Detail on methods for developing interventional procedures guidance (based on an assessment of efficacy and safety) can be found in NICE's interventional procedures programme manual.
Methods for developing HealthTech guidance are set out in the following sections. These methods apply to all HealthTech guidance. Section 3 sets out additional detail for early-use HealthTech guidance assessments (previously called early value assessment [EVA]) and section 4 sets out additional detail for existing-use HealthTech assessments (previously called late-stage assessment [LSA]).
The scoping process aims to define what questions the evaluation will answer. The scope provides the framework for the evaluation and describes a decision problem. It defines the issues for consideration and sets the boundaries for the work to be done.
Key overarching points to define in scoping are:
what use or uses of the technology will be assessed (use cases; see section 2.1.3)
what potential impacts using the technology for this use case, or use cases, may have (value proposition; see section 2.1.4).
It is important to understand how using the technology for the specified use cases is expected to achieve the proposed benefits, or value proposition. This can help to identify how the technology is expected to be used and any changes to care, practice or infrastructure that are needed for the technology to achieve its proposed impact (see sections 2.1.8 and 2.1.9).
The priorities of the health and care system are a key consideration in deciding aspects of the scope. These are identified and considered during topic prioritisation (see the chapter on identifying priorities for the health and care system in NICE-wide topic prioritisation: the manual). Health technologies can often be used in multiple different ways or for various purposes (use cases). For example, in different populations or at different points in a care pathway. The scope will define what uses of the technology to include in the assessment, using input from healthcare professionals, patients and other stakeholders. Considerations include what uses of the technology are most likely to maximise benefit to the NHS, the population of England and areas of unmet need.
Scoping will establish the potential impacts of a technology, compared with current practice (its value proposition). This can involve direct impacts on people's health and aiding earlier diagnosis. It can also involve improving access to health services, changing how care is delivered and improving efficiency of service delivery. For example, to address current system infrastructure or workforce capacity constraints or burden.
HealthTech guidance can include multiple health technologies or defined groups or classes of health technology (see section 2.1.7). This is if there is likely benefit to the NHS of evaluating multiple technologies for the use cases being assessed, and they are alternative options for 1 or more of the use cases being assessed. These are specified in the scope.
The scope can set out the criteria that technologies need to meet to be included in the assessment. These will typically be based on advice from healthcare professionals and patients. Criteria will include features or functions that are considered essential for the technology to be used in the way being assessed (use case) or to have the proposed impact (value proposition).
Interventions may be defined as a group or class of technologies that have shared features or functions. For example, laboratory tests for a particular genetic marker or analyte. This may be considered when what the technologies do or how they function are very similar or the same.
The scope can specify further detail on a technology if needed to understand its proposed use, particularly if this is integral to its value proposition. For example:
who would use the technology and the setting for use
how it should be used, including in relation to other technologies (for example, in a sequence of tests)
components or features of the technology
for technologies producing information, such as for diagnosis or prognosis or for monitoring and response assessment, how this information is intended to be used and any specific test thresholds.
In some instances, assessments may evaluate different ways technologies could be used (for example, tests used in different sequences), which can be defined in the scope.
The scope should describe any changes to infrastructure, care pathways or care delivery that are expected to be needed for the technology to be used in practice and achieve its proposed impact. For example, any additional equipment, resource or changes to service arrangements.
NICE will not develop HealthTech guidance on a technology outside of its indication or intended purpose for use, as defined by any regulatory approval for use in the UK.
Technologies not yet available in England or without appropriate regulatory approval may be included within a scope. The appropriate regulatory approval is usually a UK Conformity Assessed (UKCA) or CE mark (as a medical device). The Medicines and Healthcare products Regulatory Agency (MHRA) may apply different regulation procedures to certain products, such as in-house tests.
For technologies assessed as a group or class (see section 2.1.7), at least 1 available technology must have appropriate regulatory approval.
The scope defines the population for whom the technology is being evaluated as precisely as possible. It may highlight potential subgroups for which the technology's clinical effectiveness or value for money might differ from the overall population, or groups that need special consideration.
Identifying groups for whom the clinical or cost effectiveness may differ from the overall population is particularly important if differences relate to a potential equality issue that will need to be considered in guidance (see section 2.1.29).
The scope identifies relevant comparators that are established practice in the NHS or are recommended in existing guidance from NICE or other bodies. This can include 'no activity' if nothing is done in current practice. Comparators may include technologies that do not have regulatory approval for the population defined in the scope if they are considered established clinical practice in the NHS. The comparator will typically not include use of the intervention being assessed, even if it is currently in use in practice to some degree. Exceptions include when the assessment is focused on assessing different ways that current care can be delivered (for example, using a different threshold for established tests or using an established technology in a different setting).
The comparators should be defined as precisely as possible. It is important this accurately represents current care. It is also important that any challenges with current care which may form part of the value proposition for the intervention are accurately represented (for example, access to care, variation in practice or delays to having treatment or appointments).
Relevant outcomes and costs are those resulting directly or indirectly from the technologies being evaluated. The perspective taken in NICE's reference case (see section 4.2 of NICE health technology evaluations: the manual) should be considered when deciding relevant outcomes and costs to include in the scope.
Consideration of potentially relevant outcomes and costs should reflect the value proposition for the technology (see section 2.1.4) and any potential positive or negative impacts that using the technology, compared with the comparators, could have for patients and the healthcare system.
If available, a high-quality 'core outcome set', developed with people with the condition, may help with outcome selection. One source is the Core Outcome Measures in Effectiveness Trials (COMET) database. The Core Outcome Set Standards for Development (core outcome sets-STAD) and Core Outcome Set Standards for Reporting (core outcome sets-STAR) should be used to assess the suitability of identified core outcome sets.
Included outcomes should reflect what is important to address for the decision problem set out in the scope, rather than outcomes for which evidence is known to exist.
In addition to clinical outcomes, the scope can specify any outcomes related to the NHS and personal social services (PSS) that may be impacted by use of the technology. These can include outcomes related to resource use and system efficiency (for example, related to waiting times, or time to diagnosis or treatment).
Further outcomes can be considered when relevant, including those related to technology functions, such as measures of ability to perform a specific task or function, and those related to people's behaviour or activity. The extent to which such outcomes can be used in estimates of cost effectiveness is likely to depend on the extent to which they are predictive of impact on clinical or resource-use outcomes.
Quantitative outcomes are needed to evaluate the cost effectiveness of a technology. Consideration should be given to how potential impacts could be captured quantitively when identifying relevant outcomes. For example, for technologies that are proposed to be easier to use, relevant outcomes may be related to procedure times, incidences of successful procedures or need to repeat procedures.
Outcomes related to the needs and preferences of patients and healthcare professionals for different technologies (quantitative or qualitative; see section 2.1.25), or particular functions or features of technologies, may be useful for decision making and can be specified in the scope. This may particularly be the case when there are multiple technologies defined as interventions in the scope, and evidence that compares clinical and system outcomes between these technologies is likely to be absent or weak.
To supplement quantitative outcome measures, or when these are not possible or unlikely to be collected, qualitative outcomes can be specified in the scope. This can include informational outcomes of value to the patient for the relief, or infliction, of anxiety or for personal planning. Qualitative research can explore areas such as values, preferences, acceptability, feasibility and equity implications.
The scope may prioritise key outcomes that are most relevant to addressing the decision problem. Input should be sought from stakeholders and experts during the scoping process. The views of people with the condition and users of the technology will be particularly important when prioritising outcomes. This will ensure that specified outcomes reflect the preferences of patients and, when relevant, their carers, and healthcare professionals or other staff who would use the technology. The GRADE working group provides guidance on approaches that can help determine which outcomes should be prioritised for decision making.
The scope will include, when relevant, details of the type of evaluation that will be done during the assessment phase, for example a cost–utility or cost-comparison approach (see section 2.3.2). This will be informed by considerations of which type of evaluation is most appropriate for the technology and value proposition being considered. For example, a cost-comparison approach to economic evaluation may be specified for technologies considered likely to provide similar health benefits at similar or lower cost than comparators. This can be the case for technologies that are likely to have only a healthcare system benefit.
The scope will also specify what guidance will be developed in terms of the lifecycle approach to be used (for early, routine or existing-use guidance). This decision is made by NICE. It considers, when relevant, feedback received during the scoping process, for example at a scoping workshop, and what value NICE will add to the health and care system by producing each type of guidance. The decision is made in the context of the use case and value proposition being considered. General principles for this decision are described in table 2. The HealthTech programme makes an initial decision about whether guidance is developed for a technology or topic in line with NICE-wide topic prioritisation: the manual.
| Lifecycle approach | General principles for selecting which lifecycle approach to take |
|---|---|
|
Early use |
|
|
Routine use |
|
|
Existing use |
|
The scope will include, when relevant, details of:
issues relating to advancing equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with protected characteristics and society as a whole
potential issues relating to health inequalities, including whether the technology could address inequality or unfairness in the distribution of health across society.
Identifying relevant NICE guidance (both published and in development) is a key element of scoping. This helps to see where and how the potential recommendations are likely to relate to existing recommendations in other guidance. The scope can include, when relevant, details of related NICE guidance, such as other evaluations and clinical guidelines, and related policy developments.
Evidence is identified during the assessment phase and presented in the assessment report. This is based on the scope for the assessment and the decision problem described therein.
Sections 3.1 and 3.2 in NICE health technology evaluations: the manual describe approaches to assessing the evidence and guiding principles for evidence. The Decision Support Unit produces a series of technical support documents that provide further information on technical aspects of health technology evaluations.
All types of evidence can be considered for evaluations (although not all types will be included in the assessment report; see section 2.2.11). This includes evidence from published and unpublished data, data from non-UK sources and economic evaluations of technologies. The assessment report will comment on the quality of evidence sources, and the type and quality of evidence will be considered by the committee in its decision making (see section 2.4.6).
The NICE real-world evidence framework describes best practices for planning, doing and reporting real-world evidence studies (this includes the conduct of qualitative research studies, described in appendix 4). NICE's evidence standards framework for digital health technologies outlines critical considerations for evidence generation for digital health interventions.
Evidence exploring the views and experiences of people with the condition and healthcare professionals who will use the technology may be presented to committee. This evidence may come from published sources or from evaluations done specifically for the assessment.
Section 3.4 of NICE health technology evaluations: the manual details approaches for assessing evidence for an evaluation. Literature searches are done as an integral part of evidence identification during the assessment phase.
In addition to literature searches, evidence provided or identified by companies or other stakeholders is considered, if provided at appropriate points in response to a request from NICE (see section 1.3.4). Any unpublished evidence provided 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. Ideally it should be structured and presented in the form of a research publication. Detail should be provided in line with relevant reporting guidelines (for example, those endorsed by the EQUATOR network) to allow critical appraisal of unpublished evidence.
Evidence on predecessor versions of a technology may be considered, particularly if there is limited evidence on the currently available model or version. But the extent to which it is appropriate to use such evidence should be considered and commented on in the assessment report, for the committee to consider in its decision making.
Existing systematic reviews and meta-analyses may be used or updated, if possible and in line with the decision problem outlined in the scope. As part of the assessment a judgement will be made on which elements of the previous systematic review can be reused, and which need to be redone or updated.
The evidence review should flag when no appropriate data for outcomes specified in the scope has been identified. When possible, the assessment report should describe any identified ongoing studies or real-world data sources that may be able to address these evidence gaps.
There can be many available studies, or study types, that report on a particular outcome. This may require decisions to be made about which studies are prioritised in an assessment report for consideration by committees. NICE's Decision Support Unit technical support document 27 provides guidance on potential approaches.
The quality of a study's overall design, its execution and the validity of its results determine its relevance to the decision problem. Studies should be appraised using a checklist appropriate for the study design, where available. An assessment of the generalisability of data from studies to the decision problem is also an important consideration, particularly for non-UK studies. When there is a large number of studies, critical appraisal may be prioritised for studies considered key for decision making, particularly those providing data used for economic models.
Whenever possible, checklists for assessing published studies should be used to assess the validity of unpublished studies.
Section 3.4 of NICE health technology evaluations: the manual includes detail related to evidence synthesis, including factors that can affect effectiveness estimates and the use of pairwise meta-analysis, indirect comparisons and network meta-analyses.
Meta-analysis of test accuracy data can be complicated because of the correlation between sensitivity and specificity. In addition, there are likely to be many sources of heterogeneity across test results, arising from differences in setting, patient population, reference standard, equipment, procedures and skill levels of test operators. The cut-off point at which test accuracy data is reported may also differ between studies. Several methods for meta-analysis of test accuracy data exist. They vary in complexity and in the assumptions that need to be made. The appropriate choice of method depends on the data available and should be justified. NICE's Decision Support Unit technical support document 25 provides guidance on methods for meta-analysis of test accuracy data.
Chapter 4 of NICE health technology evaluations: the manual provides detail of the methods that should be used to assemble and synthesise evidence on a technology in an economic evaluation. This is needed to estimate the technology's relative clinical effectiveness and value for money compared with current practice in the NHS. It includes a reference case, which specifies the methods NICE considers to be most appropriate for analysis when developing guidance. This does not prevent additional analyses being done in which 1 or more aspects of the methods differ from the reference case. However, these must be justified and clearly distinguished from the reference case. The Decision Support Unit produces a series of technical support documents that provide further information on technical aspects of health technology evaluations.
The methods NICE considers to be most appropriate for estimating value for money are cost–utility analysis and cost-comparison analysis.
These analyses show the impacts of using a technology, relative to a comparator or other health technologies specified as interventions, in terms of changes in costs, or changes in both costs and quality-adjusted life years (QALYs). These changes can be based on both the short- and long-term impacts, potentially occurring across a patient's lifetime. Sections 4.2.22 to 4.2.25 of NICE health technology evaluations: the manual explain the time horizon used in economic evaluations.
Sections 4.3 and 4.4 of NICE health technology evaluations: the manual provide detail on measuring and valuing health effects in cost–utility analyses and the use of evidence on resource use and costs.
Distributional cost-effectiveness analysis (DCEA) will not be done in economic evaluations produced by external assessment groups (EAGs) on behalf of NICE for HealthTech guidance. DCEA evidence can be provided by companies as part of the information requested on the evidence base and their technology. For more information on these analyses, see section 4.12 of NICE health technology evaluations: the manual.
When any impacts of a technology are not captured, or not fully captured, in terms of incremental costs or QALY outputs from modelling and therefore cost-effectiveness estimates:
The economic evaluation should clearly highlight that such impacts are not captured in the cost-effectiveness estimates.
The assessment report should present, when possible, any incremental differences in non-cost or non-QALY outcomes generated from the model, or available from identified studies, that help quantify the impact of the technology that has not been captured in cost-effectiveness results (see section 2.3.26).
If linking effects to a QALY gain is not possible for all health-related impacts of a technology, links to a clinically relevant or a related outcome should be considered to help illustrate and quantify the impact of a health technology, compared with current practice (see above bullet point).
The assessment report should narratively discuss how the uncaptured impacts may impact on health and resource use.
Understanding the magnitude of any uncaptured impact, and how this could affect cost-effectiveness estimates, is important for decision making. Any analyses that could inform this consideration would be beneficial.
Existing economic evaluations can be used as an alternative or supplement to de novo modelling, if they are adequate, appropriate and relevant to the decision problem. Other considerations include whether the model code is available and the extent to which it can be shared. Such evaluations include those identified in a literature review, done to support existing guidance from NICE or other bodies, and any identified in responses from companies to requests for information (see section 1.3.4). Applicable economic models produced for existing NICE guidance should be used whenever possible.
Sections 4.5 to 4.7 of NICE health technology evaluations: the manual describe NICE's preferred approaches to discounting, modelling methods to generate estimates of clinical and cost effectiveness and cost comparison, and exploring uncertainty. Providing an all-encompassing definition of what constitutes a high-quality model is not possible. Economic evaluations for HealthTech guidance are made available for review (see sections 1.4.7 and 1.4.8).
Models produced for HealthTech assessments may require strong assumptions to be made. Provided that such assumptions are clearly highlighted, the committee can consider them in its decision making and decide on their appropriateness (see section 2.4.6). Assumptions included in models should, when appropriate, be validated by relevant experts. The impact of strong assumptions in models should be explored using sensitivity or scenario analyses, when possible.
Using expert elicitation or expert opinion should be considered to provide evidence to support economic evaluation work. When the elicited data is to be quantitative, preference should be given to formal elicitation techniques (see sections 3.3.21 to 3.3.23 of NICE health technology evaluations: the manual).
Details about services that would be impacted by using the technologies and how they would be impacted (in terms of greater or reduced use) should be discussed. This should include direct impacts of using the technologies, and any impacts that are likely to occur upstream or downstream of use (ideally model outputs will help to estimate the size of impact; see section 2.3.25). Details of any changes to service organisation and any other activities needed to implement the technologies should also be described.
Guidance on the use of surrogate outcomes is provided in sections 4.6.6 to 4.6.11 of NICE health technology evaluations: the manual. Lower levels of evidence to support validation of a surrogate end point (biological plausibility of relationship between surrogate end point and final outcomes, as defined in Ciani et al. 2017; see section 4.6.6 of NICE health technology evaluations: the manual) are acceptable to justify use in modelling; the acceptability of this and associated uncertainty can be considered in decision making for guidance recommendations (see section 2.3.10). Stronger evidence that the relative effect of a technology on the surrogate end point is predictive of its relative effect on the final outcome will increase confidence in generated cost-effectiveness results. When possible, the uncertainty associated with the relationship between the surrogate end points and the final outcomes should be quantified and captured in the model's probabilistic analysis.
For evaluations of diagnostic technologies (including prognostic and predictive tests and models), there may be some direct benefits from the knowledge gained and some direct harm from the testing. But most of the outcomes typically come after testing because of treatment or preventive measures being started, modified or stopped. Tests can sometimes be evaluated using clinical trials, but this is unusual. If direct data on the impact of a diagnostic technology on final outcomes is not available, it may be necessary to combine evidence from different sources. A linked evidence modelling approach should be used, which links data from different studies together to estimate impact. The links used, such as between test results, decisions about care or treatment based on this result and final outcomes should be specified and justified, for example with relevant data or justification of assumptions.
When only surrogate or intermediate outcomes (such as test accuracy) are available to support a value proposition, it is beneficial that companies provide any supporting information in response to requests for information that support the use of such outcomes. For example, evidence that the relative effect of a technology on the surrogate end point is predictive of its relative effect on the final outcome.
Value propositions for technologies can include a proposed impact on system efficiencies, which can potentially increase capacity to deliver healthcare. Relevant outcomes in such cases will be specified in the scope (see section 2.1.21).
Evidence should quantify the effect of the technology on resource use in terms of physical units (for example, days in hospital or visits to a GP). These effects should be valued in monetary terms using appropriate prices and unit costs, such as unit costs found in the Personal Social Services Research Unit (PSSRU) report on unit costs of health and social care.
Any health or other benefits that may arise from system efficiencies, such as ruling out the need for unnecessary procedures or reducing waiting times, should be considered in estimates of cost effectiveness (for example, for reducing waiting times, through impacting progression to more advanced disease states) or noted as uncaptured benefits if this is not possible (see section 2.3.6).
Reference-case analyses should be based on prices that reflect as closely as possible the prices that are paid in the NHS. This could be the public list price. When there are nationally available price reductions, the reduced price can be used in the reference-case analysis to best reflect the price relevant to the NHS. Analyses based on price reductions for the NHS will be considered only when the reduced prices are transparent and consistently available across the NHS, and when the reduced price is available for a guaranteed period. In the absence of a published list price and a price agreed by a national institution, an alternative price may be considered, provided it is nationally and publicly available. If no other information is available on costs, local costs may be used.
When a group of related technologies is being evaluated as part of a group or class (see section 2.1.7), an analysis using the individual costs for each technology should be presented in the reference case. Exceptionally, if there is a very wide range of technologies and costs to be considered, then analyses should use the weighted mean cost and the highest and lowest cost estimates.
For technologies that have multiple uses in the NHS beyond the uses under evaluation, for example diagnostic tests that could identify multiple markers or technologies that can be used across multiple populations, the average cost should initially be identified. This should be based on the expected use or throughput of the device for only the uses being evaluated. In some cases, an analysis using marginal costs may be provided in addition to the analysis based on average costs. This is if a technology is already recommended for another purpose and there is enough spare capacity to allow the use for the condition in the current evaluation.
Analyses using adjusted or apportioned technology costs can also be provided as non-reference-case analyses, for example if the technology has multiple uses beyond the indication under evaluation and introducing the new technology will lead to identifiable benefits that are not captured in health technology evaluations (see section 4.4.15 of NICE health technology evaluations: the manual for further detail).
When the cost of introducing the technology is likely to be high, for example disruptive technologies requiring new ways of working or changes to care pathways, sensitivity or threshold analyses investigating the impact of higher upfront costs associated with adopting the new technology may be beneficial to assess the robustness of cost-effectiveness estimates.
For many technologies, the level of benefit will differ for patients with differing characteristics. This can be explored by providing clinical and cost-effectiveness estimates separately for each relevant subgroup. Section 4.9 of NICE health technology evaluations: the manual provides further guidance and considerations. When possible, potentially relevant subgroups will be identified at the scoping stage (see section 2.1.14). However, this does not prevent the identification of subgroups later in the process, for example during the assessment period or committee discussions.
Guidance for presenting model results is described in section 4.10 of NICE health technology evaluations: the manual. In addition to costs and QALYs, outputs from the model should be provided that are useful to help understand the estimated impact of the technologies and what has been captured in cost-effectiveness estimates. For example, values that would be meaningful for healthcare professionals and those that show the impact of technology use on services, such as staff time and resource use.
Any outputs from models should be presented that help quantify impacts that are not captured or not fully captured in incremental cost and QALY outputs (see section 2.3.6), or composite measures of these (for example, net health benefit).
For technologies that are likely to have rapid iteration and multiple new versions after guidance is published, threshold analyses can be beneficial for parameters related to technology performance or impact that drive cost-effectiveness results, to identify a parameter 'switching value'. A switching value is the value of an input variable that would change a decision on whether the technology represents a good use of NHS resources for a given threshold (for example, £20,000 and £30,000 per QALY gained).
Key drivers of decision uncertainty should be identified in the economic evaluation to inform any recommendations for further research (see sections 2.4.20 and 2.4.21). Because the extent of further research activities that are feasible may be limited, uncertainties should be highlighted that are essential to resolve for future guidance development.
Resource impact assessment for HealthTech guidance can be done by NICE alongside, or after, guidance production (see the webpage on assessing the resource impact of NICE guidance). The assessment can:
support decisions about uses of the technologies under evaluation
complement any other economic evaluation done
help assess the expected changes in expenditure and capacity requirements as a result of implementing the guidance.
The committee may consider resource impact assessments when considering the level of uncertainty about the value for money associated with a technology (see section 2.4.9).
The committee bases its recommendations on the evidence presented, including:
information provided by non-company stakeholders or other organisations (see section 1.3.9)
the assessment report, which includes consideration of information provided by companies in response to requests for information (see section 1.3.4)
comments received on the assessment report or economic model (see sections 1.4.7 and 1.4.8)
views expressed by experts, including clinical experts, particularly their experience of the condition, current care and technology use in clinical practice, and the experience of people with lived experience of the condition.
The committee uses estimates of cost effectiveness based on cost–utility or cost-comparison analyses as the primary consideration when making decisions about the acceptability of technologies as a cost-effective use of NHS resources. Analyses will typically contain an estimate from a base-case analysis, generated using the EAG's preferred model assumptions and input parameters. Analyses will also include scenario and sensitivity analyses that can show uncertainty in, and explore the impact of alternative parameter values and model assumptions on, generated cost-effectiveness estimates. The committee considers all analyses in its decision making and can decide whether the EAG's base case is its preferred analysis, or how much weight to apply to this in decision making.
The committee should also consider the extent that any impacts of a technology are not captured, or not fully captured, in cost-effectiveness estimates, the potential magnitude of this, and how it would affect cost-effectiveness estimates (see sections 2.3.6 and 2.3.7).
Interventions with an incremental cost-effectiveness ratio (ICER) below £20,000 per QALY gained are generally considered cost effective. Above this, decisions about the acceptability of the technology as an effective use of NHS resources will specifically consider the following factors:
the degree of certainty about cost-effectiveness estimates
aspects that relate to uncaptured benefits and non-health factors. Specifically, the committee will consider:
if its decisions have a bearing on broader social considerations and the extent that these are covered by principles on social value judgements in our principles on the NICE website
if there are strong reasons to suggest that the health benefits of the technology have been inadequately captured, or otherwise considered, and therefore may misrepresent the health utility gained
aspects that relate to health inequalities.
As the ICER for a technology increases between £20,000 and £30,000 per QALY gained, and particularly over £30,000 per QALY gained, the committee will need to identify an increasingly stronger case for supporting the technology as an effective use of NHS resources, considering the factors listed in the bullets above.
The committee will consider the severity of the condition, defined as the future health lost by people living with the condition with standard care in the NHS (including use of other available treatments, diagnostics or best supportive care). The extent of unmet health need is reflected within the severity definition. Initially, the severity modifier will not be applied to HealthTech guidance. The severity of the condition should be captured within the QALY benefits and then deliberatively within decision making. NICE is exploring how the severity modifier could be applied for HealthTech guidance.
Decisions about the acceptability of a technology as an effective use of NHS resources will specifically take into account the degree of certainty around the value for money. Considerations include uncertainty expressed in cost-effectiveness estimates, and factors that may not be captured, or fully captured, in these analyses, including:
the assumptions necessary in the economic modelling
the source of parameters used to estimate cost effectiveness, typically model parameters that differ between intervention and comparator (or between different interventions). The committee should consider the reliability and generalisability of the evidence presented when considering cost-effectiveness estimates. This includes study type and assessment of study quality.
The committee may be more cautious about recommending a technology if it is less certain about its cost effectiveness. But it should be proportionate and take into account factors related to the technology and condition (for example, if the condition is rare), and how feasible or realistic it is to generate further evidence to reduce uncertainty about cost effectiveness.
The degree of certainty about a technology's value for money can be expressed qualitatively if needed. To ensure that language is used consistently, terms set out in an available common probability yardstick (available on GOV.UK's webpage on communicating probability) may be used.
The degree of certainty of the cost effectiveness of a technology should be proportionate to the impact of technology adoption on NHS resources and the risk to patients. The committee may need more robust evidence to support estimates of cost effectiveness of technologies that are expected to have a large impact on NHS resources.
Technologies that provide less health benefit at a lower cost relative to the relevant comparators (that is, that fall in the south-west quadrant of a cost-effectiveness plane) should be considered using the usual cost-effectiveness range of £20,000 to £30,000 per QALY. Any relevant additional factors should be taken into account, as described above.
The committee can make specific recommendations for subgroups of the overall population. Section 6.2.29 of NICE health technology evaluations: the manual contains further details and consideration for this.
When a cost-comparison analysis is done, key considerations include whether:
there is enough certainty that the technology has at least equivalent clinical benefits to the comparator
the technology is likely to reduce costs or resource use (for example, staff or facilities) compared with the comparator.
Interventions that are cost neutral or cost saving are generally considered cost effective. For technologies that are cost incurring, decisions about the acceptability of the technology as an effective use of NHS resources will specifically consider the following factors:
the degree of certainty about the cost impact estimates
aspects that relate to uncaptured benefits and non-health factors. Specifically, the committee will consider:
if its decisions have a bearing on broader social considerations and the extent that these are covered by principles on social value judgements in our principles on the NICE website
if there are strong reasons to suggest that the health benefits of the technology have been inadequately captured, or otherwise considered
aspects that relate to health inequalities.
As the incremental cost increases, the committee will need to identify an increasingly stronger case for supporting the technology as an effective use of NHS resources, considering the factors listed in the bullets above.
Recommendations are made only for use of technologies in the terms of the assessed use case or use cases as set out in the scope.
When interventions in a scope are defined as a group or class of health technologies (see section 2.1.7), recommendations will be issued for the whole group or class. If named technologies are specified in identified studies, this may be included in the assessment report and within the guidance document, but recommendations will not be issued for individual technologies.
The committee produces recommendations based on the extent to which the potential patient and system benefits are supported by evidence. The rationale for recommendations made is described in the guidance document. The recommendations in table 3 are relevant for routine-use HealthTech guidance. Detail on recommendations for early-use and existing-use guidance can be found in section 3 and section 4.
| Recommendation type | What this means in practice |
|---|---|
|
Can be used |
There is enough evidence that the technology provides benefits and value for money, so it should be routinely available across the NHS, and paid for using core NHS funding. |
|
Can be used during the evidence generation period |
The technology can be used as an option in the NHS during the evidence generation period and paid for using core NHS funding. During this time, more evidence will be collected to address uncertainties. Companies are responsible for organising funding for evidence-generation activities. After this, NICE will review this guidance, and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs. |
|
More research is needed |
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 or financial risks should be managed appropriately. |
|
Should not be used |
The technology does not offer benefit or value for money and should not be used in the NHS. |
The committee will recommend that a technology can be used (as an option) when it considers that there is enough evidence that it provides appropriate benefits and value for money, so should be made available in the NHS.
The committee may recommend that the technology can be used only under specific circumstances. For example, the recommendation can be optimised or restricted to people who meet specific clinical eligibility criteria, to a specific subgroup of people (see section 2.4.11), or to provision by staff with certain training or in a particular care setting. Recommendations for using a diagnostic test may also be limited to specific circumstances, such as:
the patient's characteristics
the condition's aetiology
the training and skills of those providing the test
availability of equipment
availability of other portions of the care pathway.
In exceptional circumstances, when no technologies are recommended for use in routine-use guidance, 1 or more of the technologies may be recommended for use with evidence generation, following the approach used for early-use guidance (see section 3). Considerations and rationale for decision making should follow the approach set out in section 3.4.
When the evidence of clinical or cost effectiveness or impact of a technology on other health outcomes is either absent, weak or too uncertain, the committee may recommend that more research is needed.
This type of recommendation needs to be accompanied by defined uncertainties that the committee considers it worthwhile and feasible to collect further evidence to address (see section 2.4.28).
If the benefits and value for money of a technology are not supported by the evidence and are not likely to be realised in practice, even if further evidence was generated, the technology is not recommended.
Evidence generated using a technology should typically not be used to show performance of others in the assessment. This is unless the committee can provide strong reasoning why it considers this appropriate, or the technology is being assessed as part of a group or class of technologies (see section 2.1.7).
Different recommendations can be made for different technologies included in the guidance.
Health technologies specified as interventions (see section 2.1.5) will be compared with each other, when possible, as well as with the comparator. If there is strong evidence that an intervention dominates the alternatives, it should normally be recommended. However, if 1 intervention is more effective but also more costly than another, then the comparative cost-effectiveness estimate should be considered. When multiple technologies are being compared, cost-effectiveness rankings may be used to present the results of probabilistic model analyses (see section 6.3.3 of NICE health technology evaluations: the manual for more detail).
The extent of evidence comparing an intervention with alternative interventions should be considered when deciding if, when multiple interventions are considered cost effective compared with the comparator, 1 or a subset of them should be recommended in preference to others.
When recommending multiple technologies that cannot be distinguished from each other based on cost effectiveness (see sections 2.4.25 and 2.4.26), committees may specify what should be considered when choosing between them, if it considers this appropriate. Considerations can be related to:
the price of the technologies and any additional costs associated with use, including a recommendation to use the least expensive option
environmental sustainability
factors related to technologies that are important for patients or healthcare professionals
health inequalities
accommodating people with specific clinical presentations.
For technologies with a recommendation for more research (see section 2.4.20) or for use with evidence generation (see section 2.4.19), the uncertainties that the committee needs more data on to support future decision making should be listed. While the guidance can describe broader evidence that would be beneficial, the recommendations should focus on uncertainties that are essential to future decision making and are considered feasible to address.
If technologies are recommended for use in a large population, or if there are any other reasons why guidance may take longer to be implemented, the guidance may identify subgroups of the population to whom the technology could be offered initially as part of a phased rollout. This can be based on subgroups of the population for which the technology is recommended for use, for whom the clinical effectiveness or value for money of the technology is higher than for the overall population. When considering subgroups, the committee pays particular attention to its legal obligations with respect to legislation on human rights, discrimination and equality.
When 1 or more technologies are recommended for use, the guidance will set out the rationale for this, such as a description of the evidence and demonstrated performance that underpins the positive recommendation.
For technologies that are recommended for use that may undergo rapid iteration and multiple new versions after guidance is issued, guidance may indicate ranges or values for performance of technologies or impact on outcomes that need to be maintained for it to remain cost effective (see section 2.3.27).