On October 3, despite hearing testimony from a variety of stakeholders (including CBSA) expressing significant concerns, the Colorado Prescription Drug Affordability Board (PDAB or Board) set its first Upper Payment Limit (UPL) for the autoimmune drug Enbrel. This makes Colorado the first state PDAB to take this “landmark” step toward implementing this ill-conceived mechanism to control drug costs. 

The PDAB decided to utilize the Medicare Maximum Fair Price (MFP) of $583.59 as a benchmark and, after a fairly lengthy and confusing discussion of units/dosages/packaging, rounded up to $600.00 per 50 mg/mL, which will apply to all commercially available formulations of Enbrel and will be reviewed annually.  

The Board set the effective date for this UPL as January 1, 2027, instead of “at least six months after adoption date.” 

Amy Goodman, CBSA’s Vice President and Counsel for Policy + Advocacy, provided witness testimony during the October 3 hearing. You can view a recording of the full PDAB meeting and UPL hearing (Amy’s testimony begins at 1:46:27). 

Following the Colorado PDAB’s decision to set its first UPL on Enbrel, Amy Goodman provided the following statement: 

“State-mandated payment caps on medicines are the wrong solution for patients. Colorado BioScience Association continues to emphasize government price controls won’t help patients afford or access their medications as Colorado’s Prescription Drug Affordability Board (PDAB) imposes an Upper Payment Limit (UPL) for the first time. Payment caps limit patient and prescriber choice and could reduce investments in new medicines.” 

“We are extremely disheartened to see the Board set aside the actual patients who take this medication and instead cling to the hope that setting a UPL will result in systemic savings that will somehow trickle down through insurance companies to consumers at large.” 

“However, we appreciate that the Board acknowledged that insurers and pharmacy benefit managers (PBMS) may react to the UPL imposed by the Colorado PDAB by engaging in what PDAB Chair Dr. Gail Mizner described as ‘PBM shenanigans’—instituting policies and procedures that significantly disrupt or put barriers in the way of patient access for both patients who need a UPL drug or need a different drug in the same class. Chair Mizner stated during the October 3 PDAB meeting that ‘those are two really important issues that were raised today that really need to be addressed,’ emphasizing her opinion that they ‘are legitimate concerns that need to be addressed legislatively.’” 

Amgen, which makes Enbrel, told Bloomberg Law that “‘the Board is acting unlawfully…The Board’s actions will create new access barriers for patients without improving affordability at the pharmacy counter.’” Amgen’s spokesperson stated that Amgen “‘remains committed to driving access and affordability solutions for Enbrel patients.’” 

Bloomberg Law also cited Tiffany Westrich-Robertson, a patient advocate who has been following the Colorado PDAB’s work and engaged frequently throughout the process: 

“‘This decision fails to address real, patient-identified barriers to prescription affordability and adds complexity to a system already stacked against patients,’ Tiffany Westrich-Robertson, founder of the Ensuring Access through Collaborative Health and Patient Inclusion Council, said in an emailed statement. 

“‘We are disappointed that the Colorado PDAB disregarded the concerns of patients and adopted an unproven policy that is unlikely to lower patient out-of-pocket costs and may create new barriers to care,’ Westrich-Robertson said, pointing to actions by health plans and pharmacy benefit managers that she said are some of the key drivers of high costs for patients.” 

In addition, the Pharmaceutical Research and Manufacturers of America (PhRMA) told the Denver Post that the UPL is a “‘reckless experiment’ that wouldn’t address the drivers of high costs for patients. ‘Colorado is risking patient access and jeopardizing the development of new medicines — similar to how Medicare beneficiaries are facing fewer options, more treatment denials and higher costs under the Inflation Reduction Act…Mimicking this flawed model will not safeguard patient access and affordability from these abusive practices by middlemen.’” 

The Next PDAB meeting is on November 14, but there was no discussion during the October 3 meeting about the timeline of next steps for the next two drugs selected for UPL rulemaking. CBSA will continue to work with members and partners as the PDAB and potentially the legislature consider the implementation of UPLs moving forward.