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Tumor vaccines are a type of immunotherapy that attempt to stimulate the patient's own immune system to respond to tumor antigens. Tumor vaccines have been principally investigated as a treatment of melanoma, due to the recognition that melanoma can induce an immune response, and the overall ineffectiveness of chemotherapy. Tumor vaccines can be prepared in a variety of ways. In early studies patients were injected with autologous or allogeneic tumor cells mixed with an adjuvant designed to further stimulate the immune system. Viral oncolysates involve the use of viruses (such as small pox vaccine) to lyse the tumor cells prior to rejection. This strategy is based on the concept that the mixture of viral and tumor proteins is highly immunogenic and would lead to the recognition and rejection of tumor cells by the host.
In more recent years, research has also focused on the identification, isolation, and cloning of specific tumor-associated antigens that are recognized by the host immune system. Tumor-associated antigens that have been investigated include gangliosides and melanoma-associated antigenic peptides. Tumor cells have also been modified by gene transfer techniques such that they produce cytokines (i.e., interferon or interleukin) or other proteins that stimulate the patient's immune system. While the treatment of melanoma with tumor vaccines in patients with tumors expressing carcinoembryonic antigen (CEA), prostate specific antigen (PSA), the ras oncogene, or p53 mutations.
POLICYTumor vaccines, including but not limited to melanoma vaccines, are considered investigational.
Other forms of tumor immunotherapy, specifically Adoptive Immunotherapy, are addressed in a separate policy. See also Active Specific Immunotherapy with Therapeutic Melanoma Vaccines policy.
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 HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
2/2001: Active Specific Immunotherapy with Therapeutic Melanoma Vaccines reviewed by MPAC; considered investigational
7/12/2001: MPAC statement 2/2001 added and hyperlink to Active Specific Immunotherapy with Therapeutic Melanoma Vaccines
2/8/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
5/30/2002: Code Reference section completed
11/19/2004: Code Reference section reviewed, no changes
11/7/2005: Code Reference section updated, ICD9 diagnosis code V58.12 added
3/15/2006: Policy reviewed, no changes
SOURCE(S)Wallack MK, Sivanadham M, Ditaranto K et al. Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine. Ann Surg 1997; 226:198-205.
Livingston PO, Wong GYC, Adlun S et al. Improved survival in stage III melanoma with GM2 antibodies: A randomized trial of adjuvant vaccination with GM2 ganglioside. J Clin Oncol 1994; 12:1036-44.
Cheson BD, Phillips PH, Szone M. Trials using tumor vaccines. Oncology 1997; 11: 81-90.
Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy #2.03.04
CODE REFERENCEAll codes billed are considered investigational and not eligible for coverage.