ModifiedUnitedHealthcarePolicy CS2026D0056X

Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) - Medical Benefit Drug Policy

Clinical coverage and medical benefit drug policy governing use of ocrelizumab products for treatment of multiple sclerosis for UnitedHealthcare Community Plan members in the states specified.

Policy Summary

PayerUnitedHealthcare

PolicyOcrevus (ocrelizumab) and Ocrevus Zunovo

Policy CodePolicy CS2026D0056X

Change TypeDuration update (authorization)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionRequest prior authorization for initial and continuation therapy with a maximum authorization period of 12 months and include documentation of diagnosis and clinical response as required.

SourceLink

POLICY UPDATE CHANGES

Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'.

Updated References section to reflect the most current information.

Archived previous policy version CS2025D0056W.

Updated Coverage Rationale and Supporting Information sections.

12 monthsinitial authorization duration (max)

PPMS & RMSIndications covered

J2350, J2351HCPCS codes

Lupus nephritis, RAUnproven uses listed

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Coverage Criteria

Primary Progressive Multiple Sclerosis - Initial Therapy

Covered when ALL of the following are met

PPMS Initial Therapy Criteria: Diagnosis of primary progressive multiple sclerosis (PPMS); patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any disease-modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide), B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone); and Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling.

Initial therapy

Relapsing Forms of Multiple Sclerosis - Initial Therapy

Covered when ALL of the following are met

RMS Initial Therapy Criteria: Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any disease-modifying therapy (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide), B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone); Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling; and initial authorization is for no more than 12 months.

Initial therapy

Continuation of Therapy

Covered when ALL of the following are met

Continuation Therapy Criteria: Patient has previously received treatment with Ocrevus or Ocrevus Zunovo; documentation of positive clinical response to Ocrevus or Ocrevus Zunovo therapy; patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any disease-modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide), B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone); Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling; and authorization for continuation is for no more than 12 months.

Continuation therapy

Unproven / Not Medically Necessary Uses

Unproven/Not Medically Necessary: Use of Ocrevus or Ocrevus Zunovo for lupus nephritis, rheumatoid arthritis, or systemic lupus erythematosus is unproven and not medically necessary.

Explicitly listed NMN indications

This policy does not apply to certain states that reference state-specific Medicaid clinical policies or separate guidance. Refer to the state policy noted for Arizona, Indiana, Kansas, Louisiana, Pennsylvania, and Washington. Ohio has a separate policy for Ocrevus® (ocrelizumab) and Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq). North Carolina is listed as having None (the policy applies).

UnitedHealthcare considers Ocrevus and Ocrevus Zunovo to be unproven and not medically necessary when used for the treatment of lupus nephritis, rheumatoid arthritis, and systemic lupus erythematosus. Clinical trial data and safety findings (including increased rates of serious and opportunistic infections and an unfavorable benefit‑risk profile in RA) are cited in the supporting literature and form the basis for these determinations.

Coding and Authorization Duration

Covered HCPCS Codes (reference list)HCPCS

J2350	Injection, ocrelizumab, 1 mg.
J2351	Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq

ICD-10 Codes referencedICD-10

G35.A	Relapsing-remitting multiple sclerosis.
G35.B0	Primary progressive multiple sclerosis, unspecified.
G35.B1	Active primary progressive multiple sclerosis.
G35.B2	Non-active primary progressive multiple sclerosis.
G35.C0	Secondary progressive multiple sclerosis, unspecified.
G35.C1	Active secondary progressive multiple sclerosis.
G35.C2	Non-active secondary progressive multiple sclerosis.
G35.D	Multiple sclerosis, unspecified

Authorization duration

Initial authorization durationInitial authorization is for no more than 12 months.

Continuation authorization durationAuthorization for continuation of therapy is for no more than 12 months.

Documentation requirement linked to durationContinuation authorization requires documentation of prior receipt and positive clinical response; authorization limited to no more than 12 months.

Provider Actions and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial authorization is limited to no more than 12 months. Continuation authorizations are also limited to no more than 12 months and require documentation demonstrating prior receipt of Ocrevus or Ocrevus Zunovo and evidence of a positive clinical response. Dosing must follow FDA‑approved labeling.

Initial authorization duration: <= 12 months
Continuation authorization duration: <= 12 months
Continuation requires documentation of prior receipt and positive clinical response
Dosing must be per FDA‑approved labeling

Step Therapy

Concurrent Therapy Restrictions

Do not prescribe or approve Ocrevus or Ocrevus Zunovo in combination with other disease‑modifying therapies, B‑cell targeted therapies, or lymphocyte trafficking blockers. Concurrent use with these agents is a policy exclusion and may result in denial.

Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Therapy: Diagnosis of relevant MS type (primary progressive MS or relapsing forms of MS); patient is not receiving Ocrevus or Ocrevus Zunovo in combination with disease-modifying therapy, B-cell targeted therapy, or lymphocyte trafficking blockers; dosing is in accordance with United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 months.

Initial therapy

Initial authorization

Initial authorization duration is changed to no more than 12 months.

Operational update to authorization period

Continuation Therapy Criteria

Continuation Therapy

Covered when ALL of the following are met

Continuation: Patient previously treated with Ocrevus or Ocrevus Zunovo; documentation of positive clinical response to therapy; not used in combination with disease-modifying therapy, B-cell targeted therapy, or lymphocyte trafficking blockers; dosing per United States Food and Drug Administration approved labeling; authorization for continuation is for no more than 12 months.

Continuation authorization requirements

Background

Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20‑positive B cells, a lymphocyte subset implicated in demyelination and axonal injury in multiple sclerosis. The agent depletes CD20‑expressing B cells while sparing stem cells and plasma cells, thereby preserving some immune function. Phase 3 randomized trials (for example, ORATORIO in primary progressive MS and OPERA I/II in relapsing MS) demonstrated reductions in disability progression and relapse rates versus comparator arms, supporting its use in primary progressive multiple sclerosis and relapsing forms of multiple sclerosis when criteria in this policy are met.

Definitions

PPMS — Primary progressive multiple sclerosis

DefinitionPrimary progressive multiple sclerosis (PPMS): a form of multiple sclerosis characterized by progressive neurologic decline from onset (PPMS).

Coverage stanceOcrevus or Ocrevus Zunovo are proven and medically necessary for treatment of PPMS when all PPMS criteria are met (diagnosis, no concurrent disallowed therapies, dosing per FDA labeling).

Concurrent therapy restrictionPatient must not be receiving Ocrevus or Ocrevus Zunovo in combination with disease-modifying therapies, B-cell targeted therapies, or lymphocyte trafficking blockers.

Dosing requirementDosing must be in accordance with United States Food and Drug Administration approved labeling.

Relapsing forms of MS — relapsing‑remitting and secondary progressive with relapses

Definition

Revision History

2026-02-01revisedLatest

Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'; updated coverage rationale and supporting information; updated References section and archived previous policy version CS2025D0056W.