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New Colorado board opts against price controls for high-cost cystic fibrosis drug

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Sara Wilson

(Colorado Newsline) A state board will not set an upper price limit on an expensive treatment for cystic fibrosis after deciding in a unanimous vote Friday that it is “not unaffordable” for Colorado patients.

It was the first time the state’s five-member Prescription Drug Affordability Board voted on whether to classify a drug as unaffordable, reviewing data on the drug’s accessibility, average cost per patient and generic alternatives, among other factors. The drug in question, Trikafta, is a life-changing medication for people living with cystic fibrosis with a list price of over $300,000 for a year’s supply.

“The PDAB has done extensive stakeholdering to come to this outcome today, which shows the process is working as intended. Cystic fibrosis patients express that Trikafta is affordable at this point in time and the board agreed,” said Hope Stonner, the policy coordinator for the Colorado Consumer Health Initiative.

The board was created through a 2021 law with the purpose review the prices of certain high-cost medications. If the board decides a drug is unaffordable, they have the power to set an upper payment limit on it.

There were 461 people who used Trikafta in 2022, according to the Colorado All Payer Claims Database, and the average out-of-pocket expense per patient was nearly $9,000.

Patients and patient advocates who testified to the board over the past six months worried that if Trikafta gets a price ceiling, the manufacturer Vertex would pull out of the Colorado market and they would lose access to the critical medication.

“Through this process, the patients have been placed in a very uncomfortable position. We are not here to defend the price of Trikafta. We are passionately defending our access to the drug,” Siri Vaeth, the executive director of the Cystic Fibrosis Research Institute, told the board Friday.

Patients also told the board that because of health insurance and patient assistance programs, Trikafta is accessible for most patients. While that allows patients to get the drug now, advocates worry about the stability and longevity of patient assistance programs offered by pharmaceutical companies.

“While the PDAB did deem Trikafta affordable for Colorado patients, the report highlights that this is only because of patient assistance programs — programs that Vertex does not guarantee to continue in the long term,” Stonner said. “We recognize that patient assistance programs are crucial to many at this point in time, but they also come with tremendous hoops to jump through for patients and require substantial time and resources to navigate, and this is all with little guarantee of future reliability or any success in remedying the root cause of affordability issues.”

The board is still in its review process for four other drugs: Genvoya, Enbrel, Cosentyx and Stelara. It could revisit its decision on Trikafta in the future.

“At this point, it does not seem unaffordable. We all hope it will stay that way, and I would certainly be willing to review it again if it doesn’t that way and we hear that from cystic fibrosis patients,” board chair Gail Mizner said.

Colorado joins Maryland, Maine, New Hampshire, Ohio, Oregon and Washington in having some kind of drug affordability regulatory body. Colorado, Washington and Maryland are the only ones with the power to set upper payment limits.

Colorado Newsline is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. Colorado Newsline maintains editorial independence. Contact Editor Quentin Young for questions: Follow Colorado Newsline on Facebook and Twitter.