Patients and medical providers are urging a key Colorado panel to halt work toward capping health insurance payments for the blockbuster biologic Enbrel, citing insurers’ plans to shift coverage that could put some treatments out of reach.
The Colorado Prescription Drug Affordability Board, which is close to becoming the first panel of its kind to set a statewide cap on a high-spend drug, is facing pressure from patient and health professional coalitions who say the board has failed to adequately engage with insurance companies and their pharmacy benefit managers that will be tasked with enforcing the limit on
Public outcry grew after health plan employees said in a recent survey that a payment limit is likely to affect their lists of covered drugs, or formularies. The five-member Colorado board maintains a payment limit is meant to make drugs more affordable for Coloradans, citing an average of more than $2,000 in out-of-pocket costs for Enbrel for state residents in 2022.
If a limit forces health plans to shift where Enbrel or its therapeutic alternatives are located on formularies, some patients could be unable to afford treatments considered clinical breakthroughs for arthritis and other debilitating autoimmune conditions.
“For something to be accessible, it’s got to be both affordable and available,” said Harry Gewanter, a pediatric rheumatologist and board member for the health-care advocacy group Let My Doctors Decide Action Network.
“If it’s not on the formulary, or if it’s on a different tier of the formulary, it’s not going to be available,” Gewanter said.
Health Plan Warnings
The Colorado Association of Health Plans wrote in a November 2022 letter to the state board that it was concerned about “how the proposed rules could be operationalized by a carrier and whether the enforcement of a UPL will address the real problem of the exorbitant prices set by manufacturers,” referring to the upper payment limit.
Since the organization submitted the letter, “the board has not meaningfully addressed the operational and compliance challenges we raised,” Kevin McFatridge, the association’s executive director, said in an email.
Most high-level health plan employees surveyed by Avalere Health, 74%, said they expect manufacturer rebates for a drug with a payment cap to either decrease or stay the same, and 83% said they anticipate a payment limit to cause “moderate or major disruption to formulary design.”
“Health plans do not anticipate patient costs will necessarily go down because of an upper payment limit,” said Emily Donaldson, a principal at Avalere and lead author on the study published in March.
The law establishing the Colorado board mandates that health plans pass along any savings from a cap “to reduce costs for consumers.”
If the cap is not below Enbrel’s current net cost after rebates and discounts, however, “it may not produce any savings,” and “may require carriers to explore tools to manage affordability,” McFatridge said.
These management tools could include prior authorization from a health-care provider, or a requirement that patients try an alternative treatment before receiving coverage for a health plan’s less preferred drug, known as step therapy. Both of those changes spark concern about affects to access.
‘Dictating Patient Care’
Chronic illness patients and their health-care providers say any potential disruptions to therapeutic access can be harmful to those who rely on continuous biologic use to avoid permanent damage to joints and muscles.
“They are dictating patient care,” Gewanter said of the Colorado board. He noted that Enbrel and its therapeutic alternatives, including
Tiffany Westrich-Robertson, CEO and co-founder of the International Foundation for AiArthritis, lives with inflammatory arthritis. She said in an interview that the “best case scenario” for a limit on Enbrel is that it “costs less than some of the competing biologics or therapeutic alternatives.”
That, however, would mean that “patients who rely on those alternative medications” could “face higher costs because their drug is moved to a higher formulary tier or be required to switch to Enbrel because it is a lower-cost drug,” Westrich-Robertson said.
Katelin Lucariello, deputy vice president for state advocacy at the Pharmaceutical Research and Manufacturers of America and a member of the Colorado board’s advisory council, said in an interview that the board hasn’t adequately explored a cap’s repercussions for consumers and manufacturers, which “only adds additional uncertainty and discomfort.”
“In the midst of the UPL rulemaking process, there’s still an opportunity to pause the process and explore some of these potential unintended consequences,” Lucariello said.
Measuring Access
Colorado board members and their supporters say they will continue to monitor access to Enbrel and therapeutic alternatives after a payment limit is set.
“No one can be 100% sure what will happen when we set a UPL,” Colorado PDAB Chair Gail Mizner said during the board’s July 11 rulemaking hearing. She said the board “will certainly be very much asking staff to be monitoring” the effects and can pull back a payment limit if it’s not resulting in consumer savings.
Board members also asked staff at the July meeting to reach out to health plans on potential changes to formularies and access. Staff plan to provide an update on this outreach at the August meeting, the Colorado Division of Insurance said in an email.
The board is “really working to thread that needle between bringing down costs for consumers and also making sure that there’s still the ability to manufacture and distribute this vital drug,” said Sophia Hennessy, policy and research coordinator at the Colorado Consumer Health Initiative, which supports setting a payment limit on Enbrel.
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