UnitedHealthcare Brukinsa Prior Auth Coverage Update

Coverage Criteria for Brukinsa (zanubrutinib)

Initial Authorization - Follicular Lymphoma (FL)

Covered when ALL of the following are met:

FL initial: Diagnosis of follicular lymphoma (FL)

FL disease status: Disease is relapsed, refractory, or progressive

FL prior therapy: Patient has received at least two or more lines of systemic therapy

FL combination: Brukinsa will be used in combination with obinutuzumab

Initial Authorization - Marginal Zone Lymphoma (MZL)

Covered when ALL of the following are met (any one of the MZL subtypes):

MZL subtype: Diagnosis of one of: extranodal marginal zone lymphoma (EMZL) of the stomach; extranodal marginal zone lymphoma of nongastric sites (noncutaneous); nodal marginal zone lymphoma

MZL disease status: Disease is relapsed, refractory, or progressive

MZL prior therapy: Patient has received at least one anti-CD20-based regimen (e.g., rituximab, obinutuzumab)

Initial Authorization - Splenic Marginal Zone Lymphoma

Covered when ALL of the following are met:

Splenic MZL diagnosis: Diagnosis of splenic marginal zone lymphoma

Splenic MZL disease status: Disease is relapsed or refractory

Splenic MZL prior therapy: Patient has received at least one anti-CD20-based regimen (e.g., rituximab, obinutuzumab)

Initial Authorization - Mantle Cell Lymphoma (MCL)

Covered when the following is met:

MCL diagnosis: Diagnosis of mantle cell lymphoma (MCL)

Waldenström's macroglobulinemia (WM)

Initial authorization covered for diagnosis; reauthorization requires no progression

WM diagnosis: Diagnosis of Waldenström’s macroglobulinemia (WM)

Initial authorization issued for 12 months.

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

Reauthorization issued for 12 months.

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

Initial authorization covered for diagnosis; reauthorization requires no progression

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

Initial authorization issued for 12 months.

CLL/SLL reauth: Patient does not show evidence of progressive disease while on Brukinsa therapy

Reauthorization issued for 12 months.

Hairy Cell Leukemia

Covered when ALL of the following are met; reauthorization requires no progression

HCL diagnosis: Diagnosis of hairy cell leukemia

HCL disease status: Disease is relapsed, refractory, or progressive

Initial authorization issued for 12 months.

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

Reauthorization issued for 12 months.

Primary Central Nervous System (CNS) Lymphoma

Covered when ALL of the following are met; reauthorization requires no progression

PCNSL diagnosis: Diagnosis of primary central nervous system lymphoma

Disease must be relapsed or refractory for initial authorization; initial and reauthorization issued for 12 months.

PCNSL disease status: Disease is relapsed or refractory

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

Reauthorization issued for 12 months.

Patients less than 19 years of age

Covered when the following is met:

Pediatric age: Patient is less than 19 years of age

Authorization will be issued for 12 months and prescriptions automatically process without a coverage review for members under 19.

Coverage decisions in this policy are subject to applicable state mandates and the member's specific benefit plan. Some states mandate coverage for off‑label medication uses or require use of alternate compendia; where those mandates apply, they supersede the language in this policy. In addition, plan‑specific benefit documents (for example, employer group or Medicaid benefit designs) may further modify coverage and should be consulted when determining eligibility.

Initial Therapy Rules and Indication-Specific Requirements

Initial therapy rules

Initial authorization criteria are diagnosis-specific and detailed in criteria sets; approvals typically issued for 12 months.

See criteria sets: Refer to coverage.criteria_sets entries for indication-specific initial authorization logic.

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization is granted when the patient does not show evidence of progressive disease while on Brukinsa therapy.

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

Authorization will be issued for 12 months.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Brukinsa. Initial authorization criteria differ by diagnosis; for example, follicular lymphoma (FL) requires relapsed/refractory disease, prior lines of systemic therapy, and use in combination with obinutuzumab. Authorizations are typically issued for 12 months when criteria are met.

Prior authorization required by indication — initial criteria vary by diagnosis
Typical authorization duration: 12 months when approved

Documentation Required

Combination and Prior Therapy Requirement

For follicular lymphoma (FL), Brukinsa must be used in combination with obinutuzumab and the patient must have relapsed, refractory, or progressive disease after at least two prior lines of systemic therapy. For marginal zone lymphoma subtypes (extranodal gastric, extranodal nongastric noncutaneous, nodal) and splenic marginal zone lymphoma, prior exposure to at least one anti-CD20–based regimen (e.g., rituximab, obinutuzumab) is required per the specified indications.

Prior Therapy / Step Therapy Requirements

Indication	Required prior therapies / sequencing before Brukinsa	Coverage status
Follicular lymphoma (FL)	Disease must be relapsed, refractory, or progressive; patient must have received at least two or more lines of systemic therapy; Brukinsa must be used in combination with obinutuzumab.	Covered with criteria
Extranodal marginal zone lymphoma (EMZL) of the stomach, extranodal (nongastric, noncutaneous) marginal zone lymphoma, or nodal marginal zone lymphoma	Disease must be relapsed, refractory, or progressive; patient must have received at least one anti‑CD20–based regimen (e.g., rituximab, obinutuzumab) prior to Brukinsa.	Covered with criteria
Splenic marginal zone lymphoma	Disease must be relapsed or refractory; patient must have received at least one anti‑CD20–based regimen (e.g., rituximab, obinutuzumab) prior to Brukinsa.	Covered with criteria
Mantle cell lymphoma (MCL)	No prior systemic therapy requirement specified for initial approval; diagnosis of MCL is required.	Covered with criteria

Quantity Limits and Supply Constraints

Brukinsa — supply and dispensing constraints

Typical authorization durationApprovals typically issued for 12 months

Supply/dispensing limitsSupply limits may be in place and programs may use automated approval/re‑approval processes that affect dispensing

Automated processingUnitedHealthcare may approve initial and reauthorizations based on prior claim/medication history, diagnosis codes (ICD‑10) and/or claim logic which can influence dispensing cadence

Site of Care and Program Constraints

Note

No site‑of‑care restriction specified; supply and automation may vary

The policy does not impose site‑of‑care restrictions (no infusion‑center restrictions specified); however, supply limits and use of automated approval/reapproval processes may vary by program and could affect dispensing or administration workflows.

No site‑of‑care restrictions are specified in the document.
Supply limits and automated approval processes vary by program and may affect quantity dispensed or authorization processing.

Background and Drug Information

Brukinsa (zanubrutinib) is a Bruton tyrosine kinase (BTK) inhibitor indicated for multiple B‑cell malignancies. The agent is approved for diagnoses including mantle cell lymphoma, marginal zone lymphoma subtypes, follicular lymphoma (when used in combination with obinutuzumab after at least two systemic therapies), Waldenström's macroglobulinemia, and chronic lymphocytic leukemia/small lymphocytic lymphoma. Several approvals have been granted under accelerated pathways and may depend on confirmatory data.

Definitions and Regulatory Notes

Accelerated approval — definition and implications

DefinitionAccelerated approval: indication approved based on overall response rate

Regulatory implicationContinued approval may be contingent on verification and description of clinical benefit in a confirmatory trial

Examples in this policyBrukinsa indications for MCL, MZL, and FL (with obinutuzumab) are approved under accelerated approval based on overall response rate

Coding and Billing (if applicable)

When submitting prior authorization requests, include appropriate diagnosis codes (ICD‑10) and supporting clinical documentation. UnitedHealthcare may use claim and medication history to adjudicate or automate approvals, but plan‑specific benefit language and state mandates can override the criteria in this document. For members under 19 years of age, prescriptions will automatically process without a coverage review per the benefit rules described.

Revision History and Material Changes

2026-02annual_reviewLatest

Annual review added coverage for progressive follicular lymphoma (FL) and primary central nervous system (CNS) lymphoma; background and references updated.

2025-07annual_review

Annual review with no changes to clinical criteria; background and references updated.

2024-07annual_review

Annual review added clinical coverage criteria for follicular lymphoma and hairy cell leukemia; B‑cell lymphoma formatting and background/references updated.

OpenPayer

Prior authorization and coverage criteria for Brukinsa (zanubrutinib)

Coverage Criteria for Brukinsa (zanubrutinib)

Initial Therapy Rules and Indication-Specific Requirements

Continuation / Reauthorization Criteria

Provider Actions, Prior Authorization & Documentation

Prior Therapy / Step Therapy Requirements

Quantity Limits and Supply Constraints

Site of Care and Program Constraints

Background and Drug Information

Definitions and Regulatory Notes

Coding and Billing (if applicable)

Revision History and Material Changes