MEDICAL COVERAGE POLICY

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1 Important note Even though this policy may indicate that a particular service or supply is considered covered, this conclusion is not necessarily based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the Evidence of Coverage to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and self-funded non- ERISA (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Senior Care members, this policy will apply unless Medicare policies restrict or extend coverage at odds with this Medical Policy & Criteria Statement. Senior Care policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan. CMS's Coverage Issues Manual can be found on the following website: SERVICE: Allogeneic Hematopoietic Stem- PRIOR AUTHORIZATION: Required. POLICY: ASCT, including the pre-operative evaluation, listing, the procedure, and long term post procedure follow up, all require prior authorization. SWHP may consider ASCT medically necessary for the following indications according to the criteria specified, upon the recommendation of an applicable network specialist, in patients able to withstand the rigors of the process based upon a thorough medical, psychological, and behavioral assessment; 1. Acute Myeloid Leukemia (AML): a. May consider after failed induction therapy in primary disease (age <60) b. May consider as post remission consolidation therapy in intermediate risk, poor risk, and treatment related disease (age <60) c. May consider as first line therapy in patients with antecedent hematologic disease, treatment related AML(unless favorable karyotype), or known poor prognosis karyotype (age <60) d. May consider as reduced intensity post induction therapy (age 60) e. May consider as reduced intensity consolidation therapy after first remission (age 60) f. May consider for relapsed disease following salvage chemotherapy (age <60 and age 60) g. Risk stratification based on cytogenetics and molecular abnormalities available in standard tables h. No current substance abuse problem or untreated mental health co-morbidity i. Adequate performance status with Karnofsky score 70% or Eastern Cooperative Oncology Group (ECOG) grade between 0 Page 1 of 6

2 j. Acceptable neurologic status as determined by normal history and exam or normal cytology by lumbar puncture or abnormal cytology by lumbar puncture and central nervous system disease treatment 2. Acute Lymphoblastic Leukemia: a. May consider for first post remission therapy in high risk and Philadelphia chromosome positive adult patients b. May consider in primary refractory disease or relapsed disease following second complete or partial remission in adult patients c. No current substance abuse problem or untreated mental health co-morbidity d. Adequate performance status with Karnofsky score 70% or ECOG grade between 0 e. Acceptable neurologic status as determined by normal history and exam or normal cytology by lumbar puncture or abnormal cytology by lumbar puncture and central nervous system disease treatment 3. Chronic Myeloid Leukemia: a. May consider as first line therapy b. May consider with less than complete hematologic response to primary drug therapy c. May consider for no cytogenetic response at six month follow up after initial complete hematologic response d. May consider for minor or no cytogenetic response or cytogenetic relapse at 12 month follow up after initial complete hematologic response e. May consider for partial cytogenetic response or cytogenetic relapse at 18 month follow up after initial complete hematologic response f. May consider for accelerated phase or blast crisis disease progression g. No current substance abuse problem or untreated mental health co-morbidity h. Adequate performance status with Karnofsky score 70% or ECOG grade between 0 4. Myelodysplastic Syndromes: a. May consider for clinically significant cytopenias which are unresponsive to appropriate medical therapy in select intermediate-1 risk patients b. May consider for primary therapy in intermediate-2, high, and very high risk patients c. No current substance abuse problem or untreated mental health co-morbidity d. Adequate performance status with Karnofsky score 70% or ECOG grade between 0 5. Chronic Lymphocytic Leukemia: a. May consider following a short response (< two years) to first line therapy in patient s without an 11q or 17p deletion b. May consider following complete or partial remission to first line therapy in patients with a 17p deletion c. May consider following a partial response to first line therapy in patients with an 11q deletion d. No current substance abuse problem or untreated mental health co-morbidity Page 2 of 6

3 e. Adequate performance status with Karnofsky score 70% or ECOG grade between 0 6. Non-Hodgkin s Lymphoma: a. Diffuse Large B Cell Lymphoma; 1. May consider instead of AuSCT in relapsed or refractory disease with complete or partial response to second line chemotherapy in select patients (e.g. mobilization failures and persistent bone marrow involvement) 2. May consider for relapse after AuSCT in select patients if chemotherapy sensitive disease is demonstrated and adequate performance status (Karnofsky >70%) and end organ function is present. b. Burkitt s Lymphoma; 1. May consider as consolidation therapy in select high risk patients following a complete response to induction therapy, and following second line chemotherapy 2. May consider in select patients with relapsed disease following second line chemotherapy 3. Normal neurologic history and exam or normal cytology by lumbar puncture or abnormal cytology by lumbar puncture with central nervous system treatment 4. No current substance abuse problem or untreated mental health co-morbidity 5. Adequate performance status with Karnofsky score 70% or ECOG grade between 0 7. Aplastic Anemia: a. May consider as first line therapy in patients < age 20 with an HLA matched sibling donor (or perhaps an HLA fully matched unrelated donor) and severe or very severe aplastic anemia b. May consider as first line therapy in patients ages with an HLA fully matched sibling donor and severe or very severe aplastic anemia, who are otherwise in excellent health c. May consider as first line therapy for select patients > age 45 with no significant medical co-morbidities who have an HLA identical sibling donor and severe or very severe aplastic anemia d. May consider with an HLA matched unrelated donor for patients originally treated with immunosuppressive therapy who have not adequately responded to at least two courses of such or have relapsed following therapy e. Considered the treatment of choice for children with idiopathic severe aplastic anemia and an HLA identical sibling donor f. May consider with an HLA matched unrelated donor in children with idiopathic severe aplastic anemia who fail immunosuppressive therapy 8. Fanconi Anemia: a. Once severe bone marrow failure occurs in children with an HLA identical related donor b. In the absence of an HLA identical related donor, may consider with matched unrelated donor later in course of disease once alternative treatment modalities fail (e.g. androgens and transfusions) Page 3 of 6

4 9. Wiskott-Aldrich Syndrome: a. Recommended for any patient with an HLA matched sibling donor, preferably prior to age five b. Recommended for children < age five with a severe disease course and no available HLA matched sibling donor, but an available HLA matched unrelated donor 10. Thalassemia Major: a. May be considered vs. medical management in beta Thalassemia major patients with an HLA identical related donor (or possibly an HLA matched unrelated donor) 11. Sickle Cell Anemia: a. ASCT is controversial for this disease given the many unanswered questions regarding the identification of appropriate candidates and timing of the procedure. It has been shown to be effective in this population with HLA matched sibling donors. 12. Severe Combined Immunodeficiency Disease (SCID): a. ASCT is the only potentially curative non-experimental therapy available for many primary immunodeficiencies. Early diagnosis and early transplant improve outcomes. SWHP considers ASCT experimental/investigational and thus not covered for the following indications: 1. Multiple Myeloma 2. Hodgkin s Lymphoma 3. In general, any indication not specified above. However, given the broad and dynamic nature of this field, all possible indications are not presented here. Thus requests for authorization of other indications will be considered on an individual case basis. OVERVIEW: Stem-cell transplants are used to restore the stem-cells when the bone marrow has been destroyed by disease, chemotherapy, and/or radiation. Depending on the source of the stemcells, the procedure may be called a bone marrow transplant, a peripheral blood stem-cell transplant, or a cord blood transplant. All of these in turn are included in the term hematopoietic stem-cell transplant. Hematopoietic stem-cell transplantation is used primarily for hematologic and lymphoid cancers, and to a lesser degree for a variety of other conditions. The transplanted stem-cells may originate from the patient (autologous) or from a matched donor (allogeneic). More than 30,000 autologous and 15,000 allogeneic procedures are performed annually on a worldwide basis. This policy addresses Allogeneic Stem-Cell (ASCT) and a companion policy addresses Autologous Stem-Cell (AuSCT). CMS: CMS National Coverage Determination (NCD) for Stem Cell August 4, 2010 ASCT may be considered reasonable and necessary, and a covered benefit, for patients with one of the following diagnoses: Page 4 of 6

5 1. Leukemia 2. Leukemia in remission 3. Aplastic Anemia 4. Severe Combined Immunodeficiency Disease (SCID) 5. Wiscott-Aldrich Syndrome 6. Myelodysplastic Syndromes pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study. Coverage is restricted to patients enrolled in an approved clinical study. (see NCD for detail) ASCT is not covered by CMS for the following indication: 1. Multiple Myeloma There is no applicable local coverage determination document. CODES: N/A as services are provided as part of a global package payment methodology Hayes Ratings: Chronic Lymphocytic Leukemia: C - There is a lack of well-designed prospective studies to determine the efficacy and safety of allogeneic SCT compared with standard chemotherapy and autologous SCT and the optimal regimen has yet to be established (reduced intensity conditioning versus myeloablative conditioning). Nevertheless, allogeneic SCT appears to be a reasonable option for patients with poor prognosis CLL that is refractory or has relapsed after standard therapy. Multiple Myeloma: C - The available evidence is insufficient to recommend auto-allo SCT as a routine therapy for patients with MM, but is promising enough to support continued exploration in clinical trials. Whether an allogeneic SCT should be offered after autologous SCT as part of a first-line treatment plan or only as salvage therapy for relapsed or refractory patients remains an unresolved issue of controversy. The optimal timing between autologous SCT and allogeneic SCT is also unknown. POLICY HISTORY: Status Date Action New 5/1/2011 New policy Reviewed 3/26/2012 Reviewed. Reviewed 2/28/2013 Reviewed. No revisions REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence surrounding this subject and may modify this policy at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed Page 5 of 6

6 by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Angelucci, Emanuele. Efficacy of hematopoietic cell transplantation in beta thalassemia. Up to Date 18.3, March 29, Bonilla, Francisco A. Hematopoietic cell transplantation for primary immunodeficiency. Up to Date 18.3, September 15, CMS NCD Stem Cell. August 4, Copelan, Edward A. Hematopoietic Stem-Cell. NEJM, 354:17, April 27, 2006, Hayes Technology Brief. Allogeneic Stem Cell for Chronic Lymphocytic Leukemia. March 3, 2009, updated March 9, Hayes Technology Brief. Autologous Stem Cell Followed by Nonmyeloablative Allogeneic Stem Cell for Treatment of Multiple Myeloma. October 25, InterQual 2010 Procedures Adult Criteria., Allogeneic Stem Cell. 8. Khan, Shakira, Negrin, Robert S. Hematopoietic cell transplantation for idiopathic severe aplastic anemia and Fanconi anemia in children. Up to Date 18.3, June 1, Khan, Shakira, Rodgers, Griffin P. Hematopoietic cell transplantation in sickle cell disease. Up to Date 18.3, January 5, Larson, Richard A. Post-remission therapy for acute lymphoblastic leukemia in adults. Up to Date, 18.3, September 11, Larson, Richard A. Post-remission therapy for acute myeloid leukemia in younger adults. Up to Date 18.3, September 23, Larson, Richard A. Treatment or relapsed or refractory acute lymphoblastic leukemia in adults, Up to date 18.3, September 16, NCCN Clinical Practice Guidelines in Oncology, Version Acute Myeloid Leukemia. 14. NCCN Clinical Practice Guidelines in Oncology, Version Chronic Myelogenous Leukemia. 15. NCCN Clinical Practice Guidelines in Oncology, Version Hodgkin Lymphoma. 16. NCCN Clinical Practice Guidelines in Oncology, Version Multiple Myeloma. 17. NCCN Clinical Practice Guidelines in Oncology, Version , Myelodysplastic Syndromes. 18. NCCN Clinical Practice Guidelines in Oncology, Version Non-Hodgkin s Lymphomas. 19. Shcherbina, Anna. Wiskott-Aldrich Syndrome. Up to Date 18.3, July 14, van Kampen RJ, Canals C, Schouten HC, Nagler A, Thomson KJ, Vernant JP, Buzyn A, Boogaerts MA, Luan JJ, Maury S, Milpied NJ, Jouet JP, Ossenkoppele GJ, Sureda A Allogeneic StemCell As Salvage Therapy for Patients With Diffuse Large BCell NonHodgkin's Lymphoma Relapsing After an Autologous StemCell : An Analysis of the European Group for Blood and Marrow Registry. J Clin Oncol. 2011;29(10):1342 Page 6 of 6

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