Medical Policy

Effective Date:07/22/2010 Title:Provenge (Sipuleucel-T)
Revision Date:08/01/2016 Document:BI278:00
CPT Code(s):Q2043
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

  1. Provenge (Sipuleucel-T) requires pre-authorization.
  2. Provenge (Sipuleucel-T) is used to treat advanced, resistant prostate cancer in otherwise active men.
  3. Provenge is made from the cells of the patient.
Medical Statement

Sipuleucel-T (Provenge) is considered medically necessary for members who meet the following criteria:

  1. Adult men with histologically confirmed adenocarcinoma of the prostate with radiologic evidence of metastases to soft tissue, lymph nodes or bone; and
  2. Member is asymptomatic or minimally symptomatic, without cancer-related bone pain or use of opioid analgesics for cancer pain; and
  3. Have had treatment with surgical (bilateral orchiectomy) castration or three or more months of chemical castration (luteinizing hormone releasing hormone (LHRH) agonists or antagonists); for members treated with chemical castration, serum testosterone must be less than 50 ng/dL to document adequacy of castration; and
  4. Evidence of progressive disease after surgical or chemical castration (known as castrate-resistant, hormone-refractory, or androgen-independent prostate cancer),  showing progressive measurable disease, worsening disease on bone scan, or an increasing prostate-specific antigen (PSA), as defined below:
    1. Progressive measurable disease, as evidenced by changes in size of lymph nodes or parenchymal masses on physical examination or radiographic studies; or
    2. Bone scan progression, as evidenced by one or more new lesions or increase in size of lesions (not including "flare" that occurs at commencement of hormonal therapy or chemotherapy); or
    3. PSA progression: An increase in PSA over a previous reference value, where the PSA value is a measured a minimum of one week from the reference value, and the PSA measurement is a minimum of 25 percent greater than the reference value, and an absolute-value increase in PSA of at least 5 ng/ml over the reference value, and this PSA increase is confirmed by a second value; and
  5. Member has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1(see table below); and
  6. Member has no visceral (liver, lung or brain) metastases; and
  7. Member has expected survival of at least 6 months.


Table: ECOG Performance Status

Grade ECOG
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5 Dead


Administration of more than 3 complete doses of Sipuleucel-T is considered experimental and investigational.

  1. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Vaccines for metastatic hormone-refractory prostate cancer. Emerging Drug List No. 66. Ottawa, ON: CCOHTA; December 2005.
  2. Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for phase II clinical trials in androgen independent prostate cancer: Recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol. 1999;17:3461-3467.
  3. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with Sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006;24(19):3089-3094.
  4. Rini BI, Weinberg V, Fong L, et al. Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting cells (Provenge) plus bevacizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer. 2006;107(1):67-74.
  5. McKarney L. Sipuleucel-T (Provenge®): Active cellular immunotherapy for advanced prostate cancer. Issues in Emerging Health Technologies, Issue 101. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); September 2007.
  6. Doehn C, Böhmer T, Kausch I, et al. Prostate cancer vaccines: Current status and future potential. BioDrugs. 2008;22(2):71-84.
  7. Harzstark AL, Small EJ. Sipuleucel-T for the treatment of prostate cancer. Drugs Today (Barc). 2008;44(4):271-278.
  8. Patel PH, Kockler DR. Sipuleucel-T: A vaccine for metastatic, asymptomatic, androgen-independent prostate cancer. Ann Pharmacother. 2008;42(1):91-98.
  9. Higano CS, Schellhammer PF, Small EJ, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with Sipuleucel-T in advanced prostate cancer. Cancer. 2009;115(16):3670-3679.
  10. Drake CG, Antonarakis ES. Update: Immunological strategies for prostate cancer. Curr Urol Rep. 2010;11(3):202-207.
  11. U.S. Food and Drug Administration (FDA). FDA approves a cellular immunotherapy for men with advanced prostate cancer. FDA News. Rockville, MD: FDA; April 29, 2010. Available at:
    . Accessed July 14, 2010.
  12. Antonarakis ES, Drake CG. Current status of immunological therapies for prostate cancer. Curr Opin Urol. 2010;20(3):241-246.
  13. Lassi K, Dawson NA. Update on castrate-resistant prostate cancer: 2010. Curr Opin Oncol. 2010;22(3):263-267.
  14. Dendreon Corporation. Provenge (Sipuleucel-T) suspension for intravenous infusion. Prescribing Information. Seattle, WA: Dendreon Corporation; 2010. Available at:
    . Accessed July 14, 2010.
  15. National Comprehensive Cancer Network (NCCN). Prostate cancer. NCCN Clinical Practice Guidelines in Oncology v.2.2010. Fort Washington, PA: NCCN; 2010.
  16. BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Special report: Vaccines for the treatment of prostate cancer. TEC Assessment Program. Chicago, IL: BCBSA; April 2010;24(6).
Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.