Patient Experience Data Offer Value but Pose Evaluation Challenges

Patient experience data (PED) are less a new category of evidence than a new label for outcomes payers already use, Jennifer S. Graff, PharmD, founder and principal at Innov8 Health Policy, told The American Journal of Managed Care^® in an interview at the Academy of Managed Care Pharmacy Nexus 2026 meeting, where she was a panelist for the session “The Evolving Role of Patient Experience Data in Formulary and Coverage Decision-Making.”

Graff explained that Congress has defined PED as information about how patients experience a disease and its treatment. They can come from anyone, cover physical and psychosocial impacts, and include patient preferences about benefits and risks. Patients, clinicians, caregivers, or parents may report these data, or they may be captured through performance outcomes such as the 6-minute walk test. In that sense, she said, PED is already a part of the existing repertoire of clinical outcomes but has a new name.

In addition, PED is already informing formulary decisions, Graff noted, even when it is not identified as such. In eosinophilic esophagitis, for example, clinicians may track eosinophil counts but may also ask patients how well they can eat without trouble swallowing; that second measure reflects PED. In many conditions, these outcomes serve as primary end points in clinical studies, while in others they appear as secondary or exploratory outcomes, she said. The task for decision-makers is to recognize these data and understand what makes them high quality, according to Graff.

Evaluating these data remains difficult, however; Graff said stakeholders currently lack a clear way to determine whether PED is reliable, credible, and meaningful to patients. Although the FDA has issued 4 guidance documents on patient-focused drug development, totaling about 189 pages, they were written for researchers conducting studies rather than for those evaluating them.

As a practical step, Graff recommended that formulary decision-makers consult the Voice of the Patient report for a given disease and check whether the outcomes patients care about most are those being measured in trials. If they align, she said, evaluators can trust the data are meaningful. What is still needed is “a way to help evaluators assess the reliability and credibility,” she concluded.