On July 11, the Colorado Prescription Drug Affordability Board (PDAB or Board) held its second upper payment limit (UPL) rulemaking hearing for the autoimmune drug Enbrel, moving closer to becoming the first state PDAB to try to implement this ill-conceived mechanism to control drug costs. 

In advance of the July 11 hearing, Colorado BioScience Association (CBSA) and Biotechnology Innovation Organization (BIO) submitted joint written testimony discussing our serious, continuing concerns about UPLs as a tool to accomplish the PDAB’s goals and, more specifically, about the lack of a concrete methodology for determining UPLs in a clear, consistent manner. We strongly urged the PDAB to pause before setting any UPLs and make sure it has taken all appropriate steps before moving forward with this first-of-its-kind UPL rulemaking. 

Before the first UPL rulemaking hearing on May 23, CBSA and BIO also submitted a joint comment letter discussing our serious concerns regarding Colorado’s inadequate efforts to conduct a Cost-Benefit Analysis ahead of UPL rulemaking, which risks leading to policy decisions that are not based on evidence.   

In addition, Amy Goodman, CBSA’s Vice President and Counsel for Policy + Advocacy, provided witness testimony during the July 11 hearing. You can view a recording of the full PDAB meeting and UPL hearing (Amy’s testimony begins at 1:34:17). During her testimony, Amy said, in part: 

BIO and CBSA have serious, continuing concerns about UPLs as a tool to accomplish the PDAB’s goals and, more specifically now, about the lack of a concrete methodology for determining UPLs in a clear, consistent manner. As we have previously commented, there is still a dire need for procedural safeguards and thorough, objective analyses of the likely impacts of UPLs. 

Patient groups and other stakeholders continue to express concerns about UPLs as a tool for addressing the affordability of and access to medicines and emphasize that UPLs will not improve what patients actually pay. 

Patients also emphasize that UPLs could trigger changes by insurers and PBMs which may delay or restrict access to various needed treatments, and it sounded today like there were acknowledgements from PDAB members that legislation is needed to help ensure negative unintended consequences are not experienced by patients—which really should happen before a UPL is imposed. 

Patients stress that we don’t yet know how different stakeholders and members of the supply chain will respond. “Limiting reimbursement for certain products could result in reduced availability…further limiting access and choice for patients.” The details on how and where a UPL will be applied in Colorado are critical to understanding the impact of any UPL figure. We remain concerned that it has been nearly a year and a half since this Board first voted to pursue a UPL and we still have no details on its effectuation. These details are important because the Board’s imposition of a UPL could create financial incentives that could disrupt and shift costs in a way that harms patients and other stakeholders both within Colorado and beyond Colorado’s borders. 

A Patient Sign On Letter said they “plead with you to pause this process” “[u]ntil the Board and patients have…assurances from all members of the supply chain that imposing a UPL will not disrupt patient access to needed medications.” 

More specifically, patients also highlighted serious concerns with “the lack of transparency and consistency in the UPL-setting process” you’ve initiated, calling attention to the fact that there “are currently no clear standards outlining how key categories are weighed or how decisions will be applied consistently across drugs and therapeutic classes.” 

In addition, many still have concerns about data errors and how consideration of patient input has fallen short, among other things. These problems and key, outstanding questions must be adequately addressed before the Board presses forward with setting UPLs. As the Patient Sign On Letter said, the “Board has an immense responsibility to get this process right.”