Prescription Drug Affordability Board Activity, July 2025

The 2024 Activities Summary Report and policy recommendations from the Board were finalized and submitted to the general assembly on July 1. There were eight nonsubstantive grammatical changes. 

One PDAAC member who held a healthcare consumer position resigned, and applications are being accepted. 

The PDAB has received feedback about the cost-benefit analysis in Oregon. The Oregon PDAB director was unavailable to speak at this meeting, but they are hoping to coordinate that for the next meeting. 

As part of the affordability review updates, the board directed staff to start a stakeholder workgroup to identify best practices around gathering sensitive patient information. A plan has been started, and the staff is working on getting that organized with the aim of starting meetings in September. 

They closed out by talking about federal policy updates and emerging trends, including the most favored nation executive order and the budget reconciliation bill. Board members requested an update from staff related to federal policy updates, including PBMs.

The board started this meeting in executive session to receive legal advice regarding the use of data by the board in setting an upper payment limit, pending litigation.

Bridget Dandaraw-Seritt (Advocates for Compassionate Therapy Now) brought up a lack of safeguards to ensure access to therapies and prevent nonmedical switching, which could result in negative patient outcomes and be expensive in the long run. 

The board asked for clarification on the definition of nonmedical switching. 

Dandaraw-Seritt said that nonmedical switching is something that insurance companies do to save money or make more money by switching patients to biosimilars, which could cause working therapies to stop working. 

The board also asked if lowering the cost of Enbrel would cause more insurers to be able to provide the drug, increasing access and preventing nonmedical switching. Dandaraw-Seritt said that it could be great for those that Enbrel works for, but a UPL could also disincentivise Enbrel because rebates would be lower for the drug. The board raised the fact that nonmedical switching is already happening, that there's nothing the PDAB can do to legislate that, and that the UPL would include rebates. 

Tiffany Westrich-Robertson (International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis)) raised a similar issue to Dandaraw-Seritt: patients are worried that if a UPL is set on the formulary for Enbrel that patients with the same diagnosis on a therapeutic alternative may have to pay more for their drugs. 

The board reiterated that the PDAB does not have the ability to control nonmedical switching, and that the statute does allow for the board to terminate a UPL if there are unintended consequences. The board asked staff to think about how this could be done quickly, instead of needing to wait for the next PDAB meeting. 

The PDAB agenda listed time for a presentation on Stelara Biosimilars from PORTAL and APCD Data Validation for the Cosentyx Validated Data Addendum and the Stelara Validated Data Addendum. Staff noted that there was insufficient time for these to take place, and suggested that the board move these items to the next meeting, which is what the board decide to do. 

Rule introduction

The purpose of this rule is to establish an upper payment limit for the prescription drug Enbrel. Staff described the purpose of this hearing, which was to present data, views, and arguments concerning the draft rule to establish an upper payment limit, which will mostly include time for witness testimony. 

Witness testimony

Written testimony was submitted by: International Foundation for Autoimmune & Autoinflammatory Arthritis; The Ensuring Access through Collaborative Health Coalition; Biotechnology Innovation Organization and the Colorado BioScience Association; Community Access National Network; ACTnow and Cystic Fibrosis United; Amgen, Inc; Arthritis Foundation; Children’s Hospital Colorado; Coalition of State Rheumatology Organizations; Let My Doctors DecideAction Network; Front Range PharmaLogic; Colorado Consumer Health Initiative, the Value of Care Coalition and several Colorado residents.

Tiffany Westrich-Robertson was the first to be given time to speak. She reminded the board that the figure of Enbrel costing patients $4,638 a year, which was listed in a May 2025 press release and was cited in a public comment, equaled $386.50 a month, which is often not paid because of patient assistance programs. This was reinforced in the survey run by the PDAB, where those with commercial insurance did not have an issue. She urged the board to look at what patients are saying presents an affordability problem. The board commented that they are not only focusing on insured patients; with recent federal legislation, patients will lose their Medicaid, and more patients will be uninsured. 

Sophia Hennessy of the Colorado Consumer Health Initiative testified to express the organization's support for the UPL on Enbrel. She characterized  the PDAB as a collaborative body with members from across the drug supply chain to establish if a drug is unaffordable, which the PDAB has for Enbrel. She cited statistics and surveys that indicated that cost affects patient access to Enbrel, and therefore, supported the board setting a UPL. 

Ingrid Pan, a clinical pharmacist who works with the pediatric population with rheumatic conditions and a PDAC member, was next to testify. She urged the board and the state to carefully consider the impact of accessibility for pediatric patients when considering a UPL for Enbrel. She said that Enbrel is the preferred drug for children with juvenile idiopathic arthritis, the most common autoimmune condition affecting children. The board listed 20 therapeutic alternatives for Enbrel, but those were for the adult population. The pediatric population has 12 therapeutic alternatives, many of which require a higher burden on the healthcare system to administer. While there are assistant programs, Pan also mentioned that they may be restricted, which would force higher out-of-pocket costs. The board asked about the risk that Enbrel would be taken away from patients. Pan said that conversations with Amgen indicate that they don’t know what will happen if a UPL is set, so they don’t know if the manufacturer would take patient assistance programs, which could be a possibility. The board also asked about nonmedical switching and the ease of access for Enbrel, which Pan said was easy to access now and is a preferred product for insurers. One board member asked about the increase in price. Pan said she has not seen it in copay amounts, so it has not been a problem in her practice. 

The next speaker was Melanie Kesner from the Rocky Mountain Region Director at Young Invincibles, testifying for their support of a UPL for Enbrel. She reiterated that Enbrel’s high cost, especially for young adults, is prohibitive for many, especially as many young people may lose coverage due to federal legislation. A board member reiterated the point that patient assistant programs are voluntary, and they may be taken away, or some may not qualify for them.

Bridget Dandaraw-Seritt from Advocates for Compassionate Therapy Now reiterated the point that the appeal process is not developed yet, which was something the board was supposed to do. She also mentioned that unless the UPL limits the price of Enbrel to $50 or less, Enbrel will still not be affordable without patient assistance programs. 

The next speaker, Kristy Kibler of Lupus Colorado, raised concerns about the lack of guardrails in the UPL process. She asked the board to ensure there was a robust system for access monitoring in place before UPL enforcement begins. This would include benchmarks, transparent and real-time tracking of patient outcomes, insurance coverage, and provider availability. She especially stressed establishing a defined process for pausing or pulling back the UPL if there are access issues. 

Katelin Lucariello, representing PHRMA, was concerned that the board had not established clear standards for weighing each category of the data you’re considering in UPL rulemaking. She also mentioned that the timeline to submit data to the data submission guide was rushed and inconsistent with what was offered during the affordability review. She would also like public comment to be before and after board deliberation, rather than just before. 

Bethany Pray of the Colorado Center on Law and Policy, expressed concerns about system costs and costs to individuals. The first point she made is that Amgen charges Coloradans over $90,000 a year for a drug that was developed with taxpayer money through the NIH. She posited that the price Coloradans paid for Enbrel did not reflect their contribution to its development. She mentioned that the concerns that other organizations and advocates have regarding access issues in the event that a UPL is set implicitly give Amgen the okay to set or raise prices with impunity. Last, she shared a colleague's story of receiving $12,000 in 2022 to cover the out-of-pocket cost for Enbrel, which dropped to $7,500 in 2023 without notice. After assistance was exhausted, they had to pay $2,000 in one month for Enbrel. Pray said that it’s time for a UPL. 

Amy Goodman with the Colorado BioScience Association expressed continuing concerns about UPLs as a tool to accomplish the PDAB's goals, and about the lack of a concrete methodology for determining UPLs in a clear, consistent manner. She reiterated concerns about unintended consequences and the negative effects on patients of setting a UPL, including limiting patient access to medicines, and a lack of understanding about how supply chain members will respond.

Derek Flowers from the Value of Care Coalition was the next witness. He said that no discussion of prescription drug affordability is complete without a consideration of value, which is best conveyed by patients and clinicians. Because of this, the organization commissioned a white paper surveying specialists' views on PDABs and UPLs in four states, including Colorado, where boards are operational. The survey found that specialists are concerned that PDABs have not sought their input, that they will limit available treatment options and provider autonomy, that the administrative burden will be increased, and that nonmedical switching would be increased. The board replied that they have reached out to providers and that providers are included on the board. 

Emily Zadvorny, a pharmacist and representative of the Colorado Pharmacist Society, was the last witness. She encouraged the board to look at other ways to address the affordability of drugs, rather than only looking at a UPL as the only way to address affordability. The board mentioned that they are only allowed to make a UPL per their statute, though they can recommend other options to the legislature.