medicines and Prescribing Centre manages the contract with the external supplier. In summary, the role of the external supplier is to search for and sift the evidence, critically appraise the evidence, develop a draft and liaise with expert reviewers. The role will be fully defined in the final version of the process guide.

3.3 The NICE Patient and Public Involvement Programme

The Patient and Public Involvement Programme (PPIP) provides NICE with advice on involving patients, carers and members of the public. The role of the PPIP team in the ESUOM programme, is to provide editorial input into the summary for patients 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 summary for patients.

3.4 Other NICE teams

In addition to the PPIP, to develop ESUOMs, the Medicines and Prescribing Centre works closely with members of other NICE teams to avoid overlap with other programmes and potential duplication of effort. These include; Topic Selection, Technology Appraisals, Clinical Guidelines, Communications (including Publishing), Evidence Information Services and Guidance Information Services. Their roles will be defined in the final version of the process guide.

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

The UOM Prioritisation Panel has a standing membership, who advise NICE on topics that should be prioritised for development as an ESUOM. Members of the panel are being sought from existing commissioning, medicines and pharmacy networks, and include; lay members, representatives from the Association of the British Pharmaceutical Industry (ABPI), the Medicines and Healthcare products Regulatory Agency (MHRA) and the Royal College of Paediatrics and Child Health (RCPCH). Once in place, the membership of the panel will be available on the NICE website.

3.6 External specialist commentators

The specialist commentator(s) are identified to review draft ESUOMs ahead of 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, the external supplier, national professional organisations and the New Medicines Community of Practice (see section 3.9).

3.7 Manufacturers

When a topic is selected for the ESUOMs programme, NICE informs the manufacturer^[2] of the medicine of its intention to produce an ESUOM and the expected timeframe for production. NICE invites them to provide relevant information to support the production of the ESUOM.

The manufacturer is also invited to comment on a draft of the ESUOM, 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.

3.8 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. They will be invited to comment on a draft of the ESUOM, and provide comments within a short time frame. Their role is to comment on regulatory and safety issues within the topic covered by the ESUOM.

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

The New Medicines Community of Practice was established by the Medicines and Prescribing Centre, to support those NHS staff with a role in local policy making on medicines and prescribing, including the use of unlicensed and off-label medicines. This is a group consisting of about 300 healthcare professionals, who are actively involved in local decision-making bodies such as, Area Prescribing Committees.

The New Medicines Community of Practice assist with the identification of topics (see section 4.1), and help to identify external specialist commentators, who may come from the Community of Practice itself.

3.10 Conflicts of interest

NICE staff, the external supplier, members of UOM Prioritisation Panel, 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'.