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Market Applicability Market GA KY MD NJ NY Applicable X X X X X

Gleevec ()

Override(s) Approval Duration Prior Authorization 1 year Quantity Limit

Medications Quantity Limit Gleevec (imatinib) May be subject to quantity limit

APPROVAL CRITERIA

Requests for Gleevec (imatinib) may be approved if the following criteria are met:

I. Individual has a diagnosis of one of the following:

A. Philadelphia chromosome positive (Ph+) chronic myeloid (CML) (Label, NCCN 1, 2A); OR

B. Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) (Label, NCCN 2A); OR

C. Gastrointestinal stromal tumors (GIST) (Label, NCCN 1, 2A); OR

D. Unresectable, recurrent, and/or metastatic Dermatofibrosarcoma protuberans tumors (Label, NCCN 2A); OR

E. Hypereosinophilic syndrome(HES) and/or chronic eosinophilic leukemia (CEL); OR

F. Aggressive systemic in those without D816V c-Kit (results are confirmed) or if eosinophilia is present FIP1L1-PDGFRA (Label, NCCN 2A); OR

G. Myelodysplastic-Myeloproliferative disorders associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements (Label, NCCN 2A); OR

H. Desmoid tumors (NCCN 2A); OR

PAGE 1 of 2 03/30/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0677-21 Market Applicability Market GA KY MD NJ NY Applicable X X X X X

I. Pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT) (NCCN 2A); OR

J. Subsequent therapy in metastatic or unresectable C-KIT mutated Melanoma (NCCN 2A); OR

K. Subsequent therapy in relapsed/refractory AIDS-Related Kaposi Sarcoma (NCCN 2A); OR

L. Recurrent chordoma (NCCN 2A).

Key References:

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2021. URL: http://www.clinicalpharmacology.com. Updated periodically. 2. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. 2021. 3. DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated periodically. 4. Lexi-Comp ONLINE™ with AHFS™, Hudson, Ohio: Lexi-Comp, Inc.; 2021; Updated periodically. 5. NCCN Clinical Practice Guidelines in ™. © 2021 National Comprehensive Network, Inc. For additional information, visit the NCCN website: http://www.nccn.org/index.asp. Accessed January 15, 2021. a. Acute Lymphoblastic Leukemia. V2.2020. Revised October 23, 2020. b. AIDS-Related Kaposi Sarcoma. V3.2020. Revised July 15, 2020. c. Bone Cancer. V1.2021. Revised November 20, 2020. d. Chronic . V3.2021. Revised January 13, 2021. e. Dermatofibrosarcoma Protuberans. V1.2020. Revised October 2, 2019. f. Gastrointestinal Stromal Tumors. V1.2021. Revised October 30, 2020. g. Hematopoietic Cell Transplantation. V2.2020. Revised March 23, 2020. h. Melanoma: Cutaneous. V1.2021. Revised November 25, 2020. i. Myeloid/Lymphoid Neoplasms with Eosinophilia and Fusion Genes. V3.2021. Revised August 21, 2020. j. Myelodysplastic Syndromes. V3.2021. Revised January 15, 2021. k. Pediatric Acute Lymphoblastic Leukemia. V2.2021. Revised October 22, 2020. l. Soft Tissue Sarcoma. V1.2020. Revised October 30, 2020. m. Systemic Mastocytosis. V1.2020. Revised May 21, 2020.

Federal and state laws or requirements, contract language, and Plan utilization management programs or polices may take precedence over the application of this clinical criteria.

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 the health plan.

PAGE 2 of 2 03/30/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply.