This editorial appears in the May Issue of the American Journal of Bioethics

The recent increases in the number of persons detained by ICE in the United States is affecting health care. Many health-care professionals and facilities that serve immigrant communities report a chilling Health Technology Assessment (HTA), and the value assessment frameworks that underlie this process, seek to systematically define the value of new health interventions in terms of benefits and costs. Watts and Newson aim to “critically assess the ethical grounds for including personal utility within HTA and thus to promote standardization of this concept”. Their analysis represents an important step toward long-needed clarification of the concept of personal utility, and their consideration of the ethical dimensions underlying value assessment and HTA decision-making is to be commended.

Their granular analysis also raises larger underlying ethical questions in value assessment and HTA, that is—whose values should define value, and how should these decisions be made? Traditionally, health economists, clinicians and policymakers have determined the methods of value assessment and defined benefit narrowly in terms of morbidity and mortality. More recently, HTA bodies have recognized that this narrow definition of health fails to capture many benefits that patients and families value. However, instituting a fair process for determining how an expanded concept of benefit should be defined and whose perspectives should be prioritized at various stages of value assessment requires consideration of principles of procedural justice, including transparency, inclusivity, and impartiality. In this commentary, I discuss the procedural justice implications of Watts and Newson’s analysis of the personal utility of clinical genomic testing (CGT), with a focus on their arguments for the role of patient perspectives in defining and measuring value.

At the outset, Watts and Newson draw on the principle of respect for persons to justify incorporating personal utility in value assessment and HTA. They argue that this position recognizes “patients as persons whose evaluations of the worth of healthcare technologies are ethically relevant to formal assessments of their value”. The authors also, at least initially, appear to recognize the relevance of patient and family perspectives in assessing the magnitude of value associated with various dimensions of personal utility, stating that “studies of patient-reported personal utility show that many of the most attested and highly endorsed non-clinical outcomes of genomic testing have no or only tangential connection to potential uses of the information supplied by clinical genomic testing”. In short—patients and families with relevant lived experience of the personal utility of CGT describe the intrinsic dimensions of value to be at least as great, if not greater, than those of use-value.

The authors’ position on the role of patient perspectives in value assessment shifts, however, when they reach the question of HTA decisions around reimbursement. Although patients and families reportedly value intrinsic personal utility even more than use-value, because public willingness-to-pay studies suggest the opposite, the authors conclude that public, and not patient, perspectives on value take precedent. The authors point to the “collective” nature of reimbursement decisions in publicly funded healthcare systems in prioritizing willingness-to-pay, arguing that “respect for persons carries relatively little normative weight in HTA decision making”. However, the process by which they arrived at this recommendation is less clear.

Even in the context of reimbursement decisions in publicly funded health systems, reliance on public preferences alone is hardly a foregone conclusion, and scholars have critiqued this perspective from a variety of angles. Critics point to empirical evidence that members of the public value certain outcomes differently than patients with lived experience. Others focus on dismantling a core assumption underlying reliance on public perspectives—that they represent an unbiased set of shared societal values—instead arguing that the preferences of all individuals—public or patient—are driven by beliefs shaped by their own values and experiences. In direct contradiction to Watts and Newson, scholars also have advocated for privileging patient perspectives in this context specifically on the basis of respect for persons, pointing to the importance of lived experience in understanding all dimensions of value. Still others have challenged prioritizing public perspectives on the basis of equity, arguing that reliance on public perspectives risks marginalizing the perspectives of patients with rare diseases and disabilities. While Watts and Newson’s recommendation to prioritize public perspectives over patients in reimbursement decisions may be justifiable, procedural justice requires a transparent process and examination of the range of ethical and epistemic implications underlying core methodological components of value assessment.

There are also procedural justice considerations relevant to other recommendations Watts and Newson put forth. For example, in considering the justificatory limits of including second-order personal utility in value assessment and HTA decision-making, the authors argue that this form of personal utility is “a matter of continued investment in the discovery, collection, and dissemination of wider genomic knowledge”. The question of who derives value from the expansion of CGT—and of the definition of its personal utility—is an important one. As the accompanying commentary by Lantos notes, CGT occupies “an unusual conceptual space” characterized by a “plurality of purposes.” As such, its expansion has the potential to generate benefits to other stakeholders (e.g., profits to industry, large databases to academic researchers), regardless of whether the patients and families receiving these tests directly benefit. If it is truly only parties other than patients and families advocating for these second-order personal utilities, then Newson and Watts argument may stand insomuch as these benefits are not “personal” at all.

The authors default to the authority of “public utility” to determine whether second-order utility is sufficiently valuable. However, an inclusive, deliberative process could not only resolve such concerns but also ensure that all stakeholders understand the reasons underlying any final decisions, even if they do not agree with them. While we as bioethicists certainly have a role to play in examining the ethical underpinnings of value assessment and HTA, procedural justice dictates that these decisions cannot be made by bioethicists alone. Watts and Newson’s ethical analysis is valuable insomuch as it clarifies the ways in which various ethical principles are reflected in the definition and measurement of personal utility. However, I would argue that rather than prescribing what to decide, bioethicists should focus first on identifying ethical principles for guiding how to decide, as well as processes for implementing these principles in practice.

Scholars have put forward various deliberative models for including a range of perspectives in decision-making across the value assessment and HTA process. Watts and Newson’s suggestion to integrate discussions of personal utility into the assessment of ethical, legal, and social issues (ELSI) may be consistent with such deliberative approaches. Identifying strategies for incorporating the perspectives of individuals with lived experience throughout the value assessment and HTA decision-making process is an essential element of procedural justice that goes well beyond just decisions about personal utility and CGT.

To be clear, in advocating for incorporating patient perspectives on the grounds of procedural justice, I am not claiming that CGT has extensive value, that it should be reimbursed across all clinical contexts, or that public perspectives have no role to play. While procedural justice demands a fair, transparent and inclusive process, it may be that, when the magnitude of the value derived from personal utility is examined together with other dimensions of value (including clinical utility and health outcomes), reimbursing CGT is determined unjustifiable in many contexts. However, the legitimacy of these decisions must rest on a fair and transparent process that is inclusive of diverse perspectives.

Disclosure statement

Dr. Halley has no financial conflicts of interest to disclose. From 2022–2024, she served in an uncompensated role as board member of the Undiagnosed Diseases Network Foundation.

Funding

Funding for this work is provided by the National Human Genome Research Institute grant K01HG011341. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Meghan C. Halley, PhD