CMS’s initial payment codes for chimeric antigen receptor (CAR) T-cell therapies are opposed by the medical community on the basis that they would be cumbersome to implement and wouldn’t reflect the full amount of care delivered to each patient. CAR T-cell therapies, which can cost close to $500,000, are associated with ancillary care for hospitalization, observation, and treatment of adverse events, which can cause costs to climb much higher. Payment codes do not clarify how these services will be covered, manufacturers, clinicians, cancer facilities, and patient advocates say.
Public hearings on proposed Healthcare Common Procedure Coding System (HCPCS) payment codes for axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) were conducted Wednesday morning at the CMS facility in Baltimore, Maryland. Axicabtagene ciloleucel is approved for the treatment of relapsed or refractory large B-cell lymphoma. Tisagenlecleucel is approved for relapsed or refractory large B-cell lymphoma and B-cell precursor acute lymphoblastic leukemia (ALL).
Temporary Q payment codes have been issued for the therapies, but the code language appears to be an unwieldy attempt at bundling care, manufacturers and others said. Furthermore, they noted the payment systems for these therapies were based on a payment system designed for the vastly simpler treatment regimen associated with sipuleucel-T (Provenge), an infusion-based immunotherapy for prostate cancer.
For example, current wording for code Q2041 for axicabtagene ciloleucel 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, the manufacturer, 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 difference is that leukapheresis and dose preparation would be treated as separately billable items. Speakers who testified at the hearing explained that the current coding inappropriately bundles the manufacturing process with provider-side care, forcing the many different parties involved to overcome complex administrative hurdles in deciding who gets paid, when, and how much.
Further complicating matters, for any given patient, dates of service may be spread out among multiple providers and sites of care, they said. “Our system is not set up to separate those kinds
of things,” said Aaron D. Chrisman, director of stem cell transplant and cellular therapy administration for University of Chicago Medicine, Illinois. Meanwhile, oncologists and cancer centers will have to wait as claims are adjudicated and sorted out correctly.
The manufacturing process for axicabtagene ciloleucel 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. CMS has said it would pay $395,380 for use of this agent; however, it is widely acknowledged that ancillary treatment could increase the overall cost of care to as much as $1 million. Novartis has a similar process for tisagenlecleucel, which carries a price tag of $475,000.
By contrast, with sipuleucel-T, blood cells are removed from patients and processed in a laboratory, but each infusion can be accomplished in a single office visit.
Those who testified Wednesday said it was unclear how costs for CART-cell therapy would be paid based on the CMS coding. They said that if other codes were intended to be used in conjunction with the Q codes assigned for CAR T-cell therapy, inevitable overlap would cause confusion and interfere with payment.
“We encourage CMS to take another deep look at what is involved in these services and what might have seemed like a good model to follow,” Jugna Shah, MPH, said on behalf of the Alliance of Dedicated Cancer Centers, which includes Dana-Farber Cancer Institute in Boston, Massachusetts, Fox Chase Cancer Center in Philadelphia, Pennsylvania, Memorial Sloan Kettering Cancer Center in New York, New York, and Moffitt Cancer Center & Research Institute in Tampa, Florida, among other large and prominent institutions.
A permanent decision on the coding for currently approved CAR T-cell therapies is expected no sooner than January 2019. In comments Wednesday, CMS officials acknowledged the difficulties projected that will result from the temporary Q-code assignments and indicated a willingness to make improvements. “We’ll work on looking at the code again,” an unnamed CMS official said during the hearing, which was broadcast over the Web. “Some of your comments indicated that we didn’t grasp what was going on in different settings.”
The application by Novartis for a revision of the temporary Q code assigned to its CAR T-cell therapy differs from the Kite Pharma application. Novartis seeks a higher dosage of CAR T cells incorporated into the wording. Current language specifies “up to 250 million car-positive viable T-cells” per infusion. This was based on the original CAR T-cell indication approved last year for B-cell precursor ALL that is refractory or in second or later relapse. The more recent, second indication for adult patients with relapsed or refractory large B-cell lymphoma requires infusion capability for up to 600 million modified T cells. The new wording, proposed by Novartis, would specify, a “minimum of 200,000 T cells.”
The CMS Q code wording for the Novartis product also incorporates leukapheresis and dose preparation but Novartis did not request to have those elements removed from the code
description. Asked why by a CMS official, John Coombs, primary speaker for Novartis, said that the company was aware of the concerns about payment complications. He requested that any changes made to the coding language for CAR T-cell products in general be consistent across the board.
Others who testified at the hearing added that consistency in wording and coding language that correctly addresses payment issues would become increasingly important as more CAR T-cell applications are introduced.