NICE HealthTech programme

The scoping process aims to define what questions the evaluation will answer and what will be included. 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 services and changing how care is delivered. For example, improving efficiency of service delivery, particularly if this will address current system infrastructure or workforce capacity constraints or burden.

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 This includes evidence from published and unpublished data, data from non-UK sources and economic evaluations of technologies.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.

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 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 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. Such evaluations include those identified in a literature review, done to support existing guidance from NICE or other bodies, and any identified in responses to requests for information (see section 1.3.4). 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.

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 up- 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 (including biological plausibility of relationship between surrogate end point and final outcomes) 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 responses to requests for information that support 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 need for unnecessary procedures or reducing waiting times, can 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 that 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 enough spare capacity exists 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 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 during the 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

• 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 external assessment group's (EAG's) preferred model assumptions and input parameters. Analyses will also include scenario and sensitivity analyses which 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 to be 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 may therefore 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.

A severity decision modifier will not 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 will normally 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, and how feasible or realistic it is to generate further evidence to reduce uncertainty about cost effectiveness.

When the degree of certainty about a technology's value for money cannot be expressed quantitatively, it may be expressed qualitatively using terms expressing broad ranges of probability. 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 or cost savings 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 or cost savings 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 also 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 to be 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 only made 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 typically be issued for the whole group or class. But when there is strong evidence comparing a specific technology to others within the group, it may be specified in recommendations or otherwise specified in guidance.

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.

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 further 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 technologies that are 1 of several similar options, which 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:

• price, including a recommendation to use the least expensive option

• 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.