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DESCRIPTIONSipuleucel-T (Provenge®, Dendreon Corp.) is a new class of therapeutic agent 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 then exposed in vitro to proteins that contain prostate antigens and immunologic stimulating factors, and then reinfused back into the patient. The proposed mechanism of action is that the treatment stimulates the patient’s own immune system to resist spread of the cancer.
Prostate cancer is the second leading cause of cancer-related deaths among American men with an estimated incidence of 218,890 cases and an estimated number of 27,050 deaths in 2007. The majority of cases are diagnosed at a localized stage and are treated with prostatectomy or radiotherapy. However, some patients are diagnosed with metastatic disease or recurrent disease after treatment of localized disease. Androgen ablation is the standard treatment for metastatic or recurrent disease. However, most patients who survive long enough eventually develop androgen-independent prostate cancer. At this stage of metastatic disease, docetaxel, a chemotherapeutic agent, has been demonstrated to confer a survival benefit of 1.9 to 2.4 months in randomized clinical trials. Chemotherapy with docetaxel causes adverse effects in large proportions of patients, including alopecia, fatigue, neutropenia, neuropathy, and other symptoms. Trials evaluating docetaxel included both asymptomatic and symptomatic patients, and results suggested a survival benefit for both groups. Because of the burden of treatment and its side effects, most patients therefore defer docetaxel treatment until the cancer recurrence is symptomatic.
Cancer immunotherapy has been investigated as a treatment which might be instituted at the point of detection of androgen-independent metastatic disease before significant symptomatic manifestations have occurred. The quantity of cancer cells in the patient 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. Such a delay could allow a course of effective chemotherapy, such as docetaxel, to be deferred or delayed until necessary, thus providing an overall survival benefit.
Sipuleucel-T (Provenge®, Dendreon Corp.) is a new class of therapeutic agent 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 then exposed in vitro to proteins that contain prostate antigens and immunologic stimulating factors, and then reinfused back into the patient. At reinfusion, the cells are administered as 3 intravenous infusions given approximately 2 weeks apart. The proposed mechanism of action is that the treatment stimulates the patient’s own immune system to resist spread of the cancer.
On April 29, 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 the manufacturer to conduct a postmarketing study, based on a registry design, to assess the risk of cerebrovascular events in 1,500 men with prostate cancer who receive sipuleucel-T.
Also, see the Gene-Based Tests for Screening, Detection and/or Management of Prostate Cancer medical policy.
POLICYSipuleucel-T therapy (Provenge®) may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer.
Sipuleucel-T therapy (Provenge®) 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 treatment of visceral (liver, lung or brain) metastases.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESThe use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given at the same time with the leukapheresis procedure for Provenge® has not been studied. Provenge® is designed to stimulate the immune system, and using immunosuppressive agents at the same time may alter the effectiveness and/or safety of Provenge®. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with Provenge®.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
09/28/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
05/07/2013: Added HCPCS code Q2043 to the Code Reference section.
11/06/2013: Policy reviewed; no changes.
09/04/2014: Policy reviewed; description updated. Investigational policy statement revised to change "those with" to "treatment of." Intent of policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.53
(Provenge®) Prescribing Information
www.fda.gov - Provenge® Questions and Answers
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.