CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0140B

Gazyva (obinutuzumab) — Coverage Criteria for Active Lupus Nephritis

This policy governs medical benefit coverage criteria for Gazyva (obinutuzumab) when used for non-oncology indications (specifically active lupus nephritis) and applies to the payer's applicable states listed in the document.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGazyva (obinutuzumab) — Coverage Criteria for Active Lupus Nephritis

Policy CodePolicy CS2026D0140B

Change TypeTechnical review — no material changes

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of biopsy‑proven lupus nephritis (or contraindication) and evidence of concurrent standard SLE therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Active lupus nephritisIndication

J9301HCPCS

12 monthsMax auth

REGENCYPivotal trial

Coverage Criteria for Gazyva (obinutuzumab)

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Initial Therapy

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

Initial therapy for active lupus nephritis: Diagnosis of active lupus nephritis; provider attestation that the diagnosis is biopsy proven or that biopsy is contraindicated in the patient; 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 (obinutuzumab) 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

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

Continuation therapy for active lupus nephritis: Patient has previously received Gazyva (obinutuzumab) intravenous infusion; documentation of positive clinical response to prior therapy; patient is currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants) that is not a biologic; 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.

Additional limits and requirements for coverage include documentation that the diagnosis of active lupus nephritis is biopsy proven or that biopsy is contraindicated, evidence that the patient is currently receiving at least one standard-of-care therapy for systemic lupus erythematosus (for example, antimalarials, corticosteroids, or immunosuppressants), dosing that follows the US Food and Drug Administration labeled dosing for Gazyva, and that the drug is prescribed by or in consultation with a rheumatologist or nephrologist. Authorizations for both initial and continuation therapy are limited to no more than 12 months. For continuation, documentation of prior Gazyva infusion and a positive clinical response are required.

Billing and Diagnostic Codes

HCPCS CodesHCPCS

J9301

Injection, obinutuzumab, 10 mg

Diagnosis CodesICD-10

M32.14

Glomerular disease in systemic lupus erythematosus

UPCR thresholds — trial inclusion and CRR

Trial inclusion UPCR thresholdUPCR ≥ 1 g/g

Complete Renal Response (CRR) UPCR thresholdUPCR < 0.5 g/g

Baseline UPCR in REGENCY trialMean baseline UPCR 3.3 g/g (SD 2.9)

eGFR criteria for CRR

CRR eGFR requirementeGFR ≥ 85% of baseline (CKD‑EPI 2009)

Baseline eGFR in REGENCYMean baseline eGFR 102.3 mL/min/1.73 m2 (SD 30.8)

eGFR calculation methodCalculated using the 2009 CKD‑EPI equation

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for active lupus nephritis

Prior authorization is required. Submit evidence that the patient meets all coverage criteria for active lupus nephritis, including diagnosis of active lupus nephritis, provider attestation that the diagnosis is biopsy proven or that biopsy is contraindicated, dosing per FDA labeling, and that the drug is prescribed by or in consultation with a rheumatologist or nephrologist. Initial and continuation authorizations are limited to no more than 12 months.

Step Therapy

Concurrent standard SLE therapy required

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

Initial therapy: concurrent standard therapy required.
Continuation therapy: must be receiving a non-biologic standard of care treatment.

Documentation Required

Required documentation for authorization

Provide documentation that the diagnosis of lupus nephritis is biopsy proven or that biopsy is contraindicated, plus documentation of prior or current standard of care therapy; for continuation, include documentation of prior Gazyva infusion and evidence of positive clinical response.

Provider attestation that diagnosis is biopsy proven or biopsy is contraindicated.
Record of current or prior standard SLE therapy (antimalarials, corticosteroids, or immunosuppressants).
For continuation: documentation of previous Gazyva infusion and positive clinical response.

Denial Risk

Denial risk if criteria not met

Failure to meet all required criteria for initial or continuation therapy — for example, lack of biopsy-proven diagnosis (or documentation that biopsy is contraindicated), absence of concurrent standard of care therapy, or no documentation of prior Gazyva response — may result in denial of coverage.

Use of Gazyva in combination with belimumab or voclosporin is excluded and may lead to denial if present.
Authorizations exceeding 12 months are not supported by the criteria.

Background

Obinutuzumab (Gazyva) is a monoclonal antibody that targets the CD20 antigen on pre-B and mature B lymphocytes and mediates B‑cell depletion through engagement of immune effector mechanisms, direct cell death, and complement activation. The policy references clinical trial evidence (REGENCY, a Phase III randomized study) demonstrating that adding obinutuzumab to standard therapy in patients with ISN/RPS Class III/IV (with or without V) lupus nephritis increased rates of complete renal response compared with standard therapy alone.

Definitions and Key Trial Endpoints

Obinutuzumab mechanism — CD20 targeting actions

Primary targetCD20 antigen on pre‑B and mature B lymphocytes

Immune effector engagementMediates B‑cell lysis via engagement of immune effector cells including ADCC and antibody‑dependent cellular phagocytosis

Direct cell deathDirect activation of intracellular death signaling pathways (direct cell death)

Complement activationActivates the complement cascade to promote B‑cell lysis

Complete Renal Response (CRR) — REGENCY

UPCR criterionUPCR < 0.5 g/g at Week 76

eGFR criterioneGFR ≥ 85% of baseline at Week 76 (CKD‑EPI 2009)

Intercurrent eventsNo occurrence of rescue therapy, treatment failure, death, or early study withdrawal by Week 76

Endpoint timing and studyCRR defined at Week 76 in the REGENCY (NCT04221477) Phase III trial