How Health Technology Assessments Need to Evolve to Support Health Equity Goals

Susan Garfield, DrPH, Ernst & Young LLP, Boston, MA, USA; Julie Nguyen, BSPH, Christine Hildreth, BA, Ernst & Young LLP, New York, NY, USA

Introduction

In recent decades, abundant research has quantified the breadth and impact of observed disparities in health outcomes across race, ethnicity, gender, geography, and other demographic factors. Governments, healthcare providers, payers, and suppliers are increasingly prioritizing addressing the root causes and manifestation of health inequities. In the United States, new regulatory and payment guidelines both reflect and drive this focus. The Centers for Medicare & Medicaid Services, Food and Drug Administration, and the National Committee for Quality Assurance have set forth new requirements related to payment, data and analytics, and research and development (eg, data reporting mandates) that affect payer, provider, and life sciences organizations. These requirements change the direct incentives for greater health equity focus and engagement, and the health ecosystem is honing its focus accordingly to develop action plans to address regulatory requirements. In a survey of 500 health equity executives across provider, payer, life sciences, government, and nonprofit and community organizations, 98% of respondents report expecting health equity’s prioritization within their organization to increase or remain the same in the next year.¹ In addition, 92% report expecting financial investments in health equity efforts to rise.¹ As health equity grows in salience across the health ecosystem, greater scrutiny is applied to the clinical and nonclinical factors influencing health outcomes.

While most health technology assessment (HTA) organizations have well-established clinical and economic metrics and methodologies for measuring the comparative value of new technologies, they largely do not include metrics to assess broader impact from a health equity perspective.² The following review of this area provides insights into how HTAs are evolving to consider and potentially reward the broader impact that some new health technologies can have. Incorporating health equity-oriented measures and methodologies into HTAs can provide incentives for greater investment in technologies targeting areas where significant health inequities persist, including access, affordability, and social determinant of health barriers.

"As health equity grows in salience across the health ecosystem, greater scrutiny is applied to the clinical and nonclinical factors influencing health outcomes."

Considerations in evolving HTAs to advance health equity goals

While there is broad consistency in HTA methods related to evaluation of clinical and cost impact or effectiveness, consistent representation of health equity-oriented measures has not been achieved. For example, although some HTAs currently include measures related to treatment interaction effect by race, a standardized framework for assessing health equity impact by race does not exist.² As health equity prioritization increases overall, stakeholders are exploring how to evolve HTA methodologies to support these broader goals. Through a landscape review of current HTA methodologies developed by the Institute for Clinical and Economic Review (ICER, United States), the Pharmaceutical Benefits Advisory Committee (Australia), the Canadian Agency for Drugs and Technologies in Health (CDA, Canada), the Federal Joint Committee (Germany), and the National Institute for Health and Care Excellence (United Kingdom), approaches to health equity measures, including disease disparities, clinical trial diversity, equitable clinical efficacy, implicit bias, and implications for equitable access, were examined. Additionally, a scan of thought leadership and other guidance published by these HTA organizations, research institutions, and other organizations involved in HTAs (eg, patient advocacy groups) was conducted to understand emerging approaches to health equity considerations. The findings from the landscape review of HTA methodologies and scan of emerging practices were summarized, and the following 6 approaches regarding the evolution of HTAs in the context of health equity emerged.

1. Recognize HTAs’ role in health equity advancement: To ultimately improve health equity and address disparities, ICER has recommended that HTAs go beyond providing a technical analysis of interventions. As evaluators of these technologies, HTAs are uniquely positioned to understand the settings in which these interventions will be deployed and the impact on communities. With this information, HTAs can shed light on the structural aspects of the healthcare system that are barriers to health equity and identify possible policy interventions.³

2. Establish legal frameworks to adjust HTAs: In a guide on establishing HTAs, the World Health Organization recommends that legal frameworks be established that would allow for HTAs to be adjusted to evolving policy and societal changes.⁴ This would allow for increased agility in changes to HTAs and pave the way for health equity considerations and other critical healthcare dimensions to be included in HTA methodologies.

3. Develop and align conceptual frameworks for health equity incorporation into HTA: Given the impact of HTAs on patient access and innovations, future evolution of HTA methodologies must support clear, transparent processes and fair decision making, which includes equity considerations. Researchers at the University of Toronto developed a practical tool to identify aspects of health equity across 5 phases of HTAs: scoping, evaluation, recommendations and conclusions, knowledge translation and implementation, and reassessment.² This tool has been used by the CDA to incorporate health equity concerns. Governing bodies could leverage similar tools and resources as they examine their HTA methodologies and contemplate which health equity aspects should be included to achieve a conceptual framework grounded in equitable decision making^.5

4. Identify and address data gaps related to omitted subpopulations: When evaluating the data used in HTAs, organizations should carefully identify any limitations in the data, particularly with regards to underrepresented or omitted subpopulations.³ This includes establishing thresholds for adequate representation in clinical trials and confirming that the data can capture the heterogeneity and intersectionality of treatment impact. Resources should be identified to fill data gaps prior to conducting a value assessment and appropriate time should be allocated to collect representative data.

5. Engage diverse patient groups: Advisory bodies and researchers are increasingly recognizing the need to directly engage with diverse patient groups and include impacted communities in value assessments, as demonstrated by recent guidance developed by ICER.³ Additionally, to close data gaps, stakeholders and representatives from groups that have been historically excluded from studies must be consulted to achieve adequate representation of various perspectives across racial and ethnic populations.

6. Diversify the HTA workforce: Representation of diverse backgrounds should go beyond patient engagement efforts and extend to those who do the work of HTA, including diversity in those who award and receive funding. As recommended by the Innovation and Value Initiative, diversity should extend to professional association leaders, journal editors, research sponsors, payers and purchasers, researchers, and patient organizations.⁶ A diversified HTA workforce is better positioned to improve HTA equity-oriented practices.

"Although some HTAs currently include measures related to treatment interaction effect by race, a standardized framework for assessing health equity impact by race does not exist."

Advancing health equity in HTA practice

The lack of consistent health equity guidance and evaluation frameworks creates uncertainty for manufacturers in where to best invest and what data are critical to optimize access. In order to advance practice and foster bidirectional alignment between payers or HTA organizations and manufacturers, we identified action steps to advance HTA health equity practice informed by our research and lessons learned from working in the field. Measures include involving stakeholders from diverse backgrounds in the assessment process, identifying data gaps and novel data requirements, creating equity-focused criteria to evaluate technologies, providing a platform to highlight structural aspects necessary to achieve optimal and equitable outcomes, and creating standardization to provide clarity and consistency in approaches.

1. Develop a standardized approach: Despite the growing recognition of the importance of health equity in HTAs, a globally accepted, validated approach to incorporating it is yet to be identified and implemented. Efforts should be made to standardize guidelines, parameters, and metrics specific to health equity in HTAs, enabling manufacturers to develop a unified health equity approach and invest in health equity-oriented products and data.

2. Practice clarity and consistency in health equity goals: Clear, achievable, and objective health equity goals must be defined so that manufacturers can plan early in product life cycles, allocate appropriate research budgets, and deliver the required evidence. In designing these health equity goals, governing bodies and HTA entities must translate broad health equity concepts and create concrete, measurable goals for which manufacturers can collect data.

3. Reward equity-focused interventions: Governing bodies and decision makers could reward or prioritize interventions that improve health equity and discourage those that exacerbate health inequities. Interventions that improve health equity could be incentivized in the form of less restrictive access or better pricing. For example, increasing the acceptable cost per quality-adjusted life year or the budget impact threshold could be considered for therapies that provide data related to improvements in health equity outcomes. Interventions that exacerbate health inequities could be disincentivized with reduced access or tougher price negotiations, especially in crowded therapeutic areas where there are alternate options.

4. Consider innovative approaches to data: HTA organizations and payers should consider accepting innovative ways of demonstrating impact on underserved populations, including the use of new data and metrics, real-world evidence, and advanced modeling techniques that can quantify potential differentiated impact on underserved and marginalized populations.

"Clear, achievable, and objective health equity goals must be defined so that manufacturers can plan early in product lifecycles, allocate appropriate research budgets, and deliver the required evidence."

Conclusion

There is a clear opportunity to update HTA methodologies to holistically consider health equity enablers and address systematic disparity drivers. More work is needed to mobilize HTA stakeholders (eg, professional societies and trade associations focused on health economics and/or HTA practice, manufacturers, researchers, payers, and providers) and align on core health equity objectives. Variability in health equity goals exists by market, with some focused more on racial or ethnic populations, while others are more focused on economic or geographic disparities. Evolving HTA methodologies to reflect the social, cultural, and ethical goals of the health system overall is critical. While consistency in overall approach is recommended, specific application within each market or HTA organization is likely required. Additional research and investment are needed to identify leading practice methodologies and align goals. Future efforts should include participation and perspectives from HTA entities, professional associations, research sponsors, payers and purchasers, researchers, and the communities of patients being served. Together, these diverse stakeholders can align on a realistic, actionable path forward to close disparities and achieve health equity.

References

1. Aluko Y, Garfield S, Perri K, Hildreth C, Minta B. 2024 Health Equity Outlook Report. Ernst and Young. Published 2024. Accessed April 26, 2024. https://www.ey.com/en_us/insights/health/2024-health-equity-outlook-report
2. Culyer AJ, Bombard Y. An equity framework for health technology assessments. Med Decis Making. 2012;32(3):428-441. doi:10.1177/0272989X11426484 
3. Agboola F, Whittington MD, Pearson SD. Advancing health technology assessment methods that support health equity. Institute for Clinical and Economic Review. Published March 15, 2023. Accessed March, 7, 2024. https://www.icer.org/wp-content/uploads/2022/07/ICER_Advancing-Health-Technology-Assessment-Methods-that-Support-Health-Equity_03152023.pdf 
4. World Health Organization. Health Technology Assessment Survey 2020/21. Accessed March, 7, 2024. https://www.who.int/data/stories/health-technology-assessment-a-visual-summary
5. Axler R, Reddy A, Husein F, Mittmann N. Equity-focused health technology assessment at CADTH. Can J Health Tech. 2023;3(10). doi:10.51731/cjht.2023.757
6. Bright J, Ridley M, Schultz E. Fulfilling the Promise of Equity in Value-Based Care: A Focus on Power, People, and Processes in Health Technology Assessment. Innovation and Value Initiative. Published September 2023. Accessed March 7, 2024. https://thevalueinitiative.org/wp-content/uploads/2024/01/2023-Health-Equity-Initiative-Report_FINAL_Accessible.pdf

The views reflected in this article are the views of the authors and do not necessarily reflect the views of Ernst & Young LLP or other members of the global EY organization.