The cost of a dose of medicine is generally thought to include just the pills or the fluid in the vial, but CMS has proposed a different way to handle payment for chimeric antigen receptor (CAR) T-cell therapy, one that the medical and manufacturing community thinks is unworkable. Although these agents' prices reach close to $500,000, they still reflect just the reengineered white blood cells, not all the ancillary elements of care, speakers testified at a recent hearing on CMS pricing policy.
The price of axicabtagene ciloleucel (axi-cel; Yescarta) does not include leukapheresis—the process of separating a patient’s white blood cells prior to reengineering them in a manufacturing plant—or the cost of dose preparation, a representative of the drug's manufacturer, Kite Pharma, explained at the May 16 hearing. In fact, hospitalization following infusion, provider fees along many steps of the treatment journey, and costs of aftercare—including treatment of cytokine release syndrome, which is potentially fatal but also a sign that the modified T cells are taking effect—are not a part of the well-publicized $395,380 wholesale acquisition cost (WAC, or manufacturer's price) of a single axi-cel treatment.
Although costs of those elements of care were not meant to be part of the WAC, CMS has written the temporary payment codes for CAR T-cell therapies as though they were, according to the manufacturer representatives, physicians, and patient advocates who testified. They have requested that the temporary Q code for axi-cel be rewritten to leave out leukapheresis and dose preparation.
Those elements of care are not performed in the manufacturing facility; therefore, the current wording suggests that providers and manufacturers must negotiate among themselves who gets paid what, when, and how, based on a single CMS payment. According to the testimony, the reality is that the $395,380 WAC is intended as payment for the manufacturer, and the physicians and medical facilities would bill CMS separately for their services (Figure
CAR T-cell candidates are the “sickest of the sick,” and the amount of time they spend in the hospital could add substantial amounts to the overall cost of care; therefore, those costs of care cannot be handled as a fixed cost, speakers said.
Figure. Multiple Steps in Different Locations are Required for CAR T-cell Preparation
Further, they said, the care of CAR T-cell–eligible patients involves numerous medical entities and providers. According to those who testified, CMS’ wording of Q codes for CAR T-cell therapy resembles an attempt at bundling care that would amount to a compliance nightmare for administrators. “Our system is not set up to separate those kinds of things,” said Aaron D. Chrisman, MHA, MBA, director of stem cell transplant and cellular therapy administration at University of Chicago Medicine in Illinois.
Speakers also testified that treatment centers are holding back on introducing CAR T-cell therapies because the payment issues have not been sorted out.
The hearing concerned proposed Healthcare Common Procedure Coding System payment codes for axi-cel and tisagenlecleucel (Kymriah), a Novartis product. Axi-cel and tisagenlecleucel are approved for the treatment of relapsed or refractory large B-cell lymphoma in adults. Tisagenlecleucel is also approved for B-cell precursor acute lymphoblastic leukemia (ALL) in patients up to 25 years of age.
Current wording for code Q2041 for axi-cel indicates that the infusion of “up to 200 million autologous anti-CD 19 CAR T cells” and leukapheresis and dose-preparation procedures will be treated as a single unit of care under CMS payment policy. Kite Pharma has requested that the payment code be simplified to “axicabtagene ciloleucel, up to 200 million autologous anti-CD 19 CAR T cells, per infusion.”
The manufacturing process for axi-cel takes 17 days. At the time of infusion, the patient is hospitalized up to 14 days for monitoring and treatment of inevitable side effects, Chrisman said. Novartis has a similar process for tisagenlecleucel, which carries a WAC of $475,000.
Opponents of the current Q code wording have contended that it appears to be based on a payment system devised for the simpler treatment regimen associated with sipuleucel-T (Provenge), an infusion-based immunotherapy for prostate cancer. In the case of sipuleucel-T, blood cells are removed from patients and processed in a laboratory, but each infusion can be accomplished in a single office patients and clinicians confidence in these panels’ analytical and clinical validity.”