Autologous Cellular Immunotherapy Treatment

Sipuleucel-T (PROVENGE®) is nationally covered for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer for on‑label use effective 06/30/2011. Coverage is limited to the FDA‑approved indication; off‑label uses are not nationally covered and are left to local Medicare Administrative Contractor discretion. The FDA-approved regimen is three autologous doses given about two weeks apart (total ~4 weeks), with each dose containing at least 40 million treated white blood cells.

"Sipuleucel-T (PROVENGE®) is nationally covered for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer."

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