CurrentUnitedHealthcarePolicy CSOH2026D0140.A

Gazyva (Obinutuzumab) — Medical Benefit Drug Policy (Ohio only)

Defines medical benefit coverage and medical necessity criteria for Gazyva (obinutuzumab) when used for non-oncology indications (active lupus nephritis) for members in Ohio and impacted providers.

Policy Summary

PayerUnitedHealthcare

PolicyGazyva (Obinutuzumab) — Medical Benefit Drug Policy (Ohio only)

Policy CodePolicy CSOH2026D0140.A

Change TypeNo material changes

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and document biopsy‑proven active lupus nephritis (or justify contraindication) plus current use of at least one standard‑of‑care SLE therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Indication covered

J9301HCPCS code

12 moMax auth period

OhioJurisdiction

Coverage Criteria for Gazyva (obinutuzumab)

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Initial Therapy for Active Lupus Nephritis: Diagnosis of active lupus nephritis; provider attestation that diagnosis is biopsy proven or biopsy is contraindicated; patient is currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants); patient is not receiving Gazyva in combination with Benlysta (belimumab) or Lupkynis (voclosporin); Gazyva is dosed according to US Food and Drug Administration labeled dosing; prescribed by or in consultation with a rheumatologist or nephrologist; initial authorization is for no more than 12 months.

Continuation Therapy Criteria

Covered when ALL of the following are met for continuation of therapy:

Continuation Therapy for Active Lupus Nephritis: Patient has previously received Gazyva injection for intravenous infusion; documentation of positive clinical response; patient is currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or non-biologic immunosuppressants); patient is not receiving Gazyva in combination with Benlysta (belimumab) or Lupkynis (voclosporin); Gazyva is dosed according to US Food and Drug Administration labeled dosing; prescribed by or in consultation with a rheumatologist or nephrologist; authorization is for no more than 12 months.

Oncology uses of obinutuzumab are not addressed by this non-oncology policy. Oncology indications for obinutuzumab are managed under the Medical Benefit Drug Policy titled Oncology Medication Clinical Coverage and by the NCCN Compendium, which take precedence for cancer-related prescribing and coverage determinations.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required; approvals limited to 12 months

Prior authorization is required for Gazyva (obinutuzumab) administered under HCPCS J9301 for the treatment of active lupus nephritis. When criteria are met, initial and continuation authorizations are each limited to no more than 12 months.

Step Therapy

Concomitant standard SLE therapy required

Patient must be currently receiving at least one standard-of-care treatment for active systemic lupus erythematosus (examples include antimalarials, corticosteroids, or immunosuppressants) as a condition of both initial and continuation therapy.

Examples: antimalarials, corticosteroids, or immunosuppressants

Documentation Required

Required documentation to support medical necessity

Document the diagnosis and treatment details supporting medical necessity: include a diagnosis of active lupus nephritis (ICD-10 M32.14), provider attestation that the diagnosis is biopsy proven or an explanation why biopsy is contraindicated, and current use of at least one standard-of-care SLE therapy. Also document dosing consistent with US FDA labeled dosing and that Gazyva is not being given in combination with belimumab or voclosporin; prescriber specialty (rheumatologist or nephrologist) or consultation should be recorded.

Diagnosis: active lupus nephritis (M32.14)
Biopsy proven or reason biopsy contraindicated (provider attestation)
Current standard-of-care SLE therapy (antimalarials, corticosteroids, or immunosuppressants)
Dosing consistent with US FDA labeled dosing
Not given with benlysta (belimumab) or lupkynis (voclosporin)
Prescriber specialty or consultation (rheumatologist or nephrologist)

Denial Risk

Denial risk for requests not meeting criteria

Requests that do not meet the policy criteria may be denied as not meeting medical necessity—common deficiencies include lack of biopsy proof or documented reason biopsy is contraindicated, absence of current standard-of-care SLE therapy, dosing not per FDA labeling, or concurrent use with belimumab or voclosporin.

Missing biopsy proof or no documented contraindication to biopsy
No documentation of current antimalarial, corticosteroid, or immunosuppressant therapy
Dosing not consistent with US FDA labeled dosing
Concurrent administration with belimumab (Benlysta) or voclosporin (Lupkynis)

Background

Obinutuzumab is a monoclonal antibody directed at the CD20 antigen on pre-B and mature B lymphocytes and mediates B-cell depletion through immune effector engagement, direct cell‑death signaling, and complement activation. In the REGENCY Phase III trial, obinutuzumab was studied as an add-on to standard therapy (mycophenolate mofetil and corticosteroids) in patients with biopsy‑proven ISN/RPS Class III or IV lupus nephritis (with or without Class V), demonstrating improved renal outcomes compared with placebo plus standard therapy over a 76‑week evaluation period.

Key Definitions

Complete Renal Response (CRR) — REGENCY definition

UPCR thresholdUrine protein‑to‑creatinine ratio (UPCR) < 0.5 g/g

eGFR requirementEstimated glomerular filtration rate (eGFR) ≥ 85% of baseline (calculated using 2009 CKD‑EPI equation)

Intercurrent events excludedNo occurrence of rescue therapy, treatment failure, death, or early study withdrawal at Week 76

Timepoint for assessmentAssessed at Week 76 in the REGENCY trial

Context of definitionDefined as the primary endpoint in REGENCY among patients receiving obinutuzumab plus standard therapy (MMF and corticosteroids)