CurrentColorado Rocky Mountain Health PlansPolicy N/A

Imbruvica (ibrutinib) prior authorization criteria

Defines prior authorization and reauthorization criteria for Imbruvica (ibrutinib) for Colorado Rocky Mountain Health Plans members, including pediatric automatic processing for <19 years and coverage criteria for multiple hematologic malignancies and chronic graft-versus-host disease.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyImbruvica (ibrutinib) prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateOct 1, 2025

Key ActionObtain prior authorization; approvals are issued for 12 months when diagnosis-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period for approvals

automaticprescriptions for members under 19 years (no coverage review)

multiplecovered adult diagnoses listed

usedNCCN recognition

Coverage Criteria for Imbruvica (ibrutinib)

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Initial Authorization Criteria

Imbruvica will be approved when the listed diagnosis-specific criteria are met; authorizations are issued for 12 months.

Pediatric automatic approval: Patient is less than 19 years of age.

Authorization issued for 12 months; automatic processing for members under 19 years.

Mantle cell lymphoma (MCL): Diagnosis of mantle cell lymphoma (MCL) AND one of the following: patient has received at least one prior therapy for MCL OR used in pre-treatment in combination with rituximab to limit the number of RHyperCVAD cycles.

Authorization issued for 12 months.

Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL): Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Authorization issued for 12 months.

Other specified B-cell lymphomas and related disorders: Diagnosis of one of the following: post-transplant lymphoproliferative disorders; extranodal marginal zone lymphoma (EMZL) of the stomach; EMZL of nongastric sites (noncutaneous); diffuse large B-cell lymphoma (non-germinal center DLBCL); HIV-related B-cell lymphoma; high-grade B-cell lymphoma; hairy cell leukemia; nodal or splenic marginal zone lymphoma (MZL) AND used as second-line or subsequent therapy.

Authorization issued for 12 months.

Waldenström's macroglobulinemia / lymphoplasmacytic lymphoma: Diagnosis of Waldenström's macroglobulinemia / lymphoplasmacytic lymphoma.

Authorization issued for 12 months.

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

Authorization issued for 12 months; initial approval when there is a history of prior systemic therapy failure (see cGVHD criteria).

Primary CNS lymphoma: Diagnosis of primary CNS lymphoma AND (used as second-line or subsequent therapy OR used as induction therapy if patient is unsuitable or intolerant to high-dose methotrexate).

Authorization issued for 12 months.

Reauthorization Criteria

Reauthorization will be approved when evidence of benefit or lack of progression is demonstrated.

General reauthorization for malignancies: Patient does not show evidence of progressive disease while on Imbruvica therapy.

Authorization issued for 12 months.

cGVHD reauthorization: Patient shows evidence of positive clinical response while on Imbruvica therapy.

Authorization issued for 12 months.

State mandates and member-specific benefit plans may supersede the coverage criteria in this policy. Where state law or a specific member benefit requires coverage for an indication or uses a different compendium, that mandate takes precedence over the criteria shown here.

For members under 19 years of age, prescriptions will automatically process without a coverage review. In addition, UnitedHealthcare may approve initial or reauthorization requests based solely on previous claims/medication history, diagnosis codes (ICD-10), and/or claim logic, and automated approval processes may be used. Supply limits and other utilization management programs may also apply.

Initial Therapy Criteria

Initial authorization requires diagnosis-specific conditions; some indications require prior therapy or use as second-line.

MCL initial: Diagnosis of mantle cell lymphoma (MCL) AND one of: prior therapy for MCL OR used in pre-treatment with rituximab to limit RHyperCVAD cycles.

Authorization issued for 12 months; step therapy requirement applies for MCL.

CLL/SLL initial: Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Authorization issued for 12 months.

cGVHD initial: Diagnosis of chronic graft-versus-host disease AND history of failure of at least one systemic therapy.

Authorization issued for 12 months.

Primary CNS lymphoma initial: Diagnosis of primary CNS lymphoma AND (used as second-line or subsequent therapy OR used as induction therapy if patient is unsuitable or intolerant to high-dose methotrexate).

Authorization issued for 12 months.

Other B-cell lymphomas initial: Diagnosis of a specified B-cell lymphoma (post-transplant LPD; EMZL stomach or nongastric noncutaneous; non-germinal center DLBCL; HIV-related B-cell lymphoma; high-grade B-cell lymphoma; hairy cell leukemia; nodal/splenic MZL) AND used as second-line or subsequent therapy.

Authorization issued for 12 months.

Continuation and Reauthorization Rules

Continuation/Reauthorization

Reauthorization/continuation rules require demonstration of no disease progression or positive clinical response depending on indication.

Continuation for malignancies: Patient does not show evidence of progressive disease while on Imbruvica therapy.

Authorizations renewed for 12 months when no progression is documented.

Continuation for cGVHD: Patient shows evidence of positive clinical response while on Imbruvica therapy.

Authorizations renewed for 12 months when clinical benefit is demonstrated.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are typically issued for 12 months when the member meets diagnosis-specific criteria (for example, mantle cell lymphoma with prior therapy or when used as pre-treatment with rituximab to limit RHyperCVAD cycles). For members under age 19, prescriptions will automatically process without a coverage review.

Approvals generally cover a 12-month period when criteria met
Members <19 years: automatic processing without review

Step Therapy

MCL Step Requirements

For mantle cell lymphoma (MCL), prior therapy is required OR Imbruvica may be used as pre-treatment in combination with rituximab to limit RHyperCVAD cycles. Failure to meet these step requirements may result in denial of coverage.

MCL: patient has received ≥1 prior therapy OR used as pre-treatment with rituximab to limit RHyperCVAD

Denial Risk

Provider Actions / Adjudication Notes

Failure to meet the listed coverage criteria may lead to denial of coverage. UnitedHealthcare (program/system-level) may approve initial and reauthorization requests based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim-level evidence; automated approval processes vary by program. Supply limits may apply.

Noncompliant requests risk denial of coverage
Approvals may be granted using prior claims/med history, ICD-10 codes, or claim logic
Supply limits may apply

Step	Requirement
1	For mantle cell lymphoma (MCL): patient must have received at least one prior therapy OR be treated with ibrutinib in combination with rituximab (Rituxan) as pre-treatment to limit the number of cycles of the RHyperCVAD regimen (rituximab, cyclophosphamide, vincristine, doxorubicin, and dexamethasone)

Background

Ibrutinib (Imbruvica) is a Bruton's tyrosine kinase inhibitor approved for multiple B‑cell malignancies and related disorders, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL), Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma, and chronic graft‑versus‑host disease (cGVHD) in adults and pediatric patients ≥1 year. The agent is also recognized in guideline compendia for use in various other B‑cell lymphomas and primary CNS lymphoma.

This policy uses those approved and guideline‑recognized indications to define prior authorization and reauthorization criteria for Colorado Rocky Mountain Health Plans members, and links authorization decisions to diagnosis‑specific requirements and evidence of benefit or lack of disease progression.

OpenPayer

Imbruvica (ibrutinib) prior authorization criteria

Coverage Criteria for Imbruvica (ibrutinib)

Initial Therapy Criteria

Continuation and Reauthorization Rules

Provider Actions and Authorization Requirements

Step Therapy Requirements

Background

Definitions and Reference Recognition