Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Sipuleucel-T (Provenge) may be considered medically necessary for the treatment of adults with metastatic castrate-resistant prostate cancer (mCRPC) when ALL of the following criteria are met:
- Individual is asymptomatic or minimally symptomatic; and
- A serum testosterone level of less than 50 ng/dl; and
- Serum prostate specific antigen (PSA) greater than or equal to 5.0 ng/mL; and
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and
- Have no visceral (liver, lung or brain) metastases; and
- Have a life expectancy of greater than 6 months.
mCRPC is resistant/refractory to standard hormone treatment, and is further defined as follows:
Disease progression evidenced by a progressively rising PSA, defined as a PSA rise by 2 ng/ml or more above the nadir PSA, or an increase in tumor mass despite a castrate level of testosterone less than 50 ng/dl.
The use of sipuleucel-T (Provenge) for any other indication not listed on this policy is considered experimental/investigational and, therefore, non-covered. Scientific evidence does not support its use for any other indications.