NICE health technology evaluations: the manual

The committee considers and discusses the evidence for a technology. It is an independent standing committee that produces recommendations. NICE recruits committee members through open, competitive advertising and appoints members initially for 3 years. Committee members are from:

• the NHS

• lay backgrounds (with an understanding of patient and public perspectives on healthcare)

• academia

• life sciences companies

• experts in regulation.

Full details of how NICE recruits members are in the recruitment and selection procedure for advisory bodies. NICE is committed to the values of equality, diversity and inclusion and welcomes applications for membership of the committee from all sectors of the community.

The diagnostics advisory committee recruits several specialist committee members alongside the standing committee members for each individual evaluation. They are committee members for that topic only. They typically include clinicians or researchers using the diagnostic technology or practising in the care pathway, as well as lay people with a perspective on the condition being diagnosed. Specialist committee members have the same decision-making role as standing members of the committee. Any reference to committee includes the specialist committee members.

Members will normally remain in the same committee for the duration of their membership. Sometimes members from one committee may be needed to join another committee. This is to ensure that a meeting is quorate, and that business can be done in line with the committee standing orders and terms of reference.

Although the committee seeks the views of organisations representing healthcare professionals, patients, carers, companies and government, its advice is independent. Names of committee members, standing orders and terms of reference of each committee are published on the NICE website.

A lead team is selected from the committee members at the start of each evaluation. They work with the NICE team to guide the evaluation and present the topic to the committee. The lead team normally consists of 2 or 3 committee members who focus on clinical effectiveness, value for money or patient and carer evidence (called the lay lead).

The technical team consists of the chair or vice chair of the committee along with the NICE team, which normally includes the associate director, the technical adviser and the technical lead.

The technical team is responsible for considering the evidence submissions and the external assessment report. It identifies and explores issues, comes to preliminary scientific judgements, and advises the committee in its discussion of the evidence.

The technical team will seek input from the lead team, the EAG, experts and committee members when appropriate.

The company that holds the regulatory approval (marketing authorisation, UK Conformity Assessed or CE mark, or other equivalent regulatory approval or guidance issued by the regulator) for the technology being evaluated or its agents.

Clinical experts and patient experts are selected from those nominated by consultee organisations or by NICE, taking into account the NICE policy on declaring and managing interests for NICE advisory committees. Experts are invited to provide written evidence, clarify issues about the evidence base and participate in committee meetings. They may be asked to provide advice before, during and after committee meetings. References to clinical and patient experts means the specialist committee members for diagnostics evaluations.

The EAG is an independent academic group that reviews the evidence including any stakeholder submissions and the clinical and cost effectiveness, or cost comparisons of the technology or technologies being evaluated. The EAG develops an external assessment report for the committee.

NICE invites NHS commissioning experts from NHS England and NHS Improvement and clinical commissioning groups (or other relevant commissioning organisations) to help clarify issues about the submitted evidence. They may be asked to provide advice before, during and after committee meetings about:

• their views and experiences of the technology

• the condition from an NHS perspective

• considerations about how the technology could be delivered in the NHS

• when treatment eligibility criteria may be used in the NHS for high-cost treatments, or for technologies recommended with managed access.

The NHS England and NHS Improvement national clinical lead (or a nominated deputy) for the clinical area relevant to the technology being evaluated is invited to provide an evidence submission and attend committee meetings for technology appraisal and highly specialised technology evaluations.

In some circumstances a national clinical lead is invited to attend the private session (part 2) of the committee meeting to discuss confidential information.

Stakeholders are organisations that have registered to participate in a technology evaluation.

NICE invites the following stakeholders (when relevant) to take part in the evaluation:

• the company that holds, or is expected to hold, the regulatory approval for the technology

• relevant comparator technology companies

• national organisations representing patients and carers

• organisations representing healthcare professionals

• the Department of Health and Social Care

• relevant healthcare representatives from the devolved nations

• NHS England and NHS Improvement as the commissioner for specialised services

• relevant NHS commissioning organisations

• a provider of NHS services

• any relevant groups developing clinical and social care guidelines, or public health guidance

• other related research groups (for example, the Medical Research Council and the National Cancer Research Institute)

• other groups (such as the NHS Confederation, the NHS Commercial Medicines Directorate, the Medicines and Healthcare products Regulatory Agency and the Academic Health Science Networks).

The following stakeholder groups, when relevant to the evaluation, are considered consultees and are invited to submit evidence and nominate clinical, patient and commissioning experts:

• the company that holds, or is expected to hold, the regulatory approval for the technology being evaluated

• national organisations representing patients and carers

• organisations representing healthcare professionals

• clinical, patient and NHS commissioning experts

• the Department of Health and Social Care

• the Welsh government

• NHS England and NHS Improvement as the commissioner for specialised services (for relevant evaluations)

• clinical commissioning groups (or other relevant commissioning organisations).

The Decision Support Unit is commissioned by NICE to provide a research and training resource to support NICE's technology guidance programmes and the methods of evaluation.

Members of the public may:

• comment on draft guidance consultations

• apply to observe committee meetings as public observers.

Companies are invited to submit evidence on the technology or technologies being evaluated. They should identify all evidence relevant to the evaluation, including all studies known to them, including clinical trials, follow-up studies and evidence from registries. The submission may include confidential study evidence that is not in the public domain. Companies should provide a summary of information for patients written in plain English using the template provided by NICE.

For evaluations to develop diagnostics guidance, companies are not formally invited to make an evidence submission but provide information requested on the evidence base and their technology to enable the EAG to develop the external assessment report.

At the earliest opportunity, NICE will ask companies for details of the studies they intend to include in their submission. If information is unpublished, companies should include the study reports.

In a single technology evaluation, the company must provide a systematic review of the clinical and cost evidence and an economic evaluation. Evidence requirements are explained in detail in the evidence section of this guide.

If an evaluation is updating guidance on a technology that was recommended with managed access, the company must also provide the evidence described in the published data collection agreement.

Clinical experts, patient experts and commissioning experts provide their views and experience throughout the evaluation. They help clarify issues that the technical team has identified, give written evidence, participate in any technical engagement (when needed), and attend the committee meeting (if required).

For diagnostics guidance, specialist committee members act as clinical and patient experts (but they do not give written evidence). Specialist committee members are recruited in accordance with the appointments to advisory bodies policy and procedure.

NICE commissions independent experts from one of several EAGs to review and critique the available evidence for each technology under evaluation. They produce and are responsible for an external assessment report.

For a single technology evaluation, the EAG prepares a report that assesses the evidence and any evidence submissions. The EAG may recommend that NICE requests additional analyses from the company, may do additional exploratory analyses itself, or both.

For a multiple technology evaluation (including all diagnostic evaluations), the EAG creates a report that independently synthesises the evidence from published information and any evidence submissions about the clinical effectiveness and value for money of the technologies. In addition to a systematic review of the clinical and cost evidence, the external assessment report normally includes an economic evaluation and an economic model informed by a review of the evidence. Evidence requirements are explained in section 3.

NHS England and NHS Improvement are invited to provide a written submission. It may also develop treatment eligibility criteria based on the licensed indication for the technology, clinical trial evidence, biological plausibility and treatment pathways. Treatment eligibility criteria are developed for highly specialised technologies, cancer, and high-cost technologies. NHS commissioning experts will include information about the proposed treatment eligibility criteria as part of their submission to NICE. When treatment eligibility criteria are not defined at the point of the evidence submission, NHS commissioning experts will explain in their submission what factors are being considered in the development of treatment criteria (for example, the presence of specific biomarkers).

NICE invites written submissions from all patient and carer organisations involved in the evaluation to provide perspectives on:

• the experience of having the condition (before or after diagnosis) or caring for someone with the condition

• the experience of receiving care for the condition in the healthcare system

• the experience of having specific treatments or tests for the condition

• treatment outcomes that are important to patients or carers (which may differ from the outcomes measured in the relevant clinical studies and the aspects of health included in generic measures of health-related quality of life)

• the acceptability of different treatments and modes of treatment

• their preferences for different treatments and modes of treatment

• their expectations about the risks and benefits of the technology.
  
  If the technology was previously recommended with managed access, additional patient and carer perspectives could include:

  • whether and how the experience of living with the condition has changed with access to treatment during the managed access period

  • how the treatment of the condition in the NHS has changed since the original evaluation

  • the experience of having the technology during the period of managed access.

The information is best received directly from people with the condition (or their family or carers) as written accounts of their experiences and points of view. NICE's PIP team has a template for collecting patient and carer perspectives.

The committee is interested in a range of patient and carer perspectives, especially if there are differences of opinion.

In the context of the evaluation, the committee is interested in any limitations in the published research literature identified by patient organisations. In particular, the extent to which patient-reported outcome measures, or other end points reported in clinical studies, capture outcomes that are important to patients. Patients may assess research-based evidence from a different perspective to researchers and clinicians and they may judge the evidence according to different criteria. Also, it is helpful to have the perspective of patients or carers about how relevant the clinical outcomes and the standardised generic instruments for measuring health-related quality of life (as specified in the reference case) are to the disease or condition.

NICE invites submissions from all professional organisations and relevant NHS organisations involved in the evaluation, including:

• the Royal Colleges of the appropriate clinical disciplines

• the specialist societies of the appropriate clinical disciplines

• other appropriate professional bodies and NHS organisations including commissioners of NHS services.

Healthcare professionals and commissioners of health services provide a view of the technology in relation to current clinical practice. This puts into context the evidence from studies and will help to identify any differences in outcomes from the clinical trials to that achieved in routine clinical practice.

The written submissions provide a professional view of the place of the technology in current clinical practice and in the care pathway. This includes evidence that relates to some or all of the following:

• Variations between groups of patients, in particular different baseline risks of the condition and the potential for different subgroups of patients to benefit.

• Identifying appropriate outcome and surrogate outcome measures.

• Significance of side effects or adverse reactions.

• The clinical benefits.

• Circumstances in which the technology or treatment is used, including:

  • the need for concomitant treatments

  • the settings in which technology is used (for example, primary or secondary care, or in specialist clinics)

  • the need for additional professional input (for example, community care, specialist nursing or other healthcare professionals).

• Relevant potential comparators.

• Information on unpublished evidence. Such information should be accompanied by sufficient details to enable a judgement as to whether it meets the same standards as published evidence and to determine potential sources of bias.

• Evidence from registries and clinical audit.

• Published clinical guidelines produced by specialist societies.

• The effect of potential guidance on how care is delivered.

• Education and training requirements of NHS staff.

• Patients who would use the technology.
  
  If the technology was previously recommended with managed access, then the written submissions could include:

• experience of the technology during the managed access period

• how many patients had the technology and whether anyone declined treatment, and the reasons for this

• the variation between groups of patients who had the technology and the potential for different subgroups of patients to benefit

• expected use of the technology in clinical practice

• any points of learning arising from the managed access period.