From bone breaks to temporary blindness, Elisa Comer has been through the ringer. But the Gray, Tenn., resident blames more than the immune system disorders attacking her body. She also blames frequent changes in her health plan’s drug coverage.
As many patients learn the hard way, having insurance doesn’t guarantee access to affordable medicines. And the reasons why one drug is available and another isn’t -- even with a doctor’s prescription -- often have nothing to do with what’s best for the patient.
“The person you trust to treat you recommends something and then someone invisible says, ‘No, we disagree, we’re not going to do that,’ without much or any explanation,” said Ivo Abraham, professor of pharmacy practice and science at the University of Arizona College of Pharmacy, which has campuses in Tucson and Phoenix. “It’s frustrating, if not infuriating.”
Comer -- who has rheumatoid arthritis and Sjogren’s syndrome -- has been on a drug called Humira for about nine months to treat the autoimmune diseases. Humira and other biologics, which are therapies derived from living organisms, help reduce inflammation and prevent complications. It can take months for patients to experience the full benefit from biologics, some of which need to be administered at specialized infusion clinics.
The three quarters of a year that Comer’s been on Humira is the longest stretch she’s been on the same biologic in years. That’s because her UnitedHealthcare plan’s coverage keeps changing -- and putting one biologic after another out of her reach.
At one point, due to changes in her insurance coverage, she says her out-of-pocket cost for Enbrel increased $4,000 a month, to more than $6,000 from about $2,000, forcing her to switch medications. Another time, she says, a plan change left her with what she felt was an untenable choice: To continue getting her biologic covered, she would have to leave her rheumatologist and visit a clinic owned by CVS Caremark, a UnitedHealthcare affiliate, that administered it.
“So I quit taking it,” said Comer, a volunteer patient advocate for CreakyJoints, an online community for arthritis patients and caregivers. Comer had no desire to leave the doctor she trusted, and adds that she couldn’t afford to cover the cost of the medication, Orencia, on her own. That meant spending months between biologic treatments, before starting on a new drug that cost her less out of pocket.
“We don’t have $9,000 a month to pay the cash price for that,” she said. “I don’t know a whole lot of families who do quite honestly.”
If a medication’s lack of coverage makes no sense, follow the money.
Safety and efficacy also influence coverage decisions. But when a number of drugs are available to treat the same condition, patients sometimes find that their insurance coverage changes with little warning: A medicine is no longer covered or the out-of-pocket cost is suddenly so high that a medication is now unaffordable.
These so-called non-medical switches – which are meant to contain costs for the insurer and unrelated to what a health provider recommends – can disrupt care and worsen outcomes when stable patients switch to a drug that doesn’t work as well for them.That’s a particular risk with insulin, said Karen Van Nuys executive director of the Value of Life Sciences Innovation Project at the University of Southern California Center for Health Policy and Economics.
“I know patients and doctors get really frustrated,” she said.
A change in insulin or other medicines can happen when pharmacy benefit managers (PBMs) – the middlemen between drug manufacturers and insurers – adjust the preferred insulin product on a health plan’s formulary. That forces physicians and patients to repeat the process of determining precise dosage and effective regimen, Van Nuys says, since biologic drugs, while similar, still have slight differences.
As Comer put it, “It’s really, really hard when you go through these non-medical switches, because then you have to start all over.”
A person with autoimmune disease such as rheumatoid arthritis or Sjogren’s can have flares, when inflammation increases, especially if the condition isn’t well managed. That’s what Comer says she experienced due to frequent switches and gaps in treatment--including flares in her eyes that left her legally blind in 2019.
To try to save her vision -- now restored -- Comer took the steroid prednisone, which decreases inflammation but also increases the risk for fractures. She thinks that and the non-medical switches are responsible for nearly a dozen bone breaks she suffered in a single year.
Pharmaceutical companies use rebates to win favor with PBMs.
Rebates can greatly influence formulary decisions: Are similar medications on the market? Are generics available? The drug maker that offers a PBM the biggest rebate may get preference, Van Nuys says.
The rebates come off the wholesale acquisition cost, which is the price pharmaceutical companies set for a drug but that patients don’t actually pay. While PBMs insist the lion’s share of that discount is passed on to consumers, the drug offering the largest rebate may not be the least expensive one for consumers. That means a PBM may place a more expensive -- but higher rebate -- drug in a preferred position on the formulary. Medications that aren’t listed on the formulary or that are placed on a higher tier cost more out of pocket, often rendering them unaffordable.
Sometimes being the new drug on the block works against both a medicine and the patients who need it.
Even approval by the U.S. Food and Drug Administration, which requires clinical trials and peer-reviewed results, doesn’t guarantee a spot on a formulary. Instead, PBMs and insurers might wait months or longer before covering a drug to determine how well it works and whether doctors are willing to fight for its coverage. When a drug is temporarily blocked, the only way to get insurance to cover it is for a physician to request a medical exception. That may help keep a lid on what health plans pay for new drugs, but also means a patient can’t get the drug.
“Just because you have insurance doesn’t mean you have access to everything,” said Gary Branning, an assistant professor of professional practice at Rutgers Business School and president of Managed Market Resources (MMR), a healthcare consulting and medical communications company. “They’re weighing innovation and cost against a budget.”
If a doctor’s request for a medication exception is denied, further appeal is possible. The fight can go all the way to the state insurance commissioner for commercial insurance (or a government contractor for patients covered by Medicare). If it’s overturned, the plan has to cover the bill.
Comer says she can’t even guess how much time her doctor’s office spent trying to overturn drug coverage changes on her behalf. She spent countless hours on the phone fighting the same administrative battles -- and notes, with only a hint of irony, that she’s had to be careful not to let the stress of battling closed-door drug coverage decisions worsen her conditions.
“It’s a journey in and of itself, without having to worry about the administrative side of being sick. It’d be nice to just be the patient,” Comer said. “I honestly think it was a blessing from the good Lord that I was not sitting down in the same room with the people that were making these decisions about my healthcare. I really think I would have come across that table.”
Michael Schroeder is a freelance health writer and editor based in Westfield, Indiana.
Don’t despair. There’s help for you: assistance with copays, deductibles and other expenses.
Coalition building. Raising awareness. Encouraging innovation. Changing perceptions and policy. Making medicines affordable.
Clear-cut ideas and solutions. The science, economics and policy of affordability and innovation.