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Industry and patient groups press PDAB on orphan‑drug reviews and patient engagement
Summary
At the Feb. 18 PDAB meeting, industry groups raised legal and procedural objections to reviewing orphan drugs and to how a single insulin product had been selected previously, while patient advocates urged clearer, patient‑focused community forums and prioritized drugs already targeted by Medicare negotiation.
Public witnesses at the Oregon Prescription Drug Affordability Board meeting on Feb. 18 urged caution and clarity as the board refines its approach to affordability reviews.
Daria McGrew, speaking on behalf of "pharma," told the board she had "serious concerns about the process used to select 1 insulin product as potentially unaffordable," saying the board’s earlier approach had shifted votes to focus on a single product without a clear process. She also argued that the statute’s orphan‑drug exception should preclude reviews by indication because pharmacy claims lack diagnosis codes to separate orphan from non‑orphan use.
Primo Castro of the Biotechnology Innovation Organization (BIO) echoed those concerns, saying, "BIO strongly believes that orphan drugs, including those with multiple orphan indications, should not be subject to the drug review process given the importance of the orphan drug exception." BIO urged the board to avoid undermining federal incentives for rare‑disease research.
Patient advocates and other stakeholders gave contrasting recommendations. Lauren Sant, executive director of the Caring Ambassadors Program, urged PDAB to design community forums so patients can tell their experiences and recommended survey and narrative methods rather than technical presentations. John Mullen, president of the Oregon Coalition for Affordable Prescriptions, thanked the board and said his organization faces uncertain funding as it continues advocacy work.
Insurer Regence’s Mary Ann Cooper warned the board that sweeping system reforms—proposals to delink PBM payments, eliminate specialty tiers or ban midyear formulary changes—could have unintended consequences, raise premiums and duplicate federal efforts unless accompanied by actuarial analysis and collaboration with plans, PBMs and providers.
Charlie Fisher of OSPREG urged prioritizing drugs that are part of the federal Medicare price negotiation program, noting the federal negotiations produce ready benchmarks and potential savings; he said, "If a drug is too expensive for the federal government, it's probably too expensive for Oregonians." Board members took public comments into account and discussed the legal and practical complexity of handling orphan indications; staff cautioned that parsing diagnostic codes in the APAC data is challenging and may not be feasible this year.
What’s next: The board asked staff to collect more carrier data for a smaller subset of drugs and to return with draft recommendation language for the March meeting. Public forum dates for April and May will be posted, and staff invited help with outreach and question design to encourage patient participation.
