Subject: Specialty Quantity Limit imatinib-Gleevec 1719-H P2022

Drug

GLEEVEC  (imatinib mesylate)

Policy:

I.    PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

II.  COVERED QUANTITIES 

Medication	Standard Limit	FDA-recommended dosing
Gleevec (imatinib mesylate) 100 mg tablet	120 tablets per 30 days	Ph+ CML  ·   Adults with CP: 400 mg orally daily, may increase to 600 mg daily  ·   Adults with AP or BC: 600 mg orally daily, may increase to 400 mg      twice daily  ·   Pediatrics with CP: 340 mg/m2/day (not to exceed 600 mg)   Ph+ ALL  ·   Adults: 600 mg orally daily  ·   Pediatrics: 340 mg/m2/day (not to exceed 600 mg)  MDS/MPD: 400 mg orally daily  ASM: 100 mg to 400 mg orally daily  HES/CEL: 100 mg to 400 mg orally daily  DFSP: 400 mg orally twice a day  Metastatic and/or unresectable GIST: 400 mg orally daily up to  400 mg twice daily  Adjuvant treatment of GIST: 400 mg orally daily  Dose adjustments may be required for adverse reactions, use with  strong CYP3A4 inducers, hepatic impairment, renal impairment, and  hepatotoxicity.  ·   Gleevec doses up to 1,200mg/day (600mg twice daily) may be      given to patients receiving concomitant strong CYP3A4 inducers
Gleevec (imatinib mesylate) 400 mg tablet	60 tablets per 30 days

The limits may apply to the generic equivalent medication.
* ALL: acute lymphoblastic leukemia; ASM: aggressive systemic mastocytosis; CML: chronic myeloid leukemia; CML-AP: advanced phase; CML-CP: chronic phase; CML-BC-blast crisis; DFSP: dermatofibrosarcoma protuberans; GIST: gastrointestinal stromal tumors; HES/CEL: hypereosinophilic syndrome/chronic eosinophilic leukemia; MDS/MPD: myelodysplastic/myeloproliferative diseases; Ph+: Philadelphia chromosome positive

Place of Service:

Outpatient

The above policy is based on the following references:

1. Gleevec [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2022.
2. imatinib [package insert]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc.; August 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 22, 2022