CurrentUnitedHealthcarePolicy 2025 P 1306-7

Brukinsa (zanubrutinib) prior authorization / coverage criteria

UnitedHealthcare prior authorization/notification policy for Brukinsa (zanubrutinib) defining initial authorization and reauthorization clinical criteria across labeled and NCCN-recommended hematologic malignancy indications, special rules for members <19, state mandate overrides, and program operational notes (supply limits, automated approvals).

Policy Summary

PayerUnitedHealthcare

PolicyBrukinsa (zanubrutinib) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1306-7

Change TypeAnnual reviewno criteria changes (7/2025)

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior lines of therapy and disease status; approvals are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review with no changes to criteria (7/2025).

Clinical coverage criteria added for follicular lymphoma and hairy cell leukemia (7/2024).

Updates made to B-Cell Lymphoma criteria based on NCCN recommendations (10/2023, 10/2022).

Clinical coverage criteria added for Waldenström's Macroglobulinemia, Marginal Zone Lymphoma and CLL/SLL (10/2021).

Program created (1/2020, 1/2021).

12 monthsAuthorization duration

7P&T approval years listed

MultipleCovered hematologic malignancy indications

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Coverage Summary

UnitedHealthcare prior authorization/notification policy for Brukinsa (zanubrutinib) is covered_with_criteria. Authorization is issued for 12 months when criteria are met. Prescriptions for members under 19 years of age will automatically process without a coverage review. The policy defines initial authorization and reauthorization clinical criteria across labeled and NCCN-recommended hematologic malignancy indications and notes state mandate overrides and program operational details (supply limits, automated approvals).

Policy summary — Brukinsa (zanubrutinib)

Authorization duration12 months

Coverage stancecovered with criteria

Effective date2025-10-01

Last review2025-07

Policy number2025 P 1306-7

Initial Therapy Criteria

B-Cell Lymphomas - Initial Authorization

Brukinsa will be approved based on one of the following criteria:

ANY of the following

Follicular lymphoma (FL) in combination with obinutuzumab
- Diagnosis of follicular lymphoma (FL)
- Disease is relapsed or refractory
- Patient has received at least two or more lines of systemic therapy
- Brukinsa will be used in combination with obinutuzumab
Extranodal/nodal/nongastric marginal zone lymphoma

Continuation / Reauthorization Criteria

B-Cell Lymphomas - Reauthorization

Reauthorization criterion

Patient does not show evidence of progressive disease while on Brukinsa therapy

Reauthorization criterion for WM

Patient does not show evidence of progressive disease while on Brukinsa therapy

Reauthorization criterion for CLL/SLL

Patient does not show evidence of progressive disease while on Brukinsa therapy

NCCN Recognition & Indications

Brukinsa (zanubrutinib) is a BTK inhibitor with FDA indications for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy; relapsed or refractory marginal zone lymphoma (MZL) after at least one anti‑CD20‑based regimen; relapsed or refractory follicular lymphoma (FL) in combination with obinutuzumab after two or more lines of systemic therapy; Waldenström's macroglobulinemia (WM); and chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). Several of these indications were approved under accelerated approval based on overall response rate and continued approval may require verification of clinical benefit in confirmatory trials. NCCN additionally recommends Brukinsa for relapsed/refractory hairy cell leukemia and as second‑line and subsequent therapy for various extranodal, nodal, and splenic marginal zone lymphomas.

Anti‑CD20‑based regimen: a regimen containing an anti‑CD20 antibody (e.g., rituximab, obinutuzumab), used in prior therapy definitions for marginal zone lymphomas and other criteria.

Provider Actions & Operational Notes

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Brukinsa. When the clinical criteria are met, approvals are issued for 12 months. Prescriptions for members under 19 years of age will automatically process without a coverage review.

Documentation Required

Clinical documentation to support criteria

Providers must document the patient’s diagnosis, prior lines of therapy (including the number of prior regimens and the agents used), current disease status (relapsed, refractory, or progressive), and when applicable, that Brukinsa will be used in combination with obinutuzumab to meet prior authorization criteria.

Applicable Codes

ICD-10 Diagnosis Codes (examples referenced)ICD-10

No codes listed

Clinical Evidence & References

References: Brukinsa package insert (June 2025); NCCN Drugs and Biologics Compendium (accessed June 3, 2025). Note: some FDA approvals for Brukinsa (MCL, relapsed/refractory MZL, relapsed/refractory FL in combination with obinutuzumab) were granted under accelerated approval and continued approval may be contingent upon verification of clinical benefit in confirmatory trials.

Revision History

7/2025revisedLatest

Annual review with no changes to criteria (Updated background and references).

7/2024revised

Clinical coverage criteria added for follicular lymphoma and hairy cell leukemia; updated B-cell lymphoma formatting and background/reference updates.

10/2023revised

Policy Summary

PayerUnitedHealthcare

PolicyBrukinsa (zanubrutinib) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1306-7

Change TypeAnnual reviewno criteria changes (7/2025)

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior lines of therapy and disease status; approvals are issued for 12 months.

SourceLink

On This Page

Diagnosis
- Extranodal marginal zone lymphoma (EMZL) of the stomach
- Extranodal marginal zone lymphoma of nongastric sites (noncutaneous)
- Nodal marginal zone lymphoma
Disease is relapsed, refractory, or progressive
Patient has received at least one anti-CD20-based regimen (e.g., rituximab, obinutuzumab)

Splenic marginal zone lymphoma

Diagnosis of splenic marginal zone lymphoma
Disease is relapsed or refractory
Patient has received at least one anti-CD20-based regimen (e.g., rituximab, obinutuzumab)

Diagnosis of mantle cell lymphoma (MCL)

Waldenström's macroglobulinemia (WM) - Initial Authorization

Brukinsa will be approved based on the following criterion:

ALL of the following

Diagnosis of Waldenström's macroglobulinemia (WM)

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) - Initial Authorization

Brukinsa will be approved based on the following criterion:

ALL of the following

Diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Hairy Cell Leukemia - Initial Authorization

Brukinsa will be approved based on the following criteria:

ALL of the following

Diagnosis of hairy cell leukemia
Disease is relapsed, refractory, or progressive

Patients less than 19 years of age

Brukinsa will be approved based on the following criterion: Note: prescriptions for members <19 years of age will automatically process without a coverage review — see provider actions for details.

ALL of the following

Patient is less than 19 years of age
Authorization will be issued for 12 months. Operational: prescriptions for members <19 automatically process without coverage review; refer to provider_actions for details.

Reauthorization criterion for hairy cell leukemia

Patient does not show evidence of progressive disease while on Brukinsa therapy

Denial Risk

Reauthorization denial risk

Reauthorization may be denied if there is evidence of progressive disease while the patient is receiving Brukinsa therapy.

Billing Rule

State mandates override

State mandates for benefit coverage of off-label use or required compendium references may supersede the policy language and should be followed where applicable.

Billing Rule

Automated approvals and supply limits

UnitedHealthcare may approve initial authorizations and reauthorizations using automated processes based on prior claim/medication history and diagnosis codes (ICD-10); supply limits may apply.

Updates made to B-Cell Lymphoma criteria based on NCCN recommendations; background and references updated.

10/2022revised

Updates made to B-Cell Lymphoma criteria based on NCCN recommendations; state mandate footnote added; background and references updated.

10/2021added

Clinical coverage criteria added for Waldenström's Macroglobulinemia, Marginal Zone Lymphoma and CLL/SLL; background and references updated.

1/2020added

Program created (initial program creation).

1/2021added

Program created (new program).