The Colorado Prescription Drug Affordability Board (PDAB) voted on Friday to pursue a process that could set an upper payment limit (UPL) on Enbrel, which would mark the first time any state has set a price ceiling for any drug.
Enbrel was one of five drugs the PDAB decided to conduct affordability reviews for, along with Trikafta, Genvoya, Cosentyx, and Stelara. The board has also completed affordability reviews for Trikafta and Genvoya, and determined them to be affordable to patients due to the availability of drug manufacturer/federal payment assistance programs for the drugs.
While the PDAB’s overall purpose is to render medications more accessible to patients by lowering costs, many cystic fibrosis patients had access concerns about the possibility of a UPL on Trikafta, because it has made their lives so much better, and they were unsure how a UPL would affect it. Tiffany Westrich-Robertson—a patient with autoimmune arthritis disease and CEO of the International Foundation for Autoimmune & Autoinflammatory Arthritis—voiced concerns about a possible UPL on Enbrel as well.
“We believe a restriction will only benefit payers,” Westrich-Robertson said. “It will not address any of the affordability (issues) expressed by patients in Colorado. For those who Enbrel works for, they should not lose access to it. For those responding, it should be up to the patient and their rheumatologist to decide to switch to [an alternative] drug or not.”
Hope Stonner, policy manager for the Colorado Consumer Health Initiative, spoke in support of the PDAB’s decision to pursue an Enbrel UPL, however.
“The initiative, which works to protect and promote access to affordable and equitable healthcare in the state, believes the comprehensive process of the affordability review and the process outlined in statute for the UPL has appropriate guardrails in place to protect patient access. Because we believe the goal of the PDAB is to encourage access to drugs that we know folks in the state may be struggling to (afford) or cannot access at this time.”
— Stonner
The PDAB determined that Enbrel costs about $46,000 a year for one patient—in 2022—with patients responsible for an average cost of $2,295 if they have commercial insurance or Medicare Advantage.
“We believe the UPL process can work alongside other policies that folks have called out in public comment that are already being implemented in the state to lower drug costs for patients in the system,” Stonner said. “And due to Enbrel’s high cost to the healthcare system, particularly when the report stated that the drug remains out of reach or is unaffordable for so many Colordadans. We believe Enbrel is a perfect example of the need for a PDAB in the first place, and an appropriate candidate for a UPL.”
Reid Porter, a spokesman for PhRMA, said the pharmaceutical company does not support a UPL for Enbrel.
“Price setting is not the solution to improving access and affordability for Coloradans. Patients repeatedly voiced concerns about wedging politics between patients and their doctors, but the board ultimately ignored them. The process for considering the impacts of supply chain dynamics on patient medicine costs has been flawed, inadequate, and the board’s actions could now cause genuine harm to Coloradans.”
— Porter
The board will now gather data to try and determine a UPL for Enbrel, which will likely take about six months, PDAB Chair Dr. Gail Mizner said. And although the PDAB decided to pursue a UPL on Enbrel, members could ultimately vote against setting a price ceiling for the drug.
“A vote to initiate the UPL process does not mean that we are bound to complete the UPL process,” Mizner said. “We could—if the data provided to us indicated it was not appropriate to move forward with setting a UPL—stop the process at any point in the future. The other thing to keep in mind is we’re not looking to make a decision about a UPL in a month. We’re looking at probably a six-month process of data gathering and discussion. Our vote to establish a UPL for Enbrel initiates a rulemaking process that will involve multiple public hearings.”
PDAB Director Lila Cummings said the first rulemaking hearing for Enbrel will likely be on June 7.
“And we recommend a second rulemaking hearing for Enbrel on July 19,” Cummings said.