CurrentUnitedHealthcarePolicy N/A

Step therapy for Brukinsa (zanubrutinib)

Defines step therapy (prioritization of lower-cost BTK inhibitors) and authorization criteria for coverage of Brukinsa (zanubrutinib) for UnitedHealthcare members; applies to pharmacy benefit adjudication and prescribers requesting Brukinsa. Members under 19 process without review.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Brukinsa (zanubrutinib)

Policy CodePolicy N/A

Change TypeClarification and administrative

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization showing trial of Calquence or Imbruvica or documented exception for Brukinsa coverage.

SourceLink

POLICY UPDATE CHANGES

Updated criteria wording from 'either' to 'both' to clarify verbiage with no change in clinical intent.

Removed provider attestation requirement from the criteria.

Updated name of patient support program and background/references.

12 monthsauthorization duration

Step Therapyprogram type

Calquence/Imbruvicarequired prior therapies

<19 auto-approvepediatric processing

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Pediatric (auto-approve)

Patients less than 19 years of age

Pediatric auto-approval: Patient is less than 19 years of age

Authorization issued for 12 months

Mantle Cell Lymphoma (MCL)

Mantle Cell Lymphoma (MCL) — approval when ALL of the following are met

MCL initial/continuation

ONE of: (1) Patient has a contraindication or history of intolerance to Calquence (acalabrutinib) OR Imbruvica (ibrutinib)
ONE of: (2) Patient is not an appropriate candidate based on clinical status or comorbidities for both Calquence (acalabrutinib) and Imbruvica (ibrutinib)
Both for continuation: (3) Continuation of therapy AND patient was not established via manufacturer supplied sample or assistance from the BeOne myBeOneSupport program or a 30-day free pharmacy trial

Marginal Zone Lymphoma (MZL)

Marginal Zone Lymphoma (MZL) — approval when ALL of the following are met

MZL initial/continuation

ONE of: (1) Patient has a contraindication or history of intolerance to Calquence (acalabrutinib) OR Imbruvica (ibrutinib)
ONE of: (2) Patient is not an appropriate candidate based on clinical status or comorbidities for both Calquence (acalabrutinib) and Imbruvica (ibrutinib)
Both for continuation: (3) Continuation of therapy AND patient was not established via manufacturer supplied sample or assistance from the BeOne myBeOneSupport program or a 30-day free pharmacy trial

Waldenström Macroglobulinemia (WM)

Waldenström Macroglobulinemia — approval when ALL of the following are met

WM initial/continuation

ONE of: (1) Patient has a contraindication or history of intolerance to Calquence (acalabrutinib) OR Imbruvica (ibrutinib)
ONE of: (2) Patient is not an appropriate candidate based on clinical status or comorbidities for both Calquence (acalabrutinib) and Imbruvica (ibrutinib)
Both for continuation: (3) Continuation of therapy AND patient was not established via manufacturer supplied sample or assistance from the BeOne myBeOneSupport program or a 30-day free pharmacy trial

CLL/SLL

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) — approval when ALL of the following are met

CLL/SLL initial/continuation

ONE of: (1) Patient has a contraindication or history of intolerance to Calquence (acalabrutinib) OR Imbruvica (ibrutinib)
ONE of: (2) Patient is not an appropriate candidate based on clinical status or comorbidities for both Calquence (acalabrutinib) and Imbruvica (ibrutinib)
Both for continuation: (3) Continuation of therapy AND patient was not established via manufacturer supplied sample or assistance from the BeOne myBeOneSupport program or a 30-day free pharmacy trial

Other Indications

Other indications: Brukinsa will be approved for other indications

Authorization issued for 12 months

Patients who were established on Brukinsa through receipt of a manufacturer‑supplied sample in the prescriber’s office or through assistance from the BeOne myBeOneSupport patient support program (for example, a sample card redeemable at a pharmacy or a 30‑day free trial from a pharmacy) are treated as new to therapy for initial authorization. Such members must meet the applicable initial authorization criteria for their diagnosis rather than automatically qualifying as continuations of therapy. Authorization for eligible requests is issued for 12 months.

For continuation requests, coverage is allowed only when the patient was not established on Brukinsa via a manufacturer sample or the BeOne myBeOneSupport program; if the patient was established via those means, the request must meet initial therapy requirements as described in the diagnosis‑specific criteria.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Brukinsa (zanubrutinib) requires prior authorization through UnitedHealthcare's step therapy program. Authorization may be issued for up to 12 months. Coverage may be subject to automated verification using prior claims or medication history.

Authorization duration: 12 months
Automated approval may use claims/medication history and ICD-10 diagnosis codes

Step Therapy

Step Therapy Requirement

Step therapy — member must have tried Calquence (acalabrutinib) or Imbruvica (ibrutinib) before Brukinsa is approved, unless an exception applies (see documentation and clinical exceptions below). This requirement applies across labeled indications (MCL, MZL, WM, CLL/SLL) unless the patient meets criteria for contraindication, intolerance, or clinical unsuitability to both agents, or is a continuation of therapy meeting the continuation rules.

Required prior agents: Calquence (acalabrutinib) or Imbruvica (ibrutinib)
Applies to: MCL, MZL, WM, CLL/SLL; other indications reviewed per policy

Documentation Required

Documentation Required to Support Authorization

Required clinical documentation. Providers must submit documentation that supports the diagnosis and demonstrates prior use of Calquence or Imbruvica, or documents a contraindication, intolerance, or clinical reason why both are inappropriate. For continuation requests, documentation must show the member is currently maintained on Brukinsa and must confirm the patient did not become established on therapy solely via manufacturer samples or sponsored patient support programs. If the member was initially established on therapy via free samples or manufacturer support, initial authorization criteria must be met as if the patient is new to therapy.

Acceptable documentation: prior prescription records, clinical notes describing intolerance or contraindication, medication history from claims
Continuation requirement: evidence of current use and no establishment solely via manufacturer sample or BeOne/myBeOneSupport assistance

Denial Risk

Denial Triggers and Risk Factors

Denial triggers. UnitedHealthcare may deny requests that do not meet the step therapy or documentation requirements. Denials may be based on lack of evidence of prior trial of required BTK inhibitors, insufficient documentation of contraindication/intolerance, evidence that therapy was only established via manufacturer samples or patient assistance, or inconsistent/insufficient claim/diagnosis information. Automated processes may also deny when claims/medication history or ICD-10 codes do not support the request.

Denial reasons include: no prior trial of Calquence or Imbruvica, missing documentation of contraindication/intolerance, therapy established only via samples or assistance programs, unsupported diagnosis codes or claims history

Step	Requirement	Coverage status
1	Member must try Calquence (acalabrutinib) or Imbruvica (ibrutinib) prior to Brukinsa (zanubrutinib) unless an exception is met (e.g., contraindication or history of intolerance to one agent, patient not an appropriate candidate for both, or continuation of therapy meeting continuation criteria)	Coverage allowed when requirement met

Coding and Claim Considerations

Billing Rule

Documentation and claim-history guidance for adjudication

When submitting claims and authorization requests, include the applicable diagnosis and supporting documentation; UnitedHealthcare may use claim/medication history and ICD-10 diagnosis codes to adjudicate requests and may apply supply limits or automated approval logic.

Include ICD-10 diagnosis codes corresponding to the covered indication (e.g., MCL, MZL, WM, CLL/SLL) with the PA request and claims.
Attach medication/claim history to demonstrate prior use, intolerance, or contraindication to Calquence or Imbruvica when relying on exceptions.
Document if patient was established on therapy via manufacturer samples or BeOne myBeOneSupport assistance; such patients are treated as new to therapy for initial authorization.

Background and Drug Information

Brukinsa (zanubrutinib) is a Bruton tyrosine kinase (BTK) inhibitor indicated for several B‑cell hematologic malignancies including mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), and chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL); it is also indicated in combination with obinutuzumab for follicular lymphoma after two or more lines of systemic therapy. The policy aligns Brukinsa into a step therapy program that prioritizes use of alternative BTK inhibitors (Calquence [acalabrutinib] or Imbruvica [ibrutinib]) before approving Brukinsa for most adult patients, with defined exceptions for documented contraindication or intolerance, patients who are not appropriate candidates for both alternatives, or certain continuation scenarios.

The program name for patient assistance referenced in this policy is BeOne myBeOneSupport. Members younger than 19 years are processed without coverage review and are auto‑approved under the pediatric provision; standard authorization duration for approved requests is 12 months.

OpenPayer

Step therapy for Brukinsa (zanubrutinib)

Coverage Criteria for Brukinsa (zanubrutinib)

Initial Therapy Rules

Continuation of Therapy

Provider Actions and Requirements

Step Therapy Requirements

Coding and Claim Considerations

Background and Drug Information

Definitions

Policy Revision History