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Methods to develop health technology evaluation guidance are as described in NICE health technology evaluations: the manual (including scoping, evidence, economic evaluation and committee recommendations). For early use HealthTech guidance assessments, some further detail and considerations are set out in section 2.1.
Technologies considered in HealthTech guidance can be assessed using cost utility or cost comparison analysis (see sections 4.2.11 to 4.2.13 in NICE health technology evaluations: the manual).
Detail on methods for guidance that focuses on interventional procedures (based on an assessment of efficacy and safety) can be found in NICE's interventional procedures programme manual.
Methods for health technology evaluation guidance for technologies in existing use are currently described in NICE's late stage assessment interim methods and process statement.
An overview of the types of recommendations used in guidance produced in the HealthTech programme, and what they mean in practice, is shown in table 2.
Recommendation type | What this means in practice |
|---|---|
Can be used | HealthTech guidance There is enough evidence that the technology provides benefits and value for money, so it should be routinely available across the NHS. Interventional procedures guidance (previously 'standard arrangements') There is enough evidence on the safety and efficacy of this procedure for clinicians to consider it as an option. Clinicians do not have to offer this procedure and should always discuss the available options before making a decision. |
Can be used during the evidence generation period | HealthTech guidance The technology can be used if needed in the NHS during the evidence generation period and paid for using core NHS funding, as long as any clinical, economic or system risks posed are managed. During this time, more evidence will be collected to address uncertainties. After this, NICE will review this guidance, and the recommendations may change. The technology can only be used if evidence is being generated, in line with NICE's evidence generation plan. Interventional procedures guidance (previously 'special arrangements') There are uncertainties around the safety or efficacy of this procedure. It can be used if needed while more evidence is generated to check if it is safe or clinically effective, and any risks are appropriately managed. This guidance will be reviewed and the recommendations may change. |
More research is needed | HealthTech guidance There is not enough evidence to support funding the technology in the NHS. Access to technology should be through company, research or non-core NHS funding, and clinical and financial risks should be appropriately managed. Interventional procedures guidance There is not enough evidence to know if this procedure is effective/safe. It should only be done as part of formal research. |
Should not be used | HealthTech guidance The technology does not offer benefit or value for money and should not be used in the NHS. Interventional procedures guidance The evidence suggests that the procedure does not work well enough or there are unacceptable safety risks. So, it should not be used in the NHS. |
Detail set out in this section supersedes NICE's early value assessment interim statement and covers early use HealthTech guidance (methods for guidance that focuses on interventional procedures can currently be found in NICE's interventional procedures programme manual).
Early use assessments are an evidence-based approach designed to improve the care of people and effective use of NHS resources through quicker access to promising health technologies that address high unmet need for patients or the NHS. It champions stronger partnership working between regulatory, healthcare and research organisations to benefit people and better support innovators while ensuring value for money for the NHS.
There are 4 key aims of the early use assessment approach:
To focus on promising innovations that meet the needs and priorities of people, and the health and social care system.
To enable earlier access to useful innovations through faster assessments and timely guidance production.
To better support use of technologies and evidence generation by embedding early use assessments in cross-partnership working.
To realise the benefits of promising innovations and ensure value for money for the health and social care systems.
The aims will be achieved for selected technologies by:
identifying available evidence
exploring if the technologies have the potential to address the identified unmet need and offer value for money
helping direct further evidence generation for future evaluations
determining if any clinical, economic and system risk posed by early use can be managed and, consequently, if the technologies should be used while further evidence is generated.
The standard approach to assessing the evidence for a NICE evaluation is outlined in section 3 of NICE health technology evaluations: the manual. Early use assessments happen earlier in the life cycle of a technology and so the evidence assessment has been adapted to reflect this. Rapid review methodology and principles can be used. For example, the Cochrane Rapid Reviews Methods Group provides guidance on doing rapid reviews of the effectiveness of health interventions.
It is expected that the available evidence will vary significantly between topics and technologies. If no evidence is identified that is directly relevant to the decision question, a broader evidence base should be considered. For example, evidence from the technology's use in a different population or setting.
Data on final outcomes may be limited so surrogate and intermediate outcomes should be considered. Supplemental searching and grey literature searching may also be helpful for technologies with limited published evidence. Companies and other stakeholders will be given the opportunity to provide evidence to NICE in response to a request for information (see section 1.3.4). Published and unpublished studies provided by companies and other stakeholders should be considered.
Searches should also identify existing economic evaluations and resource and cost-impact analysis that addresses similar or related decision problems that may provide relevant information for the economic evaluation.
Searches for ongoing studies should also be done.
The evidence reviews should usually be done using pragmatic rapid review approaches. For example, single screening and data extraction with 20% of studies checked by a second reviewer.
A full critical appraisal of all studies and outcomes is not expected. But discuss the potential biases in key studies, how the risk of bias could affect key outcomes, and the generalisability of the results to clinical practice in the NHS. Work in this area, for example development of topic specific signalling questions for quality assesment tools, is likely to be useful to inform planning of further studies.
The review should describe evidence gaps and suggest outcomes to focus on in future evidence generation, including those relating to patient safety. The report should describe any identified ongoing studies or data collections or real-world data sources that may address the evidence gaps.
The economic evaluation that will be most beneficial for committee decision making is likely to vary by topic, needing flexibility from assessment groups. Discuss planned work with NICE from an early stage of the assessment.
The key objectives of the economic evaluation are to:
assess how well the technologies are likely to resolve the specified unmet need
assess how likely the technologies are to offer value for money (such as being cost effective or providing similar or greater health benefits at similar or lower cost than the relevant comparator)
identify uncertainties that are likely to be key drivers of decision-uncertainty.
Highlight uncertainties that are essential to resolve for future guidance development, focusing on those that are most important to address.
Give details about services that would be impacted by using the technologies and how they would be impacted (in terms of greater or reduced use). This should include direct impacts of using the technologies, and any impacts that are likely to occur downstream of use (ideally model outputs will help to estimate size of impact; see section 2.1.20).
The economic evaluation should ideally generate estimates of clinical and cost effectiveness, or cost comparison, following as closely as possible the modelling methods and exploration of uncertainty as described in sections 4.6 and 4.7 in NICE health technology evaluations: the manual. Advice on approaches to follow can be found in the NICE Decision Support Unit's report on economic evaluation in NICE early value assessments. For example, making greater use of existing models or model outputs, or if these are not available then producing simplified models or reporting intermediate outcomes with threshold analyses.
There is likely to be less evidence and limited time to develop full new models for early use assessments. So, pragmatically decide how to provide analyses that inform considerations of how likely the technologies are to offer value for money. Assessment groups can provide analyses that may be considered more exploratory or based on larger assumptions than would usually be considered to support guidance for routine use of technologies. Clearly describe the limitations of these analyses and the assumptions made for them. The committee can then decide to what extent it uses such analyses in its decision making.
Using expert elicitation or expert opinion should be considered to provide evidence to support economic evaluation work (see sections 3.3.21 to 3.3.23 of NICE health technology evaluations: the manual).
The reference case is the same as described in section 4.2 of NICE health technology evaluations: the manual. Additional analyses can be presented when 1 or more aspects of methods differ from the reference case. But these must be justified and clearly distinguished from the reference case. Discuss with NICE as early as possible if intending to provide such analyses, for example a non-reference case type of economic evaluation.
Guidance for presenting model results is described in section 4.10 of NICE health technology evaluations: the manual. In addition to any final model outputs, such as total costs and quality-adjusted life years, provide outputs from the model that are useful to help understand the estimated impact of the technologies. For example, values that would be meaningful for healthcare professionals and those that show the impact of technology use on services.
Highlight any potential impacts of technology use that are not captured in model results. This could, for example, relate to impacts on the health and social care workforce or system efficiencies.
Present any model outputs that show how well the technologies are likely to resolve the specified unmet need.
Key goals for decision making in early use assessments are to decide if technologies should be used as an option in the NHS while further evidence is generated and to prioritise uncertainties that further data is needed for to support future decision making. This evidence is for future NICE guidance to decide whether to recommend a technology for routine use.
Recommendations will only be for the use, or uses, of the technologies as specified in the scope.
When making decisions the committee will consider if a technology has plausible potential to addresses the specified unmet need and offer value for money. It will also consider whether any clinical, system or economic risks of using the technology could be managed in practice (further description is provided in sections 2.1.26 to 2.1.29). The flow chart in figure 1 describes how these considerations link to available recommendations.
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Is there plausible potential that the technology offers value for money? For example, assessing if the technology is cost effective or provides similar or greater health benefits at similar or lower cost than the relevant comparator. Technologies considered unlikely to offer value for money typically would not meet this point. Considerations include:
The likely size of any impacts of technology use (positive, including addressing the unmet need, and negative) on patients, and, where relevant, carers, the NHS and personal social services (including impacts on system efficiencies), and the extent that available evidence or other information supports this. This should include potential impacts on patient safety.
Analyses done as part of the economic evaluation work to assess how likely the technology is to offer value for money.
Can any clinical, system or economic risks posed by using the technology be mitigated or managed in practice? For example, by specifying how the technology should be used or whether provision could be made for special safety monitoring measures. Or, if there could be reductions in technology cost or alternative ways in which the technology is charged for, particularly if there are large irreversible costs associated with using it.
Should the technology be used in the NHS as an option while further evidence is generated? Considering the potential of the technology to address the specified unmet need and offer value for money, and the extent that any risks of using the technology in practice can be managed.
When multiple technologies are considered, each should be assessed independently, unless the committee believes it is appropriate for available data that has been generated using 1 or a subset of technologies to be used for others. The committee may need to consider any difference between technologies in terms of whether they may solve the specified unmet need and any differences in further evidence needs. Different recommendations can be made for different technologies included in the guidance.
Use while further evidence is generated
If there is plausible potential that the technology will address the unmet need and offer value for money, and that any economic, system or clinical risks posed by uncertainty in evidence can be managed then the technology can be used in the NHS if needed while further evidence is generated (the evidence generation period) and be paid for using core NHS funding. Any identified measures for mitigating risks of using the technology are presented with the recommendation.
Technologies should only be used in the NHS during the evidence generation period if the evidence outlined in the evidence generation plan is being generated (see section 1.5.20).
More research is needed
More research is needed before the technology can be used routinely or funded by the NHS. Access to the technology (for the use or uses assessed in the guidance) should only be through company, research or non-core NHS funding. This can be because it is too uncertain that the technology will address the unmet need or offer value for money.
Should not be used
If the technology will not address the unmet need or offer value for money. For example, because of how it functions, potential safety issues or based on available evidence on performance, particularly if it has a high cost.
For recommendations for use while further evidence is generated the uncertainties that the committee needs further data on to support future decision making should be listed and include a focus on those that:
are essential to future decision making, and
can be resolved in 3 years from the point of guidance publication (4 years will be allowed in exceptional circumstances).
Technologies recommended for use while further evidence is generated and that complete the evidence generation process (see section 1.7) can be re-evaluated by NICE (see section 1.8).
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