CurrentNeighborhood Health Plan of Rhode IslandPolicy 2075-A

Gazyva (obinutuzumab) coverage

Coverage criteria and prior authorization requirements for Gazyva (obinutuzumab) across FDA-approved and compendial hematologic malignancy indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGazyva (obinutuzumab) coverage

Policy CodePolicy 2075-A

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization; submit TP53 mutation documentation when requesting Gazyva for TP53‑mutated mantle cell lymphoma.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth

12–30 monthsreauthorization/maintenance

1 monthglofitamab pre‑treat auth

TP53 mutationrequired biomarker

Coverage Criteria for Gazyva (obinutuzumab)

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Follicular Lymphoma (FL)

Covered when ALL of the following are met for Follicular Lymphoma (FL) depending on line and use:

FL first-line: Gazyva used in combination with CHOP, CVP, or bendamustine as first-line therapy for previously untreated stage II bulky, III, or IV follicular lymphoma, followed by Gazyva monotherapy in patients achieving at least a partial remission

Authorization of 6 months, up to 30 months total; maintenance single-agent allowed

FL subsequent therapy: Gazyva used as single agent or in combination with lenalidomide or bendamustine, or in combination with CHOP or CVP for subsequent therapy in relapsed or refractory FL after a rituximab-containing regimen

Authorization of 6 months, up to 30 months total

FL rituximab substitution: Gazyva used as a substitute for rituximab in members experiencing intolerance or rare complications from rituximab (e.g., severe mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, toxic epidermal necrolysis)

Includes maintenance and substitution scenarios; authorization durations per indication

Marginal Zone and Nodal Marginal Zone Lymphomas

Covered when ANY of the following are met for marginal zone and nodal marginal zone lymphomas:

Extranodal/splenic MZL subsequent or maintenance: Gazyva used as subsequent therapy in combination with bendamustine or lenalidomide for extranodal (MALT) or splenic marginal zone lymphoma, or used as maintenance therapy after prior treatment with Gazyva and bendamustine

Authorization of 6 months for initiation

Nodal MZL first-line or subsequent: Gazyva used as first-line therapy in combination with CHOP, CVP, or bendamustine, or as subsequent therapy with bendamustine or lenalidomide, or as maintenance following prior Gazyva and bendamustine

Authorization of 6 months for initiation

Rituximab substitution - marginal zone: Gazyva used as a substitute for rituximab in members experiencing intolerance or rare complications from rituximab (e.g., severe mucocutaneous reactions)

Includes severe mucocutaneous reactions

Pre-treatment for Glofitamab (Columvi)

Covered when ALL of the following are met for B-cell lymphomas as glofitamab pre-treatment:

Glofitamab pre-treatment: Gazyva used as single-agent pre-treatment for up to 1 dose in cycle 1 of glofitamab (Columvi) therapy for diffuse large B-cell lymphoma, high-grade B-cell lymphomas, histologic transformation of indolent lymphomas to DLBCL, HIV-related B-cell lymphomas, or post-transplant lymphoproliferative disorders1 dose, 1 month authorization

Continuation requires meeting all coverage criteria

Mantle Cell Lymphoma

Covered when ANY of the following are met for Mantle Cell Lymphoma:

MCL TP53 mutated induction: Gazyva used as induction therapy for TP53‑mutated mantle cell lymphoma in combination with venetoclax (Venclexta) and zanubrutinib (Brukinsa)

Documentation of TP53 mutation required

MCL rituximab substitute: Gazyva used as a substitute for rituximab in members experiencing intolerance or rare complications from rituximab (e.g., severe mucocutaneous reactions)

Authorization of 6 months may be granted

Aggressive B-cell Lymphomas - Rituximab substitution

Covered when used as a rituximab substitute in listed aggressive B-cell indications:

Aggressive B-cell substitute: Gazyva may be used as a substitute for rituximab in histologic transformation to DLBCL, DLBCL, high‑grade B‑cell lymphomas, Burkitt lymphoma, HIV‑related B‑cell lymphomas, post‑transplant lymphoproliferative disorders, or Castleman's disease when rituximab intolerance or rare complications are present

Authorization of 6 months may be granted

Covered Regimens and Combinations

Indication	Regimen (Gazyva combination)	Authorization notes
Previously untreated chronic lymphocytic leukemia (CLL)	Gazyva in combination with chlorambucil	Authorization of 6 months may be granted
Relapsed or refractory follicular lymphoma (FL)	Gazyva in combination with bendamustine followed by Gazyva monotherapy	Authorization of 6 months, up to 30 months total
Previously untreated or nodal marginal zone lymphoma (first-line)	Gazyva in combination with CHOP, CVP, or bendamustine	Authorization of 6 months may be granted
Marginal zone lymphoma (subsequent therapy)	Gazyva in combination with bendamustine or lenalidomide; maintenance after prior Gazyva and bendamustine	Authorization of 6 months for initiation; maintenance per criteria
TP53‑mutated mantle cell lymphoma (MCL)	Gazyva in combination with venetoclax (Venclexta) and zanubrutinib (Brukinsa)	Authorization of 6 months may be granted; documentation of TP53 mutation required
Hairy cell leukemia in members unable to tolerate purine analogs	Gazyva in combination with vemurafenib as initial therapy	Authorization of 6 months may be granted

Indication	Regimen / Use	Authorization notes
Diffuse large B‑cell lymphoma (DLBCL) and related high‑grade B‑cell lymphomas	Single‑agent Gazyva as pre‑treatment (up to 1 dose in cycle 1) prior to glofitamab (Columvi) therapy	Authorization of 1 month may be granted; continuation requires meeting all coverage criteria
Histologic transformation of indolent lymphomas to DLBCL	Single‑agent Gazyva as pre‑treatment (up to 1 dose in cycle 1) prior to glofitamab (Columvi) therapy	Authorization of 1 month may be granted; continuation requires meeting all coverage criteria
HIV‑related B‑cell lymphomas	Single‑agent Gazyva as pre‑treatment (up to 1 dose in cycle 1) prior to glofitamab (Columvi) therapy	Authorization of 1 month may be granted; continuation requires meeting all coverage criteria
Post‑transplant lymphoproliferative disorders	Single‑agent Gazyva as pre‑treatment (up to 1 dose in cycle 1) prior to glofitamab (Columvi) therapy	Authorization of 1 month may be granted; continuation requires meeting all coverage criteria

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required; authorization durations vary by indication (commonly 6 months for initiation, special durations for follicular lymphoma up to 30 months, 1 month when used as glofitamab pre-treatment).

Authorization durations: commonly 6 months for initiation; Follicular lymphoma: up to 30 months total (initial authorizations and reauthorization rules apply); Glofitamab pre-treatment: single-agent use for up to 1 dose in cycle 1 — authorization of 1 month.
Prior authorization required for all indications listed in coverage criteria.

Note

Rituximab Substitution Allowed

Gazyva may be used as a substitute for rituximab in members with rituximab intolerance or rare complications (for example: mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis).

Substitution for rituximab applies across multiple covered lymphoma indications when documented intolerance or rare complications are present.
Affected scenarios include substitution in follicular lymphoma, extranodal/nodal/splenic marginal zone lymphoma, nodal marginal zone lymphoma, mantle cell lymphoma, histologic transformation to DLBCL, DLBCL, high-grade B-cell lymphomas, Burkitt lymphoma, HIV-related B-cell lymphomas, and post-transplant lymphoproliferative disorders.

Documentation Required

Required Molecular Documentation

Submit documentation of TP53-mutation when requesting Gazyva for TP53‑mutated mantle cell lymphoma.

Molecular documentation (TP53 mutation) is required to support requests for mantle cell lymphoma treatment when the indication is TP53‑mutated disease.

Denial Risk

Experimental/Investigational Exclusions

All other indications not listed in the coverage criteria are considered experimental/investigational and not medically necessary and are subject to denial.

Compendial and listed lymphoma indications are covered per criteria; any use outside these listed indications will be reviewed as experimental/investigational and may be denied.
Examples of excluded uses: any malignancy or non-malignant condition not enumerated in the policy's coverage sections.

Indication by Line of Therapy

first-line

First-line: Use in combination with CHOP, CVP, or bendamustine as first-line therapy where specified (e.g., FL and nodal MZL)

second-line

Second-line: Use as subsequent therapy in combination with bendamustine or lenalidomide for marginal zone and follicular lymphoma as specified

salvage

Salvage/maintenance: Maintenance single‑agent use and continued treatment (e.g., FL) with possible reauthorization up to 30 months total when no progression or unacceptable toxicity is present

Definitions and Compendial Uses

Compendial uses — covered indications

DefinitionCompendial uses are indications supported by recognized compendia (e.g., NCCN) beyond specific FDA labeling.

Included lymphoma typesChronic lymphocytic leukemia/small lymphocytic lymphoma; follicular lymphoma; marginal zone lymphomas (extranodal, nodal, splenic); mantle cell lymphoma; transformed/ diffuse large B‑cell and high‑grade B‑cell lymphomas; Burkitt lymphoma; HIV‑related B‑cell lymphomas; post‑transplant lymphoproliferative disorders; Castleman's disease; hairy cell leukemia.

Policy implicationUses listed in recognized compendia are covered under the policy even when beyond specific FDA indications, subject to criteria and prior authorization.