Prescription Drug Affordability Board Activity, August 2025

Director updates included a note about skipping general public comment to make time for the rulemaking hearing, which staff clarified was not a new normal. Staff asked that written comments be sent to the board's email and noted that they anticipate an additional hearing on the Enbrel UPL. They also acknowledge comments about the flow of the hearing and the fact that the comment is at the end of the meeting. Lastly, staff said there were still open PDAAC positions. 

Staff clarified that the purpose of this rulemaking hearing was to establish an upper payment limit (UPL) for Enbrel. The board determined that the drug is unaffordable for Colorado consumers during drug reviews. 

Staff presented information to the board, starting with a recap of how the board arrived at this point in the rulemaking process. Staff also added three new metrics for consideration by the board in rulemaking hearings: drug shortage information, retail coupon amounts, and impacts to older adults and people with disabilities. They did not find a shortage for Enbrel or its therapeutic alternatives since monitoring started, and their retail coupon analysis showed the cost of the coupon amount ranged from $5 to $12 on GoodRx. Staff also updated the graph packet with additional information about the age distribution of Enbrel users in Colorado. They mentioned that they will not consider research and methods that employ dollars per QALY or similar methods and that they've reached out to many stakeholders to encourage testimony. 

The board requested a review of some of the graphs staff put together. While looking through this, the board discussed how a UPL would be enforced and how pharmacy savings would be passed to consumers, which the statute requires transparency around. They also spoke briefly about the Medicare Maximum Fair Price (MFP) and how it could affect drug prices. 

The board entered an executive session to talk about confidential pricing information. 

The board discussed using the MFP to arrive at an upper payment limit number or range. One member supported using the MFP to leverage research and negotiations the government had already done. Another member agreed that they should use the MFP: pharmacies will be offered drugs at that price, and there are already mechanisms in place. 

The board reviewed who the UPL would apply to and discussed how the UPL would affect pharmacy economics. Members discussed the idea of setting the UPL at a percentage over the MFP, including one board member, who proposed setting the limit at 5% over the most recent MFP, or another number that allows for inflation. They also discussed what would happen if Medicare stops negotiating MFPs. 

The board entered an executive session to receive legal advice on whether it could reconvene to reset the UPL criteria if the MFP should go away, as well as what the methodology would be if a drug does not have an MFP. Members concluded they could set a UPL based on the best data available in the absence of an MFP. 

The board amended and approved the draft rule, adding a reference to the dollar amount of the MFP and specifying that that figure must be revisited annually. 

12 people spoke at the meeting. Additionally, written testimony is here. 

Vanessa Lathan, with the Patient Inclusion Council, raised concerns about the impact of the UPL process on patients, asserting that 

• any UPL the board sets will still be unaffordable to vulnerable uninsured patients. 
• UPLs do not address the systemic drivers patients have identified, and
• there has not been meaningful engagement from impacted communities. 

The board chair acknowledged that UPLs will not make drugs affordable to uninsured patients, but that UPLs are the only tool the board has the power to implement. 

Tiffany Westrich-Robertson, with Ensuring Access through Collaborative Health and the Patient Inclusion Council, suggested that the board had not looked into the “why” behind patient-reported affordability challenges. Patient Inclusion Council survey found that changes in insurance out-of-pocket costs, accumulative costs, and insurance delays were some of the factors creating affordability problems and causing patients to skip or stretch doses. 

The board asked Westrich-Robertson to expand on the survey findings with non-Medicare patients. She responded that regardless of the drug, self-reported affordability challenges varied because of insurance and a lack of education about patient assistance programs. 

Katelin Lucariello, representing PhRMA, was concerned that the board was moving forward with a UPL without providing clear guidance on how it would be implemented and without establishing a process to review and rescind it. She said these processes could affect insurance coverage, which could impact pharmacy reimbursements and patient access downstream, and brought up operational and legal issues around using the MFP. 

The board chair responded that staff was working on a process to review UPLs at any point after they are set. 

Primo Castro, on behalf of the Biotechnology Innovation Organization, was concerned with the lack of transparent and consistent methodology in the rulemaking approach when setting the UPL. He said UPLs will disproportionately impact vulnerable populations by encouraging formulary exclusions, placement on less favorable tiers, and stricter utilization management. 

The board asked for clarification about how a UPL would cause a drug to be excluded from formularies or put on a higher tier. Castro replied that not all members of the ecosystem had been questioned. 

Bethany Pray of the Colorado Center on Law and Policy supported using the MFP to set the UPL price. She said that patient assistance programs are often helpful for patients, but providers have told her that it’s difficult to enroll patients in those programs. She also said that a UPL would help with premium increases in the future. Lastly, she expressed the hope that the PDAB’s actions would guide pharmaceutical companies in avoiding regulation. 

A board member asked Pray how payers would react to a UPL. She thought that other manufacturers would look at the UPL set on Enbrel and proactively lower prices to avoid having UPL sets on their drugs. 

Amy Goodman from the Colorado BioScience Association testified that the PDAB had no clear or consistent methodology for determining UPLs, since there had been no discussion of how to set a UPL with no MFP or for updating UPLs. She was also concerned that the board had not sufficiently explored to whom UPLs would apply, how they would be implemented, or what effects they would have down the supply chain. She referred to survey results published by Avalere that supported the idea that payers and PBMs made changes to formulary changes largely based on changes in rebates. 

The board responded that, given the complexity of the system, they look at all available data when considering a UPL. 

Derek Flowers from the Value of Care Coalition followed up on a conversation that ensued from the last meeting related to his testimony. The board said they’d like feedback from insurers and PBMs about their plans to manage the impact of UPLs once they’re set, but there hadn’t been a follow-up. Citing the Avalere survey mentioned in previous testimony, he flagged potential pharmacy stocking issues, formulary changes, and patient access issues. 

The board chair again asked about the why behind these assertions. Flowers replied that asking relevant stakeholders would be the best way to get a response and that there is more information in the Avalere survey. 

Austin Blumenfeld of Centennial State Prosperity testified in support of a UPL on Enbrel. He explained how often his organization hears about the cost of prescription drugs in their townhalls and surveys. He said that Coloradans support the board and that many people are overwhelmed by the cost of prescription drugs. 

Candace DeMatteis from the Partnership to Fight Chronic Disease talked about the Avalere study, which they commissioned, to ask insurers about the potential impact of UPLs, which found that patient costs would not decrease, but patient access likely would. 

One board member asked how a UPL would cause higher prices or disruptions to pharmacies. 

DeMatteis replied that the UPL would be set on the pharmacy reimbursement, not the acquisition cost. 

The board and staff clarified that this was incorrect; the UPL would be set on how much the pharmacy pays for a drug. 

DeMatteis mentioned that insurers also identified the implementation and renegotiation of some multi-year contracts as an area of costs. 

Bridget Dandaraw-Serritt (Advocates for Compassionate Therapy Now) seconded Vanessa Lathan's comments, adding that she was concerned about formulary changes based on UPLs’ impacts on rebate structures, which would incentivise the use of other medications. She said that there needs to be a waiver process for patients who cannot access a drug because of a UPL standing in the way. Lastly, she opined that UPLs may encourage alternative funding programs. 

The board asked how she saw the waiver process working; she replied that it should be on an individual basis for patients who cannot take any other medication. One board member expressed support, especially in the case of insurance providers requiring step therapy; other board members questioned whether waivers are in the scope of the PDAB, or if that would need to be addressed with pending PBM legislation. The board also asked her to expand on some of the problems with alternative funding programs. 

Ranier Simons from the Community Access National Network was concerned about the board moving forward with deliberations without solid patient protections. 

Staff responded that they were planning to present the outline of the monitoring plan—including prospective rate review filings, carrier formularies, and tiering—later in the meeting. They encouraged public feedback on this process. 

Emily Zadvorny from the Colorado Pharmacists Society raised concerns about how drugs with UPLs would impact pharmacies and, therefore, patient access to drugs. She commented that this discussion was different from the Medicare drug price negotiation program, which, she said, as many as 90% of independent pharmacies were declining to participate in because there was no guarantee that they could stay afloat. She urged officials to protect a margin for pharmacies rather than leaving private companies to determine the margins in their contracts. She also encouraged the board to ensure a fair dispensing fee for pharmacies. 

A board member sympathized with Zadvorny’s concerns, requested that staff pull data around the average administration fee, and asked whether there was some way to include this in the rule. Another board member was unsure if the PDAB statute acknowledges dispensing fees. The board chair asked staff to look into these numbers and see whether the statute would allow the PDAB to do anything regarding dispensing fees. 

The board voted to continue the rulemaking hearing in the next meeting. 

Staff presented affordability reviews that included the corrected data for Cosentyx, Stelara, and Enbrel for approval. Incorrect data was the result of the miscategorization of claims made by one of the PBMs that reported into the APDC. Staff determined that Cosentyx was still eligible for the process. The board looked at some of the updated data and discussed some of the statistics, including increasing copayments and overall cost, and determined that there was an affordability issue for Coloradans. They moved to approve the Costentyx affordability review summary with the addendum, confirmed that there is an affordability challenge, and to begin UPL rulemaking for Cosentyx. 

Staff presented the steps involved in implementing UPLs and fielded questions from the board. Afterward, they looked at a broadly outlined monitoring process for after a UPL is in place. The staff member mentioned that they were expecting to take a year to see how indicators are trending. In response to a board member's question, staff clarified that they will examine whether prior authorizations are becoming more stringent, rather than just the quantity of them.