Prescription Drug Affordability Board Activity through January 27, 2025

After routine items, Executive Director Ralph Magrish said that staff were looking into commercially available products or services to provide access to varying data points that would address frustrations expressed by board members and through the public comment process.

Beginning in February, there will be a standing agenda item about legislative updates specific to bills related to the pharmacy supply chain, coverage and reimbursement of prescription drugs. This update will be provided directly from DCBS policy staff.

The board received six written comments from Dharia McGrew from PhRMA, Rainier Simons and Jen Laws from CANN, Tiffany Westrich-Robinson from EACH Coalition, Tony Coelho from Partnership to Improve Patient Care and Dr. Harry Gewanter with Let My Doctors Decide Action Network.

Oral comments were provided by:

Eric Lohnes, PhRMA:

PhRMA requested the board to reconsider its public comment timeline. The current practice of posting materials one week in advance and requiring public comment on Sunday mornings only allows stakeholders two to three days to read, evaluate, and respond to the complex issues, which is insufficient time. They suggested amending the board's policies to commit to posting meeting materials at least two weeks prior to each meeting.

The technical feedback on the carrier data call template suggested that it didn’t make sense in the reality of the supply. The call asked plans to report distinct values of price concessions from manufacturers and pharmacy benefits managers (PBMs). Manufacturers typically pay rebates directly to PBMs, which then pass them on to health plan clients or employers. This may have contributed to confusion in affordability reviews last year. The board members had no information on rebates, but some affordability reviews had information titled PBM Concessions. We ask that you look at both the carrier data call and the review template to clarify these terms.

Ben Hughes, Health HIV:

Funds from clinics and CBOs support the broader community through contracts with health departments and service providers. Implementing upper payment limits without fully accounting for the interconnected system risks undermining access to medications and services for people living with HIV. To address these concerns, a rigorous data framework is proposed to ensure decisions on UPLs are supported by accurate, Oregon-specific data.

Hughes asked that the board pause and evaluate UPL implementation until federal guidance stabilizes, prioritizing reforms with proven efficacy to ensure Oregonians can access necessary medications. Implementation of UPLs should be informed by comprehensive data for stakeholder engagement.

Rainer Simons, CANN:

Mr. Judge's conflict of interest led to his recusal from voting on policy recommendation number 5, but he was active in the discourse leading up to the votes. He should have also recused himself from voting on policy recommendation 9 regarding dispensing fees and reimbursements, as it was highly related to his employer's profits. However, he provided significant input to the discourse concerning the measure and ultimately voted against it. While the law may not forbid commentary towards votes on issues a board member recuses themselves from, doing so is an ethical violation and is not proper management of trust in terms of the public interest.

Pharmacy protections should be prioritized over affordability, as functionally inaccessible medication may not be affordable if the pharmacy is closed or providers are unavailable.

The board approved policies to guide its work when it was established in June 2022.

The policies are posted on the PDAB website. Every year, the board reviews the policies for possible amendments. See Title: Policies and Procedures.

Policy Number 01, “Policies and Procedures” have the following items up for board vote:

11. Executive session - The removal of the last sentence under executive session that states that electronic records for the executive session are securely stored. There's no recording of the executive session so this can be deleted.
12. Meeting attendance, absences, and participation - Add additional clarifying words to indicate that on average board members are expected to participate approximately 10 to 15 hours monthly, including board meetings, meetings with staff, and board material reviews.
13. Board Issued iPad - Board members need to login into state issued iPads at least every 45 days and change passwords every 90 days. Board members will receive email or text messages for those reminders.
14. Coordinating with other entities: Board members are not obligated to speak about board business outside of board meetings and may delegate those requests to the staff if needed.

Also, board members must disclose at the beginning of each board meeting any meetings or work conducted with entities or individuals related to board activities since the last board meeting. This can include serving on other boards or committees, or engaging in business matters related to pharmacy supply chain.

Board members felt it would be “too much” to discuss all of their daily work at the beginning of every meeting, and that it would be too difficult to apply. Board chose to send the commentary back to the DOJ to review it and come up with language before the policy is adopted.

Language for the board and DOJ to review: “[Whenever possible] If a board member intends to abstain from voting on any matter or section under consideration, they must declare their intent to abstain prior to discussion related to the vote. A declaration of abstention [may] include a brief explanation such as a potential conflict of interest or other relevant reason, to ensure transparency and maintain trust in the decision-making process.”

Policy Number 04, “Public Comment” had the following item up for board vote:

2) Policy Statement:  Due to board meetings and time constraints only one person per organization will be added to the list of public comment speakers for each board meeting.

The board discussed the deadlines for written and public comments before meetings and public concerns about having insufficient time for review. The existing policy was that people had to submit written comment 72 hours before a PDAB meeting and sign up for oral comment no later than 24 hours before. They changed the written comment deadline to 48 hours before meetings.

The board voted to approval all policy changes except for Policy Number 01, “Policies and Procedures” 16, which was referred for staff to discuss with DOJ and the Ethics Commission.

The board will begin the affordability review process in upcoming months to prepare the Department of Consumer and Business Services. The board reviewed the draft template included in today's agenda materials and in PDF on the website. The board will select a subset list of drugs and insulin products from the preliminary list, which are then sent to health insurance carriers for additional information.

See template in the agenda. The template is an excel spreadsheet that gives instructions for health insurance carriers to fill out. Tabs include company information, data limitations and notes, claims and cost, plan design and price concessions.

One purpose of the PDAB is to conduct affordability reviews on prescription drugs and insulin products. In this meeting, the board reviewed the preliminary list of prescription drugs and insulin for affordability review, which will begin in the coming months. The lists are posted on the PDA website, and links are included in today's material packets.

Previously the board completed Phase 1:

The board began Phase 2, selecting prescription drugs for affordability review. See slides below.

Staff shared the spreadsheet with detailed drug and carrier information.

Carrier Prelim RX List 24-25 (screenshot, not whole list)

The board cannot review any drugs associated with rare conditions or that have orphan designation. Once those medicines are filtered out, there are 95 drugs left to review.

• Board member question: The biosimilar Humira was initially listed without an orphan designation, but it was later discovered to have one for at least one indication. The board staff should consult with a clinical consultant to verify the accuracy of the data.
• Board member question: Are physician samples included in the data? No.
• Board member question: How did we use guidance last year when making this decision around therapeutic alternatives? And the number to consider that there's market competition with a number of therapeutic alternatives? I mean, so if we're trying to pick 5 or 7 or 3? What did we as a board land on for that number?
  Answer: There was never any kind of goal or target of how many therapeutic alternatives would be identified. We retain a clinical consultant, a doctor at a pharmacy who's on faculty at Oregon State University College of Pharmacy to assist us in identifying those.

Drugs part of IRA CMS negotiation list:
One of the decisions from the first review was to remove any of the drugs that were being reviewed under the Centers for Medicare & Medicaid Services (CMS) negotiation list. The CMS will be releasing a new list in March of the new set of drugs to review. There's no obligation for the board to remove those drugs knowing that the financial impact really won't be seen until 2027 or 2028.

Insulin list:
Screen shot of spreadsheet (posted online)

The board discussed how to pick drugs, and considered filtering the list by the following:

1. Remove all drugs with orphan drug designation
2. Drugs on the IRA
3. Generics
4. Drugs that have generics
5. Filtered by most costly
6. Sort by number of carriers.

The board discussed inaccuracies in column information: conflation of “therapeutic equivalent” vs. generic, biosimilar, and therapeutic alternatives, and asked for 340b and FQAC data.