Autologous Cellular Immunotherapy for Prostate Cancer

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 05, 2020
Last Reviewed: May 19, 2020


Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy that includes antigen presenting cells that have been activated by a recombinant human protein consisting of prostatic acid phosphatase (PAP), which is expressed in prostate cancer tissue, linked with granulocyte-macrophage colony stimulating factor (GM-CSF). Cells are obtained from the individual via leukapheresis, and during ex vivo culture the PAP-GM-CSF binds to the antigen presenting cells, which induces an immune response against PAP.


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 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.

Procedure Codes


NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnostic Codes

C61  Z85.46

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date June 1, 2019

Internal Medical Policy Committee 5-19-20 Removed table attachment and criteria "No use of narcotics for cancer related pain"


Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.