Centering Equity in Cardiovascular Health Technology Assessment

Cardiovascular disease burdens and outcomes are associated with social determinants of health in Canada despite universal health coverage. (1Vervoort D. Chung J. C. Y. Ouzounian M. Access to thoracic aortic care: Challenges and opportunities in universal health coverage systems. Can J Cardiol. 2022 Jun; 38: 726-728Abstract Full Text Full Text PDF PubMed Google Scholar) Health technology assessment (HTA) processes evaluate new health interventions through a multidisciplinary lens to inform resource allocation decision-making at the health system level. In Canada, HTA is not purely driven by cost-effectiveness but also considers ethical, legal, social, and patient factors to determine whether technologies should be recommended. Equity considerations are key, balancing distributive and procedural justice, and accounting for socioeconomic disparities. This article describes HTA with a focus on Canada and presents a conceptual framework to center equity considerations in HTA. HTA refers to the comprehensive and systematic evaluation of the direct and indirect impact of new health technologies within a given context (e. g. , hospital level) or health system (e. g. , provincial or federal level). Health technologies refer to the full range of interventions and procedures that may be introduced for public health and healthcare delivery, from medications and procedures to artificial intelligence and digital health technologies. The in-depth discussion of HTA falls beyond the scope of this manuscript; however, briefly, HTA entails the formulation of an economic policy question, evidence synthesis based on published literature (and/or primary data and grey literature), stakeholder (including patient) engagement, and development of recommendations for others (typically governments, insurers, or hospital systems) to consider. (2Vervoort D. Tam D. Y. Wijeysundera H. C. Health Technology Assessment for Cardiovascular Digital Health Technologies and Artificial Intelligence: Why Is It Different? . Can J Cardiol. 2022 Feb; 38: 259-266Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar) Economic evaluations, such as cost-effectiveness analyses (CEA), form a key part of HTA decision-making. They compare the incremental costs of a new health technology against the incremental difference in clinical outcome of that technology relative to the standard of care. However, they do not inherently consider how resources are distributed within a population; in other words, pure economic evaluations do not consider equity issues or differential opportunity costs that may occur within a population. In practice, HTA is context-dependent. In Canada, there is no set cost-effectiveness threshold unlike other countries (e. g. , £20, 000-30, 000 per quality-adjusted life-year in the United Kingdom, US50, 000 in the literature) ; instead, a multitude of criteria, including patient values, ethical, legal, and social issues, are applied. Due to healthcare being administered provincially, provincial HTA agencies exist; at the national level, the Canadian Agency for Drugs and Technologies in Health (CADTH) sets national standards for HTA. Other countries with HTA agencies use different approaches; for example, HTA decision-making in the United Kingdom is primarily rooted in incremental cost-effectiveness ratios. Nevertheless, the role of HTA is well-established. In 2014, the World Health Organization and Ministries of Health adopted the World Health Assembly (WHA) Resolution WHA67. 23 on "Health intervention and technology assessment in support of universal health coverage" to recognize the role of HTA in countries' efforts to work toward universal health coverage. Despite this, many countries, including the United States, do not have formal governmental HTA processes. This is concerning in light of recommendations made by the American College of Cardiology and American Heart Association to leverage cardiovascular HTA in clinical guideline development with specific willingness-to-pay thresholds. (3Anderson J. L. Heidenreich P. A. Barnett P. G. Creager M. A. Fonarow G. C. Gibbons R. J. et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures. J Am Coll Cardiol. 2014 Jun; 63: 2304-2322Crossref PubMed Scopus (333) Google Scholar) Indeed, the rapid development of lesser-invasive procedures, digital health technologies, and artificial intelligence applications reinforces the need for robust and flexible HTA processes, which traditionally require multiple, time-intensive steps and technology-specific evidence. (2Vervoort D. Tam D. Y. Wijeysundera H. C. Health Technology Assessment for Cardiovascular Digital Health Technologies and Artificial Intelligence: Why Is It Different? . Can J Cardiol. 2022 Feb; 38: 259-266Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar) It is anticipated that such complexity and need for swift processes will grow as cardiovascular innovations happen exponentially; this should not come at the cost of, but rather in support of, health equity. Distributive and procedural justice frameworks are commonly used to approach resource allocation decision-making. Distributive justice refers to the fair distribution of goods, benefits, and burdens within a population (i. e. , outcomes), whereas procedural justice is defined by the fairness of the rules and decision-making process to make resource allocation decisions (i. e. , process). Traditionally, resource allocation in high-income countries occurred through utilitarian or egalitarian lenses as dominant streams of thought. Utilitarianism prioritizes overall maximization of satisfaction or outcomes without considering their distribution across society. However, healthcare is not a traditional good as the outcome – health – relates to people’s ability to thrive in and contribute to society, making a purely utilitarian approach unfair. Conversely, egalitarianism focuses on equality of opportunities or outcomes but does not necessarily imply fair and equitable distribution of a good (e. g. , healthcare services). Through these lenses, socioeconomic disparities were rarely explicitly addressed until recently, when patient representatives and ethicists were increasingly involved in decision-making to address real-world implications of, and potential inequity resulting from, the adoption of new technologies and programs. In Canada, leading distributive justice theories include utilitarianism and virtue ethics. Utilitarianism underlies CEA, seeking to maximize benefits across society (e. g. , finding the most cost-effective intervention). Virtue ethics reflects traits accepted or preferred by society, such as giving people the opportunity to receive care, and underlies health economic policy and decision-making in, for example, Ontario. One reflection of virtue ethics is Sen’s capability approach, which states that actions (e. g. , social programs) should be evaluated by the extent they enable people to achieve and promote the functions they value. These theories, however, are not mutually exclusive and may occur together within the same society or HTA process, as observed in Canada’s pluralistic health system. Distributive justice further requires balancing horizontal and vertical equity. Horizontal equity reflects health service availability, utilization, and outcomes, and underlies the capability theory by illustrating barriers to care. Vertical equity refers to the different needs of diverse populations, and forms the basis of virtue ethics, which generally seeks to prioritize those worst off in society. When considering the net equity impact of technologies, benefits may dissipate. In reality, opportunity costs from novel technologies are rarely the same for different socioeconomic groups. For example, policies benefiting lower-income households may introduce a greater gross but lesser net health benefit by displacing resources from other technologies or services benefiting lower-income households within fixed health budgets that cannot fund all technologies or services (e. g. , funding primary health care by reducing funding for social work). This trade-off is generally not considered due to the emphasis on gross health benefits, requiring more careful evaluation of novel technologies and involvement of patient representatives and ethicists. In pluralist societies such as Canada, there is commonly reasonable disagreement on the grounds of the principles of distributive justice as illustrated by the above conflict in resource allocation outcomes between utilitarianism and egalitarianism (and other distributive justice approaches). From a purely ethical perspective, each approach may be appropriate but result in different outcomes. To address value-based conflicts in outcomes, procedural justice considerations should be consulted for contentious resource allocation decisions. Norman Daniel’s Accountability for Reasonableness model may help guide fair priority-setting through five angles: 1. Relevance: multidisciplinary, criterion-based, and evidence-informed processes that are empirically feasible;2. Publicity: transparent and publicly accessible rationale and decision-making;3. Revision: development of a formal and iterative decision-making process to recognize constraints on reason and generation of new evidence and arguments over time;4. Enforcement: regulating the implementation of relevance, publicity, and enforcement;5. Empowerment: increasing opportunities for stakeholder engagement and reducing power imbalances. Applying such models can make resource allocation inequities (e. g. , more resources for historically marginalized populations) permissible through being informed by the norms and values of society as well as the transparency for and dialogue with the public. In other words, if the process is deemed fair, the outcome of the process can be accepted. While historically not prioritized and conceptually challenging, the above concepts allow us to propose a conceptual framework (Figure 1) to better account for socioeconomic disparities in HTA. First, quantitative methodologies to incorporate equity into HTA should be standardized, as non-standardized approaches may lead to different and potentially inequitable conclusions (4Panteli D. Kreis J. Busse R. CONSIDERING EQUITY IN HEALTH TECHNOLOGY ASSESSMENT: AN EXPLORATORY ANALYSIS OF AGENCY PRACTICES. Int J Technol Assess Health Care. 2015 Jan; 31: 314-323Crossref PubMed Scopus (11) Google Scholar). To achieve standardization, one approach is to leverage extended and distributional CEA. In practice, extended CEA was used by the World Bank Disease Control Priorities to consider health and financial benefits while also considering financial risk protection (i. e. , protection against medical impoverishment). Distributional CEA evaluates the distribution of health opportunity costs (i. e. , net health benefits) from displaced expenditure within a fixed healthcare budget, which may be accompanied by an equity-weighted index of social welfare. These approaches have been underutilized, in part due to CEA complexity and the need for granular, population-specific data. Second, patient representatives play a pivotal role in HTA by highlighting the experiences and needs of patients and families. Currently, they are involved in informing HTA questions and reviewing draft recommendations. However, it is important that these individuals are also representative of the overall (patient) population. If there are limited spots on the HTA panel, the representative should work with community-representative patient-family groups. Community-based participatory research principles can serve as a guide, emphasizing the need to work with communities as equal partners in planning, research, and decision-making, alongside accountability for reasonableness principles. (5Jones L. Wells K. Strategies for academic and clinician engagement in community-participatory partnered research. JAMA. 2007 Jan 24; 297: 407-410Crossref PubMed Scopus (417) Google Scholar) Third, value frameworks underlying HTA processes should be transparent. Transparency builds trust among communities and ensures that the underlying HTA methodologies and processes can be externally validated. Moreover, frameworks should be inclusive and representative of the community values for the context in which decision-making occurs, recognizing the population’s diversity, cultures, and history. Fourth, ethicists’ role as part of HTA should be better recognized and considered equal to the role of other experts. CEA methodologies alone are not capable of spanning the full breadth of values, opportunity cost distributions, and different ethical lenses. Ethicist expertise is necessary to inform resource allocation through existing distributive and procedural justice considerations. HTA processes in Canada are complex and inclusive, but not perfect. Opportunities exist to better address socioeconomic disparities in health policy recommendations and decision-making in Canada. Similar opportunities exist in other HTA agencies and health systems and institutions basing policies on non-HTA processes.