NICE HealthTech programme manual

Existing-use assessments are designed to support procurement and commissioning decisions, promote effective use of NHS resources and improve care, through assessing a group of similar technologies that are already in established use in the NHS. Section 2.1.28 and table 2 describe general principles for existing-use guidance topics.

There may be uncertainty about whether price variation between similar technologies is justified. For example, whether differences between technologies resulting from continuous improvements or incremental innovations have produced real differences in patient or system outcomes. Existing-use assessments can help to determine whether these differences can justify any price variation. The assessments can also help identify factors that can inform decisions about which technology to purchase. This will help healthcare professionals, procurement services and commissioners to work together to 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.

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 within a group of technologies differ from each other and the potential impacts of these differences, such as on patient outcomes or healthcare resource use.

• Scoping may investigate the development history of product lines to determine the types of innovation that have occurred and the applicability of evidence from predecessor technologies (see section 2.2.8).

• 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 what the technologies do or how they function are very similar or the same.

• The scope may not define a comparator because the assessed group of technologies (the interventions) is considered established practice. Comparisons are made between interventions.

• Outcomes related to the needs and preferences of patients and healthcare professionals for different technologies, or particular functions or features of technologies, may be useful for decision making for existing-use guidance and can be specified in the scope (see section 2.1.24).

• The scope may include relevant information on how technologies are currently provided to the NHS, for example procurement frameworks.

Scoping will identify the relevant user groups for user preference assessment and may outline potential methods for user preference assessment (see section 4.5).

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.

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

The economic evaluation that will be most beneficial for committee decision making is likely to vary by topic. See section 2.3 for full detail on economic evaluation.

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.

Exploratory analyses may be used to investigate the feasibility of justifications for price differences or to help identify areas for future evidence generation. 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 results of any such analyses should be clearly presented as exploratory, with appropriate reference to any uncertainty associated with the results. The committee can consider exploratory analyses in its decision making and decide on their appropriateness.

Existing-use assessments evaluate technologies that are in widespread or established use. People are likely to have experience of using the technologies, 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. User preference assessment increases and enhances expert input into guidance production (see section 1.3.15).

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. NICE aims for the sample of users to be as balanced and as representative as possible. Users are selected taking into account the NICE policy on declaring and managing interests for NICE advisory committees. Users are also selected based on their relevant experience, including experience of the assessed technologies, and can include experts selected to advise on other parts of the assessment.

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 external assessment group.

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). But the experts' opinions on what is important to them about the technologies cannot be considered factually inaccurate.

In addition to the user preference exercises and workshops described in section 4.5.3, 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.

The committee will apply the same considerations for decision making as described in section 2.4.

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 section 4.5)

• if more information is needed to help choose the most appropriate technology.

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

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).