ICER White Paper Recommends Health Technology Assessment Strategies to Improve Care Equity

A white paper published by the Institute for Clinical and Economic Review

(ICER) established a series of recommendations and guidelines for health technology assessment (HTA) that aim to improve health equity in the United States.¹

HTA, which evaluates evidence on new technology innovations—including new drugs or surgical devices—provides information that health insurers and policymakers can use while making decisions on insurance coverage, payment, and pricing. The paper, titled “Advancing Health Technology Assessment Methods that Support Health Equity,” explored current HTA methods in the United States and potential opportunities for improvement from a health equity standpoint.

The goal of the paper is to establish HTA methods that ensure these evaluations contribute to the overall goal of reducing health care disparities that affect racial, ethnic, and other socially disadvantaged groups. While not the only goal, health equity is a key goal of HTA conducted by groups such as ICER. “As the US wrestles more openly with its legacy of racism and broader forms of discrimination, the need to re-examine the relationship between HTA methods and ethical values has become urgent,” the authors wrote.

The paper’s recommendations are directed toward US and international HTA agencies, life sciences companies and clinical researchers who run trials, patient groups and advocates that interact with industry stakeholders, researchers and organizations that partner with HTA activities, and payer and life science companies that factor HTA into pricing and coverage decisions.

Formalizing Equity Assessment and Engaging Patients

The authors’ first recommendation regarding the selection of interventions is to establish formal processes for factoring health equity into topic selection, including evidence on whether certain groups experience systemically worse outcomes in a particular treatment area. But equity must be factored in even when a topic impacts all racial and ethnic groups equally, the authors noted.

HTA bodies can also improve by engaging with patients and patient groups during reviews to gain insight into patient views on the possible impacts of the intervention being assessed. Especially in cases when the technology being reviewed involves a condition known to be high priority in certain groups, gaining community insight is important, the authors wrote.

To engage patients and patient groups in the HTA process, recommendations include forging connections with patient and public networks to gain input from a diverse population; making informational materials accessible to patients of diverse backgrounds; gathering patient-based evidence from places with high accessibility, such as social media research; and forming diverse external advisory groups to provide one-time or ongoing input for HTA.

Evaluating Diversity in Clinical Trial Populations

Using established racial and ethnic categories, trial populations should be evaluated consistently during the HTA process, the authors advised. Diversity should be evaluated not just in terms of representing the US population, but also based on the epidemiology of the specific condition to ensure the intended patient population is represented. While this can be difficult due to a lack of reliable disease-specific prevalence estimates for some groups and conditions, and in those cases trial diversity should be evaluated based on population demographics, the authors recommended.

Establishing a minimum threshold for racial and ethnic group representation in clinical trials should also be a priority, the authors noted. During trial diversity evaluation, an overall diversity rating scale should be provided. In addition to typical race and ethnicity categories, subpopulations should also be incorporated into HTA considerations.

“On race and ethnicity, the ICER-developed framework assigns a score that ranges from 0 to 3 to each racial and ethnic category based on the estimated participation-to-prevalence ratios,” the authors explained. “Then, using the cumulative score and pre-defined cutpoints, a rating of "good," "fair," or "poor" is used to communicate the overall level of racial and ethnic diversity in a clinical trial.” If evidence supports significant differences in the net benefits in a specific subgroup compared with others, the authors recommend considering separate evidence rating and judgment for that population.

Considering Opportunities for Disparity Reduction

When an intervention has potential to reduce persistent health disparities, HTA assessment of such an intervention should be prioritized—but this decision is traditionally left to committee deliberation and often lacks evidence. Determining and bolstering the types of data that can help empirically measure potential equity impacts across disadvantaged populations would improve the HTA process.

Decisionmakers should also be informed of the relative prevalence of conditions across subpopulations, as well as relevant data that may highlight opportunities to reduce disparities with an innovation. Keeping in mind that health disparity causes are multifactorial, the authors recommend against using any single measure of disparities when making decisions.

Economic evaluation via methods such as cost-effectiveness analyses should also be reconsidered, the authors wrote, proposing novel economic methods that may be more effective. Equity-informative economic evaluations, for example, are extensions of traditional cost-effectiveness analysis that can “incorporate the distributional impacts of a health care treatment based on relevant equity stratifications.”

“There are numerous equity-informative economic evaluation methods that are capable of examining inequality differences and incorporating them alongside more traditional cost-effectiveness methods,” the authors wrote. “However, a limitation common to all of them is the current lack of data available to rigorously and robustly conduct such analyses.”

When equity-informative economic evaluation demonstrates potential to reduce disparities, this should not translate to endorsement of higher prices, the authors cautioned. Allowing the goal of disparity reduction to justify higher pricing would only increase barriers to care, they noted.

Finally, the authors recommend implementing deliberative procedures to highlight equity-relevant information in HTA reports and integrate that information into determinations of value. The possible tension between giving higher value to equity-promoting interventions and mitigating disparities should also be highlighted openly during deliberation, the authors noted. 

“Progress must be made to ensure that the methods of HTA fully incorporate considerations of health equity,” said ICER’s vice president of research Foluso Agboola, MBBS, MPH, in a statement.² “Decision-makers want to understand the implications and opportunities for health equity when they use evidence to guide pricing and insurance coverage. We have looked hard at every step of our work to ask whether we and other HTA groups can do better. One approach we will spearhead is a framework to evaluate clinical trial diversity, which will elevate the conversation on clinical trial diversity and enhance transparency and accountability, consequently promoting equity in access to clinical trials of new drugs.”

References

1. Agboola F, Whittington MD, Pearson SD. Advancing health technology assessment methods that support health equity. Institute for Clinical and Economic Review. March 15, 2023. Accessed April 7, 2023. https://icer.org/assessment/health-technology-assessment-methods-that-support-health-equity-2023/

2. ICER publishes white paper recommending health technology assessment methods that support health equity. News release. Institute for Clinical and Economic Review. March 15, 2023. Accessed April 7, 2023. https://icer.org/news-insights/press-releases/strongicer-publishes-white-paper-recommending-health-technology-assessment-methodsbrthat-support-health-equitystrong/