On May 23, the Colorado Prescription Drug Affordability Board (PDAB or Board) became the first PDAB in the country to move toward capping the price of a drug by holding an upper payment limit (UPL) rulemaking hearing. Friday’s hearing marked the first hearing (of at least three), for the first drug (Enbrel), by the first state PDAB to try to implement this mechanism to control drug costs. 

In advance of the May 23 PDAB meeting, Colorado BioScience Association (CBSA) and Biotechnology Innovation Organization (BIO) submitted a joint comment letter discussing our serious concerns regarding Colorado’s inadequate efforts to conduct a Cost-Benefit Analysis ahead of UPL rulemaking, which risks leading to policy decisions that are not based on evidence (our letter is available through the PDAB’s website here).   

Amy Goodman, CBSA’s Vice President and Counsel for Policy + Advocacy, also provided public comment during the May 23 PDAB meeting. Amy highlighted key themes raised in the written comments submitted before the meeting, which reflected a unified call from a coalition of patient groups, pharmacists, doctors, advocates, and industry leaders for the Board to pause its UPL process and make sure it takes the steps necessary to get a solid understanding of affordability and how UPLs would be implemented and impact patients before proceeding: 

• First, there is deep concern about the integrity of the data, methodology, and decision-making process underpinning affordability decisions. Multiple letters pointed to meaningful errors in the accuracy and completeness of data relied on by the Board and how proceeding with UPL hearings based on determinations using this flawed data “would be premature and potentially harmful.” 

• Second, patient organizations continue to emphasize that UPLs do not cap what patients pay, only what upstream purchasers like insurers reimburse. Without a mechanism to pass savings directly to patients, UPLs will likely leave patients’ out-of-pocket costs unchanged—or even increased. 

• Third, many stakeholders fear UPLs could disrupt patient access, cautioning that price caps like this could lead to reduced drug availability, new prior authorization barriers, formulary reconfigurations, and unintended harm to patients. 

• Fourth, the absence of a clear, standardized UPL methodology raises concerns about fairness, transparency, consistency, and opportunity for meaningful notice-and-comment. 

Amy emphasized that these letters shared a common plea: pause the process, fix the data, clarify the methodology, and meaningfully engage patients and providers. She reiterated that CBSA stands ready to work with the Board on sound, evidence-based solutions that improve affordability without compromising access or innovation. 

During the May 23 PDAB meeting (see the materials here), the Board: 

• Approved the PDAB’s 2024 General Assembly Report, as amended, pending no additional changes from the Governor’s office (to be submitted by July 1, 2025). 

• Approved the Data Submission Guide (DSG), with the changes discussed, to be shared ahead of the second UPL rulemaking hearing on July 11. 

• Approved the addendum to Enbrel’s Affordability Review Summary Report with corrected/validated data and confirmed the Board’s findings on February 16, 2024, that Enbrel is “unaffordable to Colorado consumers.” 

• Voted to begin rulemaking to establish a UPL for Enbrel. 

• Held the first UPL rulemaking hearing for Enbrel.
  
  
  • PDAB staff presented various metrics for Enbrel and the Board began discussing how they may narrow in on a UPL. 
    
  • Initial discussions indicated that the Board would likely set a UPL at or above the Inflation Reduction Act’s (IRA’s) Maximum Fair Price (MFP). 
    
  • After going into executive session, one Board member (Justin VandenBerg, PharmD, BCPS) implied that he was thinking about “splitting the difference” between the average plan paid amount (which they noted is an inflated number since it does not include rebates) and MFP. 
    
  • The PDAB ran out of time during the scheduled hearing and decided to delay witness testimony until the second hearing. 

• Voted to continue the UPL rulemaking hearing for Enbrel on July 11, 2025. Additional written testimony will be accepted until July 9 at 5:00pm MT.