Archived Policies - Medicine

Tumor Vaccines


Effective Date:08-15-2006

End Date:09-14-2006


Tumor (or Cancer) Vaccines are considered investigational or experimental. These vaccines include, but not limited to, the following:

  • Melanoma,
  • Neuroblastoma,
  • Lymphoma,
  • Multiple Myeloma, 
  • Sarcoma, and
  • Vaccines targeted for cancer of the:
    1. Breast
    2. Lungs
    3. Esophagus
    4. Prostate
    5. Kidney
    6. Colon
    7. Ovaries


Tumor (or Cancer) Vaccines claim to arm the immune system and shrink specific cancers, including melanoma, neuroblastoma, lymphoma, multiple myeloma, sarcoma, and cancers of the breast, lungs, esophagus, prostate, kidney, colorectal, and ovaries.  Unlike traditional vaccines, tumor (or cancer) vaccines do not prime the immune system to prevent illness.  They combat existing tumors and they also work in the same way as traditional vaccines, by activating disease-fighting white blood cells of the immune system to mount a counterattack.

Tumor cells express unique antigens to inform the immune system that something about these cells is foreign.  The vaccine is a way to deliver an antigen to the immune system so that immune cells can recognize the antigen as foreign and destroy any cells bearing that antigen.  These vaccines are thought to arm white blood cells (T-cells) and to destroy microscopic metastatic cells that have migrated from the primary tumor (even after the primary tumor has been removed).  This type of T-cell response is also known as a tumor-associated antigen. 

Additional tumor or cancer vaccine therapy categories include:

  • Dendritic cell vaccines, which seek out foreign tissue and alert the immune system to launch an attack; and
  • Genetically altered tumor cells, which supercharge the immune system to seek and destroy tumor cells throughout the body.  This is done by vaccinating the patient with their own tumor cells that have been injected with genetic material from altered bacteria or glycoproteins.


At the present time, there are no tumor or cancer vaccines with FDA approval.  Some tumor vaccines that use autologous tumor tissue from the patient may not be subject to FDA approval.  Phase I, II, and III clinical trials and laboratory studies are currently being conducted.


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.



Medicare Coverage:



Livingston, P.O., et al. Improved survival in stage III melanoma patients with GM2 antibodies: a randomized trial of adjuvant vaccination with GM2 ganglioside. Journal of Clinical Oncology (1994 May) 12(5): 1036-44.

Baltz, J.K. Vaccines in the treatment of cancer. American Journal of Health-System Pharmacy (1995 November 15) 52(22): 2574-85.

Schweighoffer, T., et al.Adenovirus-enhanced receptor-mediated transfer infection for the generation of tumor vaccines. Cytokines and Molecular Therapy (1996 September) 2(3): 185-91.

Clinical Trials of Cancer Vaccines. 3rd International Conference on Engineered Vaccines for Cancer and Aids, Proceedings 1996 October 9-22. Cambridge Symposia (Web site/on-line):

Vaccines. 1997 Biology Department - Cancer Vaccine Research, Brown University (Web site/on-line):

Cheson, B.D., et al. Clinical Trials Referral Source.  Trials using tumor vaccines. Oncology (Huntington) (1997 January) 11(1): 81-2, 84, and 90.

Wallack, M.K., et al. Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine: second interim analysis of data from phase III multi-institutional trial. Annals of Surgery (1997 August) 226(2): 198-206.

Demiroglu, H. Is prevention of cancer possible with tumor-specific vaccines? Medical Hypotheses (1997 September) 49(3): 281-4.

Hallin, P.A. and V.R. Adams. Cancer vaccines. Part 2. Journal of the American Pharmaceutical Association (Washington) (1997 November-December) NS37 (6): 706-9.

OncoLink Understanding Vaccine Therapy.  (1998 April 4): 1-5.  Prepared by University of Pennsylvania Cancer Center (Web Site/on-line):

Tumor Vaccines. BCBSA Consortium Health Plan Medical Policy Reference Manual (1998 April 30) Medicine: 2.03.04.

Lee, L., et al. NY-ESO-1 may be a potential target for lung cancer immunotherapy. Cancer Journal from Scientific American (1999 January-February) 5(1): 20-5.

Vermorken, J.B., et al. Active specific immunotherapy for stage II and stage III human colon cancer: a randomized trial. Lancet (1999 January 30) 353(9150): 345-50.

Mulders, P., et al. Presentation of renal tumor antigens by human dendritic cells activates tumor-infiltrating lymphocytes against autologous tumor: implications for live kidney cancer vaccines. Clinical Cancer Research (1999 February) 5(2): 445-54.

Reichardt, V.L., et al. Idiotype vaccination using dendritic cells after autologous peripheral blood stem cell transplantation for multiple myeloma -- a feasibility study. Blood (1999 April 1) 93(7): 2411-9.

Linehan, D.C., et al. Immunotherapeutic approaches to sarcoma. Seminars in Surgical Oncology (1999 July-August) 17(1): 72-7.

Special Report:  Vaccines for the Treatment of Malignant Melanoma. BCBSA-TEC Assessment; (2001 May) 16(4):  1-45.

Policy History:

Archived Document(s):

Title:Effective Date:End Date:
Melanoma Vaccines10-15-201706-30-2018
Melanoma Vaccines01-15-201710-14-2017
Melanoma Vaccines08-01-201501-14-2017
Melanoma Vaccines10-15-201407-31-2015
Melanoma Vaccines04-15-201310-14-2014
Melanoma Vaccines04-15-201104-14-2013
Melanoma Vaccines10-15-200804-14-2011
Melanoma Vaccines09-15-200610-14-2008
Tumor Vaccines08-15-200609-14-2006
Tumor Vaccines10-24-200308-14-2006
Back to Top