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.
This medical policy does not address the use of hematopoietic stem cell transplantation for germ cell tumors, including testicular tumors. For that medical policy, please refer to Hematopoietic Stem Cell Transplantation in the Treatment of Germ Cell Tumors.
POLICY
A single or second (salvage) autologous hematopoietic stem-cell transplantation for the treatment of multiple myeloma is considered medically necessary.
Tandem high-dose chemotherapy with autologous 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 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 other conditions/diseases, including, but not limited to, the following is considered investigational:
newly diagnosed multiple myeloma
responsive multiple myeloma
as salvage therapy
See also:
Autologous Hematopoietic Stem-Cell Transplantation for Malignant Astrocytomas and Gliomas
Hematopoietic Stem Cell Transplantation in the Treatment of Germ Cell Tumors
MEDICAL APPROPRIATENESS
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)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2010). Hematopoietic stem cell support for multiple myeloma. (8.01.17). Retrieved April 12, 2008 from BlueWeb. (35 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]. (2010, April). Stem cell transplantation (NCD 110.8.1, p. 2-54, 2-55). The Ingenix Complete Guide to Medicare Coverage Issues.
Hayes. Medical Technology Directory. (2006, September). High-dose chemotherapy with peripheral stem cell/autologous transplantation, treatment for multiple myeloma. Retrieved April 9, 2010 from www.Hayesinc.com/subscribers. (100 articles and/or guidelines)
Kumar, A., Kharfan-Dabala, M. A., Glasmacher, A., & Djulbegovic, B. (2009). Tandem versus single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: A systematic review and meta-analysis. Journal of the National Cancer Institute, 101 (2), 100-106. (Level 1 Evidence - Independent study)
Kumar, S. K., Mikhael, J. R., Buadi, F. K., Dingli, D., Dispenzieri, A., Fonseca, R., et al. (2009). Management of newly diagnosed symptomatic multiple myeloma: Updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines. Mayo Clinic Proceedings, 84 (12), 1095-1110.
National Cancer Institute. (2009, December). Multiple myeloma. Retrieved April 12, 2010 from http://www.cancer.gov/cancertopics/pdq/treatment/myeloma/HealthProfessional/page7#Section_366.
National Comprehensive Cancer Network. (2010, March). NCCN clinical practice guidelines in oncology™. Multiple myeloma - V.3.2010. Retrieved April 9, 2010 from http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf.
National Guideline Clearinghouse. (2008, February). The role of cytotoxic therapy with hematopoletic stem cell transplantation in the therapy of acute myeloid leukemia in adults. Retrieved April 12, 2010 from http://www.guidelines.gov.
Olin, R. L., Vogl, D. T., Porter, D. L., Luger, S. M., Schuster, S. J., Tsai, D. E., et al. (2009). Second auto-SCT is safe and effective salvage therapy for relapsed multiple myeloma. Bone Marrow Transplantation, 43 (5), 417-422. Level 3 Evidence - Independent study)
Qazilbash, M. H., Saliba, R., De Lima, M., Hosing, C., Couriel, D., Aleman, A., et al. (2006). Second autologous or allogeneic transplantation after the failure of first autograft in patients with multiple myeloma. Cancer, 106 (5), 1084-1089. (Level 3 Evidence - Independent study)
Rosinol, L., Perez-Simon, J. A., Sureda, A., de la Rubia, J., de Arriba, F., Lajuerta, J. J., et al. A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma. Blood, 112 (9), 3591-3593. (Level 3 Evidence - Independent study)
Smith, A., Wisloff, F., Samson, D., U. K. Myeloma Forum, Nordic Myeloma Study Group, & British Committee for Standards in Haematology. (2006). Guidelines on the diagnosis and management of multiple myeloma 2005. British Journal of Haematology, 132 (4), 410-451.
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: Title 56 Insurance: Chapter 7 Policies and Policyholders: Part 25 Mandated Insurer or Plan Options: 56-7-2504. Cancer treatment. Retrieved April 8, 2010 from http://www.legislature.state.tn.us/sitemap.htm.
ORIGINAL EFFECTIVE DATE: 9/1/2003
MOST RECENT REVIEW DATE: 9/12/2010
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.
This document has been classified as public information.