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Weekly Policy Blog: PDAB Deems One of Two Drugs “Unaffordable” in Recent Affordability Decisions 

By: Colorado BioScience Association   Date: 02/19/2024

On Friday, February 16, the Colorado Prescription Drug Affordability Board (PDAB or Board) completed its second and third affordability reviews, following its first decision on December 8 that the cystic fibrosis drug Trikafta is “not unaffordable.” The PDAB unanimously voted that the autoimmune disease drug Enbrel is “unaffordable for Colorado consumers” but that the HIV drug Genvoya is “not unaffordable for Colorado consumers.” The Board will decide on February 23 whether to begin the rulemaking process to establish an “upper payment limit” (UPL) for Enbrel, which would mark the first time a state has moved to cap the price of a prescription drug with a UPL. 

The PDAB’s February 16 Meeting

Enbrel Affordability Review: PDAB staff first reviewed the draft Affordability Review Report for Enbrel and allowed Board members to ask questions and provide thoughts and feedback. In addition to PDAB staff, Benjamin Rome, M.D., from Harvard’s Program On Regulation, Therapeutics and Law (PORTAL) was also on hand to help answer Board members’ questions. Board members’ questions were fairly minimal, but several Board members commented that they were concerned by the average out-of-pocket costs listed for Enbrel as well as the number of patients reporting affordability problems. The Board briefly acknowledged some limitations of that data, such as patient assistance not being reflected in reported out-of-pocket costs and patient surveys having low response rates, as well as not providing necessary context, but they did not explore further.  

Following a brief public comment period during which six individuals provided two-minute public comments, the Board decided they were comfortable moving forward with a vote on Enbrel’s affordability without any further substantive deliberations. Board member Cathy Harshbarger made the following motion: “The use of Enbrel, consistent with the labeling approved by the FDA or with standard medical practice, is unaffordable for Colorado consumers.” Board member Amy Gutierrez, PharmD, seconded the motion and the Board proceeded to vote unanimously to approve the motion (with the exception of Sami Diab, M.D., who was recused due to a conflict).

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Genvoya Affordability Review: PDAB staff then reviewed the draft Affordability Review Report for Genvoya. The most notable difference was a discussion of how, in addition to manufacturer assistance programs, government assistance programs specific to HIV care (the Ryan White HIV/AIDS Program and the AIDS Drug Assistance Program) help patients with an income below 500% of the federal poverty level access drugs like Genvoya.  

Following a brief public comment period during which six individuals provided two-minute public comments, the Board decided they were comfortable moving forward with a vote on Genvoya’s affordability without any further deliberations. Board member Amy Gutierrez, PharmD, made the following motion: “The use of Genvoya, consistent with the labeling approved by the FDA or with standard medical practice, is not unaffordable for Colorado consumers.” Board member Justin VandenBerg, Pharm.D., seconded the motion and the Board proceeded to vote unanimously to approve the motion (with the exception of Sami Diab, M.D., who was recused due to a conflict). 

General Public Comment: Four individuals provided general public comment at the end of the meeting, including Amy Goodman, Colorado BioScience Association Vice President & Counsel for Policy + Advocacy, and Kaitlin Lucariello, PhRMA Deputy Vice President of State Advocacy. Patient advocate Bridget Seritt gave compelling comments about problems with the PDAB’s process, how UPLs may cause access issues for patients, and how “it seems insurance companies and PBMs are going to be the biggest winners in this, and that is concerning.” 

Other Business: During the February 16 PDAB meeting, Insurance Commissioner Michael Conway gave opening remarks where he thanked the Board for their work and praised them for “moving so expeditiously.” PDAB Director Lila Cummings provided an update on two bills currently moving through the General Assembly related to the PDAB’s work (SB24-060 Prescription Drug Affordability Board Exempt Orphan Drugs and SB24-077 Prescription Drug Manufacturer Requirements). She also gave an overview of potential affordability review policy changes, which the Board agreed staff could run by stakeholders in advance of the Board’s review. Also, at the request of PDAB member Cathy Harshbarger, the Board went into executive session to receive legal advice regarding the public comment letter related to Genvoya from Community Access National Network (CANN). 

CBSA’s Reaction and Continuing Concerns

Following the February 16 PDAB meeting, Amy Goodman, Colorado BioScience Association Vice President & Counsel for Policy + Advocacy, said:

“As the PDAB decides whether to set an upper payment limit on a drug it has deemed unaffordable, Colorado BioScience Association continues to stress that government-imposed price caps are the wrong solution for patients. Government price controls won’t lower costs for patients and risk serious, unintended consequences, including limiting patient and prescriber choice and reducing investments in new medicines.”  

CBSA shares the PDAB’s goal of improving the affordability of medicines for patients, but we oppose the creation and enforcement of UPLs that won’t accomplish that goal and will lead to negative unintended consequences on patient access to medicines, on healthcare providers prescribing medicines, and on Colorado’s innovation ecosystem. 

CBSA echoes the concerns raised by patient advocate Tiffany Westrich-Robertson highlighted in this Denver Post article: 

“Tiffany Westrich-Robertson, who spoke on behalf of the International Foundation for Autoimmune and Autoinflammatory Arthritis, also raised concerns that the board hadn’t done enough to engage patients and find out why some said affordability was a problem. 

‘I am extremely, extremely concerned,’ she said.” 

In addition, we continue to have significant concerns with flaws and inconsistencies in the PDAB’s data as well as the inconsistency and lack of transparency in the PDAB’s process. To learn more, please see the following blog posts, letters, and articles:

Next Steps

Although timelines have repeatedly changed throughout the PDAB implementation process, as of right now, the next steps in the process are as follows: 

  • February 23, 10:00 – 11:00 am MT: The PDAB will hold a follow-up meeting to adopt the final Affordability Review Reports for Enbrel and Genvoya (including Board member edits, deliberation summary, and Board vote) and will vote on whether to begin rulemaking to establish a UPL for the drug (which would include two rulemaking hearings to discuss the precise amount of the UPL and then promulgate the exact UPL). Register here. 
  • March 15, 10:00 am – 2:00 pm MT: Preliminary affordability review data for Cosentyx and Stelara, the two drugs in the second cohort, will be presented by PDAB staff and discussed by the Board. If the Board decides to proceed with UPL rulemaking for Enbrel, the first rulemaking hearing may also be held. Register here. 
  • April 11, 9:00 am MT: Prescription Drug Affordability Advisory Council (PDAAC) Meeting. Register here. 
  • April 26, 10:00 am – 2:00 pm MT: The draft Affordability Review Reports for Cosentyx and Stelara will be reviewed. If the Board decides to proceed with UPL rulemaking for Enbrel, the second rulemaking hearing may also be held. Register here. 
  • May 3, 10:00 – 11:00 am MT: The PDAB will hold a follow-up meeting to adopt the final Affordability Review Reports for Cosentyx and Stelara (including Board member edits, deliberation summary, and Board vote) and, if needed, will vote on whether to begin rulemaking to establish UPLs for these two drugs. 
  • June 7, 10:00 am – 2:00 pm MT: PDAB meeting with potential UPL rulemaking. Register here. 
  • July 19, 10:00 am – 2:00 pm MT: PDAB meeting with potential UPL rulemaking. Register here. 
  • September 6, 10:00 am – 2:00 pm MT: PDAB meeting with potential rule and policy updates. Register here. 
  • October 18, 10:00 am – 2:00 pm MT: PDAB meeting with potential rule and policy updates. Register here.  
  • December 6, 10:00 am – 2:00 pm MT: PDAB meeting with agenda TBD. Register here. 
Categories: CBSA News