NICE process and methods

8 Evaluation of the evidence and decision-making by the committee

8 Evaluation of the evidence and decision-making by the committee

8.1 Main considerations in decision-making

The committee's main considerations when making its decisions are:

  • Benefit to patients – whether the medical technology has measurable benefit to patients over currently available health and social care system technologies, measured by relevant outcome indicators.

  • Benefit to the health and social care system – whether the medical technology is likely to reduce the burden on health and social care system staff or reduce resource use (for example staff or facilities) compared with current management.

The committee makes its recommendations based on the clinical and economic evidence, and informed by contributions from expert advisers and patient and carer organisations. The committee needs to be confident that the evidence is of sufficient quality, quantity and consistency to form the basis of robust recommendations. If there are any uncertainties, the committee makes informed judgements and describes its uncertainties in the guidance.

The committee considers how the implications of medical technologies guidance on equality at specific stages of guidance development, including topic selection, scoping and when the committee produces draft and final recommendations. Any potential equality issues raised and considered for a topic are recorded in an equality impact assessment, which is completed in accordance with the MTEP equality impact assessment procedure. The equality impact assessment is approved by the programme or centre director and published with the scope and the final guidance. Any relevant equality issues that relate directly to the guidance topic and recommendations are also accounted for in the final guidance itself. In developing its recommendations, the committee considers relevant legislation on human rights, eliminating unlawful discrimination and promoting equality. It also takes into account advice from NICE on making scientific and social value judgements. This advice is informed by the work of the Citizens Council. The committee considers the social value judgements provided in social value judgements: principles for the development of NICE guidance.

8.2 Types of recommendation

The committee produces recommendations based on the extent to which the case for adoption is supported and the potential patient and health and social care system benefits.

Table 2 Committee recommendations and the case for adoption

Case for adoption and potential benefits

Type of recommendation(s) which are normally made

For details see section

Case for adoption is fully supported

Recommendation for use

8.2.1

Case for adoption is partially supported

Recommendation for use in specific circumstances

8.2.1

Recommendation for use in specific circumstances and recommendation for development of further evidence

8.2.1 and 8.2.2

Case for adoption is not currently supported but the technology has potential to provide significant patient or healthcare system benefits

Recommendation for use in a research context

8.2.3

Case for adoption is not supported and the technology does not have potential to provide significant patient or healthcare system benefits

Recommendation highlighting this

8.2.4

The guidance includes the committee's recommendations and its considerations. These considerations summarise the main evidence taken into account by the committee, its view of this evidence, and the areas of contention and uncertainty that arose during its discussions, including the contributions from expert advisers and patient and carer organisations. The considerations section of the guidance aims to describe the degree of uncertainty associated with the recommendations, and the potential impact of such uncertainties.

8.2.1 Recommendation for use of a technology

The committee usually produces a recommendation for use of a technology when it considers that:

  • there is sufficient certainty that the technology has at least equivalent clinical and/or health and social care system benefits compared with current management, and overall uses less resources or

  • there is sufficient certainty that the technology has significantly greater clinical and/or health and social care system benefits compared with current management, and overall uses similar resources.

The committee may make recommendations for use of the technology in specific circumstances only, such as only for patients with a particular condition or by staff with certain training or in a particular care setting.

8.2.2 Recommendation for development of further evidence

When technologies are not supported by adequate evidence of clinical utility to allow a comprehensive evaluation, or to produce recommendations covering the sponsor's entire case for adoption, the committee may recommend use in specific circumstances, and may also recommend development of further evidence.

The aim of recommending the development of further evidence is to reduce uncertainty about specific issues, such as whether particular benefits suggested in the evidence submission can be realised in normal clinical settings. When recommending the development of further evidence the committee follows the framework outlined in section 8.3.

8.2.3 Recommendations for use in a research context

The committee usually produces recommendations for use in a research context when it considers that:

  • the technology has the potential to provide substantial benefits to patients and/or of releasing significant resources but

  • the case for adoption is not fully supported and there is uncertainty about whether these benefits are realisable in normal clinical settings; uncertainties may relate to whether clinical outcomes will be achieved, or to service impact (for example, the likelihood of the technology being introduced in a way that leads to the claimed benefit of released resources).

When making a recommendation for use in a research context, the committee aims to:

  • describe the most important clinical, economic, technical or other evidence gaps relating to use of the technology in the health and social care system

  • explicitly state the research questions that future studies need to address.

For this type of recommendation the committee follows the framework outlined in section 8.3. Such a recommendation is not intended to preclude the use of the technology in the health and social care system but to identify further evidence which, after evaluation, could support a recommendation for wider adoption.

8.2.4 Case for adoption not supported

If the sponsor's case for adoption is not supported by the evidence and the contributions from expert advisers and patient organisations, this is indicated in the committee's recommendations. The committee's rationale is described in the committee considerations section of the guidance.

8.3 Framework for research recommendations

The committee develops research recommendations in medical technologies guidance using the principles described in NICE's research recommendations manual.

The committee considers the following factors when deciding whether to recommend future evidence generation and data collection on medical technologies:

  • the most important evidence gaps relating to the uncertainty about the technology, and the value of information that could be derived from generating evidence to address them

  • information about ongoing or planned research on the technology

  • ethical and/or practical aspects of conducting further research

  • the likely costs and benefits of the research (to ensure that a research recommendation does not become a barrier to innovation).

These considerations aim to help guide decisions about investment in future research by identifying the types of studies that will address research questions and generate new evidence of greatest value to the NHS.

8.4 Consultation on draft recommendations

Once the committee has made its decision on a technology, draft guidance is produced and is made available for public consultation for 4 weeks.

The committee considers all comments received during consultation and, if necessary, appropriate changes are made to the draft guidance.