BlueCross BlueShield of Tennessee Medical Policy Manual

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:

• • As upfront therapy in newly diagnosed multiple myeloma

  • Responsive multiple myeloma

  • As salvage therapy

See also:

• Autologous Hematopoietic Stem-Cell Transplantation for Malignant Astrocytomas and Gliomas

• Donor Lymphocyte Infusion for Hematologic Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant

• Hematopoietic Stem Cell Transplant for Breast Cancer

• Hematopoietic Stem Cell Transplantation for Central Nervous System Embryonal and Ependymoma Tumors

• Hematopoietic Stem-Cell Transplantation for Miscellaneous Solid Tumors in Adults

• Hematopoietic Stem Cell Transplantation in the Treatment of Germ Cell Tumors

• High Dose Chemotherapy with Autologous Stem-Cell Transplant for Primary Amyloid Light-Chain (AL) Amyloidosis

• High Dose (Myeloablative) Chemotherapy with Bone Marrow, Peripheral Stem Cell, or Cord Blood Transplant for Hematopoietic Stem Cell Support

• Nonmyeloablative Allogeneic Stem Cell Transplantation (Reduced Intensity Stem Cell Transplant) for Treatment of Malignancy

• Pancreas / Pancreas-Kidney / Pancreatic Islet Cell Transplantation

MEDICAL APPROPRIATENESS

• Tandem high-dose chemotherapy with hematopoietic stem cell support is  considered medically appropriate if ANY ONE of the following criteria is met:

• • Autologous stem cells and ANY ONE of the following:

  • • Multiple myeloma is newly diagnosed

    • Multiple myeloma is responsive to treatment

  • Allogeneic stem cells and ALL of the following criteria are met:

  • • Multiple myeloma is newly diagnosed

    • The allogeneic stem cell donor and recipient have identical Human Leukocyte Antigen (HLA-Identical)

    • Individual has previously received an autologous stem cell transplant that was followed by a non-marrow ablative regimen (i.e., reduced-intensity conditioning transplant)

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.

• 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. (3:2011). Hematopoietic stem cell support for multiple myeloma. (8.01.17). Retrieved February 3, 2012 from BlueWeb. (39 articles and/or guidelines reviewed)

Complete Guide to Medicare Coverage Issues [Computer software]. (2011, November). Stem cell transplantation (NCD 110.8.1, p. 2-56 - 2-58). Ingenix.

Giralt, S. (2011). Stem cell transplantation for multiple myeloma: Current and future status. Hematology, 2011, 191-196.

Hayes. Medical Technology Directory. (2006, September). High-dose chemotherapy with peripheral stem cell/autologous transplantation, treatment for multiple myeloma - Archived. Retrieved February 13, 2012 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. (2011, January). Plasma cell neoplasms (including multiple myeloma) treatment PDQ®. Retrieved February 13, 2012 from http://www.cancer.gov/cancertopics/pdq/treatment/myeloma/healthprofessional/page9.

National Comprehensive Cancer Network. (2012, January). NCCN clinical practice guidelines in oncology™. Multiple myeloma - V.1.2012. Retrieved February 14, 2012 from http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.

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 February 14, 2012 from http://www.lexisnexis.com/hottopics/tncode/.

ORIGINAL EFFECTIVE DATE:  9/1/2003

MOST RECENT REVIEW DATE:  5/10/2012

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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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