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Autologous Cellular Immunotherapy for Prostate Cancer

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

Description

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. 

Criteria

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

Q2043

NOTE: Dosage recommendations per the FDA label.

Diagnostic Codes

C61  Z85.46

Links

I-26

  1. National Comprehensive Cancer Network (NCCN): Clinical practice guidelines in oncology, prostate cancer. NCCN. Version 1.2016.
  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.
  3. Zustovich F, Fabiani F. Therapeutic opportunities for castration-resistant prostate cancer patients with bone metastases. Crit Rev Oncol/Hematol. 2014.
  4. Singh B H, Gulley JL. Immunotherapy and therapeutic vaccines in prostate cancer: An update on current strategies and clinical implications. Asian J Androl. 2014. 2014;16(3):364-371.
  5. Small EJ, Higano CS, Kantoff PW, et al. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with Sipuleucel-T. Prostate Cancer Prostatic Dis. 2014;17(3):259-264.
  6. Lubaroff DM, Vaena D, Brown JA, et al. Vaccine immunotherapy for prostate cancer: From mice to men. Abstract. Immunol Res. 2014;59(1-3):229-235.
  7. Basch E, Loblaw DA, Oliver TK, et al. Systemic therapy in men with metastatic castrationresistant prostatecancer:American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. 2014;32(30):3436-3448.
  8. American Urological Association. Castration-resistant prostate cancer: AUA guideline. 2015. Accessed 11/19/2015.
  9. Schelhammer PF, Chodak G, Whitmore JB, et al. Lower baseline PSA predicts greater benefit from sipuleucel-T. Clinical Advances in Hematology & Oncology. 2013;(11)6:377-381.
  10. Cheng M, Fong L. Beyond Sipuleucel-T: Immune approaches to treating prostate cancer. Current Treat Options Oncol. 2014;15(1):115-126.
  11. Pieconka C, Telonis D, Mouraviev V, et al. Sipuleucel-T for the treatment of patients with metastatic castrate-resistant prostate cancer: Considerations for clinical practice. Rev Urol. 2015;17(4):203 210.
  12. Scholz M, Yep S, Chancey M, et al. Phase I clinical trial of sipuleucel-T combined with escalating doses of ipilimumab in progressive metastatic castrate-resistant prostate cancer. ImmunoTargets. 2017;11-16.
  13. Graff JN, Chamberlain ED. Sipuleucel-T in the treatment of prostate cancer: an evidence-based review of its place in therapy. Core Evidence. 2015;1-10.
  14. Yi R, Chen B, Duan P, et al. Sipuleucel-T and Androgen Receptor-Directed Therapy for Castration-Resistant Prostate Cancer: A Meta-Analysis. Jour Immun Reasearch. 2016:1-10.
  15. MICROMEDEX®SOLUTIONS Compendia. 2017. Sipuleucel-T.
  16. Clinical Pharmacology Compendia. [database online]. Tampa FL: Gold Standard, Inc. SipuleucelT.
  17. NCCN Drugs and Biologics Compendium™️ Sipuleucel-T. 2017. National Comprehensive Cancer Network (NCCN)