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Medical Policy: 05.01.30
Original Effective Date: May 2010
Reviewed: June 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Sipuleucel-T, marketed as Provenge®, by Dendreon Corp., Seattle, WA., is a new class of therapeutic agents used in the treatment of asymptomatic or minimally symptomatic, castrate-resistant (hormone-refractory), metastatic prostate cancer. While the precise mechanism of action is unknown, it is proposed that the treatment induces an immune response targeted against prostatitic acid phosphatase (PAP), an antigen expressed in most prostate cancers. Treatment consists of autologous peripheral blood mononuclear cells obtained from the patient by standard leukapheresis approximately 3 days prior to the infusion date. The cells are then exposed in vitro to proteins that contain PAP and granulocyte-macrophage colony-stimulating factor (GM-CSF) and subsequently reinfused back into the patient. Three such infusions, administered approximately 2 weeks apart, constitute a course of treatment.
Cancer immunotherapy has been investigated as a treatment which might be instituted at the point of detection of androgen-dependent metastatic disease before significant systemic manifestations have occurred. The quantity of cancer cells during this time interval is thought to be relatively low, and it is thought that an effective immune response against the cancer during this time period could effectively delay or prevent progression.
In April, 2010, The U.S. Food and Drug Administration (FDA) approved Provenge® (sipuleucel-T, Dendreon Corp.) via a Biologics Licensing Application (BLA) for “the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (for autologous use only).” Approval was contingent on agreement of Dendreon Corp. to conduct a postmarketing study, based on a registry design, to assess the risk of cerebrovascular events in 1,500 patients with prostate cancer who receive this therapy. There was concern expressed in the FDA review regarding a possible association with cerebrovascular events, as 8 of 147 sipuleucel-T-treated patients experienced cerebrovascular-related adverse events, compared to zero placebo-treated patient in 2 early trials. The FDA called the event rate a “potential safety signal.”
The results of 3 randomized, controlled trials of sipuleucel-T given in the setting of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer show an improvement in median survival of 4 months. The 2 earliest studies were not specifically designed to demonstrate a difference in overall mortality, but showed survival effects consistent with the third study which was designed to demonstrate a mortality difference. All 3 studies are also consistent in demonstrating that sipuleucel-T treatment does not delay time to measurable progression of disease. In all studies, many patients had further chemotherapy treatment at the discretion of their physician; thus, the survival benefit accrues in the context of additional treatment as needed for symptomatic recurrence.
A phase III trial of sipuleucel-T in the setting of androgen-dependent, nonmetastatic prostate cancer has completed enrollment (Provenge for the Treatment of Hormone Sensitive Prostate Cancer [PROTECT], NCT00779402) and has released some preliminary findings. No published studies are yet available from the PROTECT study, however according to news reports, preliminary findings include an increase in prostate-specific antigen doubling time in sipuleucel-T-treated subjects, and a statistically nonsignificant delay in detecting metastasis. The study is no longer recruiting participants.
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Prior Approval:
Prior approval is recommended. Submit a prior approval now.
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Policy:
Sipuleucel-T therapy may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic castrate-resistant (hormone-refractory) metastatic prostate cancer.
Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to treatment of hormone-responsive prostate cancer, treatment of those with moderate to severe symptomatic metastatic prostate cancer, and those with visceral (liver, lung, or brain) metastases.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug) initial, up to 1 hour
- Q2043 Sipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion
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Selected References:
- 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):3089-94.
- 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):3670-9.
- U.S. Food and Drug Administration. Cellular, Tissue and Gene Therapies Advisory Committee Meeting, March 29, 2007. Clinical Briefing Document: Provenge (Sipuleucel-T T). Available online at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4291B1_2a.pdf. Last accessed May 17, 2010.
- U.S. Food and Drug Administration. Press release: FDA Approves a Cellular Immunotherapy for Med with Advanced Prostate cancer. Available online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm. Last accessed May 17, 2010.
- Dendreon Corporation. Provenge® (sipuleucel-T) prescribing information. Seattle, WA; April 2010. Available online at http://www.provenge.com/pdf/prescribing-information.pdf. Last accessed May 17, 2010.
- Blue Cross Blue Shield Association Technology Evaluation Center (TEC). (2010) Special Report: Vaccines for the Treatment of Prostate Cancer. TEC Assessment Program 24(6):1-15.
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Policy History:
Date Reason Action
June 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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