Blue Cross Blue Shield of Minnesota Medical Policy


Medical Policy:
Cellular Immunotherapy for Prostate Cancer
Effective Date:
June 1, 2020
Issued Date:
May 31, 2021
Last Revision Date:
May 2020
Annual Review:
May 2021

This policy version was replaced June 27, 2022. To find the newest version, go to, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Cellular immunotherapy for prostate cancer is a treatment for androgen-independent metastatic disease before significant symptomatic manifestations have occurred. The quantity of cancer cells in the patient during this time is considered to be relatively low, and an effective immune response against the cancer could effectively delay or prevent progression. Such a delay could allow effective chemotherapy associated with adverse effects, such as docetaxel, to be deferred or delayed until necessary, thereby, providing an overall survival benefit.

Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy used in the treatment of asymptomatic or minimally symptomatic, androgen-independent (hormone-refractory), metastatic prostate cancer. It consists of specially treated dendritic cells obtained from the patient with leukapheresis. The cells are exposed in vitro to proteins that contain prostate antigens and immunologic stimulating factors, and then reinfused back into the patient. The cells are administered as three intravenous infusions, each infusion given approximately two weeks apart. The treatment is proposed to stimulate the patient’s own immune system to resist spread of the cancer.

Provenge® (sipuleucel-T) has been approved by the U.S. Food and Drug Administration (FDA) via a biologics licensing application for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. It is approved for autologous use only. Serious adverse events that have occurred with sipuleucel-T therapy include acute infusion reactions, thromboembolic events, and vascular disorders. Use of sipuleucel-T therapy in combination with chemotherapy or immunosuppressive agents, such as systemic corticosteroids, has not been studied.


Eastern Cooperative Oncology Group (ECOG) Performance Scale

  • Performance Status 0: Fully active; no performance restrictions.
  • Performance Status 1: Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
  • Performance Status 2: Capable of all selfcare but unable to carry out any work activities. Up and about >50% of waking hours.
  • Performance Status 3: Capable of only limited selfcare; confined to bed or chair >50% of waking hours.
  • Performance Status 4: Completely disabled; cannot carry out any selfcare; totally confined to bed or chair.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Sipuleucel-T therapy may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL the following criteria are met:

  • Diagnosis of metastatic, castrate-resistant (also known as castration-recurrent, hormone-refractory, or androgen-independent) prostate cancer, as defined by:
    • Disease progression despite hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH] analogs or anti-androgens); AND
    • Evidence of extrahepatic metastases on advanced imaging.
  • Asymptomatic or minimally symptomatic disease; AND
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1; AND
  • No liver metastases.

 II.  Sipuleucel-T therapy is considered EXPERIMENTAL/INVESTIGATIVE for all other indications, including but not limited to treatment of the following conditions, due to the lack of evidence demonstrating an impact on improved health outcomes:

  • Hormone-responsive prostate cancer;
  • Moderate to severe symptomatic metastatic prostate cancer.

Denial Statements

No additional statements.


Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.


CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.