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Patients and advocates urge PDAB to center out-of-pocket costs; some industry groups warn on orphan-drug reviews
Summary
Multiple patient groups, AARP, and consumer organizations told the PDAB to prioritize patient out-of-pocket burdens and access; industry and trade groups warned that reviewing orphan-designated drugs risks undermining rare-disease protections and access.
At its May 20 meeting the Oregon PDAB heard extended public comment from patients, advocacy groups and industry representatives. Patient advocates and consumer groups repeatedly asked the board to prioritize out-of-pocket costs and to consider how plan design, formulary changes and prior authorization cause 'affordability shifting.
Tiffany Westrich Robertson, representing a two-part coalition of patient organizations, cited an 18-month study of 537 respondents that documented repeated "affordability shifting," where the same person paid different amounts for the same drug over time because of insurance and formulary changes. "Policies focused primarily on price may reduce spending somewhere else within the health care system, but they do not focus on improving out of pocket costs for patients," she said, urging continued emphasis on point-of-sale caps and rebate pass-throughs.
A number of patient advocates and consumer groups urged PDAB to pursue patient-centered recommendations, including out-of-pocket caps and reforms to ensure savings reach patients. AARP volunteer Lee Bliven described large plan-paid totals and the strain on families when additional assistance is not available.
Industry commenters voiced concerns about orphan-designated products. Primo Castro of the Biotechnology Innovation Organization said the board risks undermining federal incentives if it does not implement the orphan exclusion, and Merck's Terry Lee urged the board to withdraw Keytruda from review, arguing that the PDAB statute exempts orphan-designated drugs and that reviewing some indications but not orphan populations would imperil access.
Board response and staff follow-up: staff and board members acknowledged the testimony, reminded attendees the feedback forms remain open for three months and said staff will circulate contact information for consumer assistance available through the Department of Consumer and Business Services.
Why it matters: Public testimony frames the policy trade-offs PDAB will weigh: patient-focused reforms that reduce out-of-pocket costs and system-focused approaches that may have differing distributional effects. Industry objections to orphan reviews are likely to prompt legal and procedural questions before the board makes decisions.
Next steps: PDAB will incorporate public feedback into rolling packets and staff will return in June with packet materials and draft rubric ranges for board review.
