Women and Value Assessment: Striving to Capture the Patient Experience

By Liz Hay, SWHR Communications Intern

When assessing the economic value of new drugs and other health care interventions, the factors that consider individual human needs are the most difficult to quantify but also the most essential to include.

For example, women have unique and diverse needs as patients, as caregivers, and as the primary health care decision-maker for their family. Their preferences and values in each of these roles must be taken into account. If the human element is left out of value assessment, women are left out.

SWHR engages with organizations that conduct health care value assessments to advocate for the integration of women’s health priorities into these assessments. At SWHR’s June Policy Advisory Council meeting, experts from the Innovation and Value Initiative (IVI), Patient-Driven Values in Healthcare Evaluation (PAVE), and the Institute for Clinical and Economic Review (ICER) discussed the current environment and the future of value assessment.

The Current Landscape

A recent report from the National Pharmaceutical Council (NPC), a health policy research organization, argued that there is no “best” framework for determining the value of a health care product because there are many ways to measure value. At the same time, there is an emerging consensus that the measures and inputs used in value frameworks must better reflect real-world populations. As such, the U.S. health care system needs a robust ecosystem of value assessment frameworks to inform various health care stakeholders.

SWHR’s value assessment principles for women urge the inclusion of women’s diverse value concerns in every approach to assessment. “Women especially juggle many different roles and responsibilities and what they desire most in a treatment and the ultimate benefit of that treatment will depend upon how this affects their daily responsibilities and how they are able to fulfill their role as caregiver, mother, friend, and decision-maker,” said panelist Susan dosReis, PhD, director of the University of Maryland’s PAVE Center.

Patient Heterogeneity

A significant challenge for value assessment frameworks is capturing the needs and preferences of the wide range of patients affected by any disease state. Sex and gender are factors that differentiate the health experiences of women and men, along with other identity and contextual factors that further individualize women’s health needs.

The panelists emphasized the importance of understanding patient heterogeneity, not only in clinical capacities, but also in the ways that patients prioritize tradeoffs between risks and benefits. Health interventions for the same disease may have drastically different impacts on lifestyle, and every patient weighs those outcomes differently.

IVI Executive Director Jennifer Bright said that although patient preferences have often been dismissed, they are a necessary consideration of value assessment frameworks. “We have to understand the preferences component if we’re going to have a three-dimensional picture of what value means,” she said. Bright recently co-authored a commentary in the American Journal of Managed Care with former SWHR CEO Amy M. Miller, PhD, on the importance of understanding the impact of patient heterogeneity on optimized treatment outcomes.

Real-World Evidence

Value frameworks rely on data and algorithms to generate assessments of specific treatments. While data from clinical trials are a critical source, they do not always capture the impact of a potential treatment on patient quality of life or reflect differences in treatment outcomes based on heterogeneity. To help fill this gap, value frameworks should incorporate real-world evidence (RWE), data collected during routine health care practice (such as electronic health records, claims and billing activities, and product and disease registries). For example, as part of its updated framework, ICER plans to update previous assessments to include insights from RWE. SWHR’s review of ICER’s updated framework can be found here.

Representing diverse subpopulations in value assessment relies not only on the existence of data, but also on its availability and accessibility. Patient data often ends up privately owned and inaccessible to patient groups, clinicians, and researchers. “To me, that’s where the goldmine is — unlocking the data sources and making it a common resource that can fuel research to elevate patient perspectives, that can help us understand value,” Bright said. “That’s the thing that will markedly move us toward better evidence.” She also hopes that the rapid data sharing occurring because of the COVID-19 pandemic may serve as a model for widespread change.

Patient Engagement

Yvette Venable, ICER’s new vice president of patient engagement, said that centering the patient experience at early stages of research and development for health care innovations is essential. “You can’t really define value in health care without fully understanding the experiences of those people who are affected by a condition,” she said.

Overly academic language and technical processes can make it difficult for patients to participate in value assessment. Initiatives such as University of Maryland’s PATIENTS Program are bringing patients into the research process, but further advances must be made to incorporate patient perspectives in study designs that can inform value assessment and health care decision-making. Continuing to simplify avenues for patient engagement will facilitate a collaborative approach that is inclusive of all relevant and at-risk patient populations.

Patient advocacy organizations often serve as resources in value assessments, but dosReis reminded the panel that large patient advocacy groups may not fully represent patient subgroups like the uninsured, racial and ethnic minorities, or other medically underserved populations. As with other areas of value assessment, heterogeneity must be actively considered in patient engagement.

What’s Next?

Value assessment is evolving rapidly.  The field’s need to adapt to different health care decision contexts and emerging data needs correlated to those decisions has never been greater.  The COVID-19 pandemic has accelerated novel approaches in health care delivery, data sharing, real-world clinical trial design, and how to measure value.  For example, telehealth has been crucial for accessing medical services shut down by quarantine measures but it also should not be a replacement for services where in-person visits are essential.  A practical first step is to understand what patients’ value about telehealth and for what situations, and women are uniquely positioned to provide meaningful perspectives.

Moving forward, it’s clear that patient-first thinking must shape the future of value assessment. Engaging patients in a substantial way at every step of the process is the key to effectively identifying and incorporating diverse patient preferences and values. SWHR remains committed to advocating for the integration of women’s health priorities and calls on the active participation of other stakeholders to work toward health equity in value assessment.