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Gazyva (obinutuzumab) — Clinical Coverage Criteria

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Clinical coverage criteria for use of Gazyva (obinutuzumab) across oncology indications and lupus nephritis, specifying indications, required documentation, and coding for Anthem members.

Policy Summary

PayerAnthem

PolicyGazyva (obinutuzumab) — Clinical Coverage Criteria

Policy CodePolicy CC-0121

Change TypeMaterial updates — added lupus nephritisexpanded B‑cell lymphoma indications

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateTBD

Key ActionObtain prior authorization with documentation of indication, diagnosis code(s), and required clinical documentation (eg biopsy-confirmed LN class, UPCR, eGFR) before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

Added indication and criteria for treatment of active lupus nephritis.

Updated NCCN recommendations and expanded list of B-cell lymphoma indications (CLL/SLL, hairy cell, follicular, nodal/splenic/extranodal MZL, mantle cell, Burkitt, Castleman, etc.).

Updated coding: added multiple ICD-10-CM codes and updated HCPCS J9301 inclusion.

Added new indication for the treatment of Lupus Nephritis and administrative updates for age and documentation; ICD-10-CM M32.14 and M32.15 added to coding.

Added multiple hematologic malignancy indications including hairy cell leukemia, Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma, extranodal marginal zone lymphoma of the stomach, and expanded marginal zone lymphoma criteria.

Updated combination therapy guidance to include combinations with venetoclax, ibrutinib, zanubrutinib, and Calquence in specific indications (e.g., CLL, mantle cell, follicular lymphoma).

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ModifiedAnthemPolicy CC-0121

Gazyva (obinutuzumab) — Clinical Coverage Criteria

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Clinical coverage criteria for use of Gazyva (obinutuzumab) across oncology indications and lupus nephritis, specifying indications, required documentation, and coding for Anthem members.

Policy Summary

PayerAnthem

PolicyGazyva (obinutuzumab) — Clinical Coverage Criteria

Policy CodePolicy CC-0121

Change TypeMaterial updates — added lupus nephritisexpanded B‑cell lymphoma indications

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateTBD

Key ActionObtain prior authorization with documentation of indication, diagnosis code(s), and required clinical documentation (eg biopsy-confirmed LN class, UPCR, eGFR) before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

Added indication and criteria for treatment of active lupus nephritis.

Updated NCCN recommendations and expanded list of B-cell lymphoma indications (CLL/SLL, hairy cell, follicular, nodal/splenic/extranodal MZL, mantle cell, Burkitt, Castleman, etc.).

Updated coding: added multiple ICD-10-CM codes and updated HCPCS J9301 inclusion.

Added new indication for the treatment of Lupus Nephritis and administrative updates for age and documentation; ICD-10-CM M32.14 and M32.15 added to coding.

Updated combination therapy guidance to include combinations with venetoclax, ibrutinib, zanubrutinib, and Calquence in specific indications (e.g., CLL, mantle cell, follicular lymphoma).

NCCN 1/2A/2BGuideline levels

oncology+renalMajor therapeutic areas

1New non-oncology indication

severalAdditional malignancy indications

J9301Billing code

Black boxSafety warnings

Coverage Criteria for Gazyva (obinutuzumab)

Approved Indications and Regimen-specific Criteria

Requests for Gazyva (obinutuzumab) for oncology indications may be approved if the following grouped criteria are met (logical OR/AND structure preserved):

Pediatric: Individual is under 19 years of age

Accepts pediatric use as separate approval route

CLL/SLL

CLL regimen options: Individual is using one of: (A) in combination with bendamustine for first-line treatment in individuals without del(17p)/TP53 mutation; OR (B) in combination with chlorambucil for first-line treatment in individuals without del(17p)/TP53 mutation who have significant comorbidity or age >=65; OR (C) in combination with ibrutinib for first-line treatment in individuals without del(17p)/TP53 mutation who have significant comorbidity or age >=65; OR (D) in combination with venetoclax for first-line, second-line, or subsequent treatment regardless of del(17p)/TP53 status; OR (E) in combination with acalabrutinib for first-line treatment with or without del(17p)/TP53 mutation; OR (F) as single agent first-line when covalent BTKi and BCL2i regimens are not available or feasible; OR (G) as single agent for relapsed/refractory disease
Multiple regimen options referenced to labels and NCCN

Hairy cell leukemia: Diagnosis of hairy cell leukemia AND use as initial therapy when unable to tolerate purine analogs with either: (A) single-agent use for incomplete recovery after initial therapy or relapse; OR (B) combination with vemurafenib; OR as single-agent for treatment progression after prior therapy

NCCN 2A

Waldenström Macroglobulinemia: Diagnosis of Waldenström Macroglobulinemia/lymphoplasmacytic lymphoma AND individual is unable to tolerate rituximab and rituximab biosimilars

NCCN 2A — used as rituximab substitute

Follicular lymphoma: Diagnosis of follicular lymphoma AND one of: (A) intolerant to rituximab and using as a substitute; OR (B) single-agent use in second-line or subsequent therapy; OR (C) single-agent maintenance as extended therapy after first-line chemoimmunotherapy or as second-line extended therapy following bendamustine for recurrent disease; OR (D) in combination with CHOP, CVP, bendamustine, zanubrutinib (3rd-line+), or lenalidomide (2nd+)

Label and NCCN 2A/2B references

Nodal, Splenic, Extranodal Marginal Zone Lymphoma: Diagnosis of nodal, splenic, or extranodal marginal zone lymphoma (including gastric and non-gastric noncutaneous) AND either intolerant to rituximab using as a substitute OR using in combination with CHOP, CVP, bendamustine, or lenalidomide as specified for relapsed/refractory disease (including maintenance options)

NCCN 2A

Mantle cell and other B-cell lymphomas: Mantle cell lymphoma (NCCN 2A) and other B-cell lymphomas including high-grade B-cell, HIV-related B-cell lymphomas, post-transplant lymphoproliferative disorders, diffuse large B-cell lymphoma (including histologic transformation), Burkitt lymphoma, and Castleman disease when either used as pretreatment prior to glofitamab-gxbm to mitigate cytokine release syndrome OR used as a substitute when intolerant to rituximab

Includes indications added/expanded per NCCN and policy updates

Lupus nephritis initial therapy: Individual is 18 years of age or older AND diagnosis of active lupus nephritis confirmed by renal biopsy Class III, IV, or V AND urinary protein-to-creatinine ratio (UPCR) >= 1 AND eGFR >= 30 ml/min/1.73m2 AND using in combination with standard therapy (for example, corticosteroids, mycophenolate mofetil)UPCR >=1; eGFR >=30

Label-based REGACY (NCT04221477) criteria

Lupus nephritis continuation therapy: Individual is using in combination with standard therapy AND documentation confirms a therapeutic renal response defined as improvement (or no worsening) of the UPCR compared to baseline OR no decrease in eGFR of more than 15% from baselineno eGFR decrease >15%

Continuation criteria per REGACY trial protocol

Covered Indications (summary)

Policy updated with multiple covered oncology indications, combination regimens, and a new non-oncology indication.

Covered indications: Obinutuzumab is covered for specified B-cell lymphomas and related hematologic malignancies per listed ICD-10 codes and clinical criteria; recently added coverage for lupus nephritis based on NEJM/REGACY trial evidence and label updates.

See full policy sections for indication-specific eligibility, regimen details, and required documentation (including UPCR and eGFR thresholds).

For the treatment of lupus nephritis, Gazyva (obinutuzumab) may not be approved when the individual has an active infection or when it is used in combination with other anti-CD20 agents, cyclophosphamide, tacrolimus, cyclosporine, or voclosporin (Lupkynis).

Requests for Gazyva that do not meet the specific clinical criteria listed in this policy, as well as requests for indications not described in this policy, are not approved.

The policy’s may not approve provisions were updated as part of the recent reviews. Notably, the document lists indication- and situation-specific exclusions (for example, the lupus nephritis exclusions above) and clarifies that uses lacking evidence or not meeting the stated criteria may not be approved.

Failure to meet updated indication-specific requirements or to provide required documentation (for example, biopsy-confirmed Class III/IV/V for lupus nephritis or specified lab thresholds) can trigger non-approval under these updated may not approve conditions.

Use of Gazyva when the specified clinical criteria in this policy are not met is considered not medically necessary and therefore not approved.

For lupus nephritis continuation requests, documentation of therapeutic renal response (for example, improvement or no worsening of UPCR or no decrease in eGFR >15% from baseline) is required; absence of such documentation supports a determination of not medically necessary.

The policy includes may not approve language for certain uses where evidence or guideline support is insufficient or where specific exclusions apply. Examples include denials for indications not supported by the updated criteria and the lupus nephritis combination/exclusion scenarios.

Providers should ensure required supporting documentation (diagnosis, pertinent labs, biopsy reports, and regimen details) accompanies prior authorization requests because failure to supply this information may result in non-approval under these provisions.

Covered Regimens and Combination Therapies

Regimen	Indication / Line of Therapy	Key Criteria	Coverage
Gazyva + bendamustine
CLL/SLL — first-line
Individuals without del(17p)/TP53 mutation; per NCCN (2A) for first-line combination
Covered with criteria (prior authorization required)
Gazyva + chlorambucil
CLL/SLL — first-line (age ≥65 or significant comorbidity)
Individuals without del(17p)/TP53 mutation; used when significant comorbidity or age ≥65 (Label, NCCN 2A)
Covered with criteria (prior authorization required)
Gazyva + ibrutinib
CLL/SLL — first-line (age ≥65 or significant comorbidity)
Individuals without del(17p)/TP53 mutation; combination per ibrutinib label and NCCN (2B)
Covered with criteria (prior authorization required)
Gazyva + venetoclax
CLL/SLL — first-line, second-line, or subsequent
Use in individuals with or without del(17p)/TP53 mutation; indicated for first-line and later lines per NCCN (2A)
Covered with criteria (prior authorization required)
Gazyva + acalabrutinib
CLL/SLL — first-line
Use in individuals with or without del(17p)/TP53 mutation; NCCN 1/2A support for first-line combination
Covered with criteria (prior authorization required)

Regimen	Indication	Regimen Details	Coverage
Gazyva + bendamustine → obinutuzumab maintenance up to 2 years
Follicular lymphoma — relapsed/refractory after rituximab-containing regimen
Induction with obinutuzumab plus bendamustine followed by obinutuzumab maintenance for up to 2 years (GADOLIN evidence referenced)
Covered with criteria (prior authorization required)
Gazyva with CHOP/CVP/bendamustine → obinutuzumab maintenance up to 2 years
Follicular lymphoma — relapsed/refractory after rituximab-containing regimen
Obinutuzumab used in combination with CHOP, CVP, or bendamustine for induction, followed by obinutuzumab maintenance up to 2 years as optional second-line extended therapy
Covered with criteria (prior authorization required)

Regimen	Indication	Key Trial / Criteria	Coverage
Gazyva in combination with standard therapy (e.g., corticosteroids, mycophenolate mofetil)
Active lupus nephritis (Class III, IV, or V) — initial therapy
REGACY / NCT04221477 / NEJM evidence: Adults ≥18 years with renal biopsy‑confirmed Class III, IV, or V; UPCR ≥1; eGFR ≥30 mL/min/1.73 m2; used with standard therapy
Covered with criteria (documentation of biopsy, UPCR, eGFR, and concomitant standard therapy required)

Regimen	Applicable Indications	Notes / Combinations per NCCN	Coverage
Obinutuzumab monotherapy
CLL/SLL and other B‑cell malignancies (when single‑agent use is appropriate)
Single‑agent use allowed when BTKi and BCL2i regimens are not available or not feasible; also for relapsed/refractory disease per NCCN (2A)
Covered with criteria (prior authorization required)
Obinutuzumab + venetoclax
CLL/SLL and selected B‑cell malignancies
Combination supported for first‑line and later lines (venetoclax combinations per NCCN); applicable regardless of del(17p)/TP53 status for venetoclax combos
Covered with criteria (prior authorization required)
Obinutuzumab + ibrutinib (or acalabrutinib/zanubrutinib)
CLL/SLL — first‑line in select patients; other B‑cell malignancies per NCCN
Ibrutinib combination for first‑line in individuals with comorbidity or age ≥65 (NCCN/label); acalabrutinib and zanubrutinib combinations cited in updates and NCCN guidance
Covered with criteria (prior authorization required)
Obinutuzumab + chlorambucil or bendamustine
CLL/SLL or other indolent B‑cell lymphomas where appropriate
Chlorambucil recommended for older/comorbid patients; bendamustine combinations supported by GADOLIN and NCCN as induction options
Covered with criteria (prior authorization required)

Billing and Diagnostic Coding

HCPCSHCPCS

J9301

Injection, obinutuzumab, 10 mg [Gazyva]

ICD-10-CM DiagnosesICD-10

B20	Human immunodeficiency virus [HIV] disease
C82.00-C82.99	Follicular lymphoma
C83.00-C83.09	Small cell B-cell lymphoma
C83.10-C83.19	Mantle cell lymphoma
C85.20-C85.29	Mediastinal (thymic) large B-cell lymphoma
C83.30-C83.38	Diffuse large B-cell lymphoma
C83.398	Diffuse large B-cell lymphoma of other extranodal and solid organ sites
C83.70-C83.79	Burkitt lymphoma
C83.80-C83.89	Other non-follicular lymphoma
C85.10-C85.19	Unspecified B-cell lymphoma

1–10 of 19

1/2

Added ICD-10-CM Codes (select)ICD-10

M32.14	Lupus nephritis
M32.15	Lupus nephritis

ICD-10-CM Codes added/ reviewed in updatesICD-10

C83.10-C83.19	Follicular lymphoma / related
C83.30-C83.38	Other indolent B-cell lymphomas
C83.398	Other lymphoma codes
C83.70-C83.79	Marginal zone lymphoma codes
C83.80-C83.89	Extranodal marginal zone lymphoma codes
C85.10-C85.19	Diffuse large B-cell/other B-cell lymphoma groupings
C85.80-C85.89	Other specified non-Hodgkin lymphomas
C88.00	Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma
C88.40	Castleman disease / related
D47.Z1	Monoclonal gammopathy / related

Urinary protein-to-creatinine ratio (UPCR) — thresholds and notes

UPCR threshold for initial LN treatmentUrinary protein-to-creatinine ratio (UPCR) >= 1 required for initial approval of lupus nephritis treatment

UPCR used in trial outcome definitionsComplete renal response referenced in trials as UPCR < 0.5

Documentation requirementDocumentation of measured UPCR must be provided with initial request (per biopsy-confirmed Class III/IV/V LN)

eGFR — renal function thresholds and trial response criteria

eGFR threshold for initial LN treatmentEstimated glomerular filtration rate (eGFR) >= 30 ml/min/1.73 m2 required for initial approval of lupus nephritis treatment

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — approvals only when indication-specific criteria are met

Prior authorization is required for Gazyva (obinutuzumab); approvals are granted only when the member meets the specific indication-based clinical criteria listed in the policy (diagnosis, regimen/combo requirements, biomarker/age/comorbidity conditions, or documented rituximab intolerance).

Approvals limited to indications and regimen options enumerated (e.g., CLL/SLL regimens, follicular lymphoma uses, hairy cell, mantle cell, marginal zone, and lupus nephritis criteria).
Lupus nephritis initial and continuation criteria must be met for approval (see biopsy, UPCR, eGFR thresholds and combination with standard therapy).

Prior Authorization

Prior authorization documentation — indication, diagnosis code(s), and clinical rationale required

Prior authorization requests must include documentation of the requested indication, the relevant ICD-10 diagnosis code(s), and a clinical rationale linking the member’s condition to the specific policy criteria; coding updates added ICD-10-CM M32.14 and M32.15 for lupus nephritis and expanded lymphoma listings.

Line of Therapy Rules

first-line

First-line CLL: Diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma AND use in combination with one of: bendamustine (first-line for individuals without del(17p)/TP53), chlorambucil (first-line for individuals without del(17p)/TP53 with significant comorbidity or age >=65), ibrutinib (first-line for individuals without del(17p)/TP53 with significant comorbidity or age >=65), acalabrutinib (first-line with or without del(17p)/TP53), or venetoclax (first-line option regardless of del(17p)/TP53 status); OR as single agent first-line when covalent BTKi and BCL2i regimens are not available or feasible.

NCCN 1/2A/2B and labeling referenced; select regimen choice depends on mutation status and comorbidity.

second-line

Second-line and subsequent therapy: Use as single-agent or in combination (for example, with venetoclax) for second-line or subsequent treatment of CLL/SLL; follicular and marginal zone lymphoma criteria also permit single-agent or specified combinations (lenalidomide, bendamustine, CHOP/CVP) in second-line or later settings.

Regimen positioning follows NCCN and label guidance; venetoclax combinations allowed irrespective of del(17p)/TP53 status.

Biomarker and Genetic Testing Requirements

del(17p)/TP53 — definition and clinical relevance

Definitiondel(17p) is a cytogenetic abnormality reflecting loss of the TP53 gene and is associated with poor prognosis and short response to chemotherapy

Clinical relevancePresence/absence of del(17p)/TP53 informs CLL/SLL regimen selection and recommended use of Gazyva (treatment options differ by status)

Testing implicationDel(17p) status should be known when selecting first-line regimens (guidance referenced in NCCN/labeling)

TP53 — testing and relevance to therapy selection

TP53 testing relevanceTP53 (including del(17p)) is referenced for clarity in CLL combination treatment notes and influences regimen choice (e.g., single-agent vs combinations)

Regimen impact

Background and Evidence

Gazyva (obinutuzumab) is an anti-CD20 monoclonal antibody indicated primarily for multiple B‑cell malignancies and, per the recent update, for active lupus nephritis in combination with standard therapy. The agent targets the CD20 surface antigen on B cells and is used as single-agent therapy or in combination regimens across first-line, subsequent-line, and maintenance settings as specified by indication and guideline references.

NCCN references — compendia and guideline summary

Primary compendia citedNCCN Clinical Practice Guidelines in Oncology (B-Cell Lymphomas V1.2026, CLL V2.2026, Hairy Cell Leukemia V2.2026)

NCCN recommendation levels referencedGuideline recommendation levels (1, 2A, 2B) from NCCN are used to support regimen and indication guidance

Use in policy developmentNCCN guidelines are referenced as primary sources for regimen positioning and indication expansions included in the policy

Key trials — pivotal clinical trials cited

Definitions and Terms

Del (17p) mutation — definition and clinical relevance

DefinitionDel (17p) mutation: cytogenetic loss of TP53 often with mutation of remaining allele; associated with short treatment-free interval, short median survival, and poor chemotherapy response

Clinical impactServes as a prognostic marker and affects selection of therapy in B-cell malignancies (notably CLL/SLL)

Testing noteDel(17p) status should be identified as part of disease workup per policy guidance when relevant to regimen choice

Line of Therapy — definitions and policy-specific examples

First-line therapy definitionFirst-line therapy is the initial or primary treatment for the diagnosis; examples include combinations with bendamustine, chlorambucil, acalabrutinib, ibrutinib, or venetoclax with Gazyva per indication

Second-line/third-line

Revision History and Policy Changes

2026-02-20Annual review / wording and coding updatesLatest

Annual review updated wording and formatting, aligned criteria with NCCN 1 and 2A recommendations, expanded B‑cell lymphoma indications, clarified 'may not be approved' language for lupus nephritis, and added ICD-10-CM codes B20, C85.20-C85.29, D47.Z2.

2025-12-08Select review / new indication added

Select review added a new indication for the treatment of lupus nephritis with administrative updates for age and documentation; ICD-10-CM M32.14 and M32.15 were added to coding.

Policy Summary

PayerAnthem

PolicyGazyva (obinutuzumab) — Clinical Coverage Criteria

Policy CodePolicy CC-0121

Change TypeMaterial updates — added lupus nephritisexpanded B‑cell lymphoma indications

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateTBD

Key ActionObtain prior authorization with documentation of indication, diagnosis code(s), and required clinical documentation (eg biopsy-confirmed LN class, UPCR, eGFR) before initiating therapy.

SourceLink

On This Page

Trial-based response requirement (REGACY)REGACY trial defined complete renal response requirement including eGFR >= 85% of baseline

Documentation requirementProvide current eGFR value with initial request (in addition to biopsy and UPCR)

Continuation therapy renal response — UPCR/eGFR improvement or no worsening

Continuation therapy renal response criterionDocumentation of therapeutic renal response required for continuation (improvement or no worsening of UPCR compared to baseline)

eGFR stability criterion for continuationNo decrease in eGFR of more than 15% from baseline for continuation approval

Combination therapy requirementContinuation requests must show ongoing use in combination with standard therapy (eg corticosteroids, mycophenolate mofetil)

Include the exact diagnosis (for example, CLL/SLL, follicular lymphoma, or lupus nephritis) and the ICD-10-CM code that corresponds to the policy-listed codes.
Provide clinical rationale that demonstrates the member meets regimen- or biomarker-specific requirements (e.g., del(17p)/TP53 status, age/comorbidity criteria, or rituximab intolerance).

Step Therapy

Document rituximab intolerance or sequencing rationale

When approval is based on rituximab intolerance or sequencing, the provider must document the intolerance or the clinical rationale for using obinutuzumab instead of rituximab (for example, intolerance to rituximab or inability to use BTKi/BCL2i regimens when single-agent use is claimed).

Rituximab intolerance is an eligibility pathway across multiple lymphoma subtypes (e.g., follicular, marginal zone, mantle cell, Waldenström, hairy cell).
Document prior therapies and the specific intolerance or contraindication to rituximab/biosimilars.

Note

Combination/sequence therapy — follow indication-specific combination and NCCN guidance

Follow the policy guidance on combination and sequence regimens: obinutuzumab may be used with agents such as venetoclax, ibrutinib, zanubrutinib, and acalabrutinib per the indication-specific regimens and NCCN/label recommendations.

CLL regimens include combinations with bendamustine, chlorambucil, ibrutinib, venetoclax, and acalabrutinib depending on del(17p)/TP53 status, age, and comorbidity.
Policy lists combinations with venetoclax and zanubrutinib for TP53-mutated disease and cites use as pretreatment prior to glofitamab-gxbm to mitigate CRS.
Follicular and marginal zone lymphoma combinations include CHOP, CVP, bendamustine, zanubrutinib (later-line), and lenalidomide as specified.

Documentation Required

Required clinical documentation — biopsy class, UPCR, eGFR, and prior/concomitant therapy

For lupus nephritis and other indications, include required clinical documentation: biopsy-confirmed Class III, IV, or V lupus nephritis, urinary protein-to-creatinine ratio (UPCR), eGFR, and history of prior therapies or concomitant standard therapy.

Initial LN requests must document renal biopsy class (III, IV, or V), UPCR ≥ 1, eGFR ≥ 30 ml/min/1.73 m2, and concurrent use with standard therapy (e.g., corticosteroids, mycophenolate mofetil).
Continuation LN requests must document therapeutic renal response (improvement or no worsening of UPCR vs baseline or no eGFR decrease >15% from baseline).

Documentation Required

Documentation must support diagnosis and indication — include new LN and expanded lymphoma listings

Documentation must support the specific diagnosis and indication listed in the policy, including newly added lupus nephritis and expanded lymphoma subtypes; include member age and any administrative details referenced in recent updates.

For newly added LN indication, include age ≥18 and evidence meeting REGACY/label criteria as described.
For expanded lymphoma listings, provide the exact subtype and supporting clinical notes consistent with policy ICD-10-CM codes.

Denial Risk

Denial risk — requests may be denied when criteria or documentation are not met

Requests that do not meet the policy’s listed clinical criteria or lack the required documentation may be denied or not approved per the policy.

Noncompliance with indication-specific thresholds (e.g., UPCR, eGFR, biopsy class) or missing proof of rituximab intolerance/prior therapies are grounds for denial.
Requests for unlisted indications are not approved.

Denial Risk

Lupus nephritis exclusions — active infection or concurrent anti‑CD20/other listed agents excludes approval

For lupus nephritis, approval is excluded if the individual has an active infection or if obinutuzumab is being used concurrently with other anti‑CD20 agents, cyclophosphamide, tacrolimus, cyclosporine, or voclosporin (Lupkynis).

Do not submit requests claiming concurrent use with other anti‑CD20 agents or the listed immunosuppressants; these scenarios are specifically not approved.

Denial Risk

Denial triggers — unmet updated indication criteria or documentation/coding gaps

Failure to meet updated indication-specific criteria (including new lupus nephritis criteria or expanded lymphoma indications) or to provide the required clinical documentation and coding updates may result in non‑approval.

Include required ICD-10-CM codes added in the update (e.g., M32.14, M32.15) and evidence that the member meets the revised clinical thresholds.
Missing or insufficient documentation for new or expanded indications is a documented denial trigger.

first-line (alternate listing)

First-line (additional indications): Policy includes first-line regimen guidance beyond CLL: acalabrutinib combination for first-line CLL (with or without del(17p)/TP53) and first-line use in select B-cell lymphoma subtypes per NCCN when specified; refer to indication-specific sections for details.

Document history and NCCN references support expanded first-line listings.

NCCN and labeling recommend different Gazyva combinations depending on TP53/del(17p) status (e.g., chlorambucil/bendamustine combinations for those without del(17p))

DocumentationPolicy references TP53/del(17p) when documenting eligibility for specific CLL regimens; include mutation status in prior authorization documentation when applicable

GADOLIN (obinutuzumab plus bendamustine induction and obinutuzumab maintenance) — J Clin Oncol 2018 supporting use in rituximab-refractory indolent NHL

NEJM lupus nephritis trial (REGACY / NCT04221477)Furie RA et al., N Engl J Med 2025: Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis

iLLUMINATEiLLUMINATE: Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line CLL (Lancet Oncol) cited for combination regimens

Second-line therapy is used after progression on first-line; third-line after progression on first- and second-line — policy specifies single-agent or combination uses in these settings

Maintenance therapyMaintenance therapy is intended to maintain response and prevent relapse (policy lists up to 2 years of obinutuzumab monotherapy maintenance after induction in follicular lymphoma)

Annual review / expanded malignancy indications

Annual review added hairy cell leukemia, Waldenström macroglobulinemia/lymphoplasmacytic lymphoma, expanded follicular and marginal zone lymphoma criteria, and updated coding with multiple ICD-10-CM codes (C83.10-C83.19, C83.30-C83.38, C83.398, C83.70-C83.79, C83.80-C83.89, C85.10-C85.19, C85.80-C85.89, C88.00, C88.40, D47.Z1).

2024-08-16Select review / regimen update

Select review added mantle cell lymphoma in combination with venetoclax and updated 'may not approve' criteria (no coding changes).

2024-03-11Select review / regimen formatting and additions

Select review added zanubrutinib combination in follicular lymphoma and reformatted 24‑month maintenance use (no coding changes).

2024-02-23Annual review / marginal zone criteria added

Annual review added criteria for marginal zone lymphomas (no coding changes).

2023-02-24Annual review / hairy cell leukemia added

Annual review added a hairy cell leukemia indication and updated coding to include ICD-10-CM C91.40-C91.42.

2022-02-25Annual review / wording and formatting

Annual review made wording and formatting changes (no coding changes).

2021-02-19Annual review

Annual review documented with no changes to clinical criteria or coding.

2020-11-20Select review / regimen update

Select review updated chlorambucil combination with NCCN details and added combination use with ibrutinib (no coding changes).

2020-02-21Annual review / combination therapy updates

Annual review updated combination treatment guidance to include venetoclax and added combination use with acalabrutinib (Calquence) per labeling and NCCN; added TP53 reference for clarity (no coding changes).

2019-06-10Select review / venetoclax combination added

Select review added combination treatment with venetoclax for CLL based on venetoclax labeling and NCCN recommendations (no coding changes).

2019-05-17Annual review / initial policy review

First review of Gazyva clinical criteria with minor wording and formatting changes and addition of references (no coding changes).

Revision summary: This policy was revised 02/20/2026 with material changes including addition of an indication for treatment of lupus nephritis (select review 12/08/2025) and multiple updates expanding covered hematologic malignancy indications and combination regimens. Administrative updates include documentation and age specifications; ICD-10-CM codes M32.14 and M32.15 were added.