CMS Opens NCA for Provenge Therapy

With news of Provenge (sipuleucel-T) being approved April 29 by the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS) has opened a national coverage analysis (NCA) for the autologous cellular immunotherapy treatment of prostate cancer.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. Provenge is designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge, administered intravenously in a three-dose schedule given at about two-week intervals, is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance the patient’s response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer.

Certified Hematology and Oncology Coder CHONC

CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) this year.

Public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer are being accepted during the initial 30-day public comment period, which began June 30. Instructions on submitting public comments can be found on the CMS Coverage Information Exchange webpage. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of the CMS webpage.


Provenge is manufactured by Seattle-based Dendreon Corp.

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