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