CurrentCignaPolicy N/A

Alunbrig Drug Quantity Management Policy

Defines quantity limits and exceptions for Alunbrig (brigatinib tablets) by strength/form for retail and home delivery dispensing, and the criteria under which quantity-limit overrides are considered medically necessary. Approvals are provided for 1 year unless noted.

Policy Summary

PayerCigna

PolicyAlunbrig Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeAnnual revision; name update

Effective Date

Next Review DateNov 21, 2025

Key ActionIf the Drug Quantity Management rule is not met at point of service, determine coverage by the policy criteria; exceptions are covered only when the specified per-strength/form criteria are met and approvals are for 1 year unless noted.

SourceLink

POLICY UPDATE CHANGES

Policy name was changed from 'Oncology - Alunbrig DQM Policy - Per Rx' to 'Oncology (Oral - Anaplastic Lymphoma Kinase-Positive Agent) - Alunbrig DQM Policy - Per Rx'.

Annual revisions on 11/21/2023 and 12/11/2024 indicated 'No criteria changes.'

3Strengths with quantity limits listed (30 mg, 90 mg, 180 mg)

1Starter Pack listing

2Override reasons specified (dose reduction, CYP3A inducer)

Coverage Summary

Alunbrig quantity limits and overrides (Retail vs Home Delivery)

Alunbrig 30 mg — Retail maximum60 tablets

Alunbrig 30 mg — Home Delivery maximum180 tablets

Alunbrig 30 mg — Override (dose reduced to 120 mg) Retail120 tablets per dispensing

Alunbrig 30 mg — Override (dose reduced to 120 mg) Home Delivery360 tablets per dispensing

Alunbrig 30 mg — Override (on moderate/strong CYP3A inducer) RetailUp to 360 tablets per dispensing

Alunbrig 30 mg — Override (on moderate/strong CYP3A inducer) Home DeliveryUp to 1,080 tablets per dispensing

Alunbrig 90 mg — Retail maximum30 tablets

Alunbrig 90 mg — Home Delivery maximum90 tablets

Alunbrig 90 mg — OverrideNo quantity-limit overrides recommended; standard limits apply

Alunbrig 180 mg — Retail maximum30 tablets

Alunbrig 180 mg — Home Delivery maximum90 tablets

Alunbrig 180 mg — Override (on moderate/strong CYP3A inducer) Retail60 tablets per dispensing

Alunbrig 180 mg — Override (on moderate/strong CYP3A inducer) Home Delivery180 tablets per dispensing

Alunbrig Starter Pack — Retail maximum30 tablets (1 pack)

Alunbrig Starter Pack — Home Delivery maximum30 tablets (1 pack)

Alunbrig Starter Pack — OverrideNo quantity-limit overrides recommended; standard limits apply

Quantity Limit Exception Criteria (by strength/form)

General Policy Statement

All approvals are provided for 1 year in duration, unless otherwise noted. Exceptions to the quantity limits listed are covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

Drug Quantity Limits apply to Alunbrig (brigatinib tablets) by strength/form with specified Retail and Home Delivery maximum quantity per prescription.

Exceptions to the specified quantity limits are approved only when the specific criteria for that strength/form are met (detailed per-strength in exception criteria).

Alunbrig 30 mg tablets - Exception Criteria

Approve quantity limit override when ALL of the following are met:

ONE of: Patient requires a dose reduction to 120 mg once daily.

If met, approve 120 tablets per dispensing at retail or 360 tablets per dispensing at home delivery.

ONE of: Patient is taking a moderate or strong cytochrome P450 (CYP)3A inducer.

If met, approve requested quantity not to exceed 360 tablets per dispensing at retail or 1,080 tablets per dispensing at home delivery. Examples of CYP3A inducers include, but are not limited to, carbamazepine, rifampin, rifabutin, ritonavir, St. John's wort.

Alunbrig 90 mg tablets - Exception Criteria

No overrides recommended.

No quantity-limit overrides are recommended for 90 mg tablets; standard Drug Quantity Limits apply (Retail maximum 30 tablets, Home Delivery maximum 90 tablets).

Alunbrig 180 mg tablets - Exception Criteria

Approve quantity limit override when ALL of the following are met:

Patient is taking a moderate or strong cytochrome P450 (CYP)3A inducer.

If met, approve 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery. Examples of CYP3A inducers include, but are not limited to, carbamazepine, rifampin, rifabutin, ritonavir, St. John's wort.

Alunbrig Starter Pack - Exception Criteria

No overrides recommended.

No quantity-limit overrides are recommended for the Starter Pack; standard Drug Quantity Limits apply (Retail maximum 30 tablets [1 pack], Home Delivery maximum 30 tablets [1 pack]).

Provider Actions & Documentation Requirements

Prior Authorization

Quantity Limit Overrides Require Criteria

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria. Exceptions to the quantity limits are approved only when the specified per-strength/form criteria are met. All approvals are provided for 1 year in duration unless otherwise noted.

Documentation Required

Documentation for CYP3A Inducer

When requesting a quantity‑limit override because the patient is taking a moderate or strong CYP3A inducer, document the specific inducer in the medical or pharmacy record. Examples of CYP3A inducers noted in the policy include carbamazepine, rifampin, rifabutin, ritonavir, and St. John's wort.

Carbamazepine
Rifampin
Rifabutin
Ritonavir
St. John's wort

Documentation Required

Documentation for dose reduction to 120 mg

When requesting a quantity‑limit override for the 30 mg strength because the patient requires a dose reduction to 120 mg once daily (per dose‑modification guidance), document the clinical need for the reduced dosing regimen in the medical record.

Background & Product Information

Alunbrig (brigatinib) is indicated for adults with ALK-positive metastatic non-small cell lung cancer (NSCLC). The product is available as 30 mg, 90 mg, and 180 mg tablets and a Starter Pack (7 x 90 mg and 23 x 180 mg). Dosing recommendations include starting at 90 mg once daily for 7 days then increasing to 180 mg once daily if tolerated; the prescribing information provides dose-modification guidance for adverse reactions and for coadministration with CYP3A modulators.

CYP3A inducer: Examples include carbamazepine, rifampin, rifabutin, ritonavir, and St. John's wort (moderate/strong inducers referenced for quantity overrides).

Retail maximum quantity per Rx: The maximum number of tablets allowed per retail prescription as specified per strength/form (e.g., 30 mg = 60 tablets, 90 mg = 30 tablets, 180 mg = 30 tablets, Starter Pack = 30 tablets (1 pack)).

Home Delivery maximum quantity per Rx: The maximum number of tablets allowed per home delivery prescription as specified per strength/form (e.g., 30 mg = 180 tablets, 90 mg = 90 tablets, 180 mg = 90 tablets, Starter Pack = 30 tablets (1 pack)).

Alunbrig tablets prescribing information, ARIAD/Takeda; February 2022.