CurrentCignaPolicy N/A

Oncology - Bosulif Drug Quantity Management Policy - Per Rx

Defines per-prescription quantity limits and allowable overrides for Bosulif (bosutinib) formulations (50 mg capsules, 100 mg tablets/capsules, 400 mg tablets, 500 mg tablets) for Cigna-administered benefit plans; approvals are valid for 1 year unless noted.

Policy Summary

PayerCigna

PolicyOncology - Bosulif Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeQuantity limits added; overrides added

Effective Date

Next Review Date

Key ActionAdhere to specified per-dispensing quantity limits by strength/formulation and document when a patient's dose cannot be achieved using a commercially-available single-strength product to support override approvals.

POLICY UPDATE CHANGES

Bosulif 50 mg capsules quantity limits of 30 capsules per dispensing at retail and 90 capsules per dispensing at home delivery were added.

Bosulif 100 mg capsules quantity limits of 90 capsules per dispensing at retail and 270 capsules per dispensing at home delivery were added.

Annual revision with no criteria changes noted (11/12/2024).

5Formulations addressed

3With override rules

2No overrides recommended

Quantity Limits and Override Criteria

General Program and Approval Duration

All approvals are provided for 1 year in duration, unless otherwise noted.

Drug Quantity Management program applies to Bosulif; if quantity management rule not met at point of service, coverage determined by criteria below

Approvals provided for 1 year unless otherwise noted

Bosulif 50 mg capsules and 100 mg capsules - Standard quantity limits (prior to overrides)

Standard retail and home delivery maximum quantities as listed in policy.

50 mg capsules: Retail Maximum Quantity per Rx = 30 capsules; Home Delivery Maximum Quantity per Rx = 90 capsules

100 mg capsules: Retail Maximum Quantity per Rx = 90 capsules; Home Delivery Maximum Quantity per Rx = 270 capsules

Bosulif 50 mg capsules - Covered when ALL of the following are met

Approve when the specific condition below is met; any other exception is not medically necessary.

Coverage / Override condition: Patient is taking a dose that does not correspond to a commercially-available dosage form (i.e., the dose requires multiple same-strength tablets be used OR would otherwise require two or more strengths to be used)

If met, approve requested quantity not to exceed 210 capsules per dispensing at retail or 630 capsules per dispensing at home delivery

Bosulif 100 mg tablets and 100 mg capsules - Covered when ALL of the following are met

Approve when the specific condition below is met; any other exception is not medically necessary.

If met, approve requested quantity not to exceed 180 tablets or capsules per dispensing at retail or 540 tablets or capsules per dispensing at home delivery

Bosulif 100 mg tablets - Quantity limits

Quantity limits for 100 mg tablets; overrides referenced in the 100 mg section.

Retail Maximum Quantity per Rx = 90 tablets

Home Delivery Maximum Quantity per Rx = 270 tablets

Overrides follow the 100 mg tablets/capsules section (approve up to 180 retail / 540 home when dose does not correspond to a commercially-available dosage form)

Bosulif 400 mg tablets - Quantity limits

Retail and home delivery maximum quantities as listed in policy.

Retail Maximum Quantity per Rx = 30 tablets

Home Delivery Maximum Quantity per Rx = 90 tablets

No overrides recommended

Bosulif 500 mg tablets - Quantity limits

Retail and home delivery maximum quantities and override guidance (500 mg has no overrides recommended).

Bosulif 400 mg tablets: Retail Maximum Quantity per Rx = 30 tablets; Home Delivery Maximum Quantity per Rx = 90 tablets

No overrides recommended for 400 mg

Bosulif 500 mg tablets: Retail Maximum Quantity per Rx = 30 tablets; Home Delivery Maximum Quantity per Rx = 90 tablets

No overrides recommended

Provider Actions

Billing Rule

Retail and Home Delivery Maximum Quantity per Rx

Adhere to specified per-dispensing quantity limits by strength/formulation (e.g., 100 mg tablets: retail 90, home delivery 270; 400/500 mg tablets: retail 30, home delivery 90; 50 mg capsules: retail 30, home delivery 90).

100 mg tablets: retail 90 / home delivery 270
400 mg tablets: retail 30 / home delivery 90
500 mg tablets: retail 30 / home delivery 90
50 mg capsules: retail 30 / home delivery 90

Prior Authorization

Override approval for non-commercial dosing

For patients whose prescribed dose does not correspond to a commercially-available dosage form (requires multiple same-strength tablets or multiple strengths), approve increased quantities up to stated maxima per formulation (50 mg: retail 210 / home 630; 100 mg: retail 180 / home 540).

50 mg formulation override maximum: retail 210 / home delivery 630
100 mg formulation override maximum: retail 180 / home delivery 540

Documentation Required

Clinical justification for override

Document that the patient's dose cannot be achieved using commercially-available single-strength product(s) to support override approvals.

Clinical Evidence & Definitions

Primary citation: Bosulif tablets prescribing information, Pfizer; September 2023 (prescribing information).

Dosing varies by adult versus pediatric populations and by disease phase: adults typically receive 400 mg once daily for newly-diagnosed chronic phase and 500 mg once daily for chronic/accelerated/blast phase with resistance or intolerance; pediatric dosing is BSA-based (examples: 150–500 mg depending on BSA and disease status) and may require combining strengths to attain the desired dose.

Commercially-available dosage form: a marketed single product strength such that the prescribed dose can be achieved without using multiple same-strength tablets or combining two or more strengths. This definition is used to determine eligibility for override approvals when a patient’s prescribed dose does not correspond to a commercially-available dosage form (for example, when the dose would require multiple same-strength tablets or multiple strengths to achieve).

Revision History

Early Annual Revision (prior year, review date 11/01/2023)added

Bosulif 50 mg capsules quantity limits of 30 capsules per dispensing at retail and 90 capsules per dispensing at home delivery were added. Also added an override to approve requested quantity up to 210 (retail) / 630 (home) when dose does not match commercially-available dosage form.

Early Annual Revision (prior year, review date 11/01/2023)added

Bosulif 100 mg capsules quantity limits of 90 capsules per dispensing at retail and 270 capsules per dispensing at home delivery were added. Also added an override to approve requested quantity up to 180 (retail) / 540 (home) when dose does not match commercially-available dosage form.

11/12/2024revisedLatest

Annual revision with no criteria changes noted (11/12/2024).

OpenPayer

Oncology - Bosulif Drug Quantity Management Policy - Per Rx

Coverage Summary

Quantity Limits and Override Criteria

Provider Actions

Applicable Codes

Clinical Evidence & Definitions

Revision History