The Colorado Prescription Drug Affordability Board (PDAB) will not be pursuing an upper payment limit (UPL) on Trikafta following its affordability review on the drug.
Trikafta was one of five drugs PDAB decided to conduct affordability reviews for, along with Enbrel, Genvoya, Cosentyx, and Stelara. Board members can recommend UPLs for any of the drugs deemed to be unaffordable during their affordability reviews.
Following the completion of Trikafta’s affordability review, board members voted unanimously that the drug was not unaffordable for Colorado consumers during PDAB’s Dec. 8th meeting. The US Food and Drug Administration approved the use of Trikafta for cystic fibrosis (CF) patients (age 12 and older, with at least one F508del mutation) in October 2019. Since then, it has been a game-changer for many CF patients who say it has vastly improved their lives.
Many CF patients voiced concerns about placing a UPL on Trikafta during PDAB meetings, citing access concerns. CF patient Dr. Samantha Monson, a psychologist in Denver, discussed those concerns with State of Reform prior to PDAB’s vote on the drug. She said that—although PDAB’s overall purpose is to render medications more accessible to patients by lowering costs—CF patients were concerned about Trikafta access because it has improved their lives so much, and they were unsure of how a UPL would affect it.
“I think costs need to be contained,” Monson said. “You have to start somewhere, and a UPL is a place to start. It’s going to work for some medications, and for some, it won’t. The process has not matured to be able to safeguard the ultimate issue, which is access. It’s well-intentioned, but it needs to mature and develop. The biggest skeptics said this will be devastating. I think the UPL process needs to be better tested and refined with medications that people’s lives are not so dependent on. If access was jeopardized unintentionally, there would be no other medication that’s close to Trikafta.”
Board members discussed Trikafta during their Dec. 15th meeting as well. PDAB Director Lila Cummings said the board acknowledged that Trikafta’s therapeutic alternatives were inferior— clinical-effectiveness evidence indicated Trikafta was superior to them—during the drug’s affordability review.
Trikafta (which is only taken by a few hundred Coloradans) has a list price of $300,000 a year, but many insurers cover the cost of the prescription, and pay about $15 per month for it. PDAB’s affordability review found that the majority of Medicaid patients paid a maximum of $3 for each prescription drug fill, Cummings said.
PhRMA spokesperson Reid Porter discussed PDAB’s decision on Trikafta with State of Reform.
“The board made a decision in response to concerns raised by patients who could be negatively affected by government price setting. Now it is vital that Colorado and other states across the country continue to listen to patients and fully understand the potential impact of their decisions on any medications under review. Creating bureaucratic barriers between patients and their doctors could make it very difficult for patients to access life-saving medications.
Instead of focusing on misguided price-setting, Colorado should address the root cause of the problem: health insurance practices and the self-serving actions of pharmacy benefit managers who control and often increase costs at the pharmacy counter.”
— Porter
The board is now focused on affordability reviews for Genvoya and Enbrel. During its Dec. 15th meeting, PDAB Chair Dr. Gail Mizner noted that board members heard from several medical experts, physicians, and other medical experts during Tikafta’s affordability review.
“And I have the feeling we really should try to maintain that standard as much as we can for all the drugs that we review,” Mizner said. “I would like to have a minimum of two physicians and, if possible, two pharmacists give us information in terms of medical expertise.”
While PDAB heard a lot of input from the CF community during Trikafta’s affordability review, it has not heard as much from patients who take Genvoya or Enbrel, Mizner said.
“So I wanted to see if there was any way the staff could gather any more information from those patients,” she said.
That could be more of a challenge with Genvoya, as the drug is used to treat HIV patients who might not be as willing to provide information due to stigmas around the virus.
“I think it’s going to be tough, but worth the effort,” board member Justin VandenBerg, PharmD, said. “I would hate to not get enough input and make decisions, and then find out afterwards that maybe there could’ve been a little bit better dialog.”
In order to collect more information, PDAB will reopen surveys for Genvoya and Enbrel, Cummings said. Patients and caregivers can fill surveys out here, while individuals with scientific and medical training can fill them out here. PDAB will also try to give HIV patients an opportunity to keep their survey information confidential.
“While we might still ask for the information or require it, we’ll take extra steps to make sure that their names are never disclosed in the reports or in any of the board’s public documents,” Cummings said. “We will attempt to do that.”
PDAB’s next meeting will be on Feb. 16th, 2024, at 1 p.m.