The Patient Perspective Approach Should Guide Value Assessments of COVID-19 Vaccines

As the United States continues its mass rollout of the COVID-19 vaccine, key questions remain concerning how policymakers should value these treatments ¬– and how we should measure societal benefits associated with getting vaccinated. The type of framework used to make these decisions will have major conseqences for how future vaccination programs are implemented and it is therefore cruial that these discussions prominently feature the patient voice.

As we have seen, racial and ethnic minority groups are most impacted by COVID-19, which highlights the importance of including patient perspectives from communities largely underrepresented in value assessment. Yet challenges to more broadly include patient perspectives in value assessments persist. To start, there are limited elements of value that are derived solely from the patient perspective – a gap that has hindered the inclusion of the patient voice into current value assessment frameworks.

Meaningful patient engagement is critical to overcome the challenges in making value assessment more patient-centric. Engaging directly with patients to understand their values, experiences, and individualized treatment preferences will ensure that value assessment, and any subsequent health care decision making, more accurately reflects the individualized health care needs of patients. This has been the chief aim of the Patient-Driven Values in Healthcare Evaluation (PAVE) Center’s ongoing research efforts to establish meaningful and measurable variables that can be integrated into existing value assessment frameworks and health technology assessments.

One of our recent research projects makes use of a mixed methods design that integrate both qualitative and quantitative data, such as one-on-one discussions with patient stakeholders from diverse medical backgrounds including mental health, rheumatic disease and oncology, among others. Through a series of structured interviews and guided activities, patient representatives were asked to evaluate a list of value elements derived from PAVE patient stakeholders and guided by the lived experiences of patients. This stakeholder engagement, which formed the bedrock of this formative work to make value assessment more patient-centered, helped us identify, synthesize and refine a distinct set of 42 unique patient-informed value elements from which prioritized disease specific value elements can be pulled for use in economic evaluation and value assessment.

We recommend evaluators tailor these patient-driven value elements, using qualitative methods, to the preferences of the target patient community. The tailored set of value elements then can be quantified and weighted to reflect their importance in patient decision-making. We have research underway to use this approach to assess the value of therapies for Chronic Obstructive Pulmonary Disease and for Major Depressive Disorder.

The PAVE patient-centered value elements hold great promise for understanding patient decision-making relevant to the emerging vaccines. Applying this approach, we can tailor the value elements to patient communities, including ethnic minorities and those most negatively impacted by COVID-19. Quantification of patient preferences for the benefit-risk of vaccines for COVID-19 will enable a patient-centered value assessment of the vaccines recently approved as well as those in the pipeline.

Our goal moving forward is to advance methods to tailor the value elements to individual patient groups, to quantify these elements to assess meaningful and patient-centered benefit-to-risk trade-offs, and to translate this into economic evaluations and health technology assessment. Above all, our work provides a series of novel, individualized variables that will help drive future research into patient-centered value assessment. And now, we have PAVEd a way forward to do so.

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Susan dosReis, PhD is a professor in the Department of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy and director of Patient-Driven Values in Healthcare Evaluation (PAVE) and a PhRMA Foundation Center of Excellence.