Process and methods
3 Who is involved in the medical technologies evaluation programme
- 3.1 The MTEP team
- 3.2 Editors
- 3.3 Adoption support
- 3.4 Guidance information services
- 3.5 Public involvement programme
- 3.6 Topic oversight group
- 3.7 Medical technologies advisory committee
- 3.8 Expert advisers
- 3.9 Patients and carers
- 3.10 External assessment centres
- 3.11 Sponsors
- 3.12 Stakeholders
- 3.13 Members of the public
MTEP is part of NICE's Centre for Health Technology Evaluation. The programme team consists of the associate director and technical, project management and administrative staff who support the committee in developing medical technologies guidance. The main tasks of the team are:
assess notified technologies against the eligibility criteria
prepare topic briefings used by the topic oversight group during selection and routing
produce medtech innovation briefings (MIBs).
For all technologies that are routed to the committee for evaluation, the team will:
commission external assessment centres to assess evidence
prepare overviews of the assessment reports, and additional analyses and evidence if needed
arrange public consultation on the committee's draft recommendations
draft the final guidance
ensure that agreed timelines and quality assurance processes are followed.
NICE editors review the draft and final guidance, making changes for consistency, accuracy and plain English. The editors also provide a lay explanation of the recommendations and the rationale behind them ('information for the public') and prepare the final guidance for publication.
NICE provides advice and tools to support the local implementation of its guidance. In general, the adoption support team:
ensures intelligent dissemination to the appropriate target audiences
actively engages with the health and social care system, local government and the wider community
works nationally to encourage a supportive environment
provides tools to support putting NICE guidance into practice
demonstrates significant costs or savings at local and national levels
evaluates uptake of NICE guidance
develops educational material to raise awareness of NICE guidance and encourages people to contribute to its development.
NICE may develop adoption support tools depending on the needs identified for the individual technology. These tools are developed with advice from expert advisers, patient and carer organisations, the sponsor and committee members, as appropriate.
The guidance information services team searches for information and evidence from conventional sources and 'grey' literature. This MTEP team then uses this information to inform topic briefings for the topic oversight group.
The public involvement programme recruits and supports lay members of the committee, identifies patient and carer organisations (see section 3.9), encourages members of the public and patient organisations to contribute during consultation, and establishes links with patient organisations with an interest in medical technologies guidance. NICE uses the terms 'patient organisation' and 'patient group' when referring to patients, carers, and community and other lay organisations and charities, including those representing people from groups protected by equalities legislation.
The topic oversight group comprises representatives from the related NICE guidance programmes, NICE advisory committees, external stakeholders and other programme team members.
The group has 2 functions:
to assess notified medical technologies and determine if the team should produce a topic briefing on the technology and/or a medtech innovation briefing
to review topic briefings, determine if the technologies are suitable for evaluation, and route them to the appropriate NICE programme.
The committee is an independent standing committee with a range of expertise. It comprises clinicians who develop and use medical technologies, scientists, people who can provide a lay perspective on the issues affecting patients and the health and social care system, experts in regulation and the evaluation of healthcare, and people with experience of the medical technologies industry.
The committee normally meets monthly in public. Agendas and minutes of committee meetings are published on the NICE website. The minutes record only what was discussed by whom and in what order; they do not record the committee's draft recommendations. Committee members must declare any conflicts of interest in line with the NICE policy on conflicts of interest.
Committee members are recruited in accordance with the NICE recruitment and selection to advisory bodies policy and procedure.
Expert advisers are usually healthcare professionals or technical specialists who use the medical technology in a clinical or research setting or have experience of the condition and the related clinical pathway.
NICE seeks advice from expert advisers on each technology. Expert advisers provide advice about technologies which complements clinical evidence and findings from research. New technologies often have potential benefits and risks that are not yet fully described in the scientific literature. Expert advisers provide insight into these issues, supported by accounts of their clinical or technical experience, which complement the published evidence, particularly when this is limited. Expert advisers may not be familiar with the technology, in which case they provide advice and opinion based on their clinical or technical experience, and insights into the potential usefulness of the technology in the relevant care pathway.
Expert advisers may be asked to give advice on:
the validity of the notification and whether the technology is relevant to the health and social care system
the topic briefing
the assessment report
adoption support tools, such as costing tools and audit tools (see section 7)
any potential equality issues in relation to the technology.
Expert advisers are asked to declare conflicts of interest in line with the NICE policy on conflicts of interest. These are presented to the topic oversight group and the committee when topics are considered.
Experts who meet one or more of the criteria below are not eligible to advise the programme:
a doctor who is under investigation by the General Medical Council, and who has had interim restrictions placed on their practice, or who has been removed from the Medical Register
other professionals who are under investigation for professional misconduct, or who have been found to be in breach of appropriate professional standards by the relevant professional body
anyone who has received a prison sentence or a suspended sentence of 3 months or more in the last 5 years
anyone who has retired from clinical practice.
During topic selection, expert advisers complete a questionnaire about the topic and/or comment on the topic briefing. On request, NICE sends copies of the completed questionnaires to the professional body that nominated or ratified each expert adviser. Completed questionnaires are also available from NICE on written request, in accordance with the provisions of the Freedom of Information Act 2000.
During the evaluation itself, the MTEP team decides if the expert advisers identified at the topic selection stage still to have relevant experience and expertise. Any who do are invited to comment on the scope and to provide written comments to the committee during the evaluation. If additional expert advisers are needed to ensure an appropriate balance between knowledge of the technology and knowledge of the care pathway, they are selected in the same way during topic selection.
During topic selection, expert advisers are identified in several ways:
NICE asks professional bodies (including Royal Colleges, specialist societies and other professional associations) to nominate them.
NICE identifies them on a topic basis from NICE's existing pool of expert advisers, all of whom have been ratified by their professional body.
Current expert advisers may recommend others with relevant knowledge; expert advisers identified in this way are ratified by their professional body.
The sponsor suggests clinicians with experience of using the technology, or technology developers with relevant knowledge; expert advisers identified in this way are ratified by their professional body.
The chair, vice chair or committee members recommend people with relevant knowledge; expert advisers identified in this way are ratified by their professional body.
NICE welcomes expert advisers from all sectors of the community.
NICE asks patient and carer organisations to provide information about living with the condition to which the technology relates, about any patients who may need special consideration, and about using the technology and/or comparator technologies. Patient and carer organisations can provide insight into outcomes and describe ease of use, discomfort, effect on diverse activities and other aspects of quality of life. This information is included in the topic briefing considered by the topic oversight group.
NICE commissions external assessment centres from a range of organisations, including the health and social care system and academic bodies. These centres are chosen by public tender and must meet quality control requirements. The centres provide independent assessments of the evidence and produce assessment reports for the committee (section 5.5). The centres have knowledge of and expertise in appropriate methods of evaluation.
Normally, sponsors of medical technologies notify technologies to NICE for evaluation. They should provide sufficient information for the topic oversight group to decide whether or not to select the product for evaluation.
If the technology is selected for guidance development, the sponsor provides a clinical and economic evidence submission, based on the scope, which includes relevant cost modelling (section 5.4). This may be based on published or unpublished data, including confidential data prepared for regulatory purposes.
The sponsor has the opportunity to comment on the draft scope, comment on the committee's draft recommendations during consultation, and to request clarification during resolution (section 6).
NICE encourages interested parties (people and organisations) to register as a stakeholder in a technology through the NICE website. Registered stakeholders can register at any time during the course of an evaluation. NICE sends electronic updates to registered stakeholders throughout the evaluation. These updates are triggered by changes to the website page for the technology (for example, when consultation begins).
The programme team notifies relevant professional bodies and relevant patient and carer organisations when a technology that may be of interest to them is first mentioned on the website. Registered stakeholders are invited to comment on the draft scope.
To promote public attendance at committee meetings, NICE publishes a notice and draft agenda on its website announcing each meeting at least 20 working days before the meeting. At this point, members of the public who wish to attend the meeting can register on NICE's website. Up to 20 places are available, depending on the size of the venue. If attendance at any meeting is oversubscribed, NICE selects attendees according to its allocation procedure. To allow wide public access, NICE reserves the right to limit attendees to 1 representative per organisation. The closing date for receipt of completed application forms is 10 working days before the meeting. NICE publishes the final agenda on its website 5 working days before the meeting. Once registration has closed, NICE contacts successful applicants to invite them to the meeting. Along with the invitation, applicants receive a code of conduct for public attendees and frequently asked questions. If a meeting is cancelled, NICE gives attendees as much notice as possible.
Public access to meetings is granted in accordance with NICE policies and subject to the standing orders of the committee.