As many as 40,000 chronically ill seniors are choosing to endure uncomfortable, time-consuming intravenous infusions because Medicare doesn’t sufficiently cover far more convenient, and less distressing, at-home treatments with the arthritis drug Humira.
When rheumatoid arthritis patients enroll in Medicare, switching from private insurance plans, self-administered medications such as Humira and Xeljanz become unaffordable overnight, thanks to the program’s convoluted pricing of at-home prescription drugs. To reduce patients’ out-of-pocket expenses, rheumatologists often suggest a workaround: regular, hour-plus visits to a hospital or infusion center for intravenous drug treatments.
While at-home treatments carry their own risks, the medication change can also cause side effects for some patients whose symptoms have been stable for years on a self-administered biologic such as Humira.
Humira has become the prime example of how drugmakers can manipulate the patent system to extend their period of marketing exclusivity. AbbVie extended its patent protection from 2016 into 2023 by exploiting loopholes in patent law and lawsuits, allowing it to avoid competition and charge consumers ever-higher prices. Less well known are the consequences of those maneuvers for Medicare patients.
Rheumatologist Madelaine Feldman calls it the “birthday story”: “We have a patient who’s 64, and they’ve been stable on Humira or whatever self-injectable they’ve been taking,” she said. “And then they turn 65.”
Suddenly, the patient’s copays skyrocket under their new Medicare drug plan, leading their rheumatologist to switch them from Humira — which is self-administered by sticking an injector pen just underneath the skin — to a similar drug that’s intravenously infused in a clinical setting, often up to twice a month.
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“It’s just easier,” said Joseph Huffstutter, a rheumatologist in Hixson, Tenn. “They often have a much larger copay for an injectable than they will for an infuseable.”
For Humira, rheumatologists usually substitute regular infusions of the biologic infliximab, as often as every few weeks. In addition to the drug being inconvenient, approximately 5% of people treated with infliximab suffered an acute reaction such as fever and chest pain, according to one study.
Publicly available Medicare data show 39,798 beneficiaries were treated with infliximab in 2022, the most recent year in the dataset. It’s impossible to know how many of these would prefer at-home treatments, but the choice is largely out of their hands under the current system. And infliximab is only one of many infused drugs that is substituted to make treatments affordable under Medicare.
Drug infusions are covered under Medicare Part B because they’re administered at hospitals or infusion centers. At-home prescription drugs obtained through pharmacies fall under Part D, which makes patients pay a percentage of their prescription’s cost for part of the year, instead of a flat copay — a feature known as the “coverage gap.” For expensive specialty drugs, that can run to well over $1,000 a month.
Patients enter the coverage gap once their copays cross a threshold, set at $5,030 in 2024, and then need to pay 25% of a medication’s list price. For a drug like Humira, this can be as much as $1,500 a month.
The workaround gets lifesaving drugs into patients at a lower price tag, but they often pay another kind of price.
When Linda Kaser turned 65, she was treating her arthritis with Xeljanz XR pills, a specialty drug similar to a biologic that’s under patent until 2034. She learned the pills would cost her over $4,000 a month under Medicare Part D. Her rheumatologist used the workaround, switching her to Rituxan infusions — a comparable biologic drug that, after a small deductible, is fully covered by her Medicare supplement insurance.
Four times a year, Kaser now has to travel an hour to get her infusion, which takes four hours, then travel an hour back to her home in Ave Maria, Fla. She appreciated her rheumatologist’s savvy, she said, but “I wasn’t happy to give up four hours of my life for an infusion when I can just self-inject or take a pill.”
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While the cost to patients is clear, it’s hard to estimate the true cost to the Medicare program — and ultimately taxpayers — of the shift from Part D to Part B drugs. A drugmaker like AbbVie can pay a Medicare Part D plan to keep Humira as a preferred drug on its formulary. This negotiated payment is called a “rebate,” and it’s kept secret — so it’s impossible to know the actual total price of the drug to the plan. For Part B drugs, the drug price is far more transparent.
Publicly available Medicare pricing data from 2022 shows Humira cost $58,000 annually, excluding rebates, versus around $9,000 for Inflectra infusions. Xeljanz XR pills cost almost $36,000 a year, excluding rebates, versus $21,000 for Rituxan.
“This opacity is a feature of the system. It is not a bug,” said Karen Van Nuys, a Medicare policy and data expert at Yale University. “It’s very hard to get an apples to apples comparison,” which works to the benefit of plan managers and drug companies.
On top of the drug price, Van Nuys emphasized the additional costs involved in infusion centers where a patient occupies a bed, plus the time of doctors and nurses, which can easily run into thousands of dollars. “The resources we are devoting to that process have got to be greater than if you self-administer an injector pen at home,” she said. Those costs are ultimately borne by the taxpayers.
Huffstutter said that some of his patients enjoy the individual care they get at their infusion center. Feldman added that it’s easy for patients to make mistakes when self-administering. She recalls a Medicare beneficiary who forgot to stop her Humira before an elective foot surgery and had to have her toe amputated.
These choices are complicated and personal, but Huffstutter wishes the pricing was fairer so patients “would have a medical decision to make, not a financial one.”
The next year could bring changes for rheumatoid arthritis patients on Medicare. After Humira’s patent protection finally expired in 2023, biosimilars are becoming more widely available. The added price competition could make Humira more affordable, though rebate schemes can work against this by disadvantaging biosimilars.
Even more promising, the coverage gap’s cost will be greatly diminished in 2025, as part of President Biden’s Inflation Reduction Act. The law will put a yearly cap of $2,000 on what seniors pay out of pocket for their prescription drugs in Part D, which they can choose to split into monthly payments.
“You’re going to see less and less of this huge migration over to Part B once patients who are stable on Part D drugs can actually afford them,” said Feldman. “If I could have kept these patients on the drug they would be stable on, I would have. But I couldn’t.”
STAT’s coverage of patent issues is supported by a grant from the Commonwealth Fund. Our financial supporters are not involved in any decisions about our journalism.
