The Centers for Medicare and Medicaid Services announced it has started the process of deciding whether to cover the costly prostate cancer immunotherapeutic agent sipuleucel-T (Provenge).
In late April, the FDA approved Provenge for the treatment of men with asymptomatic or minimally symptomatic metastatic prostate cancer, after clinical trials showed treatment with Provenge improved median overall survival by 4.1 months compared with placebo (25.8 months versus 21.7 months).
Provenge is extremely expensive. Each infusion costs $31,000, and three infusions over the course of a month are necessary, bringing the total cost of treatment to $93,000.
In its National Coverage Decision (NCD), CMS will decide whether paying for Provenge is reasonable and necessary.
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