BOSULIF (bosutinib)

BOSULIF (bosutinib)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
• Indicated for the treatment of adult patients with newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML). This indication is approved under accelerated approval based on molecular and cytogenic response rates.  Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow-up trial.

Coverage Criteria:

For diagnosis of Chronic Myelogenous/Myeloid Leukemia:

• Dose does not exceed 600 mg per day; AND

• Diagnosis of Philadelphia chromosome-positive chronic myelogenous/myeloid leukemia (Ph+ CML); AND

• Prescribed by or in consultation with a hematologist/oncologist; AND

• Trial and failure, contraindication, or intolerance to generic imatinib

Reauthorization Criteria:

For diagnosis of Chronic Myelogenous/Myeloid Leukemia:

• Dose does not exceed 600 mg per day; AND

• Patient does not show evidence of progressive disease while on Bosulif therapy

Coverage Duration:

 
•    Initial: 1 year
•    Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing and Administration

  • Recommended dose is taken orally once daily with food

  • Tablet is to be swallowed whole and should not be broken or cut

  • For newly-diagnosed CP Ph+ CML: the recommended dose is 400 mg once daily with food

  • For CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy: recommended dose and schedule is 500 mg once daily with food

  • Dose escalation: dose escalation by increments of 100 mg once daily to a maximum of 600 mg once daily was allowed in patients who did not achieve or maintain a hematologic, cytogenic, or molecular response and who did not have Grade 3 or high adverse reactions at the recommended starting dosage

• Drug Interactions

  • Strong and moderate CYP3A inhibitors: avoid concomitant use with Bosulif

  • Strong CYP3A inducers: avoid concomitant use with Bosulif

  • Proton pump inhibitors: use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors

Policy Updates:

•    11/15/2022 – New policy approved by P&T.

References:

1. Bosulif Prescribing Information. Pfizer. New York, NY. May 2021.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed on March 18, 2020.