Alemtuzumab (Campath )

Transcription

1 Last Review Date: April 8, 2016 Number: MG.MM.PH.24 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ( EmblemHealth ) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Alemtuzumab (Campath) is a recombinant DNA-derived, humanized monoclonal antibody. It is directed against a small (21 to 28 kd) glycosylphosphatidylinositol-anchored glycoprotein, CD52, which is expressed on the surface of normal as well as malignant B- and T-lymphocytes, natural killer cells, monocytes, macrophages, but not on hematopoietic progenitor cells. Thus, alemtuzumab has a potential broad application across a spectrum of B- and T-cell malignancies. The proposed mechanism of action for alemtuzumab is antibody-dependent lysis of leukemic cells following cell surface binding. Dosage and Administration Campath Package Insert Related Medical Guideline Alemtuzumab (Lemtrada) Off-Label Use of FDA-Approved Drugs and Biologicals Guideline Alemtuzumab (Campath) is considered medically necessary for any of the following conditions: 1. Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) 2. Treatment of mycosis fungoides or Sezary syndrome with histologic evidence of large cell transformation and aggressive growth rate in non-candidates for high-dose therapy 3. Second-line therapy for individuals with stage III mycosis fungoides or Sezary syndrome that is refractory to or progressive following initial treatment options

2 Page 2 of 8 4. Second-line therapy or subsequent therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, or anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma in in non-candidates for high-dose therapy 5. Adult T-cell leukemia/lymphoma in nonresponders to first-line therapy for acute disease or lymphoma in noncandidates for high-dose therapy 6. Single-agent therapy for relapsed or refractory primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions or cutaneous ALCL with regional nodes (excludes systemic ALCL) 7. T-cell prolymphocytic leukemia, as primary treatment for symptomatic disease or second-line therapy 8. T-cell large granular lymphocytic leukemia, second-line therapy for persons with progressive or refractory disease 9. Single agent therapy for Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma that does not respond to primary therapy or for progressive or relapsed disease Limitations/Exclusions Alemtuzumab (Compath) is s considered investigational and not medically necessary when the medically necessary criteria are not met and including, but not limited to, the following diagnoses: 1. Acute lymphoblastic leukemia 2. Aplastic anemia 3. Arthritis 4. Autoimmune cytopenias 5. Eosinophilic myeloid disorders/eosinophilic diseases 6. Graft-versus-host disease 7. Guillain-Barre syndrome 8. Histiocytic sarcoma 9. Myelodysplastic syndrome 10. Polyradiculoneuropathies (e.g., Guillain-Barré syndrome and chronic inflammatory demyelinating polyradiculoneuropathy) 11. Pure red cell aplasia 12. Scleroderma/systemic sclerosis 13. Severe combined immunodeficiency 14. Solid organ transplantation (including antibody induction therapy and antibody-mediated rejection) 15. Sporadic inclusion body myositis 16. Uveitis 17. Vasculitis Applicable Procedure Codes J0202 Injection, alemtuzumab, 1 mg

3 Page 3 of 8 Applicable Diagnosis Codes C83.00 Small cell B-cell lymphoma, unspecified site C83.01 Small cell B-cell lymphoma, lymph nodes of head, face, and neck C83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodes C83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limb C83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb C83.06 Small cell B-cell lymphoma, intrapelvic lymph nodes C83.07 Small cell B-cell lymphoma, spleen C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites C83.50 Lymphoblastic (diffuse) lymphoma, unspecified site C83.51 Lymphoblastic (diffuse) lymphoma, lymph nodes of head, face, and neck C83.52 Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes C83.53 Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes C83.54 Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb C83.55 Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb C83.56 Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes C83.57 Lymphoblastic (diffuse) lymphoma, spleen C83.58 Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites C83.59 Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites C83.80 Other non-follicular lymphoma, unspecified site C83.81 Other non-follicular lymphoma, lymph nodes of head, face, and neck C83.82 Other non-follicular lymphoma, intrathoracic lymph nodes C83.83 Other non-follicular lymphoma, intra-abdominal lymph nodes C83.84 Other non-follicular lymphoma, lymph nodes of axilla and upper limb C83.85 Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb C83.86 Other non-follicular lymphoma, intrapelvic lymph nodes C83.87 Other non-follicular lymphoma, spleen C83.88 Other non-follicular lymphoma, lymph nodes of multiple sites C83.89 Other non-follicular lymphoma, extranodal and solid organ sites C83.90 Non-follicular (diffuse) lymphoma, unspecified, unspecified site C83.91 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck C83.92 Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes C83.93 Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes C83.94 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb C83.95 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb C83.96 Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes C83.97 Non-follicular (diffuse) lymphoma, unspecified, spleen C83.98 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites C83.99 Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites C84.00 Mycosis fungoides, unspecified site C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes

4 Page 4 of 8 C84.03 Mycosis fungoides, intra-abdominal lymph nodes C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.10 Sezary disease, unspecified site C84.11 Sezary disease, lymph nodes of head, face, and neck C84.12 Sezary disease, intrathoracic lymph nodes C84.13 Sezary disease, intra-abdominal lymph nodes C84.14 Sezary disease, lymph nodes of axilla and upper limb C84.15 Sezary disease, lymph nodes of inguinal region and lower limb C84.16 Sezary disease, intrapelvic lymph nodes C84.17 Sezary disease, spleen C84.18 Sezary disease, lymph nodes of multiple sites C84.19 Sezary disease, extranodal and solid organ sites C84.40 Peripheral T-cell lymphoma, not classified, unspecified site C84.41 Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck C84.42 Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes C84.43 Peripheral T-cell lymphoma, not classified, intra-abdominal lymph nodes C84.44 Peripheral T-cell lymphoma, not classified, lymph nodes of axilla and upper limb C84.45 Peripheral T-cell lymphoma, not classified, lymph nodes of inguinal region and lower limb C84.46 Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes C84.47 Peripheral T-cell lymphoma, not classified, spleen C84.48 Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites C84.49 Peripheral T-cell lymphoma, not classified, extranodal and solid organ sites C84.60 Anaplastic large cell lymphoma, ALK-positive, unspecified site C84.61 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck C84.62 Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes C84.63 Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes C84.64 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb C84.65 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb C84.66 Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes C84.67 Anaplastic large cell lymphoma, ALK-positive, spleen C84.68 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites C84.69 Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites C84.70 Anaplastic large cell lymphoma, ALK-negative, unspecified site C84.71 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck C84.72 Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes C84.73 Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes C84.74 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb C84.75 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb C84.76 Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes C84.77 Anaplastic large cell lymphoma, ALK-negative, spleen

5 Page 5 of 8 C84.78 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites C84.79 Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites C84.A0 Cutaneous T-cell lymphoma, unspecified, unspecified site C84.A1 Cutaneous T-cell lymphoma, unspecified lymph nodes of head, face, and neck C84.A2 Cutaneous T-cell lymphoma, unspecified, intrathoracic lymph nodes C84.A3 Cutaneous T-cell lymphoma, unspecified, intra-abdominal lymph nodes C84.A4 Cutaneous T-cell lymphoma, unspecified, lymph nodes of axilla and upper limb C84.A5 Cutaneous T-cell lymphoma, unspecified, lymph nodes of inguinal region and lower limb C84.A6 Cutaneous T-cell lymphoma, unspecified, intrapelvic lymph nodes C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen C84.A8 Cutaneous T-cell lymphoma, unspecified, lymph nodes of multiple sites C84.A9 Cutaneous T-cell lymphoma, unspecified, extranodal and solid organ sites C84.Z0 Other mature T/NK-cell lymphomas, unspecified site C84.Z1 Other mature T/NK-cell lymphomas, lymph nodes of head, face, and neck C84.Z2 Other mature T/NK-cell lymphomas, intrathoracic lymph nodes C84.Z3 Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes C84.Z4 Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb C84.Z5 Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb C84.Z6 Other mature T/NK-cell lymphomas, intrapelvic lymph nodes C84.Z7 Other mature T/NK-cell lymphomas, spleen C84.Z8 Other mature T/NK-cell lymphomas, lymph nodes of multiple sites C84.Z9 Other mature T/NK-cell lymphomas, extranodal and solid organ sites C85.10 Unspecified B-cell lymphoma, unspecified site C85.11 Unspecified B-cell lymphoma, lymph nodes of head, face, and neck C85.12 Unspecified B-cell lymphoma, intrathoracic lymph nodes C85.13 Unspecified B-cell lymphoma, intra-abdominal lymph nodes C85.14 Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb C85.15 Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb C85.16 Unspecified B-cell lymphoma, intrapelvic lymph nodes C85.17 Unspecified B-cell lymphoma, spleen C85.18 Unspecified B-cell lymphoma, lymph nodes of multiple sites C85.19 Unspecified B-cell lymphoma, extranodal and solid organ sites C85.20 Mediastinal (thymic) large B-cell lymphoma, unspecified site C85.21 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck C85.22 Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes C85.23 Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes C85.24 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb C85.25 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb C85.26 Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen C85.28 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites C85.29 Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites C85.80 Other specified types of non-hodgkin lymphoma, unspecified site C85.81 Other specified types of non-hodgkin lymphoma, lymph nodes of head, face, and neck C85.82 Other specified types of non-hodgkin lymphoma, intrathoracic lymph nodes

6 Page 6 of 8 C85.83 Other specified types of non-hodgkin lymphoma, intra-abdominal lymph nodes C85.84 Other specified types of non-hodgkin lymphoma, lymph nodes of axilla and upper limb C85.85 Other specified types of non-hodgkin lymphoma, lymph nodes of inguinal region and lower limb C85.86 Other specified types of non-hodgkin lymphoma, intrapelvic lymph nodes C85.87 Other specified types of non-hodgkin lymphoma, spleen C85.88 Other specified types of non-hodgkin lymphoma, lymph nodes of multiple sites C85.89 Other specified types of non-hodgkin lymphoma, extranodal and solid organ sites C85.90 Non-Hodgkin lymphoma, unspecified, unspecified site C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C85.93 Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb C85.96 Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C85.97 Non-Hodgkin lymphoma, unspecified, spleen C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites C86.0 Extranodal NK/T-cell lymphoma, nasal type C86.1 Hepatosplenic T-cell lymphoma C86.2 Enteropathy-type (intestinal) T-cell lymphoma C86.3 Subcutaneous panniculitis-like T-cell lymphoma C86.5 Angioimmunoblastic T-cell lymphoma C86.6 Primary cutaneous CD30-positive T-cell proliferations C88.0 Waldenstrom macroglobulinemia C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse C91.90 Lymphoid leukemia, unspecified not having achieved remission C91.92 Lymphoid leukemia, unspecified, in relapse C91.Z0 Other lymphoid leukemia not having achieved remission C91.Z2 Other lymphoid leukemia, in relapse References 1. Brannagan TH 3rd. Current treatments of chronic immune-mediated demyelinating polyneuropathies. Muscle Nerve. 2009;39(5): Capalbo S, Delia M, Dargenio M, et al. Mycosis fungoides/sezary syndrome: A report of three cases treated with Campath-1H as salvage treatment. Med Oncol. 2003;20(4): Chow JK, Chan TK. Low-dose subcutaneous alemtuzumab is a safe and effective treatment for chronic acquired pure red cell aplasia. Hong Kong Med J. 2013;19(6): Ciancio G, Burke GW 3rd. Alemtuzumab (Campath-1H) in kidney transplantation. Am J Transplant. 2008;8(1): Ciancio G, Burke GW, Gaynor JJ, et al. A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up. Clin Transplant. 2008;22(2): Compath. [Product Information] Cambridge, MA. August Accessed March 30, 2016.

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