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DESCRIPTIONTumor vaccines are a type of active immunotherapy that attempts to stimulate the patient’s own immune system to respond to tumor antigens. A wide range of vaccine types are available including use of autologous tumor cells, allogeneic tumor cells, and tumor-specific moieties including peptides, gangliosides, and DNA plasmids. A variety of mechanisms appear to exist as possible obstacles to successful active immunotherapy using vaccines. Current areas of investigation include new and different vaccine preparations, as well as various forms of immune modulation to enhance vaccine effectiveness.
Vaccines using crude preparations of tumor material were first studied by Ehrlich over 100 years ago, but the first modern report suggesting benefit using these in cancer patients did not appear until 1967. Melanoma has been viewed as a particularly promising target for vaccine treatment because of its immunologic features, which include the prognostic importance of lymphocytic infiltrate at the primary tumor site, the expression of a wide variety of antigens, and the occasional occurrence of spontaneous remissions. Melanoma vaccines can be generally categorized or prepared in the following ways:
At the present time, no melanoma vaccine has received approval from the FDA.
Related medical policy -
POLICYMelanoma vaccines are considered investigational.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY2/2001: Approved by Medical Policy Advisory Committee (MPAC), ICD-9 diagnosis code 154.2-154.3, 172.0-172.9, 184.0-184.2, 184.4, 187.1, 187.4, 187.7, 187.9, 190.0-190.3, 190.5-190.6, 190.9 added
7/5/2001: Code Reference section updated, ICD-9 diagnosis code 197.5, 198.2, 198.4, 198.82, 230.5-230.6, 232.0-232.9, 233.3, 233.5-233.6, 234.0 added
7/12/2001: Hyperlinks added
2/14/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
10/20/2004: Code Reference section updated, non-covered ICD-9 diagnosis code 154.2-154.3, 172.0-172.9, 184.0-184.2, 184.4, 187.1, 187.4, 187.7, 187.9, 190.0-190.3, 190.5-190.6, 190.9, 197.5, 198.2, 198.4, 198.82, 230.5-230.6, 232.0-232.9, 233.3, 233.5-233.6, 234.0 deleted
11/7/2005: Code Reference section updated; ICD-9 diagnosis code V58.12 added
7/10/2009: Policy reviewed, no changes
08/02/2011: Removed "Active Specific Immunotherapy with Therapeutic" from the policy title and statement.
11/06/2013: Policy description updated; no changes to policy statement. Deleted outdated references from the Sources section.
07/01/2014: Policy reviewed; no changes.
08/18/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 diagnosis code V58.12 from the Code Reference section.
09/18/2015: Policy description updated regarding vaccine types. Policy statement unchanged. Investigative definition updated in Policy Guidelines section.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.03.04
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.