Subject: Specialty Quantity Limit Bosulif 1720-H P2023a
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
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Medication
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Standard Limit
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FDA-recommended dosing
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Bosulif (bosutinib) 50 mg capsule
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30 capsules per 30 days
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Adult newly-diagnosed chronic phase Ph+ CML: 400 mg once daily
Pediatric newly-diagnosed chronic phase Ph+ CML: 300 mg/m2 once daily
Adult chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy: 500 mg once daily
Pediatric chronic phase Ph+ CML with resistance or intolerance to prior therapy: 400 mg/m2 once daily
The maximum dose in pediatric and adult patients is 600 mg once daily.
Dose adjustments may be necessary for response, adverse reactions, renal impairment, or hepatic impairment.
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Bosulif (bosutinib) 100 mg capsule
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300 capsules per 30 days
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Bosulif (bosutinib) 100 mg tablet
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90 tablets per 30 days
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Bosulif (bosutinib) 400 mg tablet
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30 tablets per 30 days
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Bosulif (bosutinib) 500 mg tablet
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30 tablets per 30 days
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*Ph+: Philadelphia chromosome-positive; CML: chronic myelogenous leukemia
Place of Service:
Outpatient
The above policy is based on the following references:
- Bosulif [package insert]. New York, NY: Pfizer Inc.; September 2023.
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.
November 12, 2023