CurrentMass General Brigham Health PlanPolicy N/A

Brukinsa (zanubrutinib) — Coverage and Prior Authorization

Defines prior authorization, coverage criteria, limitations, and specialty pharmacy requirements for zanubrutinib (Brukinsa) under the commercial/exchange pharmacy benefit for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBrukinsa (zanubrutinib) — Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and supply documentation of diagnosis, prior therapies (when required), provider specialty or oncology/hematology consultation, and appropriate dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration

120Quantity limit

≥18Minimum age

Required (some)Prior therapy

Coverage and Medical Necessity Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Mantle Cell Lymphoma (relapsed or refractory)

Covered when ALL of the following are met for Mantle Cell Lymphoma (relapsed or refractory):

MCL Age: 1. The member is ≥ 18 years of age

MCL Indication: 2. The member is using Brukinsa for the treatment of mantle cell lymphoma

MCL Prior Therapy: 3. The member has had 1 prior therapy for mantle cell lymphoma (see appendix)

Appendix lists acceptable prior induction regimens

Provider Specialty: 4. Provider specialty is oncology/hematology, or medication prescribed in consultation with oncologist/hematologist

Dosing: 5. Appropriate dosing

Marginal Zone Lymphoma (relapsed or refractory)

Covered when ALL of the following are met for Marginal Zone Lymphoma (relapsed or refractory):

MZL Age: 1. The member is ≥ 18 years of age

MZL Indication: 2. The member is using Brukinsa for the treatment of relapsed or refractory marginal zone lymphoma

MZL Prior Therapy: 3. The member has had 1 prior therapy with an anti-CD20-based regimen.

Provider Specialty: 4. Provider specialty is oncology/hematology, or medication prescribed in consultation with oncologist/hematologist

Dosing: 5. Appropriate dosing

Waldenström's Macroglobulinemia

Covered when ALL of the following are met for Waldenström's Macroglobulinemia:

WM Age: 1. The member is ≥ 18 years of age

WM Indication: 2. The member is using Brukinsa for the treatment of Waldenström's macroglobulinemia

Provider Specialty: 3. Provider specialty is oncology/hematology, or medication prescribed in consultation with oncologist/hematologist

Dosing: 4. Appropriate dosing

This policy applies to the commercial/exchange pharmacy benefit only. It does not apply to MassHealth UPPL or other non-commercial lines of business. Brukinsa is designated as a specialty medication and must be dispensed by a contracted specialty pharmacy. Prior authorization is required under the commercial/exchange pharmacy benefit.

Initial Authorization Requirements

Initial Therapy

Initial authorization criteria are indication-specific and require age, diagnosis, prior therapy where specified, and oncology/hematology provider involvement:

Initial Indications: See indication-specific criteria for MCL, MZL, and Waldenström's macroglobulinemia

Appendix provides acceptable prior MCL regimens

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Brukinsa (zanubrutinib). This agent is managed under the pharmacy benefit and is designated as a specialty drug; it must be filled at a contracted specialty pharmacy. Prior authorization requests should include the clinical documentation described below and will be reviewed by the plan prior to coverage.

Specialty pharmacy fill required — prescription must be dispensed by a contracted specialty pharmacy.
Pharmacy benefit prior authorization required for commercial/exchange members.

Step Therapy

No step therapy program applies to Brukinsa. There is no requirement to fail an alternative Bruton tyrosine kinase (BTK) inhibitor or other agents before approval of Brukinsa under this policy.

Documentation Required

Required Documentation

Submit the following documentation with the prior authorization request. Incomplete documentation may delay review or result in denial.

Primary diagnosis and relevant ICD-10 code.
Pertinent clinical history including disease stage, symptoms, and baseline disease assessments.
Documentation of prior therapies (dates, agents, responses, and reasons for discontinuation) when applicable.
Current therapy information: if member is already receiving Brukinsa, include start date, current dose, and evidence of clinical benefit for reauthorization.
Provider specialty and credentials (oncologist/hematologist preferred) and contact information.
Pertinent labs, imaging, and physician progress notes supporting medical necessity.

Denial Risk

Documentation and Eligibility — Denial Risk

Requests lacking the required documentation or for members who are not already on therapy (when continuation criteria are claimed) risk denial. Reauthorization requires physician documentation of improvement in the member's condition. Authorization for members new to the plan who are currently receiving Brukinsa may be considered when documentation supports ongoing therapy; samples or manufacturer patient assistance program supplies do not by themselves establish eligibility.

Dispensing and Specialty Pharmacy

Billing Rule

Specialty pharmacy dispensing required

Brukinsa is designated a specialty medication and must be dispensed by a contracted specialty pharmacy per the plan's specialty limitations.

Fill at a contracted specialty pharmacy as specified in the policy.
Contact the pharmacy benefit phone or fax numbers in the policy for specialty fill coordination.

Background and Drug Information

Zanubrutinib (Brukinsa) is a selective, covalent Bruton tyrosine kinase (BTK) inhibitor that binds to BTK’s active site to block B‑cell receptor signaling, reducing malignant B‑cell proliferation and tumor growth. It is used to treat certain B‑cell malignancies, including mantle cell lymphoma, marginal zone lymphoma, and Waldenström’s macroglobulinemia.