How do we advance equity goals in health technology assessment (HTA)?

Pharma News: In the words of Nelson Mandela “Health cannot be a question of income; it is a fundamental human right.” Health innovation must centre the ethical imperative of equity in order to achieve cost and efficiency goals.

While health technology assessment (HTA) agencies have primarily focused on efficacy and safety of a medicine or medical device, the Institute for Clinical and Economic Review (ICER) has published a new white paper evaluating the functions of HTA through an equity lens. It has proposed key methods through which HTA can support society’s goal of improving health equity* for racial, ethnic and other socially marginalised groups.

The ICER’s recommendations are directed toward US and international HTA agencies, for pharma, medtech and biotech companies, researchers who run clinical trials, patient groups and advocates, and all stakeholders including payers that factor HTA into reimbursement decisions.

This is locally relevant as the current HTA Review Terms of Reference (ToR) refers to funding and approval pathways that give consideration to equity of access in relation to First Nations people, people from culturally and linguistically diverse backgrounds, those living in rural and remote areas, people of low socioeconomic status and other marginalised groups in our communities.

“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.

“Decision-makers want to understand the implications and opportunities for health equity when they use evidence to guide pricing. 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.”

The underlying paradigm of HTA limits the patient voices needed to address the roots of health inequity. Areas of particular concern include the methods used to interpret clinical trial evidence that is not adequately representative of racial and ethnic minority groups, the way that quality of life and health gains are measured within cost-effectiveness analysis, the question of whether special priority should be given to the health of certain groups in society in order to close health disparities, and the role provided for patients and families to contribute to the HTA process.

ICER’s Director of Health Economics, Dr Melanie Whittington, stated “ICER has experimented since its founding with different ways to make the consideration of factors beyond clinical effectiveness and cost-effectiveness more transparent and consequential in technology appraisal. There is a need for HTA bodies to know how to incorporate equity into the methods of health technology assessment, and whether that can be achieved through novel methods that are extensions to traditional cost-effectiveness analyses, through evidence-informed deliberative practices, or both.”

Learning about the experience of diverse patients and their views of the potential impact of the intervention on health equity should be a key goal of any HTA program before it begins to analyse evidence. However, taking steps to ensure inclusion of diverse consumer voices may prove challenging in light of the speed and intensity of the HTA assessment. Barriers to gaining input from patients from diverse backgrounds include health literacy, lack of trust in healthcare authorities, and geographic and socio-economic factors.

To gain more diverse input into HTA evaluations, the authors recommend broadening connections with patient and public networks, making informational materials accessible to patients of diverse backgrounds, addressing logistical barriers to patient involvement and providing relevant compensation to consumers for their time. Conducting social media research is another consideration to improve the representativeness of patient insights as long as appropriate measures are taken to address the ethical, legal and social considerations in gathering and using the data for HTA purposes. In fact, a framework for applying social media research to HTA is currently under development by the HTAi Patient and Citizen Involvement Group.

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.

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 healthcare 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.”

Finally, the authors recommended 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. 

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*Health equity means the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.