Clinical Policy Bulletin: Stem Cells for Hematopoietic Cell Transplant

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1 Stem Cells for Hematopoietic Cell Transplant Page 1 of 8 Clinical Policy Bulletin: Stem Cells for Hematopoietic Cell Transplant Number: 0190 Policy Aetna considers compatibility testing of prospective donors who are closefamily members (first-degree relatives (i.e., parents, siblings and children) or second degree relatives (i.e., grandparent, grandchild, uncle, aunt, nephew, niece, halfsibling)) and harvesting and short-term storage of peripheral stem cells or bone marrow from the identified donor medically necessary when an allogeneic bone marrow or peripheral stem cell transplant is authorized by Aetna. Aetna considers umbilical cord blood stem cells an acceptable alternative to conventional bone marrow or peripheral stem cells for allogeneic transplant. Aetna considers medically necessary the short-term storage of umbilical cord blood for a member with a malignancy undergoing treatment when there is a match. Note: The harvesting, freezing and/or storing umbilical cord blood of nondiseased persons for possible future use is not considered treatment of disease or injury. Such use is not related to the person s current medical care. Notes: When a covered family member of a newborn infant has a medically necessary indication for an allogeneic bone marrow transplant and wishes to use umbilical cord blood stem cells as an alternative, Aetna covers the testing of umbilical cord blood for compatibility for transplant under the potential recipient s plan. Performance of HLA typing and identification of a suitable donor does not, in and of itself, guarantee coverage of allogeneic bone marrow or peripheral stem cell transplantation. Medical necessity criteria and plan limitations and exclusions may apply. See also the following CPBs related to bone marrow and peripheral stem cell transplantation:

2 Stem Cells for Hematopoietic Cell Transplant Page 2 of 8 CPB Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma CPB Hematopoietic Cell Transplantation for Hodgkin's Disease CPB Hematopoietic Cell Transplantation for Selected Childhood Solid Tumors CPB Hematopoietic Cell Transplantation for Multiple Myeloma CPB Hematopoietic Cell Transplantation for Breast Cancer CPB Hematopoietic Cell Transplantation for Autoimmune Diseases and Miscellaneous Indications CPB Hematopoietic Cell Transplantation for Testicular Cancer CPB Hematopoietic Cell Transplantation for Thalassemia Major and Sickle Cell Anemia CPB Hematopietic Cell transplantation for Aplastic Anemia and other Bone Marrow Failure Syndromes CPB Non-myeloablative Bone Marrow/Peripheral Stem Cell Transplantation (Mini-Allograft / Reduced Intensity Conditioning Transplant) CPB Hematopoietic Cell Transplantation for Ovarian Cancer CPB Donor Lymphocyte Infusion CPB Hematopoietic Cell Transplantation for Selected Leukemias CPB Hematopoietic Cell Transplantation for Chronic Myelogenous Leukemia CPB Hematopoietic Cell Transplantation for Solid Tumors in Adults CPB Hematopoietic Cell Transplantation for Primary Immunodeficiency Disorders CPB Hematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia CPB Hematopoietic Cell Transplantation for Myelodysplastic Syndrome CPB Hematopoietic Cell Transplantation for Myelofibrosis CPB Hematopoietic Cell Transplantation for Inherited Disorders and Genetic Diseases Background According to the American Academy of Pediatrics (2007), cord blood transplantation has been shown to be curative in patients with a variety of serious diseases. Physicians should be familiar with the rationale for cord blood banking and with the types of cord blood banking programs available. Physicians consulted by prospective parents about cord blood banking can provide the following information: Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant's cord blood (i.e., pre-malignant changes in stem cells). Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in

3 Stem Cells for Hematopoietic Cell Transplant Page 3 of 8 cord blood. Although not standard of care, directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation. Cord blood donation should be encouraged when the cord blood is stored in a bank for public use. Parents should recognize that genetic (e.g., chromosomal abnormalities) and infectious disease testing is performed on the cord blood and that if abnormalities are identified, they will be notified. Parents should also be informed that the cord blood banked in a public program may not be accessible for future private use. Because there are no scientific data at the present time to support autologous cord blood banking and given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation, private storage of cord blood as "biological insurance" should be discouraged. Cord blood banks should comply with national accreditation standards developed by the Foundation for the Accreditation of Cellular Therapy (FACT), the U.S. Food and Drug Administration (FDA), the Federal Trade Commission, and similar state agencies. At a minimum, physicians involved in procurement of cord blood should be aware of cord blood collection, processing, and storage procedures. Eapen and colleagues (2010) stated that umbilical-cord blood (UCB) is increasingly considered as an alternative to peripheral blood progenitor cells (PBPCs) or bone marrow, especially when an human leukocyte antigen (HLA)- matched adult unrelated donor is not available. These investigators aimed to determine the optimal role of UCB grafts in transplantation for adults with acute leukemia, and to establish whether current graft-selection practices are appropriate. They used Cox regression to retrospectively compare leukemia-free survival and other outcomes for UCB, PBPC, and bone marrow transplantation in patients aged 16 years or over who underwent a transplant for acute leukemia. Data were available on 1,525 patients transplanted between 2002 and A total of 165 received UCB, 888 received PBPCs, and 472 received bone marrow. Umbilical-cord blood units were matched at HLA-A and HLA-B at antigen level, and HLA-DRB1 at allele level (n = 10), or mis-matched at 1 antigen (n = 40) or 2 antigens (n = 115). Peripheral blood progenitor cells and bone-marrow grafts from unrelated adult donors were matched for allele-level HLA-A, HLA-B, HLA-C, and HLA-DRB1 (n = 632 and n = 332, respectively), or mis-matched at 1 locus (n = 256 and n = 140, respectively). Leukemia-free survival in patients after UCB transplantation was comparable with that after 8/8 and 7/8 allele-matched PBPC or bone-marrow transplantation. However, transplant-related mortality was higher after UCB transplantation than after 8/8 allele-matched PBPC recipients (hazard ratio [HR] 1.62, 95 % confidence interval [CI]: 1.18 to 2.23; p = 0.003) or bonemarrow transplantation (HR 1.69, 95 % CI: 1.19 to 2.39; p = 0.003). Grades 2 to 4 acute and chronic graft-versus-host disease (GVHD) were lower in UCB recipients compared with allele-matched PBPC (HR 0.57, 95 % CI: 0.42 to 0.77; p = and HR 0.38, 95 % CI: 0.27 to 0.53; p = 0.003, respectively), while the incidence of chronic, but not acute GVHD, was lower after UCB than after 8/8 allele-matched bone-marrow transplantation (HR 0.63, 95 % CI: 0.44 to 0.90; p = 0.01). These

4 Stem Cells for Hematopoietic Cell Transplant Page 4 of 8 data support the use of UCB for adults with acute leukemia when there is no HLAmatched unrelated adult donor available, and when a transplant is needed urgently. CPT Codes / HCPCS Codes / ICD-9 Codes CPT codes covered if selection criteria are met: Management of recipient hematopoietic progenitor cell donor search and cell acquisition Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogenic autologous Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing, per donor specific cell depletion within harvest, T-cell depletion tumor cell depletion red blood cell removal platelet depletion plasma (volume) depletion Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear, or buffy coat layer Bone marrow harvesting for transplantation Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor Cordocentesis (intrauterine), any method HLA typing; A, B, or C, multiple antigens DR/DQ, multiple antigens lymphocyte culture, mixed (MLC) lymphocyte culture, primed (PLC) Compatibility test each unit; immediate spin technique

5 Stem Cells for Hematopoietic Cell Transplant Page 5 of incubation technique antiglobulin technique electronic Other CPT codes related to the CPB: Modifiers 4A - 4Z Histocompatibility/Blood Typing/Identity/Microsatellite HCPCS codes covered if selection criteria are met: G0364 S2140 S2142 S2150 Bone marrow aspiration performed with bone marrow biopsy through the same incision on the same date of service Cord blood harvesting for transplantation, allogeneic Cord blood-derived stem-cell transplantation, allogeneic Bone marrow or blood-derived stem-cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre-and post-transplant care in the global definition ICD-9 codes covered if selection criteria are met: (not all-inclusive): Malignant neoplasm Other ICD-9 codes related to the CPB: V59.02 Donors, blood, stem cells V59.3 Donors, blood, bone marrow The above policy is based on the following references: 1. Arcese W, Aversa F, Bandini G, et al. Clinical use of allogeneic hematopoietic stem cells from sources other than bone marrow. Haematologica. 1998;83(2): Wagner JE. Allogeneic umbilical cord blood transplantation. Cancer Treat Res. 1997;77: Alberta Heritage Foundation for Medical Research (AHFMR). Cord blood transplantation. Technote TN 3. Edmonton, AB: AHFMR; Alberta Heritage Foundation for Medical Research (AHFMR). Stem cell transplantation. Technote TN 8. Edmonton, AB: AHFMR; 1997.

6 Stem Cells for Hematopoietic Cell Transplant Page 6 of Newburger PE, Quesenberry PJ. Umbilical cord blood as a new and promising source of unrelated-donor hematopoietic stem cells for transplantation. Curr Opin Pediatr. 1996;8(1): Gluckman E. Umbilical cord blood transplant in human. Bone Marrow Transplant. 1996;18(Suppl 2): Wagner JE, Rosenthal J, Sweetman R, et al. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: Analysis of engraftment and acute graft-versus-host disease. Blood. 1996;88(3): Wagner JE, Kernan NA, Steinbuch M, et al. Allogeneic sibling umbilicalcord-blood transplantation in children with malignant and non-malignant disease. Lancet. 1995;346(8969): Varadi G, Elchalal U, Shushan A, et al. Umbilical cord blood for use in transplantation. Obstet Gynecol Surv. 1995;50(8): Wagner JE. Umbilical cord blood transplantation. Transfusion. 1995;35 (8): Varadi G, Elchalal U, Brautbar C, et al. Human umbilical cord blood for hematopoietic progenitor cells transplantation. Leuk Lymphoma. 1995;20(1-2): Wagner JE. Umbilical cord blood stem cell transplantation. Am J Pediatr Hematol Oncol. 1993;15(2): Mugishima H, Harada K, Chin M, et al. Effects of long-term cryopreservation on hematopoietic progenitor cells in umbilical cord blood. Bone Marrow Transplant. 1999;23(4): Kline RM, Bertolone SJ. Umbilical cord blood transplantation: Providing a donor for everyone needing a bone marrow transplant? South Med J. 1998;91(9): Johnson PWM, Simnett SJ, Sweetenham JW, et al. Bone marrow and peripheral blood stem cell transplantation for malignancy. Health Technol Assess. 1998;2(8): Arcese W, Aversa F, Bandini G, et al. Clinical use of allogeneic hematopoietic stem cells from sources other than bone marrow. Haematologica. 1998;83(2): Adamson JW. Cord blood stem cell banking and transplantation. Stem Cells. 1997;15(Suppl 1): Lu S, Ende N. Potential for clinical use of viable pluripotent progenitor cells in blood bank stored human umbilical cord blood. Life Sci. 1997;61 (12): American College of Obstetricians and Gynecologists (ACOG), Committee on Obstetric Practice. Routine storage of umbilical cord blood for potential future transplantation. ACOG Committee Opinion No. 183, April Int J Gynaecol Obstet. 1997;58(2): Yunkap Kwankam MM, Hailey D, Jacobs P. Cord blood transplantation. HTA 13. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); Jacobs P, Hailey D, MacLean N. Allogeneic stem cell transplantation methods. HTA 18. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); 2000.

7 Stem Cells for Hematopoietic Cell Transplant Page 7 of Swedish Council on Technology Assessment in Health Care (SBU). Transplantation of stem cells from umbilical cord blood - early assessment briefs (Alert). Stockholm, Sweden: SBU; BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Transplanting adult patients with hematopoietic stem cells from placental and umbilical cord blood. TEC Assessment Program. Chicago IL: BCBSA; 2001;16(17). Isoyama K, Ohnuma K, Kato K, et al. Cord blood transplantation from unrelated donors: A preliminary report from the Japanese Cord Blood Bank Network. Leuk Lymphoma. 2003;44(3): Barker JN, Wagner JE. Umbilical-cord blood transplantation for the treatment of cancer. Nat Rev Cancer. 2003;3(7): Koh LP. Unrelated umbilical cord blood transplantation in children and adults. Ann Acad Med Singapore. 2004;33(5): Cohen Y, Nagler A. Umbilical cord blood transplantation--how, when and for whom? Blood Rev. 2004;18(3): Brinch L, Husebekk A, Funderud S, Lyngstadaas A. Use of hematopoietic stem cells from cord blood [summary]. SMM-Report 4/2003. Oslo, Norway: The Norwegian Knowledge Centre for the Health Services (NOKC); Pichon Riviere A, Augustovski F, Regueiro A, et al. Storage of cord blood hematopoietic stem cells [summary]. Report IRR No. 36. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); Edozien LC. NHS maternity units should not encourage commercial banking of umbilical cord blood. BMJ. 2006;333(7572): American Academy of Pediatrics Section on Hematology/Oncology, American Academy of Pediatrics Section on Allergy/Immunology, Lubin BH, Shearer WT. Cord blood banking for potential future transplantation. Pediatrics 2007;119(1): Eapen M, Rocha V, Sanz G, et al; Center for International Blood and Marrow Transplant Research; Acute Leukemia Working Party Eurocord (the European Group for Blood Marrow Transplantation); National Cord Blood Program of the New York Blood Center. Effect of graft source on unrelated donor haemopoietic stem-cell transplantation in adults with acute leukaemia: A retrospective analysis. Lancet Oncol. 2010;11(7): Atsuta Y, Morishima Y, Suzuki R, et al; for the Japan Marrow Donor Program and the Japan Cord Blood Bank Network. Comparison of unrelated cord blood transplantation and HLA-mismatched unrelated bone marrow transplantation for adults with leukemia. Biol Blood Marrow Transplant. 2012;18(5): Zhang H, Chen J, Que W. A meta-analysis of unrelated donor umbilical cord blood transplantation versus unrelated donor bone marrow transplantation in acute leukemia patients. Biol Blood Marrow Transplant (8):

8 Stem Cells for Hematopoietic Cell Transplant Page 8 of 8 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. CPT only copyright 2008 American Medical Association. All Rights Reserved.

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