ASCO urges CMS to withdraw coverage analysis for PCa immunotherapy

The American Society of Clinical Oncology has submitted comprehensive comments to the Centers for Medicare & Medicaid Services expressing concern about its decision to open a national coverage analysis (NCA) for sipuleucel-T (Provenge).

Sipuleucel-T received FDA approval for the treatment of advanced prostate cancer in April.

Federal law envisions that the Medicare program will provide coverage for FDA-approved cancer indications. However, ASCO said its comments raise broader concerns regarding what it considers to be a lack of clarity for the basis of the NCA and the implications this example may have for other FDA-approved cancer treatments.

ASCO urged CMS to withdraw the current NCA and look for other mechanisms to gather information, such as a potential meeting convening scientific experts to address specific questions or a meeting of the Medicare Evidence Development & Coverage Advisory Committee.

"Under any scenario, we urge CMS to provide clear public statements regarding Medicare’s current policies governing the coverage of this therapy and to address the issue of how any potential future changes in coverage policies at the local or national levels could impact individuals who might be mid-therapy," Allen Lichter, MD, CEO of ASCO, said in the comments.