ACCC Submits Comments to CMS on NCA for CAR T Therapy

On June 15, 2018, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel).  In comments its to the agency , ACCC urged that CMS:

• Adopt a national coverage policy ensuring full Medicare coverage of CAR T therapies for their FDA-approved indications in all settings of care permitted by their labeling and REMS.
• Allow Medicare Administrative Contractors (MACs) to cover FDA-approved CAR T therapies for indications listed in national compendia or supported by certain literature.
• Clarify that the FDA-approved indications for CAR T therapies are covered by Medicare during the NCA process and complete that process as soon as possible to maintain uninterrupted patient access to these therapies.

Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline.

Read ACCC Comment Letter

Posted 6/20/2018