Relative Effectiveness Assessment (REA) is a type of assessment that evaluates the effectiveness of a new technology compared with alternative treatment(s) and it plays a key role in the reimbursement status of pharmaceuticals across many healthcare systems1. EUnetHTA have tried to come up with a unified approach and framework for the Health Technology Assessment (HTA) that could satisfy different countries within the European Union (EU). The result is the HTA Core Model®2. The aim of this framework is to establish a standardised HTA process at a European level, which can streamline and unify this process, allowing pharmaceutical and biotech companies to communicate the value of their products more efficiently across healthcare systems. The HTA Core Model® contains different components called “domains”, not all of which are at European level. The HTA Core model for Relative Effectiveness Assessment (REA) is a simplified version of the HTA Core Model®, which covers the European domains only.
What is the HTA Core Model for Rapid Relative Effectiveness Assessment (REA)?
The HTA Core Model for REA abbreviated as ‘Model for Rapid REA’ is a methodological framework for the collaborative production and sharing of HTA information. The model for Rapid REA defines the key elements which are scrutinised in an HTA and enables standardised reporting. The main aims of the Model for Rapid REA are:
- To improve the applicability and transferability of HTA information between HTA projects
- To enable collaboration between HTA agencies by providing a common framework for the development of rapid REA
- To avoid duplication of work
Rapid REAs contain an analysis of a health technology compared to other relevant intervention(s), which is limited to a given timeframe. The model covers generic research questions for four types of technologies:
- Pharmaceuticals
- Diagnostic Technologies
- Medical and Surgical Interventions
- Screening Technologies
The three main components of the HTA Core Model for REA, which is based on the HTA Core Model® are:
- HTA ontology containing an extensive list of generic questions which may be asked in an HTA
- Methodological guidance helping researchers to address the questions in the model
- Common reporting structure providing a standard output format of HTA projects
Background
The HTA Core Model® has a unique structure, which divides the information into nine domains. Given the Model for Rapid REA is designated for assessments within a limited timeframe, it comprises the first four domains of the HTA Core Model®. The remaining domains represent individual country responsibilities (Figure 1). The aim of that is to facilitate the systematic presentation of information. Each domain is then divided into topics and each topic is further divided into issues, which are essentially the questions that should be assessed in an HTA (Figure 2).
Domains
Description and technical characteristics of technology (TEC)
This domain contains information on technology under assessment and its technical characteristics (e.g. type of device, or therapy, mode of action, point of differentiation vs. comparators, purpose, who is intended to be using it etc.). The regulatory and reimbursement status of the technology may or may not be listed depending on the context of the assessment. The language used should be such that it allows those who are unfamiliar with the technology, get a good understanding of the technology. Pictures, diagrams and videos can be used in this section to help the reader familiarise themselves with the specifics of the technology.
Health problem and current use of the technology (CUR)
This domain puts the focus on the target group and condition, epidemiology, and patterns of use of the technology under investigation. It also gives insights into disease burden both from an individual and societal perspective. The qualitative description, including pathophysiology, natural history, diagnostic methods, prognosis, epidemiology, risk factors for the conditions and available treatments, should also be covered as part of this section. If the technology will be indicated for a specific patient subpopulation, its description should be clearly presented in this domain. Any challenges or issues associated with the use of the technology, such as off-label use, compliance, overdiagnosis and misuse should also be discussed.
Clinical Effectiveness (EFF)
This domain should contain information on the relative benefits of the technology compared with one or more alternatives in terms of efficacy, which can be assessed in a randomised controlled trial (RCT) or under routine conditions. The two key elements of a benefit assessment under routine conditions are:
- The most relevant interventions should be directly compared where possible
- Studies should include patients who are typical of day-to-day healthcare settings
The scope of REAs is to evaluate the relative benefits of a technology (i.e. its effectiveness) under routine conditions and ideally these data should come from RCTs. However, evidence on effectiveness could also come from real-world data (non-RCT studies).
Examples of assessed health benefits which are considered in this section include clinically meaningful endpoints, such as mortality, morbidity and quality of life (QoL). For life-threatening conditions, mortality and/or survival are the desired primary endpoints, whereas morbidity and health-related quality of life (HRQoL) are deemed secondary endpoints. In contrast, in non-life-threatening conditions, morbidity and HRQoL are the preferred primary endpoints. Surrogate endpoints can only be used if they have been validated rigorously.
Safety (SAF)
Since 2016, EUnetHTA have conducted 48 REAs in total – 20 pharmaceutical technology assessments and 28 other technology assessments. That has allowed them to gain invaluable learnings on how the Model for Rapid REA works and where there is room for improvement in this process. This is still a relatively new procedure that evolves with every product that goes through it. The challenge with the Model for Rapid REA is that it remains to be seen how the EU will implement this framework so that it satisfies the requirements of all individual country healthcare systems.
References:
- Kleijnen, S., George, E., Goulden, S., d’Andon, A., Vitré, P., Osińska, B., Rdzany, R., Thirstrup, S., Corbacho, B., Nagy, B.Z. and Leufkens, H.G., 2012. Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions. Value in health, 15(6), pp.954-960.
- HTA Core Model for Rapid Relative Effectiveness (2015). EUNetHTA. Available at: https://eunethta.eu/wp-content/uploads/2018/01/JA2-WP5-HTA-Core-Model-for-Rapid-REAs.pdf
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