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 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. There are three potential donor sources of stem cells. Autologous stem cells are collected from either the bone marrow or the peripheral blood of the patient. Stem cells may be harvested from the peripheral blood using a pheresis technique. To increase the number of stem cells in the peripheral circulation, autologous donors may be pretreated with a course of chemotherapy or hematopoietic growth factors, or both. Donors providing allogeneic blood stem cells are mobilized with growth factors only. Also blood harvested from the umbilical cord and placenta shortly after delivery of an infant contains stem and progenitor cells. Although cord blood is an allogeneic source, stem cells are immunologically naïve and are associated with a lower incidence of rejection or graft versus host disease. Chronic myelogenous leukemia is a malignancy arising from a primitive hematopoietic stem cell and is characterized by the presence of a chromosomal abnormality called the Philadelphia chromosome. The natural history of the disease consists of an initial indolent phase, lasting at least three years, that typically transforms into an accelerated phase, followed by a blast crisis, which is usually the terminal event. II. DEFINITIONS ABLATION is the removal of a part, pathway, or function by surgery, chemical destruction, electrocautery or radiofrequency. ANTIGENIC is the provoking of an immune response or acting with antibodies. Page 1
2 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. SYNGENEIC hematopoietic stem cells are those harvested from an identical twin. Their use is limited by the rarity of identical twins. III. POLICY High dose chemotherapy with allogeneic stem cell support may be considered medically necessary as a treatment of chronic myelogenous leukemia. Cross-references For additional information on transplants, please reference one of the following policies: MP Cord Blood as a Source for Stem Cells MP Organ and Tissue Transplants IV. EXCLUSIONS High dose chemotherapy with autologous stem cell support is considered investigational as a treatment of chronic myelogenous leukemia, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. 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 2
3 VII. REFERENCES Apperley J. Managing the patient with chronic myeloid leukemia through and after allogeneic stem cell transplantation. Hematology 2006; 2006: Baccarani M, Saglio G, Goldman J, Hochhaus A, Simonsson B, Appelbaum F, et al. Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. Blood. 2006; 108(6): BCBSA TEC Assessment, Tab 3. Bornhauser M, Kroger N, Schwerdtfeger R, Schafer-Eckart K, Saver HG, Scheid C, et al. Allogeneic haematopoietic cell transplantation for chronic myelogenous leukaemia in the era of imatinib: a retrospective multicentre study. Eur J Haematol 2006; 76(1): Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) , Stem Cell Transplantation. 1/3/06. CMS [Website]: sket=ncd%3a110%2e8%2e1%3a4%3astem+cell+transplantation. Accessed January 22, Cornelissen J, Löwenberg B. Role of allogeneic stem cell transplantation in current treatment of acute myeloid leukemia. Hematology2005; 2005: Druker BJ, Sawyers CL, Capdeville R, et al. Chronic myelogenous leukemia. In: Hematology 2001 (Am Soc Hematol Education Program Book); GP Schechter, VC Broudy, ME Williams (eds.). Washington, DC: American Society of Hematology, 2001; pp Garcia-Manero G, Talpaz M, Kantarjian HM. Current therapy of chronic myelogenous leukemia. Intern Med 2002; 41(4): Gratwoh A, Brand R, Apperly J, Crawley C, Ruutu T, Corradini P, et al. Allogeneic hematopoietic stem cell transplantation for chronic myeloid leukemia in Europe 2006: transplant activity, long-term data and current result. An analysis by the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Haematologica 2006; 91(4): Mauro, MJ, Maziarz, RT. Stem cell transplantation in patients with chronic myelogenous leukemia: when should it be used? Mayo Clinic Proceedings 2006; 81(3): Page 3
4 Mauro MJ, Deininger MW. Chronic myeloid leukemia in 2006: a perspective. Haematologica 2006; 91(2): McBride NC, Cavenagh JD, Newland AC, et al. Autologous transplantation with Philadelphia-negative progenitor cells for patients with chronic myeloid leukaemia (CML) failing to attain a cytogenetic response to alpha interferon. Bone Marrow Transplant 2000; 26(11): McGlave PB, Shu XO, Wen W, et al. Unrelated donor marrow transplantation for chronic myelogenous leukemia: 9 years' experience of the national marrow donor program. Blood 2000; 95(7): Meloni G, Capria S, Vignetti M, et al. Ten-year follow-up of a single center prospective trial of unmanipulated peripheral blood stem cell autograft and interferon-alpha in early phase chronic myeloid leukemia. Haematologica 2001; 86(6): Michallet M, Thiebaut A, Philip I, et al. Late autologous transplantation in chronic myelogenous leukemia with peripheral blood progenitor cells mobilized by G- CSF and interferon-alpha. Leukemia 2000; 14(12): National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology- Chronic Myelogenous Leukemia V /20/06. [Website]: Accessed January 22, National Cancer Institute. Chronic Myelogenous Leukemia (PDQ ): Treatment (Health Professional Version). 11/15/07. [Website]: Accessed January 22, O'Dwyer ME, Mauro MJ, Druker BJ. Recent advancements in the treatment of chronic myelogenous leukemia. Annu Rev Med 2002; 53: Pigneux A, Faberes C, Boiron JM, et al. Autologous stem cell transplantation in chronic myeloid leukemia: a single center experience. Bone Marrow Transplant 1999; 24(3): Podesta M, Piaggio G, Sessarego M, et al. Autografting with Ph-negative progenitors in patients at diagnosis of chronic myeloid leukemia induces a prolonged prevalence of Ph-negative hemopoiesis. Exp Hematol 2000; 28(2): Szatrowski TP. Progenitor cell transplantation for chronic myelogenous leukemia. Semin Oncol 1999; 26: Taber s Cyclopedic Medical Dictionary, 19 th edition. Page 4
5 Weisdorf DJ, Anasetti C, Antin JH, et al. Allogeneic bone marrow transplantation for chronic myelogenous leukemia: comparative analysis of unrelated versus matched sibling donor transplantation. Blood 2002; 99(6): 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* * The Federal Employee Program (FEP) may include specific conditions in which autologous bone marrow transplantation may be considered eligible for coverage. ** Refer to Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) , Stem Cell Transplant. IX. POLICY HISTORY MP CAC 3/25/03 CAC 3/29/05 CAC 3/28/06 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: 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
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