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Arthritis patients pressured by Medicare turn to cheaper IV drugs

Up to 40,000 chronically ill seniors choose to endure uncomfortable and time-consuming intravenous infusions because the government health insurance Medicare does not adequately cover the far more convenient and less stressful treatment of the arthritis drug Humira at home.

When patients with rheumatoid arthritis switch from private health insurance to Medicare, self-administered drugs such as Humira and Xeljanz become unaffordable overnight because of the complicated pricing of prescription drugs that the program requires for self-administered drugs. To reduce patients' out-of-pocket costs, rheumatologists often propose a solution: regular, hour-plus visits to a hospital or infusion center for intravenous drug treatments.

While home treatment carries its own risks, switching medications may also cause side effects in some patients whose symptoms have remained stable for years despite self-administered biologic treatment with Humira.

Humira has become a prime example of how pharmaceutical companies can manipulate the patent system to extend their exclusivity in the market. AbbVie extended its patent protection from 2016 to 2023 by exploiting loopholes in patent law and lawsuits. This allowed the company to bypass competition and impose ever higher prices on consumers. Less well known are the consequences of these maneuvers for Medicare patients.

Rheumatologist Madelaine Feldman calls it the “birthday story”: “We have a 64-year-old patient who is stable on Humira or another self-injectable drug,” she says. “And then he turns 65.”

Suddenly, the patient's copayments under his new Medicare drug plan skyrocket, prompting his rheumatologist to switch him from Humira — which he administers to himself by sticking an injection pen just under his skin — to a similar drug given intravenously in a clinic, often up to twice a month.

“It's just easier,” says Joseph Huffstutter, a rheumatologist in Hixson, Tennessee. “The co-payment for an injectable drug is often much higher than for an infusion drug.”

Humira is usually replaced by rheumatologists with regular infusions of the biologic infliximab, given up to every few weeks. Aside from the drug being inconvenient, about 5% of people treated with infliximab experienced an acute reaction such as fever and chest pain, according to one study.

Publicly available Medicare data show that in 2022, the most recent year in the dataset, 39,798 beneficiaries were treated with infliximab. It's impossible to know how many of them would prefer treatment at home, but under the current system, the choice is largely out of their hands. And infliximab is just one of many infused drugs being used as a substitute to make treatments affordable under Medicare.

Drug infusions are covered by Medicare Part B because they are administered in hospitals or infusion centers. Prescription drugs obtained at home from a pharmacy are covered by Part D, which requires patients to pay a percentage of the cost of their prescription for part of the year rather than a flat copayment — an arrangement known as the “coverage gap.” For expensive specialty drugs, this amount can be well over $1,000 a month.

Patients fall into the coverage gap when their copayments exceed a threshold, which will be $5,030 in 2024, and must then pay 25 percent of a drug's list price out of pocket. For a drug like Humira, that can amount to as much as $1,500 a month.

This workaround allows patients to receive life-saving medicines at a lower price, but they often pay a different price for them.

When Linda Kaser turned 65, she was treating her arthritis with Xeljanz XR tablets, a specialty drug similar to a biologic that is patented until 2034. She learned the tablets would cost her more than $4,000 a month under Medicare Part D. Her rheumatologist used this workaround and switched her to Rituxan infusions – a comparable biologic that is fully covered by her Medicare supplemental insurance after a small deductible.

Four times a year, Kaser now has to drive an hour to get her infusion, which takes four hours, and then an hour back to her home in Ave Maria, Florida. She is grateful for her rheumatologist's expertise, she says, but “I wasn't happy to sacrifice four hours of my life for an infusion when I can just give myself a shot or take a pill.”

While the costs to patients are clear, it is difficult to estimate the true cost to the Medicare program – and ultimately to taxpayers – of switching from Part D to Part B drugs. A drug manufacturer such as AbbVie can pay a Medicare Part D plan to keep Humira as a preferred drug in its drug schedule. This negotiated payment is called a “rebate” and is kept secret – so it is impossible to actually Total price of the drug for the plan. For Part B drugs, the drug price is much more transparent.

Publicly available Medicare pricing data from 2022 show that Humira costs $58,000 annually without rebates, compared to about $9,000 for Inflectra infusions. Xeljanz XR pills cost nearly $36,000 annually without rebates, compared to $21,000 for Rituxan.

“This lack of transparency is a feature of the system. It's not a bug,” said Karen Van Nuys, a Medicare policy and data expert at Yale University. “It's very difficult to compare apples to apples,” which benefits plan managers and drug companies.

In addition to the drug price, Van Nuys emphasized the additional costs incurred at infusion centers where one patient occupies a bed, as well as the time of doctors and nurses, which can easily run into the thousands of dollars. “The resources we devote to this process have to be greater than if you were to self-administer an injection pen at home,” she said. These costs are ultimately borne by taxpayers.

Huffstutter said some of his patients really appreciate the personalized attention they receive at their infusion center. Feldman added that patients easily make mistakes when self-administering. She recalls a Medicare beneficiary who forgot to stop taking Humira before scheduled foot surgery and had to have her toe amputated.

These decisions are complicated and personal, but Huffstutter wants to see fairer pricing so patients “have to make a medical decision, not a financial one.”

Next year could bring changes for Medicare patients with rheumatoid arthritis. After Humira's patent protection finally expires in 2023, biosimilars will become more widely available. Increased price competition could make Humira more affordable, although rebate systems may counteract this by penalizing biosimilars.

Even more promising, the cost of the coverage gap will be significantly reduced under President Biden's Inflation Reduction Act in 2025. The law imposes an annual $2,000 cap on the out-of-pocket costs seniors pay for their Part D prescription drugs, which they can spread over monthly payments.

“This massive switch to Part B will become less and less as patients who are stable on Part D drugs can afford them,” Feldman said. “If I could have kept those patients on the drug they were stable on, I would have. But I couldn't.”

STAT's reporting on patent issues is supported by a grant from Commonwealth Fund. Our Financial supporters are not involved in decisions about our journalism.