Colorado moves forward with price caps for unaffordable prescriptions despite possible litigation

(Via AP Storyshare)

For those seeking treatments for autoimmune diseases, relief in the form of more affordable drug treatments may be on the way. At a July 3 meeting, Colorado’s Prescription Drug Affordability Review Board voted unanimously to proceed with setting price caps for two prescription drugs: Stelara and Cosentyx.

The board members reviewed separate reports that found both drugs to be both essential and unaffordable for Colorado patients. The investigation found that the average out-of-pocket costs for patients with commercial insurance on Stelara and Cosentyx were $5,875 and $2,801 per year respectively. For a patient without insurance, Cosentyx costs an average of $46,948 per year.

Both Stelara and Cosentyx are used to treat chronic autoimmune diseases, such as Crohn’s disease, ulcerative colitis and plaque psoriasis. Neither drug is a quick fix. They are long-term therapies that patients often remain on for years.

According to Megan Purdy, an emergency medicine resident at Denver Health and an ulcerative colitis patient herself, steep prices come with a hidden cost.

“Many of my patients will be on these medications and oftentimes they do come in having missed doses — unable to get insurance coverage for these medications, unable to afford them,” she said.

Cosentyx and Stelara have been on the board’s radar since last summer, when it selected five pharmaceuticals from a list of 604 potentially unaffordable prescriptions. The board’s decision starts a process that will solicit more information from doctors, industry stakeholders and patients before setting price limits on the drugs.

Since 2019, eight U.S. states have established prescription drug affordability review boards and five have included a process for setting upper payment limits. So far, no states have moved passed the affordability review step. Colorado could be the first to establish an upper payment limit for a specific drug.

In February, the board initiated its first ever price-capping process for the arthritis drug Enbrel. The drug’s manufacturer, Amgen, sued the state of Colorado in federal court the following month. The company argued that a state-mandated price interferes with numerous laws and constitutional clauses designed to protect businesses and patent-holders. It called for the state to end the process and dissolve the review board. The case is pending, and oral arguments are scheduled for October.

Advocates expect similar lawsuits from Johnson & Johnson, the patent-holder of Stelara, and Novartis, the patent-holder for Cosentyx.

“It’s a pretty common tactic from pharma to sue when they are faced with price controls,” said Priya Telang, a spokesperson for the Colorado Consumer Health Initiative. “We expect a lawsuit coming from them soon.”

Though no litigation has been filed so far, some opponents are already making their voices heard. At the July 3 meeting, public commenters, including a Johnson & Johnson spokesperson and a Maryland-based pediatric rheumatologist, spoke out in frustration.

“I have come to realize over the last month or so that it honestly doesn’t really matter what I say, patients say, or other organizations say, if we are receiving funding from pharmaceutical companies,” said Tiffany Westrich-Robertson, the CEO of the International Foundation for Autoimmune and Autoinflammatory Arthritis.

Westrich-Robertson and others argued that insurers would maintain the same out-of-pocket costs for the drugs and pocket the savings. Board members were receptive to that concern, but they also expressed optimism that they could figure out how to hold insurers accountable.

“We don’t know for certain what the effects of setting an upper payment limit would be,” board member Gail Mizner testified. “Hearing from insurers is really going to be a key part of the upper payment limit process.”

Under the state law that created the board, insurers will be required to submit an annual report documenting how savings from price caps were passed on to consumers. Advocates argue that the board is working to ensure that guardrails are in place to protect consumers from profiteering.

“The board is approaching this really cautiously and carefully,” Telang told KUNC.

In the coming months, the board will research the cost of manufacturing Stelara and Cosentyx to calibrate its eventual price cap. Though the July 3 meeting set the motion in process, the board could still decide to end its deliberations at any time and forgo a payment limit.

In its next meeting, scheduled for Friday, July 19 at 10 a.m., the board will meet with the Prescription Drug Affordability Advisory Council, which includes representatives from various stakeholder groups including drug companies, pharmacists and labor unions. The meeting is open to the public, and you can register to attend at this link.

This story was updated at 10:32pm on July 23, 2024 to reflect that Tiffany Westrich-Robertson’s appeared at the July 3 meeting of the Prescription Drug Affordability Board as a representative of the International Foundation for Autoimmune and Autoinflammatory Arthritis.

Gabe Allen, KUNC