CurrentNeighborhood Health Plan of Rhode IslandPolicy 3411-A

Zanubrutinib (Brukinsa) coverage criteria

Defines prior authorization criteria and coverage conditions for zanubrutinib (Brukinsa) for specified hematologic malignancies when approval criteria are met; applies to Neighborhood Health Plan of Rhode Island members receiving the drug.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZanubrutinib (Brukinsa) coverage criteria

Policy CodePolicy 3411-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (including TP53 test results when applicable) to request up to 12 months of authorization when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Authorization duration for initial and continuation approvals

5+FDA-approved indications listed

MultipleCompendial (off-label) hematologic indications considered

Zanubrutinib (Brukinsa) — Coverage Criteria

General coverage statement

Indications listed below (FDA-approved and compendial) are covered when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

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FDA-approved indications — criteria trees by diagnosis

Authorization of 12 months may be granted when the corresponding criteria are met for each indication.

Mantle cell lymphoma (MCL)

Used for adult patients with MCL who have received at least one prior therapy.
ALL of the following
- TRIANGLE regimen defined as alternating R-CHOP + Brukinsa/R-DHAP + platinum (carboplatin, cisplatin, or oxaliplatin) regimen.
- Test results confirming TP53 mutation (documentation required).
Used in combination with venetoclax (Venclexta) and obinutuzumab (Gazyva) as induction therapy for TP53 mutated disease.
Used in combination with rituximab for pre-induction therapy or maintenance therapy.

Waldenstrom macroglobulinemia (WM)

Used for treatment of Waldenstrom's macroglobulinemia as a single agent.

Marginal zone lymphoma (MZL)

Relapsed or refractory marginal zone lymphoma (including gastric MALT, non-gastric MALT, nodal MZL, and splenic MZL) who have received at least one anti-CD20-based regimen (e.g., rituximab or obinutuzumab).
Authorization of 12 months may be granted when criteria are met.

Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL)

Used as a single agent for CLL/SLL (authorization of 12 months may be granted).
Authorization may be granted for histologic (Richter) transformation to diffuse large B-cell lymphoma in combination with tislelizumab.

Relapsed or refractory follicular lymphoma

Used in combination with obinutuzumab (Gazyva) after two or more lines of systemic therapy (third-line and subsequent therapy).

Hairy cell leukemia

ALL of the following
- Member had disease progression after receiving therapy for relapsed or refractory disease.
- Requested medication will be used as a single agent.

Compendial uses (considered covered when criteria met)

Compendial indications accepted per policy (authorization of 12 months may be granted when criteria met).

ANY of the following

Mantle cell lymphoma (compendial mention separate from FDA)
Chronic lymphocytic leukemia / Small lymphocytic lymphoma
Gastric and non-gastric MALT lymphoma (extranodal marginal zone lymphoma)
Nodal marginal zone lymphoma
Splenic marginal zone lymphoma
Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma / Bing-Neel Syndrome
Hairy cell leukemia
Follicular lymphoma

Continuation of therapy / Reauthorization

Authorization of 12 months may be granted for continued treatment when reauthorization is requested and criteria are met.

ALL of the following

Indication is listed in the coverage criteria section.
There is no evidence of unacceptable toxicity while on current regimen.
There is no evidence of disease progression while on current regimen.

Authorization Duration and Reauthorization

This policy defines prior authorization criteria and coverage conditions for zanubrutinib (Brukinsa) for specified hematologic malignancies for Neighborhood Health Plan of Rhode Island members. Authorization of 12 months may be granted for initial treatment when the corresponding criteria are met for each indication and the member has no exclusions to the prescribed therapy. Indications listed below (FDA-approved and compendial) are covered when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

For continuation of therapy, authorization of 12 months may be granted when the reauthorization request meets criteria: the indication is listed in the coverage criteria section, there is no evidence of unacceptable toxicity on the current regimen, and there is no evidence of disease progression while on the current regimen.

Prior Authorizations and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for zanubrutinib (Brukinsa); authorization may be granted for up to 12 months when the applicable clinical criteria for the requested indication are met.

Documentation Required

TP53 mutation testing when applicable

When the request is for TP53‑mutated disease (for example, MCL induction as part of the TRIANGLE regimen or induction with venetoclax plus obinutuzumab), submit test results confirming the TP53 mutation with the prior authorization request.

Documentation Required

Evidence of prior therapies

Provide documentation of prior lines of therapy when required by the specific indication (examples include at least one prior therapy for MCL, at least one anti‑CD20–based regimen for marginal zone lymphoma, and two or more prior systemic therapies for follicular lymphoma).

Clinical Background

Zanubrutinib (Brukinsa) is a Bruton's tyrosine kinase (BTK) inhibitor indicated for multiple B‑cell malignancies. The agent is listed in this policy to align FDA‑approved indications with select compendial uses and to define coverage criteria for use in these hematologic conditions.

FDA‑approved indications include treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, Waldenstrom's macroglobulinemia (WM), relapsed or refractory marginal zone lymphoma (MZL) after at least one anti‑CD20 regimen, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed or refractory follicular lymphoma in combination with obinutuzumab after two or more lines of systemic therapy.

This policy also references specific regimens and combinations that may be required or considered for certain uses: the TRIANGLE regimen (alternating R‑CHOP + Brukinsa/R‑DHAP + platinum [carboplatin, cisplatin, or oxaliplatin]) for induction in TP53‑mutated MCL; combinations with rituximab for pre‑induction or maintenance; and combinations with venetoclax and obinutuzumab for induction in TP53‑mutated disease. When requests are for indications dependent on mutation status (e.g., TP53‑mutated MCL) or specific regimen components, submission of test results confirming TP53 mutation and documentation of prior lines of therapy are required per the policy.

Defined Terms

Definition: TRIANGLE regimen

TermTRIANGLE regimen

DefinitionAlternating R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) + Brukinsa/R-DHAP (rituximab, dexamethasone, cytarabine) + platinum (carboplatin, cisplatin, or oxaliplatin) regimen used for induction in TP53‑mutated mantle cell lymphoma.

Components (examples)R-CHOP; Brukinsa/R-DHAP; platinum agent (carboplatin, cisplatin, or oxaliplatin)

Indication contextUsed as a component of induction therapy for mantle cell lymphoma with documented TP53 mutation.