CMS proposes national Medicare coverage for CAR-T therapy
The CMS on Friday proposed nationwide Medicare coverage for a rapidly developing and high-cost cancer therapy that leverages a person's immune cells to fight cancer.
The proposed decision promises a financial windfall for hospitals offering the treatment, as the bundled payments for covering the therapy and side effects could climb as high as $1.5 million per patient.
The proposal also marks another major milestone for the chimeric antigen receptor, or CAR-T cell therapy, less than two years after the U.S. Food and Drug Administration approved two separate treatments by Novartis and Gilead Sciences. It would change current policy that lets local Medicare administrative contractors decide whether to pay for the therapies.
The agency's proposal for national coverage determination would require Medicare to pay for CAR-T treatments given in a CMS-approved registry or clinical study. Patients would need to be monitored for at least two years after receiving the treatment so the CMS can flag the types of patients for whom the therapy is effective, potentially leading to Medicare coverage without a registry or clinical trial.
The two FDA-approved therapies are Novartis' Kymriah, treating leukemia in children and young adults, and Gilead's Yescarta for certain non-Hodgkin lymphomas in adults. Both are extremely expensive and have high co-pays under Medicare. The therapies are created individually for each patient.
According to the CMS, Medicare pays $439,000 for Kymriah with a listed co-pay of $88,000, and $395,000 for Yescarta, with a listed co-pay of $79,000. For traditional Medicare, the co-pay is capped at the inpatient hospital deductible, or $1,364 for 2019.
Analysis of 10 months of patient data by the Texas-based healthcare consulting company Vizient estimated that adults receiving CAR-T therapy needed a median 15-day hospital stay, costing an average total of just over $82,000, and a median direct cost of just over $43,000.
This is higher than a July 2018 estimate from JAMA Oncology that projected an average of $30,000 to $36,000 in additional per-patient costs beyond the drug treatments.
Patients under age 25 saw even higher costs, Vizient found in a separate analysis. For them, the median hospital stay was 17 days. The median total cost of hospitalization for the therapy was $280,276 with a direct cost of about $152,633.
The cost question drives the friction for insurance plans as more patients are likely to start trying CAR-T treatment.
Kristine Grow, senior vice president for communications at America's Health Insurance Plans (AHIP) said insurers are still reviewing CAR-T therapies on a case-by-case basis and following FDA safety notices and new clinical findings.
The group had no direct comment on the proposal yet, but underscored the insurer concern with costs and justifying those costs with the proven effectiveness of the treatment.
"Of note, these therapies, while innovative, do not have the long-term evidence to confirm they are a lifetime cure," Grow said. "Many of these gene therapies have not yet effectively demonstrated long-term safety or duration of effect. In other words, the data collected on gene therapies is still relatively in its infancy."
Individual plans still determine coverage, she added. But although some insurers are eying models that tie payment to outcome for especially expensive treatments, Grow said they're not a "panacea to the root problem of excessively high drug prices."
Ted Okon, executive director of the Community Oncology Alliance which represents community oncologists said the proposal doesn't come as a surprise as the CMS tries to gather more data on how the therapies work across a broader swath of patients.
"Generally a lot of this is reasonable," said Okon, whose group isn't really invested in the therapy since it currently depends on inpatient hospital care.
He noted the mix of "miracle results" and serious side effects and said the proposal acknowledges the need for a lot more data. He also said it's a step toward figuring out how and whether these treatments can be widely financed.
"I think it's buckling down to try to get additional data, so the agency can make more intelligent decisions both about the nature of this therapy, and following it after the fact, and also the idea of, 'How are we going to pay for this?'"
CAR-T therapy is one of several types of treatment called adoptive cell transfer, or ACT, in which a patient's immune cells are gathered to treat their cancer. But so far CAR-T is the most advanced form of ACT and the only one approved by the FDA.
Updated: This story has been updated to reflect the correct timeframe for Vizient's data analysis.
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