Evaluation of ethical aspects in health technology assessment: more methods than applications?

Abstract

Health technology assessment (HTA) emerged with the increased need for systematical evaluation of health technologies in the 1970s. From its very beginning, ethics was a constitutive part of HTA, and over the years a wide range of approaches have been suggested to address ethical aspects of health technologies. Despite a vast variety of methodologies in ethics, there is no consensus about the appropriateness of the existing methods. Moreover, while the available methods are many, their applications are few. While methods for addressing ethical issues in HTA have been richly reviewed, their applications are poorly tracked. Hence, a bottom up approach, that is, from practice to theory, may turn out to be as helpful as a top-down review. We need a review of the examples of ethics in HTA so we better can learn how the methods are used in practice, analyze the role of context, and better can assess the merits of the various methods.

Keywords:

• consensus
• empirical studies
• ethics
• health technology assessment
• methods

Health technology assessment (HTA) emerged with the increased need for the systematical evaluation of health technologies in the 1970s [1]. From its very beginning ethics was a constitutive part HTA, and early definitions of technology assessment explicitly enclose ethics [2–5]. Over the years a wide range of approaches have been applied to address ethical aspects of health technologies [6,7]. However, relatively few HTA reports include ethics in any systematic way [8,9]. In contrast to other parts of HTA, such as systematic reviews of outcomes and safety and economic analysis, there is little agreement on how to do ethics in HTA [10]. There may be a lack of resources to perform ethics analysis, and there are differences in culture between HTA experts and ethicists [11].

This picture is very much confirmed in a recent and elaborate systematic review where Assasi and co-authors identify a wide range of guidance documents for incorporation of ethics in HTA and give a comprehensive overview of their methodologies [12]. The review identified 43 conceptual frameworks or practical guidelines: 21 in scholarly articles and 22 in HTA guidelines. The identified conceptual frameworks varied in their philosophical approach, comprehensiveness, and structure. Assasi et al. classified the frameworks to four general categories:

• Reflection through ethical principles and theories (classical methods).

• Supplementing classical methods with participatory and interactive approaches.

• Providing pragmatic tools for obtaining and synthesizing ethical data.

• Frameworks for discussion of ethical data for making HTA decisions.

They also found that ethical guidance documents were designed for different purposes throughout the HTA process, ranging from helping HTA producers in the identification, appraisal, and analysis of ethical data to supporting decision makers in making better-informed, value-sensitive decisions. Moreover, Assasi et al. found that existing methods are generally meant to be used by professional ethicists or HTA practitioners with a knowledge and skill in ethical analysis.

These insights are very useful to get a better understanding of the similarities and differences between various frameworks or guidelines for ethics in HTA. However, it gives little guidance for when to use, how to choose amongst, and how to use such frameworks. The authors conclude that the choice of a framework seems to depend on the context in which technology is being assessed, the purpose of analysis, and the availability of required resources. They state that ‘it seems difficult to choose a procedural approach that allows for optimum integration of ethical issues in HTA’ [12].

One reason for this may be that many of the frameworks are seldom used, and we therefore lack knowledge of their applicability in practice. There appear to be many frameworks, but few examples. This is also illustrated by Assasi et al.’s review, where only a few case studies were found to illustrate the identified frameworks. This indicates that there may be many methods, but few applications [13]. However, the reason why Assasi et al. have identified few examples of applications, is that the authors have searched for and referred specific methodological works (articles and HTA guidelines), in which case studies and examples may be (nearly) absent. This may be due to the simple fact that methodological articles and guidelines do not have room for full-fledged case studies, or that such case studies may be so context specific, that their illustrative value is limited. Hence, a more specific analysis of examples of ethical evaluation of health technologies may be useful for understanding how they can be applied in practice, see how their application depends on context and ease our assessment of the merits of the various methods.

Allow us to present but one example, mentioned in Assasi et al.’s review, that is, the Socratic Approach. See online Supplementary Appendix 1 (supplementary material can be found online at www.informahealthcare.com/suppl/10.1586/14737167.2015.990886). As can be seen from the Supplementary Appendix 1, the same health technology has been addressed with a series of approaches by several agencies. A technology or application based review of the methods in ethics (compared to a theoretical framework based review) may be useful to understand the contextual differences (in HTA setting) that can explain and guide the assessment, selection, and use of the various frameworks. Seeing how the same technologies have been assessed by different methods, may be helpful when deciding on whether and how to address ethical issues in HTA. The same goes for seeing the same methodology being used for assessing different technologies. Hence we may need to focus less on methodologies, and more on technologies and context. Context here should include the stakeholders, and particularly the patient group, as well as the HTA process.

The requirements of ethics qualifications for applying the various ethics frameworks also obtain little attention. As the applicability of the presented frameworks is very different, the demand of ethics and philosophy expertise varies greatly. Some approaches are applicable without special training, such as the approaches of Swedish Council on Health Technology Assessment (SBU), Institute for Quality and Efficiency in Health Care (IQWiG), European Network for Health Technology Assessment (EUnetHTA) and others, while others presuppose knowledge in philosophy, such as casuistry and coherence analysis, and some need expertise in Science and Technology Studies, such as Social Shaping of Technology.

However, the questions who qualifies as an ethicist in HTA and which qualifications are necessary to meet HTA requirements adequately, are important and subject of current debates in the International Network of Agencies for HTA and the HTA international Interest Sub-Group on Ethics in HTA. Ethicists and philosophers are normally not trained in Evidence-based Medicine, HTA, or health policy decision-making processes, while HTA experts are rarely trained in ethics. Advanced ethical analyses of complex health technologies appear to need both qualifications.

Another important question following from Assasi et al.’s excellent review is how the preferences and expertise of persons performing ethics analysis in HTA influence the choice and application of the methods, as well as their outcome. We welcome further contribution in these issues. A bottom up approach, that is, from practice to theory, may turn out to be as helpful as a top-down review. We need a review of the examples of ethics in HTA so we better can learn how the methods are used in practice, analyze the role of context, and better can assess the merits of the various methods.

Disclaimer

The sole responsibility for the content of this article lies with the authors. It does not necessarily reflect the opinion of the European Union. The European Commission is not responsible for any use that may be made of the information contained therein.

Financial & competing interests disclosure

KB Lysdahl's work and part of B Hofmann's work is co-funded by the European Union under the Seventh Framework Programme (Grant Agreement No. 30614) as part of the project INTEGRATE-HTA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.