CurrentUnitedHealthcarePolicy N/A

Imbruvica (ibrutinib) prior authorization/notification

Defines prior authorization and reauthorization criteria for Imbruvica (ibrutinib) use across hematologic malignancies and chronic graft-versus-host disease for UnitedHealthcare members; applies to pharmacy medical benefit processing (members under 19 auto-process).

Policy Summary

PayerUnitedHealthcare

PolicyImbruvica (ibrutinib) prior authorization/notification

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization (approvals issued for 12 months) unless member is under 19 years, which auto-processes without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

members <19auto-process

P&T 2018-2024approval history

annual reviewsreview cadence

may applysupply limits

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Coverage Criteria for Imbruvica (ibrutinib)

Patients less than 19 years of age

Covered when ALL of the following are met

Pediatric initial approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

Mantle cell lymphoma (MCL) initial therapy

Covered when BOTH of the following are met

MCL initial approval: Diagnosis of mantle cell lymphoma (MCL)

AND one of: patient has received at least one prior therapy OR used in pre-treatment in combination with rituximab to limit cycles with R-HyperCVAD

B-cell lymphoma indications

Covered when ONE of the following diagnoses is present and associated line-of-therapy criteria are met

Other B-cell lymphoma indications: Diagnosis of one of: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), histologic transformation to diffuse large B-cell lymphoma (DLBCL), extranodal marginal zone lymphoma (EMZL) of the stomach or nongastric sites, post-transplant lymphoproliferative disorders, HIV-related B-cell lymphoma, diffuse B-cell lymphoma (non-GCB DLBCL not a candidate for transplant), high-grade B-cell lymphoma, nodal or splenic marginal zone lymphoma (MZL)

Some diagnoses require use as second-line or subsequent therapy

Reauthorization

Reauthorization covered when ALL of the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Imbruvica therapy (or shows evidence of positive clinical response where specified)

Authorization will be issued for 12 months

Waldenström's Macroglobulinemia

Covered when ALL of the following are met

Waldenström's initial: Diagnosis of Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma

Authorization will be issued for 12 months

Chronic graft-versus-host disease (cGVHD)

Covered when ALL of the following are met

cGVHD initial: Diagnosis of chronic graft-versus-host disease (cGVHD)

AND history of failure of at least one other systemic therapy (e.g., corticosteroids, mycophenolate); authorization will be issued for 12 months

Primary CNS lymphoma

Covered when BOTH of the following are met

Primary CNS lymphoma: Diagnosis of primary CNS lymphoma

AND one of: used as second-line or subsequent therapy OR used as induction therapy if patient is unsuitable or intolerant to high-dose methotrexate; reauthorization requires no progressive disease

Coverage decisions in this policy apply to UnitedHealthcare members subject to the plan’s benefit language and applicable state law. State mandates for off‑label medication use or mandated compendia may supersede the provisions of this document; when such mandates apply, the state requirement takes precedence over the policy or notification criteria in this document. Additionally, members under 19 years of age have prescriptions that will automatically process without a coverage review as noted elsewhere in the policy.

This section describes the conditions under which Imbruvica will be approved. If the specific coverage criteria are not met for a given request, a denial is implied; the document does not list a separate "not medically necessary" catalogue in this portion. Providers should therefore ensure submitted information demonstrates how the patient meets the stated criteria to avoid an adverse determination.

Covered Regimens and Combination Uses

Regimen	Indication / Purpose	Coverage status
Imbruvica (ibrutinib) used in combination with Rituxan (rituximab)	Pre-treatment to limit the number of cycles of R-HyperCVAD (rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone) for mantle cell lymphoma (MCL)	Covered with criteria

Line-of-Therapy Specifications

second-line

Second-line use: Used as second-line or subsequent therapy for specified indications (e.g., several B-cell lymphomas, primary CNS lymphoma)

May require prior exposure to at least one therapy or be used in specified combinations/lines of therapy

first-line

First-line (induction alternative): Used as induction therapy if patient is unsuitable or intolerant to high-dose methotrexate

Applies to primary CNS lymphoma

Coding and Authorization Duration

Codes referencedmixed

N/A	No specific CPT/HCPCS/NDC/ICD-10 codes listed in this portion of the document

Authorization duration — standard authorization period

Standard authorization periodAuthorization will be issued for 12 months

Applies to pediatric approvalsIssued when patient is less than 19 years of age

Reauthorization alignmentReauthorization authorizations are also issued for 12 months when criteria are met

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for most members. For members under 19 years of age, the prescription will automatically process without a coverage review. Some state mandates may supersede the criteria below.

Prior authorization required for most members (automatic processing for <19 years)
State mandates may supersede these prior authorization requirements

Note

Automated Approval Pathways

Approvals may be granted based solely on previous claim or medication history, diagnosis codes (ICD-10), and claim logic. UnitedHealthcare uses automated approval and re-approval pathways where program or therapeutic-class-specific automation is available.

Automated approval possible using prior claims/medication history and ICD-10 diagnosis codes
Automation usage varies by program and therapeutic class

Step Therapy

Indication-Specific Prior Exposure / Step Requirements

For certain indications (for example, mantle cell lymphoma), approval may require prior exposure or step-therapy — e.g., at least one prior therapy for MCL or use as pre-treatment in combination with rituximab to limit R-HyperCVAD cycles. Providers should document prior therapies or combination regimens when applicable.

Mantle cell lymphoma (MCL) may require prior therapy or specific combination use (e.g., with rituximab)
Document prior therapies or combination regimens when requesting authorization

Documentation Required

Documentation for Approval

Providers should expect that approval will often rely on prior claim/medication history and appropriate diagnosis coding. Supporting documentation may be requested, and clinical notes should align with submitted ICD-10 codes and claim logic.

Include relevant ICD-10 diagnosis codes on the claim
Ensure prior medication and therapy history is clearly documented in the medical record

Denial Risk

Denial Risk and Automated Denial Triggers

Failure to meet the listed coverage criteria or provide required documentation may result in denial of the request. State-mandated coverage requirements may override these criteria. Potential automated denial triggers include lack of prior claim history, missing or non-matching diagnosis codes, or claim logic that does not support the requested indication.

Denial may occur if coverage criteria are not met or documentation is incomplete
Automated denials can be triggered by missing prior claims, absent or incorrect ICD-10 codes, or mismatched claim logic
If a state mandate applies, it may supersede a denial under these criteria

Billing Rule

Supply Limits

Supply limits may apply depending on the member's program and the therapeutic class. Check program-specific limits when submitting requests.

Supply limits may be enforced based on program and therapeutic class
Verify quantity/supply limitations prior to authorization submission

Background

Imbruvica (ibrutinib) is described in this policy as the Bruton tyrosine kinase inhibitor addressed by the coverage criteria and prior‑authorization rules. The policy applies those criteria to the drug’s licensed and guideline‑supported indications and to certain off‑label situations subject to applicable state mandates and compendia references.

Definitions and FDA-labeled Indications

FDA-labeled indications

CLL/SLLChronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)

CLL/SLL with 17p deletionCLL/SLL with 17p deletion

Waldenström's macroglobulinemiaWaldenström's macroglobulinemia (WM)

Chronic graft-versus-host disease (cGVHD)cGVHD — FDA approved for patients age ≥1 year after failure of one or more lines of systemic therapy

Policy Summary

PayerUnitedHealthcare

PolicyImbruvica (ibrutinib) prior authorization/notification

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization (approvals issued for 12 months) unless member is under 19 years, which auto-processes without coverage review.

SourceLink

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