CurrentNeighborhood Health Plan of Rhode IslandPolicy 2075-A

Obinutuzumab (Gazyva) — Coverage Criteria for Hematologic Malignancies

Defines prior authorization, coverage criteria, and authorization durations for obinutuzumab (Gazyva) for FDA-approved and compendial hematologic malignancy indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyObinutuzumab (Gazyva) coverage for B‑cell malignancies

Policy CodePolicy 2075-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; typical initial authorizations are 6 months (1 month for glofitamab pre-treatment; up to 30 months total for follicular lymphoma).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial auth (many indications)

up to 30 monthsMax FL total

1 monthGlofitamab pre-treatment

TP53Required biomarker doc

Coverage Criteria for obinutuzumab (Gazyva)

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Follicular Lymphoma - Covered scenarios

Follicular Lymphoma (FL) - initial, subsequent, maintenance

FL covered uses: Use in combination with CHOP, CVP, or bendamustine as first-line; single agent or in combination with lenalidomide, bendamustine, CHOP or CVP for subsequent therapy; use as maintenance monotherapy; substitute for rituximab in rituximab-intolerant patients; combination with zanubrutinib as third-line+ therapy.

Authorization 6 months for initial therapy; continued treatment authorization up to 12 months per reauthorization and up to 30 months total.

Marginal Zone Lymphomas - Covered scenarios

Marginal Zone Lymphomas (extranodal, nodal, splenic)

Extranodal/splenic MZL: Subsequent therapy in combination with bendamustine or lenalidomide; maintenance when previously treated with obinutuzumab and bendamustine; substitute for rituximab in rituximab-intolerant patients.

Authorization of 6 months may be granted.

Nodal MZL: First-line in combination with CHOP, CVP, or bendamustine; subsequent therapy with bendamustine or lenalidomide; maintenance if previously treated with obinutuzumab and bendamustine; substitute for rituximab in rituximab-intolerant patients.

Authorization of 6 months may be granted.

Obinutuzumab as glofitamab pre-treatment

Pre-treatment for glofitamab (Columvi)

Glofitamab pre-treatment: Authorization of 1 month may be granted for obinutuzumab as single-agent pre-treatment for up to 1 dose in cycle 1 of glofitamab therapy for listed B-cell malignancies (mantle cell lymphoma, DLBCL, high-grade B-cell lymphomas, histologic transformation of indolent lymphomas to DLBCL, HIV-related B-cell lymphomas, and post-transplant lymphoproliferative disorders).

Applies only when used as single-agent pre-treatment for glofitamab.

High-grade B-cell and other compendial indications

Aggressive B-cell lymphomas and other listed high-grade indications

High-grade and other B-cell lymphomas: Covered compendial uses include mantle cell lymphoma, diffuse large B-cell lymphoma, high-grade B-cell lymphomas (including double/triple hit), Burkitt lymphoma, HIV-related B-cell lymphomas, post-transplant lymphoproliferative disorders, Castleman's disease, and histologic transformation of indolent lymphomas to DLBCL.

Obinutuzumab may be used as a substitute for rituximab in rituximab-intolerant members for these conditions; mantle cell lymphoma induction for TP53-mutated disease may be authorized in combination with venetoclax and zanubrutinib.

Continuation / Reauthorization criteria

Reauthorization / continuation

Reauthorization: For continuation requests, authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen (specific maximum durations noted for follicular lymphoma: authorization up to 12 months per reauthorization and up to 30 months total).

All members requesting continuation for glofitamab pre-treatment must meet all coverage criteria.

Regimen / Combination	Indication / Use Case	Authorization notes
Chlorambucil + obinutuzumab
Chlorambucil + obinutuzumab
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + obinutuzumab
CVP (cyclophosphamide, vincristine, prednisone) + obinutuzumab
Bendamustine + obinutuzumab
Lenalidomide + obinutuzumab
Zanubrutinib + obinutuzumab (third-line and subsequent therapy for follicular lymphoma; also used with venetoclax for TP53‑mutated mantle cell lymphoma)
Vemurafenib + obinutuzumab (hairy cell leukemia for patients unable to tolerate purine analogs)
Venetoclax + zanubrutinib + obinutuzumab (induction for TP53‑mutated mantle cell lymphoma)
Obinutuzumab single‑dose pre‑treatment (one dose in cycle 1) prior to glofitamab (Columvi)

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests. Typical initial authorizations are commonly for 6 months; specific indications may have shorter (e.g., 1 month pre‑treatment for glofitamab) or longer (up to 30 months total for follicular lymphoma maintenance) authorization periods as outlined in the coverage criteria. Reauthorizations for listed indications may be granted for 12 months when there is no evidence of unacceptable toxicity or disease progression.

Typical initial authorization: 6 months for most indications
Glofitamab pre‑treatment: authorization of 1 month for up to 1 dose in cycle 1
Follicular lymphoma initial: 6 months, up to 30 months total; reauthorization: 12 months when stable

Note

Rituximab Substitution Allowed for Intolerance/Rare Complications

The requested medication may be used as a substitute for rituximab when a member has documented intolerance or rare, serious complications from rituximab (for example mucocutaneous reactions such as paraneoplastic pemphigus, Stevens‑Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, or toxic epidermal necrolysis).

Substitution allowed for follicular lymphoma, extranodal/nodal/splenic marginal zone lymphoma, mantle cell lymphoma, histologic transformation/other listed B‑cell lymphomas

Documentation Required

Documentation of TP53 Mutation Required

Submit documentation of TP53‑mutation when requesting therapy for TP53‑mutated CLL/SLL or for mantle cell lymphoma where TP53 mutation status is relevant to the requested regimen. This documentation is required to initiate prior authorization review for those indications.

TP53 mutation report or pathology/genetic testing results must be provided with the request

Denial Risk

Non‑covered Indications — Denial Risk

Requests for indications not listed in the coverage criteria are considered experimental/investigational and will be denied as not medically necessary.

All uses not explicitly listed in the policy's covered indications are non‑covered

Line of Therapy (First-line, Second-line, Salvage)

first-line | second-line | salvage

Classify the requested use by line of therapy

Line-specific uses: First-line: CLL in combination with chlorambucil; FL first-line with CHOP/CVP/bendamustine; Nodal MZL first-line with CHOP/CVP/bendamustine. Subsequent lines: FL, MZL, and other indications when used with bendamustine, lenalidomide, or other listed regimens; third-line+ FL option with zanubrutinib. Salvage/other: as listed in compendial indications and when used as rituximab substitute for intolerance.

Use line classification to determine initial authorization duration (typically 6 months for initial therapy).

Biomarker and Genetic Testing Requirements

TP53 / del(17p) documentation requirements

When requiredSubmit documentation of the presence of TP53‑mutation for TP53‑mutated CLL/SLL and for mantle cell lymphoma when TP53‑mutated disease is treated as induction in combination with venetoclax and zanubrutinib.

Clinical contextRequired when obinutuzumab is used in combination with high‑dose methylprednisolone for CLL/SLL with del(17p)/TP53 mutation (first‑line or relapsed/refractory).

Authorization relevanceAuthorization of 6 months may be granted for CLL/SLL treatments including when del(17p)/TP53 mutation is present and treated with appropriate combinations.

ScopeDocumentation applies to prior authorization review and must be submitted to initiate review for TP53‑mutated indications.

Related regimensTP53 documentation is specifically mentioned for use with venetoclax and zanubrutinib in mantle cell lymphoma induction and with high‑dose methylprednisolone in CLL/SLL with del(17p)/TP53 mutation.

Definitions and Drug Information

Gazyva (obinutuzumab) — definition and indications

Generic and brand nameGazyva (obinutuzumab) — monoclonal anti‑CD20 antibody (brand and generic listed).

Mechanism of actionAnti‑CD20 monoclonal antibody targeting B‑cell CD20 antigen to mediate B‑cell depletion.

FDA‑approved indications (examples)Indicated for previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil; indicated for follicular lymphoma in combination with bendamustine followed by maintenance monotherapy and with chemotherapy for previously untreated bulky/stage II–IV disease.

Compendial and additional usesAlso used in mantle cell lymphoma (including as a rituximab substitute for rituximab‑intolerant patients) and across multiple high‑grade B‑cell and other compendial indications per policy.

Role in combination regimensUsed with chlorambucil (CLL), bendamustine ± maintenance (FL), with chemotherapy (CHOP/CVP) for FL and nodal MZL, and as pre‑treatment for glofitamab in select B‑cell malignancies.

Authorized Regimens and Combination Therapies

Regimen / Combination	Indication / Use Case	Authorization notes
Chlorambucil + obinutuzumab
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + obinutuzumab
CVP (cyclophosphamide, vincristine, prednisone) + obinutuzumab
Bendamustine + obinutuzumab
Lenalidomide + obinutuzumab
Zanubrutinib + obinutuzumab (third-line+ for follicular lymphoma; also as part of TP53‑mutated mantle cell lymphoma induction in combination with venetoclax)
Vemurafenib + obinutuzumab (hairy cell leukemia in patients intolerant of purine analogs)
Venetoclax + zanubrutinib + obinutuzumab (induction for TP53‑mutated mantle cell lymphoma)
Obinutuzumab single‑dose pre‑treatment (one dose in cycle 1) prior to glofitamab (authorization up to 1 month)

Background and Clinical Context

Obinutuzumab (Gazyva) is a monoclonal anti‑CD20 antibody used to target B‑cell malignancies. It is indicated for multiple B‑cell neoplasms listed in the compendial uses, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma, marginal zone lymphomas (extranodal, nodal, splenic), mantle cell lymphoma, diffuse large B‑cell lymphoma, high‑grade B‑cell lymphomas, Burkitt lymphoma, HIV‑related B‑cell lymphomas, post‑transplant lymphoproliferative disorders, Castleman’s disease, and hairy cell leukemia. Per the policy, treatment outside these FDA‑approved or compendial indications is not supported.

Policy Revision History

2025document_copyright

2025-07package_insert_reference

Gazyva (obinutuzumab) package insert dated July 2022 is cited as a reference supporting indications and usage statements in the policy.

2025authorization_durations_addedLatest

Authorization durations clarified: typical initial authorizations of 6 months for many indications, 1-month authorization for glofitamab pre-treatment, and up to 30 months total for follicular lymphoma maintenance/continuation.