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Autologous Cellular Immunotherapy for Prostate Cancer

Section: Injections
Effective Date: June 01, 2019
Revised Date: May 31, 2019


Sipuleucel-T (Provenge) is a therapeutic agent used in the treatment of asymptomatic or minimally symptomatic, androgen-independent (castration-resistant), metastatic prostate cancer. The agent comprises specially treated dendritic cells obtained from the patient through leukapheresis. The cells are then exposed in vitro to proteins that contain prostate antigens and immunologic-stimulating factors and are then reinfused back into the patient. The proposed mechanism of action is that treatment stimulates the patient's own immune system to resist cancer spread. 


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 (See Table Attachment); and
  • Have no visceral (liver, lung or brain) metastases; and
  • No use of narcotics for cancer related pain; and
  • Have a life expectancy of greater than 6 months. 

*mCRPC is a form of prostate cancer that is resistant/refractory to standard hormone treatment, and is further defined as follows: 

Disease progression evidenced by a progressively rising prostate specific antigen (PSA) (defined as a PSA rise by 2 ng/ml or more above the nadir PSA) or an increase in tumor mass on bone scan, X-ray, computerized tomography (CT) scan or magnetic resonance image (MRI) despite a castrate level of testosterone less than 50 ng/dl. 

The use of sipuleucel-T 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.

Procedure Codes


NOTE: Dosage recommendations per the FDA label.

Diagnostic Codes

C61  Z85.46



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  2. Shore ND, Mantz CA, Dosoretz DE, et al. Building on Sipuleucel-T for immunologic treatment of castration-resistant prostate cancer. Cancer Control. 2013;20(1):1-16.
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