Officials at the Centers for Medicare & Medicaid Services announced reimbursement rates for outpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, settling on a fee that is roughly the wholesale acquisition cost plus 6%.
The agency will pay $395,380 to those who administer axicabtagene ciloleucel (Yescarta) on an outpatient basis and $500,839 for outpatient use of tisagenlecleucel (Kymriah), a similar CAR T-cell therapy for cancer patients. The two drugs have list prices of $373,000 and $475,000, respectively.
Courtesy Novartis
Novartis's tisagenlecleucel (Kymriah) is approved for pediatric acute lymphoblastic leukemia.
Although CMS set the Medicare Part B copayment for axicabtagene ciloleucel at $79,076, the agency later clarified that out-of-pocket expenses for Medicare patients are capped at around $1,340 in 2018 – the amount of the inpatient hospital deductible.
The Medicare rate is a first step to being able to use and get paid for CAR T-cell therapies, said Richard T. Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. However, the rate is not as straight forward as it sounds, he pointed out.
“This is big news,” Dr. Maziarz said in an interview. “This allows us to start to deliver these therapies, but there is a risk: If we give this in the outpatient setting and someone ends up needing hospitalization, we may end up not being reimbursed for the drug product.”
That’s because of CMS’s 3-day payment window rule, Dr. Maziarz explained: If medical treatment is provided in an outpatient setting and the patient needs inpatient care within 72 hours, all payments prior to that 72-hour window become part of the inpatient stay, according to the rule. Inpatient reimbursement varies depending on treatment, previous patient comorbidities, and complications during their stay. Analysts say that inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted so doctors can monitor them for serious side effects.
“If I have a drug that costs me $373,000, what happens if I admit the patient?” Dr. Maziarz said. “I don’t get $373,000; I get between $8,000 and $18,000. So if we give this and someone gets sick in 48 hours, then we may be at risk for losing.”