CurrentColorado Rocky Mountain Health PlansPolicy IEXD0227.01

Gazyva® (Obinutuzumab) – Individual Exchange Medical Benefit Drug Policy

Medical benefit drug policy for Gazyva (obinutuzumab) intravenous infusion for non-oncology indications, specifically coverage criteria for active lupus nephritis for Individual Exchange plans (excludes MA, NV, NY). It provides initial and continuation authorization criteria, applicable codes, clinical evidence summary, and administrative considerations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGazyva® (Obinutuzumab) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0227.01

Change TypeNew policy

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization before initiating or continuing Gazyva and document active lupus nephritis plus required non-biologic standard‑of‑care therapy and specialist involvement where indicated.

SourceLink

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy effective 01/01/2026.

1Covered Indication (non-oncology)

3States excluded (MA, NV, NY)

12Max authorization (months)

Coverage Summary

Coverage stance: covered_with_criteria for Gazyva (obinutuzumab) for active lupus nephritis. Scope: Medical benefit drug policy for Gazyva intravenous infusion for non-oncology indications focused on active lupus nephritis for Individual Exchange plans; excludes Massachusetts, Nevada, and New York. Effective date: 2026-01-01. Last review date: 2026-01-01. Policy number: IEXD0227.01.

Initial Therapy Criteria

Active Lupus Nephritis - Initial Therapy (first listing)"

Gazyva (obinutuzumab) is proven for the treatment of active lupus nephritis when all of the following criteria are met:

Active Lupus Nephritis - Initial Therapy (first listing)

Diagnosis of active lupus nephritis
Standard of care: 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
Concomitant therapy exclusion: Patient is not receiving Gazyva in combination with Benlysta (belimumab) or Lupkynis (voclosporin)
Dosing: Gazyva is dosed according to US Food and Drug Administration labeled dosing
Authorization length: Initial authorization is for no more than 12 months12 months

Active Lupus Nephritis - Initial Therapy (biopsy-proven variant)"

Gazyva (obinutuzumab) is medically necessary for the treatment of active lupus nephritis when all of the following criteria are met:

Active Lupus Nephritis - Initial Therapy (biopsy-proven variant)

Diagnosis of active lupus nephritis
Biopsy attestation: Provider attestation that diagnosis is biopsy proven or biopsy is contraindicated in the patient
Standard of care: 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
Concomitant therapy exclusion: Patient is not receiving Gazyva in combination with Benlysta (belimumab) or Lupkynis (voclosporin)

Continuation Therapy Criteria

Active Lupus Nephritis - Continuation of Therapy (first listing)"

For continuation of therapy, all of the following:

Active Lupus Nephritis - Continuation of Therapy (first listing)

Prior receipt: Patient has previously received Gazyva injection for intravenous infusion
Response documentation: Documentation of positive clinical response
Provider must document response to support ongoing therapy
Standard of care: 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
Concomitant therapy exclusion: Patient is not receiving Gazyva in combination with Benlysta (belimumab) or Lupkynis (voclosporin)
Dosing: Gazyva is dosed according to US Food and Drug Administration labeled dosing
Authorization length: Authorization is for no more than 12 months12 months

Active Lupus Nephritis - Continuation of Therapy (biopsy-proven variant)"},{

For continuation of therapy, all of the following:

Active Lupus Nephritis - Continuation of Therapy (biopsy-proven variant)

Prior receipt: Patient has previously received Gazyva injection for intravenous infusion
Response documentation: Documentation of positive clinical response
Provider must document response to support ongoing therapy
Standard of care: 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
Concomitant therapy exclusion:

Actions & Requirements for Providers

Prior Authorization

Authorization required

Initial and continuation authorizations are required prior to starting therapy and are limited to no more than 12 months per authorization.

J9301

Documentation Required

Diagnosis confirmation and prior therapy

Document an active lupus nephritis diagnosis and current receipt of at least one non-biologic standard-of-care (SOC) therapy for SLE (e.g., antimalarials, corticosteroids, or immunosuppressants). For biopsy-proven criteria, include provider attestation that the diagnosis is biopsy proven or that biopsy is contraindicated.

Documentation Required

Specialist involvement

Prescriptions should be by or in consultation with a rheumatologist or nephrologist for criteria that require specialist involvement.

Denial Risk

Concomitant therapy exclusion

Claims may be denied if Gazyva (obinutuzumab) is given in combination with Benlysta (belimumab) or Lupkynis (voclosporin).

Documentation Required

Evidence of response for continuation

For continuation requests, document prior receipt of Gazyva infusion and evidence of a positive clinical response to support ongoing therapy.

Clinical Evidence Summary

46.4% vs 33.1%REGENCY CRR Week 76 (obinutuzumab vs placebo)

271 patientsPrimary trial population (ISN/RPS Class III/IV ± V on MMF + corticosteroids)

The pivotal REGENCY Phase III trial enrolled 271 patients with ISN/RPS Class III or IV (± Class V) lupus nephritis treated with mycophenolate mofetil plus corticosteroids; patients were randomized to obinutuzumab or placebo and followed to Week 76.

REGENCY primary efficacy result (CRR at Week 76): 46.4% with obinutuzumab vs. 33.1% with placebo (difference 13.4; 95% CI: 2.0, 24.8; p = 0.0232).

Policy emphasis: this is a non-oncology indication (active lupus nephritis) and REGENCY served as the pivotal Phase III trial supporting the benefit in that population.

Background

Obinutuzumab is a CD20-directed monoclonal antibody that mediates B‑cell lysis via engagement of immune effector cells (including antibody‑dependent cellular cytotoxicity, ADCC), by directly activating intracellular death signaling pathways (direct cell death), and by activation of the complement cascade; it may also mediate antibody‑dependent cellular phagocytosis.

This policy specifically addresses the non-oncology use of obinutuzumab for active lupus nephritis and references pivotal clinical trial data in that indication.

Definitions used in the policy include Standard of Care (SOC) non-biologic therapies (e.g., antimalarials, corticosteroids, immunosuppressants) and the trial-defined Complete Renal Response (CRR): UPCR < 0.5 g/g; eGFR ≥ 85% of baseline; and no rescue therapy, treatment failure, death or early study withdrawal.

Definitions

Standard of care (SOC) treatment for SLENon-biologic therapies such as antimalarials, corticosteroids, or immunosuppressants (e.g., MMF in REGENCY)

Complete renal response (CRR)UPCR < 0.5 g/g; eGFR ≥ 85% of baseline (CKD‑EPI); and no rescue therapy, treatment failure, death, or early study withdrawal (as defined in REGENCY)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGazyva® (Obinutuzumab) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0227.01

Change TypeNew policy

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Gazyva® (Obinutuzumab) – Individual Exchange Medical Benefit Drug Policy

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unapproved Uses / Concomitant Therapy Exclusions

Applicable Codes

Actions & Requirements for Providers

Clinical Evidence Summary

Background

Revision History