Colorado prescription drug board declares Enbrel unaffordable in national first

A Colorado board voted unanimously Feb. 16 to consider setting a maximum price for a drug to treat autoimmune diseases, launching the state into uncharted territory and setting up a possible showdown with the drug's manufacturer.

Colorado's Prescription Drug Affordability Board voted that the injectable drug Enbrel is unaffordable to patients in the state. The medication can cost patients and their insurance companies more than $46,000 a year.

The board also considered Genvoya, a combination pill for HIV, but determined that medication was affordable because of patient assistance programs.

The vote allows the board to consider setting a maximum price for Enbrel in Colorado when it meets again next week, which would be the first time any state took that step with any prescription drug. The level at which the drug's price might be capped was not discussed at Friday's meeting.

Enbrel is approved for multiple diseases where the immune system attacks body tissues, including four types of arthritis and the most common form of the skin condition psoriasis.

The vote was an important step toward bringing down drug costs, said Hope Stonner, policy manager of the Colorado Consumer Health Initiative.

"Patients who rely on Enbrel—and all patients, frankly—must be able to afford their needed medications," she said in a statement. "We support the board's ruling today and hope they set an upper payment limit so that patients can find financial relief alongside their physical relief."

Drugmakers whose products have gone before the board have raised alarms that Colorado patients may no longer be able to buy their drugs if the state sets a maximum price, while consumer advocates said they were bluffing to protect their revenues.

The state's All-Payer Claims Database found Enbrel cost more than $46,000 a year per patient, with patients responsible for an average of $2,295 in 2022 if they were covered by commercial insurance or Medicare Advantage. The database found at least 3,400 people in the state used Enbrel that year.

The Prescription Drug Affordability Board's charge is to determine whether drugs are affordable for patients, rather than for the system as a whole. In December, the board ruled that a $200,000-a-year drug for cystic fibrosis was affordable, because assistance programs covered most out-of-pocket costs for patients.

A small survey found most respondents who took Enbrel reported they had at least one problem related to the drug's costs. Eight of 38 Coloradans who answered the survey said the costs pushed them into medical debt, and 20 said they had to cut back on other expenses. Nine people reported they skipped doses of Enbrel or stretched the time between doses to save money.

Board member Amy Gutierrez, who is a pharmacist, said the number of patients reporting affordability problems concerned her.

"That's a big percent that would have to choose between paying their rent or food, getting their drug or transportation," she said.

In a letter submitted to the board, Enbrel's maker Amgen said patients might be unable to access the drug if the state set a lower price. But Brett Johnson, who spoke on behalf of Amgen at the board's meeting, stuck to concerns about the process and the perception that Enbrel was treated differently than Trikafta, the cystic fibrosis drug.

"Roughly half the (Enbrel) patients paying $100 or less said they never had trouble affording their medicine," he said.

Tiffany Westrick-Robertson, who spoke on behalf of the International Foundation for Autoimmune and Autoinflammatory Arthritis, also raised concerns that the board hadn't done enough to engage patients and find out why some said affordability was a problem.

"I am extremely, extremely concerned," she said.

Enbrel's price has risen continuously since the late 1990s, according to the board's draft affordability report. The per-patient price was about $13,000 higher in 2022 than it had been in 2018, and the average share that patients were responsible for rose about $600 in that time.

The list price for Enbrel, before rebates paid to middlemen, rose 1,582% between November 1998 and January 2024. Drugmakers have pointed to rebates as one of the main reasons patients are paying more for medication, as well as insurance companies' decisions about how much of the cost to pass on.

Still, raising the list price by that much is excessive, board member Cathy Harshbarger said.

"What (the increase) should be is up for debate, but what it shouldn't be is 1,500%," she said.

Genvoya's per-patient cost also had increased, rising more than $8,000 in four years to $32,196 in 2022, according to the board's report on that drug. The share assigned to patients was $2,616 in 2022, but government programs for HIV patients help cover the cost for people earning up to five times the federal poverty line, said board member Dr. Gail Mizner.

"This particular medication… because of the robustness of the program, patients are getting it," she said.

All of the 22 people who responded to a survey about Genvoya said they spent $100 or less on their medication each month. Four reported they had to cut costs in other areas of their lives to afford their medication, though.

The number of people in Colorado using Genvoya dropped by half from 2018 to 2022 as other drugs became available. Board member Justin VandenBerg, a pharmacist, said the utilization trend suggests it may not be a significant financial challenge for the state in the future.

"It looks like maybe we're catching this on the back end," he said.

2024 MediaNews Group, Inc. Distributed by Tribune Content Agency, LLC.