Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL), First- Line Therapy

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Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL), First- Line Therapy Medical Oncology Services: Hodgkin Lymphoma; Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL), First- Line Therapy POLICY INITIATED: 06/30/2019 MOST RECENT REVIEW: 06/30/2019 POLICY # HH-5504 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, DOXORUBICIN HYDROCHLORIDE, 10 MG J9000 INJECTION, BLEOMYCIN SULFATE, 15 UNITS J9040 INJECTION, VINBLASTINE SULFATE, 1 MG J9360 DACARBAZINE, 100 MG J9130 CYCLOPHOSPHAMIDE; ORAL, 25 MG J8530 CYCLOPHOSPHAMIDE, 100 MG J9070 VINCRISTINE SULFATE, 1 MG J9370 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 Definition: 1. Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is a rare type of Hodgkin lymphoma (HL) that tends to grow more slowly than classic Hodgkin lymphoma. If early- stage NLPHL is bulky or is causing B symptoms, the main treatment is usually chemotherapy followed by radiation therapy. 37 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. First-Line Therapy for Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL) 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: ◦ Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL); ◦ First-line treatment; and ANY of the following: • Stage 1A or 2A with unfavorable risk factors: bulky mediastinal disease (greater than 10 cm); B symptoms; ESR greater than 50; greater than 3 sites of disease; • Stage 1A or 2A with no unfavorable risk factors; • Stage 1 or 2, unfavorable and non-bulky. ASSOCIATED CHEMOTHERAPY REGIMENS ABVD CHOP Cyclophosphamide + Vinblasine + Prednisolone (CVP) . First-Line Therapy for Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL) per the drug regimens shown in the table below may be reasonable and appropriate when the patient’s medical record demonstrates ALL of the following: ◦ Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL); 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 ◦ Stage 3 or 4; ◦ Unfavorable risk factors: bulky mediastinal disease (greater than 10 cm); B symptoms; ESR greater than 50; greater than 3 sites of disease. ASSOCIATED CHEMOTHERAPY REGIMENS ABVD CHOP . First-Line Therapy for Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL) 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: ◦ Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL); ◦ Maintenance therapy. ASSOCIATED CHEMOTHERAPY REGIMENS Rituximab . First-Line Therapy for Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL) per the drug regimens shown in the table below may be reasonable and appropriate when the patient’s medical record demonstrates the following: ◦ Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL). ASSOCIATED CHEMOTHERAPY REGIMENS Cyclophosphamide + Vinblasine + Prednisolone (CVP) 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. Eich HT, Diehl V, Görgen H, et al. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin’s lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010;28:4199– 4206. 2. Engert A, Plutschow A, Eich HT, et al. Reduced treatment intensity in patients with early-stage Hodgkin’s lymphoma. N Engl J Med. 2010;363:640–652. 3. Meyer R, Gospodarowicz M, Connors J, et al. ABVD alone versus radiation based therapy in limited stage Hodgkin’s lymphoma. N Engl J Med. 2012;366:399–408. 4. Bonadonna G, Bonfante V, Viviani S, et al. ABVD plus subtotal nodal versus involved-field radiotherapy in early-stage Hodgkin’s disease: long-term results. J Clin Oncol. 2004;22:2835–2841. 5. Gordon LI, Hong F, Fisher RI, et al. Randomized phase III trial of ABVD versus Stanford V with or without radiation therapy in locally extensive and advanced-stage Hodgkin lymphoma: an intergroup study coordinated by the Eastern Cooperative Oncology Group (E2496). J Clin Oncol. 2013;31:684–691. 6. Advani RH, Hoppe RT, Baer DM, et al. Efficacy of abbreviated Stanford V chemotherapy and involved field radiotherapy in early stage Hodgkin’s disease: mature results of the G4 trial. Ann Oncol. 2013;24:1044–1048. 7. Edwards-Bennett SM, Jacks LM, Moskowitz CH, et al. Stanford V program for locally extensive and advanced Hodgkin lymphoma: the Memorial Sloan-Kettering Cancer Center experience. Ann Oncol. 2010;21:574–581. 8. von Tresckow B, Plutschow A, Fuchs M, et al. Dose-intensification in early unfavorable Hodgkin’s lymphoma: final analysis of the German Hodgkin Study Group HD14 trial. J Clin Oncol. 2012;30:907–913. 9. Engert A, Haverkamp H, Cobe C, et al. Reduced-intensity chemotherapy and PET-guided radiotherapy in patients with advanced stage Hodgkin’s lymphoma (HD15 trial): a randomized, open-label, phase 3 non-inferiority trial. The Lancet. 2012;379(9828):1791–1799. 10. Younes A, Bartlett NL, Leonard JP et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med.2010;4;363:1812–1821. 11. Adcetris [package insert]. Bothell, WA: Seattle Genetics, Inc; 2015. 12. Montoto S, Camós M, López-Guillermo A, et al. Hybrid chemotherapy consisting of C-MOPP/ABV as first-line treatment forpatients with advanced Hodgkin disease. Cancer. 2000;88(9): 2142–2148. 13. Takenaka T, Mikuni C, Miura A, et al. Alternating combination chemotherapy C-MOPP and ABVD in clinical stage II–IV Hodgkin’s disease: a multicenter phase II study (JCOG 8905). The Lymphoma Study Group of the Japan Clinical Oncology Group. Jpn J Clin Oncol. 2000;30(3):146–152. 14. Josting A, Rudolph C, Reiser M, et al. Time-intensified dexamethasone/cisplatin/cytarabine: an effective salvage therapy with low toxicity in patients with relapsed and refractory Hodgkin’s disease. Ann Oncol. 2002;13(10):1628–1635. 15. Abali H, Urün Y, Oksüzoğlu B, Budakoğlu B, et al. Comparison of ICE versus DHAP as salvage chemotherapy in patients with relapsed or refractory lymphoma. Cancer Invest. 2008;26(4):401–406. 16. Aparicio J, Segura A, Garcera S, et al. ESHAP is an active regimen for relapsing Hodgkin’s disease. Ann Oncol. 1999; 10(5):593–595. 17. NCCN Clinical Practice Guidelines in Oncology™. Hodgkin Lymphoma.V.2.2015.Available at: http://www.nccn.org/ professionals/physician_gls/pdf/hodgkins.pdf. Accessed February 10, 2016. 18. Fernández de Larrea C, Martinez C, et al. Salvage chemotherapy with alternating MINE-ESHAP regimen in relapsed or refractory Hodgkin’s lymphoma followed by autologous stem cell transplantation. Ann Oncol. 2010;21(6):1211–1216. 19. Johnston PB, Inwards DJ, Colgan JP, et al. A phase II trial of the oral mTOR inhibitor everolimus in relapsed Hodgkin lymphoma. Am J Hematol. 2010;85:320–324. 20. Gopal AK, Press OW, Shustov AR, et al. Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget
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