MEDICAL POLICY POLICY TITLE

MEDICAL POLICY POLICY TITLE HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES ...
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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

Original Issue Date (Created):

January 1, 2006

Most Recent Review Date (Revised):

June 17, 2008

Effective Date:

July 1, 2009- RETIRED

I.

DESCRIPTION/BACKGROUND High-Dose Chemotherapy High-dose chemotherapy (HDC) involves the administration of cytotoxic agents using doses several times greater than the standard therapeutic dose to induce myeloablation. Whole body radiotherapy may also be 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 an infusion of stem cells to repopulate the bone marrow. In some instances, non-myeloablative regimens are used in conjunction with infusions of donor allogeneic stem cells. These conditioning regimens are known as “mini-transplants.” and are addressed in MP-9.030, Nonmyeloablative Allogeneic Stem Cell Transplantation for Treatment of Malignancy. There are 3 potential sources of allogeneic stem cells as follows:

 Bone marrow cells harvested from a related or unrelated donor.

 Peripheral stem cells: Unlike autologous cells, the harvest of the stem cells is not preceded by a course of chemotherapy. Several pheresis procedures may be required.

 Umbilical cord blood: Blood harvested from the umbilical cord and placenta shortly after delivery of neonates contains stem and progenitor cells. Although cord blood is an allogeneic source, these stem cells are immunologically “naïve” and thus are associated with a lower incidence of rejection or graft versus host disease. Myelodysplastic syndrome (MDS) refers to a heterogeneous group of clonal hematopoietic disorders characterized by impaired maturation of hematopoietic cells and a tendency to transform into acute myelocytic leukemia (AML). MDS can occur as a primary (i.e., idiopathic form), or be secondary to cytotoxic therapy, ionizing radiation, or other environmental insult. Chromosomal abnormalities are seen in 40%–60% of patients, Page 1 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

frequently involving deletions of chromosome 5 or 7, or an extra chromosome (i.e., trisomy 8). The most widely accepted classification system for MDS is the French-AmericanBritish (FAB) system that identifies 5 types of MDS with increasing numbers of circulating blast cells as follows: Refractory anemia (RA) Refractory anemia with ringed sideroblasts (RARS) Refractory anemia with excess blasts (RAEB) Refractory anemia with excess blasts in transformation (RAEBT) Chronic myelomonocytic leukemia (CMML) Patients either succumb to disease progression to AML or to complications of pancytopenias. Patients with higher blast counts or complex cytogenetic abnormalities have a greater likelihood of progressing to AML than do other patients. Myeloproliferative Disorders The myeloproliferative disorders are characterized by the slow but relentless expansion of a clone of cells with the potential evolution into a blast crisis similar to AML. Myeloproliferative disorders include the following:

 Polycythemia vera (PV) is characterized by an expansion of the total red cell mass. Initial treatment focuses on phlebotomy to reduce red cell mass and viscosity. However, the disease inevitably progresses and after a median survival of fifteen years, patients typically succumb to thrombotic complications or leukemic evolution.

 Essential thrombocythemia (ET) is characterized by an isolated expansion of the megakaryocytic lineage. The median survival is ten years with most deaths due to thrombotic complications.

 Agnogenic myeloid metaplasia with myelofibrosis, also known as primary myelofibrosis is characterized by marrow fibrosis, splenomegaly, and extramedullary hematopoiesis. 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., involving a donor and a recipient. 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 and irregular Page 2 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

bones (red marrow). Yellow marrow is mostly fat and stored energy. Red marrow produces all types of blood cells. CHROMOSOME refers to a linear strand made of DNA that carries genetic information. CYTOTOXIC AGENT is any pharmacologic compound that inhibits the proliferation of cells within the body. GRAFT-VERSUS-HOST disease refers to immunological injury suffered by an immunosuppressed recipient of a bone marrow transplant. The donated lymphoid cells (the “graft”) attack the recipient (the “host”), causing damage to the skin, liver, and gastrointestinal tract. HEMATOPOIETIC pertains to or affecting the production and development of blood cells. LEUKOCYTE refers to a white blood cell. MYELOABLATIVE refers to treatment designed to destroy most all blood cells and cancer cells. PHERESIS refers to the removal of blood or other body fluids from a patient, separating certain elements (e.g., immunogloblulins, platelets, or red blood cells) and reinfusing the remaining elements into the patient. RADIOTHERAPY is the treatment of disease with ionizing or nonionizing radiation. STEM CELL refers to any cell that can give rise to more specifically differentiated daughter cells; a formative cell. III.

POLICY High-dose myeloablative or non-myeloablative chemotherapy with allogeneic stem-cell support may be considered medically necessary as a treatment of myelodysplastic syndrome. High-dose chemotherapy with allogeneic stem-cell support may be considered medically necessary as a treatment of myeloproliferative disorders. Cross-references MP-9.001 Cord Blood as a Source of Stem Cells MP-9.002 Organ and Tissue Transplantation Services MP-9.030 Nonmyeloablative Allogeneic Stem Cell Transplantation for Treatment of Malignancy

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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

IV.

EXCLUSIONS High-dose myeloablative or non-myeloablative chemotherapy with allogeneic stem-cell support as a treatment of myelodysplastic syndrome or myeloproliferative disorders, except for conditions as listed above, is considered investigational, 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.

VII. REFERENCES Anderson JE. Allogeneic hematopoietic cell transplantation for myelodysplastic and myeloproliferative disorders. In: Thomas ED, Blume KG, Forman SJ, eds. Hematopoietic Cell Transplantation. Malden, MA, Blackwell Science, Inc, 1999. Anderson JE. Bone marrow transplantation for myelodysplasia. Blood Rev. 2000; 14(2): 63-77. Barrett AJ, Savani BN. Allogeneic stem cell transplantation for myelodysplastic syndrome. Semin Hematol 2008; 45(1): 49-59. BCBSA 1992 TEC Assessment, p. 421.

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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

Benesch M, Deeg HJ. Hematopoietic cell transplantation for adult patients with myelodysplastic syndromes and myeloproliferative disorders. Mayo Clin Proc. 2003; 78(8): 981-990. Blaise D, Vey N, Faucher C, et al. Current status of reduced intensity conditioning allogeneic stem cell transplantation for acute myeloid leukemia. Haematologica 2007; 92(4): 533-41. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD) 110.8.1, Stem Cell Transplantation. 1/3/06. CMS [Website]: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=110.8.1&ncd_version=4&basket=n cd%3A110%2E8%2E1%3A4%3AStem+Cell+Transplantation. Accessed March 11, 2008. Deeg HJ, Storer B, Slattery JT, et al. Conditioning with targeted busulfan and cyclophosphamide for hemopoietic stem cell transplantation from related and unrelated donors in patients with myelodysplastic syndrome. Blood 2002; 100(4): 1201-7. Deschler B, de Witte T, Mertelsmann R, et al. Treatment decision-making for older patients with high-risk myelodysplastic syndrome or acute myeloid leukemia: problems and approaches. Haematologica 2006; 91(11): 1513-22. de Witt T, Brand R, van Biezen A, et al. The role of stem cell source in autologous hematopoietic stem cell transplantation for patients with myelodysplastic syndromes. J Clin Oncol 2005; 23 (36): 9387-93. Huisman C, Meijer E, Petersen EJ, et al. Hematopoietic stem cell transplantation after reduced intensity conditioning in acute myelogenous leukemia patients older than 40 years. Biol Blood Marrow Transplant 2008; 14(2): 181-6. Kroger N, Bornhauser M, Ehninger G, et al. Allogeneic stem cell transplantation after a fludarabine/busulfan based reduced intensity conditioning inpatients with myelodysplastic syndromes or secondary acute myeloid leukemia. Ann Hematol 2003; 82(6): 336-42. Laport GG, Sandmaier BM, Storer BE, et al. Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome and myeloproliferative disorders. Biol Blood Marrow Transplant 2008; 14(2): 246-55. Martino R, Caballero R, Simon JA, et al. Evidence for a graft-versus-leukemia effect after allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning in acute myelogenous leukemia and myelodysplastic syndromes. Blood 2002; 100(6): 2243-5.

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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

Mesa RA. Navigating the evolving paradigms in the diagnosis and treatment of myeloproliferative disorders. Hematology Am Soc Hematol Educ Program 2007; 2007: 355-62. National Cancer Institute. Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation: Questions and Answers. [Website]: http://www.cancer.gov/cancertopics/factsheet/Therapy/bone-marrow-transplant. Accessed March 11, 2008. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, v. 2.2008; http://www.nccn.org/professionals/physician_gls/PDF/mds.pdfAccessed March 12, 2008. Tauro S, Craddock C, Peggs K, et al. Allogeneic stem-cell transplantation using a reducedintensity conditioning regimen has the capacity to produce durable remissions and long-term disease-free survival in patients with high-risk acute myeloid leukemia and myelodysplasia. J Clin Oncol 2005; 23(36): 9387-93. Valcarcel D, Martino R. Reduced intensity conditioning for allogeneic hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myelogenous leukemia. Current Opin Oncol 2007; 19(6): 660-6. Valcarcel D, Martino R, Caballero D, et al. Sustained remissions of high-risk acute myeloid leukemia and myelodysplastic syndrome after reduced-intensity conditioning allogeneic hematopoietic transplantation: chronic graft-versus-host disease is the strongest factor improving survival. J Clin Oncol 2008; 26(4): 577-84. Virchis A, Koh M, Rankin P, et al. Fludarabine, cytosine, arabinoside, granulocytestimulating factor with or without idarubicin in the treatment of high risk acute leukaemia or myelodysplastic syndromes. Br J Haematol 2004; 124(1): 26-32. Woods WG, Barnard DR, Alonzo TA, et al. Prospective study of 90 children requiring treatment for juvenile myelomonocytic leukemia or myelodysplastic syndromes: a report from the Children’s Cancer Group. J Clin Oncol 2002; 20(2): 434-40.

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.

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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

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] Indemnity

[N] PPO

[N] SpecialCare

[N] HMO

[N] POS

[N] CHIP HMO

[N] FEP HMO

[Y] SeniorBlue*

[N] FEP PPO

[Y] SeniorBlue PPO* * Refer to Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 110.8.1, Stem Cell Transplantation. IX.

CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

38204 38205 38206 38208

38209 38210 38211

38212 38213 38214

38230 38240 38241

38242 86812 G0265

G0266 G0267 J9000

Q0083 Q0084 Q0085

S2140 S2142 S2150

4102 4103 4105

4108 4191 9979

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MEDICAL POLICY POLICY TITLE

HIGH-DOSE CHEMOTHERAPY AND ALLOGENEIC STEM CELL TRANSPLANT FOR MYELODYSPLASTIC DISEASES AND MYELOPROLIFERATIVE DISEASES

POLICY NUMBER

MP-9.036

X. POLICY HISTORY MP 9.036

CAC 7/26/05 CAC 6/27/06 CAC 6/26/07 CAC 5/27/08 Policy approved for retirement effective 7/1/2009. Information added into policy 9.037 as of 7/1/2009. Effective 10/1/14- 9.037 was retired. Refer to new policy: 9.056.

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