On July 3, the Colorado Prescription Drug Affordability Board (PDAB or Board) voted to initiate the upper payment limit (UPL) rulemaking process for two more drugs, Stelara and Cosentyx, after deeming them “unaffordable for Colorado consumers” in June.  

In advance of the July 3 PDAB meeting, CBSA and BIO submitted a joint comment letter urging the PDAB to carefully consider how it acts on the directive to consider setting UPLs and imploring the PDAB to tread carefully to ensure Colorado does not harm patients in its quest to be the first in the nation to implement this experimental program.  

Amy Goodman, CBSA’s Vice President and Counsel for Policy + Advocacy, also provided public comment during the July 3 PDAB meeting, reminding the PDAB that they have the power—and the responsibility—to determine whether setting a UPL would actually accomplish the goals of helping patients afford and access drugs necessary for their health. Amy emphasized that there are critical questions that have yet to be answered: 

• How will UPLs work? 
• What impact will they have? 
• Who will UPLs help or hurt? 

As the PDAB proceeds with the UPL rulemaking process, patients and the rest of the country will be watching. They are counting on the PDAB to engage in an honest, thoughtful, open-minded, in-depth inquiry into those key questions—and not simply discuss what number the PDAB thinks sounds right for a UPL. CBSA will continue to strongly advocate that UPLs are the wrong solution for patients in the months leading up to the PDAB’s first set of UPL rulemaking hearings for Enbrel, which are scheduled to begin in September 2024. 

Stelara UPL Vote  

During the PDAB’s July 3 meeting, the Board reviewed the Draft Affordability Review Report for Stelara and voted to adopt the final report with changes to the executive summary discussed during the meeting, which reflected the Board’s comments regarding (1) how higher costs result for patients when plans put the drug on a higher tier, and (2) that payers “typically” balance their cost with insurance premiums, but it is not required. The Board heard public comment from four individuals on whether to select Stelara for establishment of a UPL. Three of the four individuals, including one from Johnson & Johnson, expressed serious concerns about the PDAB moving to impose a UPL on Stelara. Before taking a vote, PDAB Chair Dr. Gail Mizner reiterated that a vote to initiate the UPL rulemaking process does not mean the PDAB has to complete the process.  

Following deliberations that largely focused on all of the outstanding questions regarding the role of insurance carriers and pharmacy benefit managers (PBMs) in drug pricing and the drug supply chain—and the need to hear more from those entities during the UPL rulemaking process, the PDAB unanimously voted to select Stelara for establishment of a UPL. 

Cosentyx UPL Vote  

During the PDAB’s July 3 meeting, the Board reviewed the Draft Affordability Review Report for Cosentyx and voted to adopt the final report with changes to the executive summary discussed during the meeting, including the Board’s softened assertion that patient assistance programs “may not be sustainable and reliable on a long-term basis” (as opposed to the statement originally drafted by PDAB staff that said patient assistance programs “are unreliable and inconsistent”). The Board heard public comment from three individuals on whether to select Cosentyx for establishment of a UPL. Two of the three individuals expressed serious concerns about the PDAB moving to impose a UPL on Cosentyx. During their deliberations on Cosentyx, the Board said that the overarching themes and questions discussed for Stelara apply to Cosentyx as well. With Dr. Sami Diab abstaining due to a conflict of interest, the PDAB voted to select Cosentyx for establishment of a UPL. 

The PDAB’s July 3 votes marked the close of the Affordability Review stage for the first five drugs selected by the Board, with Stelara and Cosentyx becoming the second and third drugs to move forward to the UPL rulemaking stage, following the vote to initiate UPL rulemaking for Enbrel in February. 

UPL Rulemaking Process

PDAB staff previously laid out the following timeline for its remaining 2024 meetings, including three UPL rulemaking hearings for Enbrel: 

• 7/19 PDAB/PDAAC Joint Meeting
  • PDAB/PDAAC check-in 
  • Discuss rulemaking to align the Affordability Review Rule with statutory language that goes into effect 1/1/25, and any other desired changes 

• 9/6 Enbrel UPL Rulemaking Hearing #1 

• 9/6 – 10/18 
  • Stakeholder meetings for Enbrel UPL (after 9/6 hearing so people have something to react to) 
  • Stakeholder meeting on Affordability Review Rule (redline version of rule will be available prior to meeting) 

• 10/18 
  • Enbrel UPL Rulemaking Hearing #2 
  • Rulemaking hearing for updates to Affordability Review Rule 

• 12/6: Enbrel UPL Rulemaking Hearing #3 

During the July 3 meeting, PDAB staff discussed some additional details of the UPL rulemaking process: 

• A guide for stakeholder engagement during UPL rulemaking will be published later this month. 
  
• Regular “office hours” will be held for process questions, likely every other week. 
  
• Stakeholder meetings will be held that Board members can attend, with one or more focused on patients and caregivers and one or more focused on members of the supply chain. 
  
• There will be opportunities for one-on-one meetings with PDAB staff. 
  
• There will be at least three UPL rulemaking hearings for each drug, which will start as early as September 2024. PDAB staff emphasized that, during these hearings, testimony can turn into a conversation with staff or members of the Board, unlike with public comment during PDAB meetings.