GLEEVEC) GLEEVEC (Imatinib Mesylate)

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imatinib mesylate (GLEEVEC) GLEEVEC (imatinib mesylate) Diagnoses Considered for Coverage: • Acute Lymphoblastic Leukemia (ALL) - Philadelphia chromosome positive • Aggressive Systemic Mastocytosis (ASM) • Chronic Eosinophilic Leukemia (CEL) • Chronic Myeloid Leukemia (CML) - Philadelphia chromosome positive • Dermatofibrosarcoma protuberans (DFSP) • Gastrointestinal Stromal Tumor (GIST) • Hypereosinophilic syndrome (HES) • Myelodysplastic Syndrome (MDS) Coverage Criteria: For diagnosis of Acute Lymphoblastic Leukemia (ALL), approve if: • Patient is Philadelphia Chromosome positive, and • Not being used in combination with another kinase inhibitor [e.g. Bosulif (bosutinib), Iclusig (ponatinib), Sprycel (dasatinib), or Tasigna (nilotinib)], and • Dose does not exceed 600 mg per day. For diagnosis of Chronic Myelogenous Leukemia (CML), approve if: • Not being used in combination with another kinase inhibitor [e.g. Bosulif (bosutinib), Iclusig (ponatinib), Sprycel (dasatinib), or Tasigna (nilotinib)], and • Dose does not exceed 800 mg per day. For diagnosis of dermatofibrosarcoma (DFSP), approve if: • Dose does not exceed 800 mg per day. For diagnosis of GIST, approve if: Treatment • Being used for unresectable or metastatic disease, and • Dose does not exceed 800 mg per day. Prophylaxis after surgical resection • Dose does not exceed 400 mg per day. For diagnosis of Myelodysplastic or Myeloproliferative disease, Aggressive Systemic Mastocytosis (ASM), or Chronic Eosinophilic Leukemia (CEL): • Dose does not exceed 400 mg per day. For diagnosis of Hypereosinophilic syndrome (HES), approve if: • Recommended by an allergist or immunologist specialist, and • Dose does not exceed 400 mg per day. For brand-name Gleevec: • Meets above coverage criteria for generic, and • Allergic or intolerable side effect to the generic formulation. Coverage Duration: Length of benefit Effective: 12/01/2020 .

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Clinical Outcome in Pediatric Patients with Philadelphia Chromosome
cancers Article Clinical Outcome in Pediatric Patients with Philadelphia Chromosome Positive ALL Treated with Tyrosine Kinase Inhibitors Plus Chemotherapy—The Experience of a Polish Pediatric Leukemia and Lymphoma Study Group Joanna Zawitkowska 1,*, Monika Lejman 2 , Marcin Płonowski 3, Joanna Bulsa 4, Tomasz Szczepa ński 4 , Michał Romiszewski 5, Agnieszka Mizia-Malarz 6, Katarzyna Derwich 7, Gra˙zynaKarolczyk 8, Tomasz Ociepa 9, Magdalena Cwikli´ ńska 10, Joanna Trelińska 11, Joanna Owoc-Lempach 12, Ninela Irga-Jaworska 13, Anna Małecka 13, Katarzyna Machnik 14, Justyna Urba ńska-Rakus 14, Radosław Chaber 15 , Jerzy Kowalczyk 1 and Wojciech Młynarski 11 1 Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin, 20-059 Lublin, Poland; [email protected] 2 Laboratory of Genetic Diagnostics, Medical University of Lublin, 20-059 Lublin, Poland; [email protected] 3 Department of Pediatric Oncology, Hematology, Medical University of Bialystok, 15-089 Bialystok, Poland; [email protected] 4 Department of Pediatrics, Hematology and Oncology, Medical University of Silesia, 40-752 Katowice, Poland; [email protected] (J.B.); [email protected] (T.S.) 5 Department of Hematology and Pediatrics, Medical University of Warsaw, 02-091 Warsaw, Poland; [email protected] 6 Department of Pediatric Oncology, Hematology and Chemotherapy, Medical University of Silesia, 40-752 Katowice, Poland; [email protected] 7 Department of Pediatric Oncology, Hematology and
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