4 Existing use HealthTech guidance assessments

Detail set out in this section supersedes NICE's late-stage assessment interim statement and covers existing use HealthTech guidance.

4.1 Background

4.1.1

Existing use assessments are designed to support procurement and commissioning decisions, promote effective use of NHS resources, and improve care, through assessing technologies already in existing or established use in the NHS.

4.1.2

If there is price variation between alternative technologies that are options for a use case, there may be uncertainty about whether this is justified, for example, if some technologies have had continuous improvement or incremental innovation. Existing use assessments aim to determine whether differences between alternative technologies justify the price variation or otherwise identify factors that can inform decisions about which technology to purchase. This will help procurement services and commissioners make well-informed decisions. This will also ensure that effective technologies that are value for money are available for use while maintaining an appropriate level of choice in the system. This is in line with the 3 main objectives of the Department of Health and Social Care's medical technology strategy for the NHS to have the right product, at the right price, in the right place.

4.2 Scoping

4.2.1

The scope for existing use assessments will follow the methods described in section 2.1, except that:

Value propositions should focus on how the interventions differ from each other and the potential impacts of these differences.
Specific characteristics of the technologies being assessed can be identified, including any additional functions or features that may not be essential for use but are proposed to be beneficial. These can relate to clinical or system impacts and outcomes, but also potential impacts on the usability of a technology and patient experience.
Technologies included in the scope of an assessment may be grouped according to shared features, functions or other characteristics. This may particularly be the case when a feature, function or characteristic is proposed to drive beneficial impact (see previous bullet point and section 2.1.7).
The scope may not define a comparator.
The scope may include relevant information on how technologies are currently provided to the NHS, for example, procurement frameworks.

4.2.2

Scoping will identify the relevant user groups for user preference assessment and may outline potential methods (see section 4.4.6).

4.2.3

Technologies in existing use are more likely to be present in registries or post-marketing surveillance datasets than newly available technologies. Scoping may identify real-world data sources that could support the evaluation.

4.3 Evidence

4.3.1

Section 2.2 describes the approaches for using evidence for HealthTech guidance assessments.

Evidence identification

4.3.2

The aim of the evidence review is to identify the most relevant evidence relating to the decision problem defined in the scope. 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 problem, a broader evidence base may be considered. For example, evidence from the technology's use in a different population or setting.

4.3.3

Post-market surveillance data and non-clinical technical assessments may be used, if appropriate, when topics have little or no evidence, or to complement published clinical evidence.

Evidence reviews

4.3.4

The evidence review will be done as described in sections 2.2.6 to 2.2.15.

4.3.5

Pragmatic or rapid review methodology and principles can be used in the literature review, with specific components of the systematic review process either being restricted or omitted. For example, the Cochrane Rapid Reviews Methods Group provides guidance on doing rapid reviews of the effectiveness of health interventions. Justification and rationale for this should be described in the assessment protocol, along with clear explanation of the components of the review process that have been restricted or omitted.

4.3.6

Technologies assessed in existing use guidance may have larger volumes of evidence than technologies at an earlier stage of their lifecycle. Decisions about what studies to include, or prioritise, in the assessment report will need to be made. The protocol for the assessment should describe the approach taken. NICE's Decision Support Unit technical support document 27 provides guidance on potential approaches.

4.4 Economic evaluation

4.4.1

The economic evaluation that will be most beneficial for committee decision making is likely to vary by topic.

4.4.2

The key objectives of the economic evaluation are to:

estimate the relative cost effectiveness of available technologies, or groups of technologies with certain features, functions or other characteristics
identify key uncertainties.

4.4.3

See section 2.3 for full detail on economic evaluation.

4.4.4

Regression analyses may be used to determine the proportion of price variation that can be attributed to different features, functions or characteristics of technologies.

4.4.5

Exploratory analyses may be used to investigate potential justifications for price differences. For example, threshold or sensitivity analysis to investigate how changes in the effectiveness of technologies affect whether they represent good value for money at a given threshold (for example, £20,000 per QALY gained). The committee can consider exploratory analyses in its decision making and decide on their appropriateness.

User preference assessment

4.4.6

Existing use assessments evaluate technologies that are in widespread or established use. People are likely to have experience of using the technologies and so can provide insights into which factors are important to them when choosing which technology to use. This experience can be useful for committee considerations, especially when there is less evidence available to evaluate clinical and cost effectiveness.

4.4.7

Users are people whose experience with the technologies would allow them to make informed choices between different options. Ideally, they have experience of direct involvement in deciding to choose 1 technology over another. This could include people who:

have the condition that the technology is intended for (for example, people with a stoma choosing a colostomy bag)
prescribe the technology (for example, a nurse choosing an appropriate wound dressing)
use the technology frequently (for example, sonographers choosing an ultrasound machine).

The most relevant user group or groups for determining user preference will be identified during scoping. Users are selected taking into account the NICE policy on declaring and managing interests for NICE advisory committees and can include experts selected to advise on other parts of the assessment.

4.4.8

Alongside the clinical and economic evaluation, additional information may be collected about factors that are important to users when selecting a technology. This information can be used to assess how well these factors are captured by the clinical and economic evaluation. A user preference assessment will involve user preference exercises and workshops. The objectives are to:

identify users who are key decision makers when choosing a technology
identify the key criteria that are important to users of the technology when deciding which technology to choose
understand the importance of these criteria to users
understand how users apply these criteria when choosing a technology
identify how well the clinical and cost effectiveness evidence presented in the assessment report captures criteria that are important to users.

This assessment may be done by NICE or an EAG.

4.4.9

A user preference report will report the results from the user preference assessment. The user preference report is subject to factual accuracy checking (see section 1.4.7). Because the views of the users are subjective, they cannot be considered inaccurate.

4.4.10

In addition to the user preference exercises and workshops described in section 4.4.8, other activities may be done to further explore factors that influence technology choice. These may include but are not limited to:

surveys of users or other groups of healthcare professionals or people with relevant experience
reviews of literature which discuss relevant experience.

4.5 Decision making

4.5.1

The key goal for decision making in existing use assessments is to determine if price differences between technologies are justified. The committee will apply the same considerations as described in section 2.4.

4.5.2

The committee can consider:

if there are differences in clinical or cost effectiveness that can justify price variations between technologies
factors not captured in the clinical evidence or economic modelling that could affect value, such as preferences identified through user preference assessments (see sections 4.4.6 to 4.4.10)
if more information is needed to help choose the most appropriate technology.

4.5.3

Recommendations will only be for the use, or uses, of the technologies as specified in the scope.

4.5.4

Recommendations may refer to individual technologies, or groups of technologies defined by having certain features or functions, depending on the approach defined during scoping (see section 4.2.1).

Types of recommendations

**Table 4 Overview of recommendations used in existing use guidance**
Recommendation type	What this means in practice
Price difference is justified for a technology or technologies with certain features or functions	There is enough evidence that a technology or feature provides benefits and value for money, so it is acceptable to pay more for that technology or technologies with that feature.
Not enough evidence to justify paying extra for any of the technologies or technologies with certain features or functions	There is not enough evidence to justify paying extra for any of the technologies or technologies with certain features or functions. There may be factors that are not based in clinical or economic evidence that could be considered when choosing a technology.
Do not pay more for a technology or feature	There is evidence that a higher price is not justified for a technology or a feature of a technology, so it is not acceptable to pay more when there is a less-expensive alternative option.

4.5.5

Price difference is justified for a technology or technologies with certain features or functions.
If there is enough evidence that a technology, or a group of technologies with certain features or functions, provides appropriate benefits and value for money at its price relative to the prices of other options, price difference can be justified. Recommendations may specify justifiable differences in cost for certain technologies or technologies with certain features or functions.

4.5.6

There is not enough evidence to justify paying extra for any of the technologies or technologies with certain features or functions.
If the evidence of clinical or cost effectiveness is absent, weak or too uncertain, no technology will be recommended over others. In this circumstance, committees may specify what should be considered when choosing between the technologies, 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, including factors highlighted in the user preference report
impact on health inequalities
accommodating people with specific clinical presentations.

4.5.7

Do not pay more for a technology or feature.
If there is evidence that a higher price is not justified for a technology or feature of a technology because proposed benefits and value for money are not likely to be realised in practice.

4.5.8

Existing use guidance can make research recommendations when further evidence will be useful to support future decision making. See section 2.4.28.

4.5.9

Recommendations may include additional factors that the committee agrees are important considerations related to the technologies. This can include, but is not limited to:

specifying an appropriate range of technologies that need to be available
providing information and guidance for procurement and commissioning, people with the condition, or healthcare professionals
guidance on the basic requirements for a technology.