Subject: Specialty Quantity Limit imatinib-Gleevec 1719-H P2023
|
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:
- Gleevec [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2022.
- imatinib [package insert]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc.; September 2022.
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, 2023
