CurrentCignaPolicy N/A

Drug Quantity Management Policy - Imbruvica (ibrutinib) per Rx

Defines per-prescription retail and home-delivery maximum quantity limits and exception rules for Imbruvica (ibrutinib) formulations for Cigna-administered health benefit plans; applies to providers and pharmacies submitting claims for covered members.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Imbruvica (ibrutinib) per Rx

Policy CodePolicy N/A

Change TypeNew policy — material change

Effective DateN/A

Next Review DateJul 12, 2023

Key ActionRequest quantity-exception prior authorization with documentation of the clinical indication when higher-dose regimens are required.

SourceLink

POLICY UPDATE CHANGES

New policy created to provide exceptions to previously existing quantity limits.

30retail max qty per Rx (70 mg caps/tabs)

90home delivery max qty per Rx (70 mg)

120retail max qty per Rx (140 mg caps)

360home delivery max qty per Rx (140 mg caps)

324 mL

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Coverage Criteria — Formulation Limits & Rules

Formulation-specific quantity limits and exceptions

Drug Quantity Limits and allowed exceptions per formulation are as follows:

70 mg capsules: Retail max 30 capsules per Rx; Home delivery max 90 capsules per Rx. Exception: if a patient requires 210 mg once daily, approve 90 capsules per dispensing at retail or 270 capsules per dispensing at home delivery.210 mg dosing exception

Supports dosing regimens achieved via multiple capsules.

140 mg capsules: Retail max 120 capsules per Rx; Home delivery max 360 capsules per Rx.none

No exceptions specified in policy.

140 mg tablets: Retail max 30 tablets per Rx; Home delivery max 90 tablets per Rx.none

No exceptions specified in policy.

280 mg tablets: Retail max 30 tablets per Rx; Home delivery max 90 tablets per Rx. Exception: if the patient requires 560 mg once daily to treat central nervous system lymphoma, mantle cell lymphoma, marginal zone lymphoma, or other B-cell lymphomas, approve 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery.560 mg dosing exception

Other B-cell lymphomas include diffuse large B-cell lymphomas, AIDS-related B-cell lymphomas, post-transplant lymphoproliferative disorders, double/triple hit lymphoma, and high-grade B-cell lymphoma.

420 mg tablets: Retail max 30 tablets per Rx; Home delivery max 90 tablets per Rx. Exception: if the patient requires 840 mg once daily to treat central nervous system lymphoma, approve 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery.840 mg dosing exception

Higher-dose CNS lymphoma regimen.

70 mg/mL oral suspension: Retail max 324 mL per Rx; Home delivery max 972 mL per Rx. Exception: if the patient requires 840 mg once daily to treat central nervous system lymphoma, approve 432 mL per dispensing at retail or 1,080 mL per dispensing at home delivery. Policy allows rounding up to nearest bottle to accommodate doses up to 560 mg daily and provides specific higher-volume exception for 840 mg dosing.560 mg and 840 mg dosing exceptions

Bottle size 108 mL referenced in policy.

For 140 mg capsules and 140 mg tablets, the policy specifies No exceptions to the stated quantity limits. Requests for quantities exceeding the per‑prescription maximum for these formulations will not be eligible for exception under this Drug Quantity Management program.

Quantity Limits — Formulation Summary

Imbruvica (ibrutinib) — Per‑prescription quantity limits

General quantity ruleSee formulation-specific limits — per-Rx retail and home-delivery maximums are specified by formulation (capsules, tablets, suspension).

Retail max per Rx (70 mg capsules / several tablet strengths)30 units per Rx (retail).

Home delivery max per Rx (70 mg capsules / several tablet strengths)90 units per Rx (home delivery).

Retail/home max for 140 mg capsulesRetail 120 capsules per Rx; Home delivery 360 capsules per Rx — no exceptions specified for 140 mg capsules.

Oral suspension limitsRetail max 324 mL per Rx; Home delivery max 972 mL per Rx; allows rounding to nearest 108 mL bottle to accommodate 560 mg dosing; exceptions for 840 mg dosing.

Initial Therapy — Dosing Context

Dosing context

Typical and off-label dosing information that supports quantity exceptions.

Standard dosing: 420 mg once daily is the recommended dose for CLL, SLL, and Waldenström macroglobulinemia (adults); pediatric and graft-versus-host disease dosing described in product information. Dose reductions to 280 mg or 140 mg may be used for adverse events, interactions, or hepatic impairment.420 mg

Dose reductions to 280 mg or 140 mg may be needed.

Higher/off-label dosing: 560 mg once daily is recommended for mantle cell lymphoma, marginal zone lymphoma, and other B-cell lymphomas; CNS lymphoma dosing up to 560 mg or 840 mg once daily. These higher doses form the basis for quantity exceptions (examples: 210 mg via multiple 70 mg capsules; 560 mg and 840 mg regimens).560-840 mg

Supports formulation-specific exception approvals (see limits by strength).

Provider Actions — Prior Authorization & Documentation

Prior Authorization

Quantity exception prior authorization

Quantity exception prior authorization — Quantity exceptions for Imbruvica are allowed when documented clinical indications require higher doses (examples: 210 mg, 560 mg, 840 mg). Approvals are provided for 1 year in duration; documentation should support the clinical indication and requested quantity per the exception. If the Drug Quantity Management rule is not met for the requested medication at point of service, coverage will be determined by the criteria.

Imbruvica 70 mg capsules: For a required dose of 210 mg once daily, approve 90 capsules per dispensing (retail) or 270 capsules per dispensing (home delivery).
Imbruvica 280 mg tablets: For a required dose of 560 mg once daily (e.g., CNS lymphoma, mantle cell lymphoma, marginal zone lymphoma, or other B-cell lymphomas), approve 60 tablets per dispensing (retail) or 180 tablets per dispensing (home delivery).
Imbruvica 420 mg tablets: For a required dose of 840 mg once daily to treat central nervous system lymphoma, approve 60 tablets per dispensing (retail) or 180 tablets per dispensing (home delivery).
Imbruvica 70 mg/mL oral suspension: For a required dose of 840 mg once daily to treat central nervous system lymphoma, approve 432 mL per dispensing (retail) or 1,080 mL per dispensing (home delivery).
All approvals are for 1 year; documentation must support the clinical indication and requested quantity.

Continuation Criteria — Approval Duration

Approval duration

Approvals are provided for 1 year in duration.

Approval duration: All approvals for Imbruvica quantity exceptions are provided for 1 year.1 year

Renewal requires meeting criteria again.

Step Therapy / Point-of-Service Rule

Step	Requirement	Coverage Determination
1	Drug Quantity Management rule applies at point of service	If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the criteria below; approvals are provided for 1 year in duration.

Definitions — Imbruvica Formulations

Imbruvica formulations and dosing context

Available strengths and forms70 mg capsules; 140 mg capsules; 140 mg, 280 mg, and 420 mg tablets; 70 mg/mL oral suspension (108 mL per bottle).

Typical dosing referenced420 mg once daily is the recommended dose for CLL, SLL, and Waldenström macroglobulinemia. Dose reductions to 280 mg or 140 mg QD may be needed.

Higher/off‑label dosing that affects quantity limits560 mg QD for mantle cell, marginal zone and other B‑cell lymphomas; CNS lymphoma dosing up to 560 mg or 840 mg QD — these higher doses underpin exception criteria.

Oral suspension specificsSuspension concentration 70 mg/mL; bottle size 108 mL; policy allows rounding up to nearest bottle for 560 mg dosing and provides exceptions for 840 mg dosing.

Formulation note used in limitsQuantity limits and exceptions are formulation‑specific (capsules, tablets, suspension) with per‑Rx retail and home‑delivery maximums defined by strength/formulation.

Background

Imbruvica (ibrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor used to treat multiple B‑cell malignancies and chronic graft‑versus‑host disease. Dosing varies by indication—commonly 420 mg once daily for CLL/SLL and Waldenström macroglobulinemia, with higher regimens (for example, 560 mg or up to 840 mg once daily) described for certain B‑cell lymphomas and central nervous system involvement. Dose reductions may be necessary for adverse events, drug interactions, or hepatic impairment; the policy’s quantity exceptions are tied to these higher‑dose clinical indications.