On Friday, February 23, the Colorado Prescription Drug Affordability Board (PDAB or Board) decided to initiate an “upper payment limit” (UPL) rulemaking process for the autoimmune disease drug Enbrel after deeming it “unaffordable for Colorado consumers” on February 16. The Denver Post described this decision as “a first-in-the-nation step that raises questions about whether a single state can reduce drug costs without unintended consequences.” CBSA submitted a comment letter in advance of the recent PDAB meeting and will continue to strongly advocate that UPLs are the wrong solution for patients in the coming months leading up to the PDAB’s decision on whether and how to set a specific UPL for the first time. 

Enbrel UPL Vote  

During the PDAB’s February 23 meeting, the Board voted to adopt the final Affordability Review Report for Enbrel (with the changes discussed on February 16) and then took public comment on whether to select Enbrel for establishment of a UPL. Five of the six individuals who provided public comment expressed serious concerns about the PDAB moving to impose a UPL on Enbrel. Before taking a vote, PDAB Chair Dr. Gail Mizner clarified that a vote to initiate the UPL rulemaking process does not mean the PDAB has to complete the process. Without any further deliberation, the PDAB voted to “Select Enbrel for establishment of [a UPL]” and then voted to “Direct staff to initiate rulemaking to establish [a UPL] for Enbrel with the Secretary of State so that we can hold our first rulemaking hearing at a future meeting that accommodates the Board’s overall schedule.” PDAB staff laid out a new, tentative UPL rulemaking timeline that includes two rulemaking hearings—the first on June 7 and the second on July 19.  

CBSA’s Continued Advocacy

In advance of the February 23 PDAB meeting, CBSA submitted a comment letter urging the PDAB to carefully consider how it acts on the directive to consider setting UPLs. This letter is also available on the PDAB website. CBSA will continue to strongly advocate that UPLs are the wrong solution for patients in the coming months leading up to the PDAB’s decision on whether and how to set a specific UPL for the first time. 

Dear Prescription Drug Affordability Board Members and Staff:  

Last week, you made an unprecedented decision to deem one of the first three prescription drugs under your review unaffordable for Colorado patients. That decision has been scrutinized by patients and many other impacted stakeholders as rushed, informed by limited patient input and flawed data, and lacking clear understanding of why some patients are having difficulty accessing or affording the drug.   

Tomorrow, just one week later, you are faced with another unprecedented decision to initiate rulemaking to set an upper payment limit (UPL) for that drug—a proposed solution that many understand will not change what most patients actually pay for their medicines.      

Each of these decisions is first-of-its-kind in this country and risks serious unknown and unintended consequences for Colorado patients, prescribers, and health innovators. Tomorrow’s decision is one that must not be rushed or made prematurely without adequate economic study and absolute confidence in the real impacts of this decision on patient out-of-pocket costs, on access disruptions, and on investment in innovation.          

Affordability is a complex issue which looks different for each patient dependent on a multitude of factors, including income level, other financial burdens, treatment options, insurance coverage and plan design, discounts or other patient assistance programs, etc.   

Colorado’s life sciences community and our state leaders share an unwavering commitment to improving patient lives. We all agree—patients need access to effective, affordable medicines. However, a one-size-fits-all UPL is the wrong solution for Colorado patients. To truly accomplish the PDAB’s charter of making drugs more affordable and accessible for Coloradans, we must work collaboratively on calculated solutions that simplify and transform the whole complex drug pricing supply chain, which also includes wholesalers, pharmacy benefit manufacturers (PBMs), and insurance companies, each taking substantial cuts on every drug dispensed or administered to patients. We must consider and balance the intersection of cost, access, and innovation. 

Because the Board has been directed by the legislature to consider setting UPLs on drugs to lower costs for consumers and to “ensure they can access prescription drugs necessary for their health,” the Board has the responsibility to determine whether setting a UPL on a drug will actually accomplish those goals.  

Pushing fast-paced, unprecedented change in a complex healthcare system that has been broken for decades without adequate modeling and economic study of the ripple effects risks serious unintended consequences for patients, our state, and the rest of our country, which is now looking to follow Colorado’s lead on drug pricing. It risks harming patients with reduced access to needed medicines, threatening investments in development of new, innovative therapies, and disrupting our momentum as a world-class health innovation ecosystem.       

Throughout the Board’s selection and review of the first three drugs that have undergone an affordability review, we, along with many other stakeholders, have repeatedly raised concerns about reliance on flawed, incomplete data and misunderstandings, lack of transparency and consistency in process, and disparate treatment of the drugs.   

When considering whether to set the very first upper payment limit on a prescription drug, the Board must tread carefully to ensure Colorado does not harm patients in its quest to be the first in the nation to implement this experimental program.   

We appreciate your efforts to help Colorado patients access effective, affordable medicines. We also implore you to slow down to fully study and understand the implications of your decision and the economics of the entire drug supply chain before deciding whether to set an artificial price cap on a drug that thousands of chronically ill Colorado patients rely on to treat life-altering symptoms of debilitating medical conditions.  

Sincerely, 

Elyse Blazevich  

President and CEO 

Colorado BioScience Association 

PDAB Meeting & UPL Rulemaking Timeline

• 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. The Board will also conduct a UPL rule and policy review. 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. The Board will also continue conducting a UPL rule and policy review. 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: The PDAB will hold its first UPL rulemaking hearing for Enbrel. Register here. 
• July 19, 10:00 am – 2:00 pm MT: The PDAB will hold its second UPL rulemaking hearing for Enbrel. Register here.  

Other Business Conducted During the February 23 PDAB Meeting

• The Board voted to adopt the final Affordability Review Report for the HIV drug Genvoya (with the changes discussed on February 16), after deeming it “not unaffordable for Colorado consumers” on February 16. 
• PDAB staff discussed their plan to gather additional information for Cosentyx and Stelara, including reopening the surveys for individuals with scientific and medical training and for patients and caregivers for two to three weeks, as well as conducting outreach to physicians and pharmacists who are actively prescribing and dispensing the selected drugs. PDAB Chair Dr. Mizner asked about getting an outside expert to review the surveys before staff reopen them because of the feedback they’ve gotten expressing serious concerns about the flawed and insufficient nature of the questions. PDAB staff said they can look into that and report back at the next PDAB meeting, so the surveys won’t reopen until after that March 15 meeting. 
• The Board voted to form an ad hoc work group in preparation for the General Assembly report, which will include recommendations “concerning legislative and regulatory policy changes to increase the affordability of prescription drugs and reduce the effect of excess costs on consumers and commercial health insurance premiums in the state.” CBSA is hopeful that the work group will consider and potentially recommend alternative tools that may be more effective than UPLs at addressing affordability and access. PDAB Chair Dr. Mizner and PDAB member Amy Gutierrez, PharmD, volunteered to participate in the ad hoc work group along with select members of the PDAAC. The work group may meet more than once in March and/or April, perhaps piggybacking on the April 11 PDAAC meeting, in order to meet these timeline goals: 
  • April 26: Board finalizes draft report contents. 
  • June 7: Board finalizes report contents. 
  • July 1: Report delivered to General Assembly.