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Diffuse Large B-Cell Lymphoma, Second-Line Therapy

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Diffuse Large B-Cell Lymphoma, Second-Line Therapy Medical Oncology Services: Non Hodgkin Lymphoma; Diffuse Large B-Cell Lymphoma, Second-Line Therapy POLICY INITIATED: 06/30/2019 MOST RECENT REVIEW: 06/30/2019 POLICY # HH-5513 Overview Statement The purpose of these clinical guidelines is to assist healthcare professionals in selecting the medical service that may be appropriate and supported by evidence to improve patient outcomes. These clinical guidelines neither preempt clinical judgment of trained professionals nor advise anyone on how to practice medicine. The healthcare professionals are responsible for all clinical decisions based on their assessment. These clinical guidelines do not provide authorization, certification, explanation of benefits, or guarantee of payment, nor do they substitute for, or constitute, medical advice. Federal and State law, as well as member benefit contract language, including definitions and specific contract provisions/exclusions, take precedence over clinical guidelines and must be considered first when determining eligibility for coverage. All final determinations on coverage and payment are the responsibility of the health plan. Nothing contained within this document can be interpreted to mean otherwise. Medical information is constantly evolving, and HealthHelp reserves the right to review and update these clinical guidelines periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from HealthHelp. All trademarks, product names, logos, and brand names are the property of their respective owners and are used for purposes of information/illustration only. Associated Procedure Codes: Procedure Code Description Code INJECTION, DEXAMETHASONE ACETATE, 1 MG J1094 INJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1 MG J1100 INJECTION, GEMCITABINE HYDROCHLORIDE, 200 MG J9201 INJECTION, OXALIPLATIN, 0.5 MG J9263 INJECTION, IFOSFAMIDE, 1 GRAM J9208 INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG J9293 PROCARBAZINE HYDROCHLORIDE, ORAL, 50MG S0182 INJECTION, DOXORUBICIN HYDROCHLORIDE, 10 MG J9000 Clinical Guidelines for Medical Necessity Review of Medical Oncology Services. http://www.healthhelp.com | © 2019 HealthHelp. All rights reserved. 16945 Northchase Dr #1300, Houston, TX 77060 (281) 447‐7000 INJECTION, RITUXIMAB, 10 MG J9312 INJECTION, BRENTUXIMAB VEDOTIN, 1 MG J9042 INJECTION, CISPLATIN, POWDER OR SOLUTION, 10 MG J9060 INJECTION, CYTARABINE, 100 MG J9100 INJECTION, CARBOPLATIN, 50 MG J9045 INJECTION, MESNA, 200 MG J9209 VINCRISTINE SULFATE, 1 MG J9370 CYCLOPHOSPHAMIDE; ORAL, 25 MG J8530 CYCLOPHOSPHAMIDE, 100 MG J9070 ETOPOSIDE; ORAL, 50 MG J8560 INJECTION, BENDAMUSTINE HCL, 1 MG J9033 INJECTION, BENDAMUSTINE HCL (BELRAPZO), 1 MG C9042 Definition: 1. Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in the United States and worldwide, accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the United States. More than 18,000 people are diagnosed with DLBCL each year. DLBCL is an aggressive (fast-growing) NHL that affects B-lymphocytes. B-cells are lymphocytes that make antibodies to fight infections and are an important part of the lymphatic system. Although it can occur in childhood, the occurrence of DLBCL generally increases with age, and most patients are over the age of 60 at diagnosis. Guideline: Medical Oncology treatments may be medically appropriate and supported by evidence to improve patient outcomes for the following indications and regimens. Unless otherwise stated, patients should demonstrate physical capability and appropriate clinical status as evidenced by either an Eastern Cooperative Oncology Group (ECOG) Performance Status Grade of 2 or less OR a Karnofsky Performance Status (KPS) Grade of 70 or greater. Second-Line Systemic Therapy for DLBCL per the drug regimens shown in the table below may be reasonable and appropriate when the patient’s medical record demonstrates the following: ◦ Intent to proceed with autologous stem cell transplant. ASSOCIATED CHEMOTHERAPY REGIMENS DHAP + Rituximab Clinical Guidelines for Medical Necessity Review of Medical Oncology Services. http://www.healthhelp.com | © 2019 HealthHelp. All rights reserved. 16945 Northchase Dr #1300, Houston, TX 77060 (281) 447‐7000 ESHAP + Rituximab GDP + Rituximab GemOx + Rituximab ICE + Rituximab MINE + Rituximab . Second-Line Systemic Therapy for DLBCL per the drug regimens shown in the table below may be reasonable and appropriate when the patient’s medical record demonstrates the following: ◦ Poor candidate for high-dose therapy. ASSOCIATED CHEMOTHERAPY REGIMENS CEPP + Rituximab Dose-Adjusted R-EPOCH GDP + Rituximab GemOx + Rituximab Lenalidomide + Rituximab RCEOP Rituximab . Second-Line Systemic Therapy for DLBCL per the drug regimens shown in the table below may be reasonable and appropriate when the patient’s medical record demonstrates BOTH of the following: ◦ Poor candidate for high-dose therapy; ◦ CD30 positive lymphoma (CD 30+). ASSOCIATED CHEMOTHERAPY REGIMENS Bendamustine + Rituximab Brentuximab Vedotin Clinical Guidelines for Medical Necessity Review of Medical Oncology Services. http://www.healthhelp.com | © 2019 HealthHelp. All rights reserved. 16945 Northchase Dr #1300, Houston, TX 77060 (281) 447‐7000 Clinical Guidelines for Medical Necessity Review of Medical Oncology Services. http://www.healthhelp.com | © 2019 HealthHelp. All rights reserved. 16945 Northchase Dr #1300, Houston, TX 77060 (281) 447‐7000 References 1. Coiffier B, Thieblemont C, Van Den Neste E, et al. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemo- therapy in DLBCL patients: a study by the Groupe d’Etudes des Lymphomes de l’Adulte. Blood. 2010;116:2040–2045. 2. Feugier P, Van Hoof A, Sebban C, et al, Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d’Etudes des Lymphomes de l’Adulte. J Clin Oncol. 2005;23:4117–4211. 3. Pfreundschuh M, Trumper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7:379–391. 4. Pfreundschuh M, Schubert J, Ziepert M, et al. Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomized controlled trial (RICOVER-60). Lancet Oncol. 2008;9:105–116. 5. Cunningham D, Hawkes EA, Jack A, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381:1817–1826. 6. Purroy N, Lopez A, Vallespi T, et al. Dose-adjusted EPOCH plus rituximab (DA-EPOCH-R) in untreated patients with poor risk large B-cell lymphoma. A phase 2 study conducted by the Spanish PETHEMA Group [Abstract]. Blood. 2009;114:Abstract 2701. 7. Wilson WH, Dunleavy K, Pittaluga S, et al. Phase II study of dose-adjusted EPOCH and rituximab in untreated diffuse large B-cell lymphoma with analysis of germinal center and post-germinal center biomarkers. J Clin Oncol. 2008;26:2717–2724. 8. Wilson WH, Jung SH, Porcu P, et al. A Cancer and Leukemia Group B multi-center study of DA-EPOCH-rituximab in untreated diffuse large B-cell lymphoma with analysis of outcome by molecular subtype. Haematologica. 2012;97:758–765. 9. Chao NJ, Rosenberg SA, Horning SJ. CEPP(B): An effective and well-tolerated regimen in poor-risk, aggressive non-Hodgkin’s lymphoma. Blood. 1990;76:1293–1298. 10. Martino R, Perea G, Caballero MD, et al. Cyclophosphamide, pegylated liposomal doxorubicin (Caelyx), vincristine and prednisone (CCOP) in elderly patients with diffuse large B- cell lymphoma: results from a prospective phase II study. Haematologica. 2002;87:822–827. 11. Zaja F, Tomadini V, Zaccaria A, et al. CHOP-rituximab with pegylated liposomal doxorubicin for the treatment of elderly patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2006;47:2174–2180. 12. Bessell EM, Burton A, Haynes AP, et al. A randomized multicentre trial of modified CHOP versus MCOP in patients aged 65 years and over with aggressive non-Hodgkin’s lymphoma. Ann Oncol. 2003;14:258–267. 13. Bezwoda W, Rastogi RB, Erazo Valla A, et al. Long-term results of a multicentre randomised,comparative phase III trial of CHOP versus CNOP regimens in patients with intermediate- and high-grade non-Hodgkin’s lymphomas. Novantrone International Study Group. Eur J Cancer. 1995;31:903–911. 14. Sonneveld P, de Ridder M, van der Lelie H, et al. Comparison of doxorubicin and mitoxantrone in the treatment of elderly patients with advanced diffuse non-Hodgkin’s lymphoma using CHOP versus CNOP chemotherapy. J Clin Oncol. 1995;13:2530–2539. 15. Garcia-Suarez J, Banas H, Arribas I, et al. Dose-adjusted EPOCH plus rituximab is an effective regimen in patients with poor-prognostic untreated diffuse large B-cell lymphoma: results from a prospective observational study. British Journal of Haematology. 2006;211:276–285. 16. Moccia AA, Schaff K, Hoskins P, et al. R-CHOP with etoposide substituted for doxorubicin (R-CEOP): excellent outcome in diffuse large B cell lymphoma for patients with a contraindi- cation to anthracyclines.
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