CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Brukinsa (zanubrutinib) — coverage criteria

Defines accepted indications, limits, and documentation standards for authorization of zanubrutinib (Brukinsa) for members across applicable lines of business; applies to network providers submitting medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBrukinsa (zanubrutinib) — coverage criteria

Policy CodePolicy N/A

Change TypeAdded indication(s)template conversion

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with supporting FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or qualifying peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1377 Brukinsa guideline.

Added a new indication (unspecified) during the March 2025 update.

Added follicular lymphoma indication to include use with obinutuzumab in April 2024.

J8999billing code listed for zanubrutinib

320 mgsingle dose maximum allowed

120 caps/momonthly quantity limit

Commercial; Exchange; Medicaid

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.

Coverage Criteria for Zanubrutinib (Brukinsa)

B-Cell Lymphomas (Mantle Cell Lymphoma, Nodal/Extranodal/Splenic Marginal Zone Lymphoma)

Covered when ALL of the following are met:

ALL of the following

The member has mantle cell lymphoma or nodal/extra-nodal/splenic marginal zone lymphoma.
Brukinsa (zanubrutinib) will be used as monotherapy.
Disease progression on at least one prior treatment, including an anti-CD20 agent (e.g., rituximab/rituximab biosimilar).

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

Covered when ANY of the following (per CLL/SLL indications):

ANY of the following

Brukinsa (zanubrutinib) may be used as monotherapy in adult members with CLL/SLL for initial or subsequent line therapy.
Brukinsa (zanubrutinib) may be used in combination with Tevimbra (tislelizumab-jsgr) in adult members with CLL/SLL for the histologic (Richter) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status).
Members must have the del(17p)/TP53 mutation OR be chemotherapy refractory or unable to receive chemoimmunotherapy.

Follicular Lymphoma (FL)

Covered when ALL of the following are met:

ALL of the following

Brukinsa (zanubrutinib) may be used with Gazyva (obinutuzumab).
Member has relapsed or refractory follicular lymphoma.
Member has failed on two or more lines of systemic therapy.

Waldenström's Macroglobulinemia (WM)

Covered when ALL of the following are met:

ALL of the following

The member has a diagnosis of Waldenström's Macroglobulinemia (WM).
Brukinsa (zanubrutinib) will be used as monotherapy.
Use may be for initial therapy or therapy for relapsed disease.

EXCLUSION CRITERIA:

- Brukinsa (zanubrutinib) is not covered when used after disease progression with the same regimen or after prior disease progression on a BTK inhibitor (e.g., ibrutinib, acalabrutinib).

- Dosing exceeds the single dose limit of Brukinsa (zanubrutinib) 320 mg.

- Treatment exceeds the maximum limit of 120 (80 mg) capsules per month.

- Investigational use of Brukinsa (zanubrutinib) for off‑label indications that lack sufficient evidence or are not generally accepted by the medical community. Sufficient evidence is defined by CMS‑recognized compendia or acceptable peer‑reviewed literature. Considerations for sufficient evidence include: whether the patient and cancer characteristics are adequately represented in the published evidence; whether the administered oncologic regimen is adequately represented; whether reported study outcomes are clinically meaningful (e.g., ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefit ≥ 3 months for OS/PFS); whether the experimental design is appropriate for the question under study; and the strength of study design (randomized trials preferred, nonrandomized trials with substantial subjects may be supportive, while case reports and abstracts without full articles lack adequate support).

Billing and Quantity Limits

Drug HCPCS CodeHCPCS

J8999

zanubrutinib

inv-08: Single dose limit — <= 320 mg

Single dose maximum320 mg per single dose

Source policy limit typeSingle dose limit (documented in Exclusion Criteria)

Consequence of exceedingDosing above 320 mg may trigger denial as excluded use

inv-09: Monthly capsule limit — <= 120 capsules per month (80 mg strength)

Monthly capsule maximum120 capsules per month (80 mg strength)

Equivalent maximum monthly doseUp to 9,600 mg/month if using 80 mg capsules (120 x 80 mg)

Consequence of exceeding

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization and continuation rules: Prior authorization is required for Brukinsa (zanubrutinib) requests and must be submitted to Evolent for processing. Continuation requests for a medication that would otherwise be not approvable are exempt from this policy when ALL of the following are true: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required through Evolent for all medication requests.
Continuation exemption applies when no progression, <30-day lapse from prior authorization within past year, and no new medications added.

Documentation Required

Documentation Requirements

Required supporting documentation: All requests must be supported by one or more of the following sources: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the evidence standards described in the policy (see exclusion criteria for adequacy of evidence).

Key Definitions

inv-15: Monotherapy — Use of Brukinsa alone without combination anti‑neoplastic agents in the specified indications.

DefinitionUse of Brukinsa (zanubrutinib) alone without combination anti-neoplastic agents in the specified indications (e.g., mantle cell lymphoma, marginal zone lymphoma, Waldenström's macroglobulinemia)

Allowed indications as monotherapyMantle cell lymphoma; nodal/extranodal/splenic marginal zone lymphoma; Waldenström's macroglobulinemia; CLL/SLL (initial or subsequent line)

Restriction noteFor some B-cell lymphomas (MCL/MZL), monotherapy coverage requires disease progression on at least one prior treatment including an anti-CD20 agent

inv-16: Continuation request — Conditions for exemption from re‑review (no progression, lapse <=30 days, no new drugs).

Continuation exemption conditionsNo disease progression on the requested medication

Timing requirement

Line-of-Therapy Rules

inv-17: mixed — line-of-therapy branching and requirements

CLL/SLL initial or subsequent: Brukinsa (zanubrutinib) may be used as initial or subsequent line therapy for adult CLL/SLL patients (monotherapy)

MCL/MZL prior therapy required: Used as monotherapy after disease progression on at least one prior treatment including an anti-CD20 agent for mantle cell lymphoma or nodal/extranodal/splenic marginal zone lymphoma

Prior progression on ≥1 prior therapy including an anti-CD20 agent (e.g., rituximab) is required

FL relapsed/refractory: Use with Gazyva (obinutuzumab) for relapsed or refractory follicular lymphoma after failure of two or more systemic therapies

Requires failure of ≥2 prior systemic therapies

WM initial or relapsed:

Biomarker and Genetic Test Requirements

inv-18: del(17p)/TP53 — biomarker requirement entry.

Required biomarkerdel(17p)/TP53 mutation

Context of requirementRequired for combination use of zanubrutinib with tislelizumab (Tevimbra) for Richter transformation to DLBCL

Alternative qualifiersIf del(17p)/TP53 present OR patient is chemotherapy refractory or unable to receive chemoimmunotherapy, combination may be covered

Background on Zanubrutinib

Zanubrutinib (Brukinsa) is an oral Bruton tyrosine kinase (BTK) inhibitor indicated for multiple B‑cell malignancies. Within this policy it is recognized for use as monotherapy in mantle cell lymphoma, nodal/extra‑nodal/splenic marginal zone lymphoma, and Waldenström's macroglobulinemia; for chronic lymphocytic leukemia/small lymphocytic lymphoma as initial or subsequent line therapy; and in specific combination regimens for follicular lymphoma (with obinutuzumab) and Richter transformation (with tislelizumab) per the documented criteria. Coverage is aligned with FDA labeling and accepted oncology compendia and requires supporting evidence consistent with those sources.

Policy Revision History

2025-03template_conversion_and_new_indicationLatest

Converted to the new Evolent guideline template, replaced prior UM ONC_1377 Brukinsa guideline, and added a new indication.

2024-04added_indication

Added follicular lymphoma indication to include use of zanubrutinib with obinutuzumab (Gazyva).