MEDICAL POLICY POLICY TITLE

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1 Original Issue Date (Created): July 1, 2002 Most Recent Review Date (Revised): Effective Date: April 15, 2008 July 1, RETIRED I. DESCRIPTION/BACKGROUND High dose chemotherapy (HDC) involves the administration of cytotoxic agents using doses several times greater than the standard therapeutic dose. In some cases, whole body or localized radiotherapy is also given and is included in the term HDC when applicable. The most significant side effect of HDC is marrow ablation and thus HDC is accompanied by a reinfusion of stem cells to repopulate the bone marrow. Autologous stem cells, either collected from the patient s bone marrow or peripheral blood, are the most commonly used for adult solid tumors. This policy addresses use of HDC with stem cell support for solid tumors, including small cell lung cancer, malignant melanoma, tumors of the gastrointestinal tract (including colon, rectum, pancreas, stomach, esophagus, gallbladder, and bile duct), genitourinary system (renal cell carcinoma, cervical carcinoma, cancer of the uterus, fallopian tubes, and prostate gland), tumors of the head and neck, soft tissue sarcoma, thyroid tumors, tumors of the thymus and tumors of unknown primary origin. II. DEFINITIONS ABLATION refers to the removal of a part, pathway, or function by surgery, chemical destruction, electrocautery or radiofrequency. ALLOGENEIC refers to having a different genetic constitution but belonging to the same species, i.e., involves a donor and a recipient. AUTOLOGOUS refers to originating within an individual, i.e., self-donation. BONE MARROW is the soft tissue in the marrow cavities of long bones (yellow marrow) and in the spaces between trabeculae of spongy bone in the sternum and other flat bones (red marrow). Yellow marrow is primarily fat and stored energy. Red marrow produces all types of blood cells. CYTOTOXIC AGENT is any pharmacologic compound that inhibits the proliferation of cells within the body. Page 1

2 III. POLICY High dose chemotherapy (HDC) with autologous or allogeneic stem cell support is considered investigational for the following malignancies, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure: Cancer of the bile duct Cancer of the fallopian tubes Cervical cancer Colon cancer Esophageal cancer Gall bladder cancer Lung cancer, any histology Malignant melanoma Nasopharyngeal cancer Neuroendocrine tumors Pancreatic cancer Paranasal sinus cancer Prostate cancer Rectal cancer Renal cell cancer Soft tissue sarcomas Stomach cancer Thyroid tumors Tumors of the thymus Tumors of unknown primary origin Uterine cancer. Page 2

3 Cross-references For other solid tumors, please reference one of the following: MP High Dose Chemotherapy and Hematopoietic Stem Cell Support for Breast Cancer MP High Dose Chemotherapy and Hematopoietic Stem Cell Support for Ovarian Cancer MP High Dose Chemotherapy and Hematopoietic Stem Cell Support for Malignant Astrocytomas and Gliomas MP High Dose Chemotherapy and Hematopoietic Stem Cell Support for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma MP Organ and Tissue Transplants IV. EXCLUSIONS N/A V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. Page 3

4 VII. REFERENCES Airoldi M, De Crescenzo A, Pedani F, et al. Feasibility and long-term results of autologous PBSC transplantation in recurrent undifferentiated nasopharyngeal carcinoma. Head Neck 2001; 23(9): BCBSA TEC Assessment. Salvage HDC/ALLOSCS for relapse following HDC/AuSCS for non-lymphoid solid tumors tab 11. Blay JY, Bouhour D, Ray-Coquard I, et al. High-dose chemotherapy with autologous hematopoietic stem-cell transplantation for advanced soft tissue sarcoma in adults. J Clin Oncol 2000; 18(21): Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD , Stem Cell Transplantation. 1/3/2006. CMS [Website]: cd%3a110%2e8%2e1%3a4%3astem+cell+transplantation. Accessed January 21, Crivellari G, Monfardini S, Stragliotto S, et al. Increasing chemotherapy in small-cell lung cancer: from dose intensity and density to megadoses. Oncologist 2007; 112(1): Elias AD, Ayash L, Frei E, et al. Intensive combined modality therapy for limited-stage small-cell lung cancer. J Natl Cancer Inst 1993; 85(7): Imamura M, Asano S, Harada M, Ikeda Y, Kato K, et al. Current status of hematopoietic cell transplantation for adult patients with hematologic diseases and solid tumors in Japan. Int J Hematol 2006; 83 (2): Mosby s Medical, Nursing, & Allied Health Dictionary, 6 th edition. National Cancer Institute. Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation: Questions and Answers. [Website]: Accessed January 21, Nieto Y, Shpall EJ. Autologous stem-cell transplantation for solid tumors in adults. Hematol Oncol Clin North Am 1999; 13(5): Nishimura M, Nasu K, Ohta H, et al. High dose chemotherapy for refractory urothelial carcinoma supported by peripheral blood stem cell transplantation. Cancer 1999; 86(9): Pedrazzoli P, Ledermann JA, Lotz JP, et al. High dose chemotherapy with autologous hematopoietic stem cell support for solid tumors other than breast cancer in adults. Ann Oncol 2006; 17(10): Rosti G, Ferrante P, Ledermann J, et al. High-dose chemotherapy for solid tumors: results of the EBMT. Crit Rev Oncol Hematol 2002; 41(2): Page 4

5 Taber s Cyclopedic Medical Dictionary, 19th edition. Seynaeve C, Verweij J. High-dose chemotherapy in adult sarcomas: no standard yet. Semin Oncol 1999; 26(1): Vaughan WP. NCCN: High-dose chemotherapy. Applications of high-dose chemotherapy with bone marrow/stem cell support in solid tumors. Cancer Control 2001; 8(6 suppl 2): VIII. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP POS [N] PPO [N] HMO [N] CHIP HMO [Y] SeniorBlue* [Y] SeniorBlue PPO* [N] Indemnity [N] SpecialCare [N] POS [Y] FEP HMO** [Y] FEP PPO** * Refer to Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) , Stem Cell Transplantation. ** The Federal Employee Program (FEP) may include specific conditions in which autologous bone marrow transplantation may be considered eligible for coverage. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 5

6 IX. POLICY HISTORY MP CAC 3/25/03 CAC 4/26/05 CAC 4/25/06 CAC 3/27/07 CAC 3/25/08 Policy approved for retirement effective 7/1/2009. Information added into policy as of 7/1/2009. Effective 10/1/ was retired. Refer to new policy: Page 6