Tandem High Dose Chemotherapy with Hematopoietic Stem Cell Support
DESCRIPTION
High-dose chemotherapy (HDC) with hematopoietic stem cell support (SCS), which includes both autologous and allogeneic stem-cell support, is used to treat certain diseases. HDC involves the administration of cytotoxic agents at doses several times greater than the standard therapeutic chemotherapy doses. In some cases, whole body or localized radiotherapy is also given in the process of HDC. The goal is to eradicate cancer cells; however, HDC is toxic to the bone marrow and causes marrow ablation.
Hematopoietic stem cells, found normally within the bone marrow, facilitate continuous blood cell production. To help restore these cells after the completion of the HDC, hematopoietic stem cells are infused from either autologous bone marrow or peripheral blood stem cell transplantation.
Typically one course of HDC is given. Following HDC with hematopoietic stem cell support, many individuals experience recurrence of the disease. Two courses or tandem doses of HDC are typically administered at two to six month intervals, irrespective of the individual's remission status, but contingent on recovery from prior toxicity.
Tandem transplantation with the initial course by autologous stem cell support followed by an allogeneic SCS from a Human Leukocyte Antigen-identical sibling donor (HLA-identical) has proven to be superior to tandem transplantations using autologous SCS for both courses.
POLICY
Tandem high-dose chemotherapy with autologous stem-cell support is considered medically necessary. (See Medical Appropriateness below).
Tandem high-dose chemotherapy with autologous stem-cell support followed by a non-marrow ablative regimen and allogeneic stem-cell support is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below).
Tandem high-dose chemotherapy with autologous stem-cell support, for the treatment of other conditions/diseases, is considered investigational.
Tandem high-dose chemotherapy with allogeneic stem-cell support, for the treatment of newly diagnosed or responsive multiple myeloma and other conditions/diseases, is considered investigational.
See also:
MEDICAL APPROPRIATNESS
Tandem high-dose chemotherapy with autologous stem-cell support is considered medically appropriate if ANY ONE of the following criteria is met:
Multiple myeloma is newly diagnosed
Multiple myeloma is responsive to treatment
Tandem high-dose chemotherapy with autologous stem-cell support followed by a non-marrow ablative regimen and allogeneic stem-cell support is considered medically appropriate if ALL of the following criteria are met:
Multiple myeloma is newly diagnosed
The donor has an identical Human Leukocyte Antigen (HLA-Identical)
ADDITIONAL INFORMATION
Human Leukocyte Antigen is an essential element to immune function. There is a very low chance that two unrelated individuals will have identical HLA molecules.
Responsive multiple myeloma is defined as a tumor showing either a complete or partial remission.
Partial remission is defined as at least a 50% reduction in tumor burden, typically measured in terms of serum levels of beta-2 microglobulin or monoclonal immunoglobulins, both considered tumor makers for multiple myeloma.
For individuals scheduled for tandem autologous transplants, mobilization before the first cycle usually yields sufficient stem cells to permit two transplant cycles.
One randomized control study was found in the published literature that validates the application of tandem high-dose chemotherapy with hematopoietic stem cell support.
SOURCES
American Society of Clinical Oncology. (2001, December). Tandem transplants increase response in multiple myeloma patients. Retrieved March 17, 2003 from http://asco.org/asco/shared/asco_print_view/1,1168,_12-002122-00_17-002122-00_18-007756-00_19-007757-00_20-001,00.html.
Attal, M., Harousseau, J. L., Facon, T., Guilhot, F., Doyen, C., Fuzibet, J. G., et al. (2003). Single versus double autologous stem-cell transplantation for multiple myeloma. The New England Journal of Medicine, 349, (26), 2495-2502. (Level 2 Evidence - Industry Sponsored)
Barlogie, S., Jagannath, K. R., Desikan, S., Mattox, D., Vesol, D., Siegel, G., et al. (1999). Total therapy with tandem transplants for newly diagnosed multiple myeloma. Blood, 93 (1), 55-65. (Level 2 Evidence - Industry Sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2007). Single or tandem courses of high-dose chemotherapy plus hematopoietic stem cell support for multiple myeloma. (8.01.17). Retrieved April 7, 2008 from BlueWeb. (37 articles and/or guidelines reviewed)
Bruno, B., Rotta, M., Patricarca, F., Mordini, N., Allione, B., Carnevale-Schianca, F., et al. (2007). A comparison of allografting with autografting for newly diagnosed myeloma. The New England Journal of Medicine, 356 (11), 1110-1120. (Level 2 Evidence - Independent study)
Complete Guide to Medicare Coverage Issues [Computer software]. (2007, November) Stem cell transplantation (NCD 110.8.1, p. 2-52 to 2-53). St. Anthony Publishing.
Moreau, P., Facon, T., Attal, M., Hulin, C., Michallet, M., Maloisel, F. et al. (2002). Comparison of 200 mg/m2 melphalan and 8 Gy total body irradiation plus 140 mg/m2 melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: Final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial. Blood, 99 (3), 731-735. (Level 2 Evidence - Industry Sponsored)
Technology Evaluation Center. (1998, May). "Tandem" HDC/AuSCS for newly diagnosed or responsive multiple myeloma (Vol.15, No.8). Chicago: BlueCross BlueShield Association. (71 articles and/or guidelines reviewed)
Technology Evaluation Center. (1999, March). Single or tandem HDC/AuSCS for resistant multiple myeloma (Vol.13, No.26). Chicago: BlueCross BlueShield Association. (106 articles and/or guidelines reviewed)
Tennessee Code Annotated. §56-7-2504 (1995). Policyholders/Part 25 Mandated Insurer or Plan Options. Cancer treatment. Retrieved July 20. 2004 from http://198.187.128.12/tennessee/lpext.dll?f=templates&fn=fs-main.htm&2.0.
Tricot, D., & Barlogie, B. (2000). Multiple myeloma: update on the Arkansas experience-Year 2000. University of Arkansas for Medical Science, Little Rock, AR. Retrieved March 19, 2003 from http://mmserver.cjp.com/gems/blood/ABMT.10.Tricot.pdf. (Level 2 Evidence)
ORIGINAL EFFECTIVE DATE: 9/1/2003
MOST RECENT REVIEW DATE: 9/14/2008
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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