CurrentUnitedHealthcarePolicy CS2O25DOOS6W

Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase) coverage

Defines UnitedHealthcare Medical Benefit Drug Policy coverage criteria, authorization durations, exclusions, and applicable procedure and diagnosis codes for Ocrevus and Ocrevus Zunovo for treatment of primary progressive multiple sclerosis and relapsing forms of multiple sclerosis. Policy excludes certain states and provides background/evidence and non-covered indications.

Policy Summary

PayerUnitedHealthcare

PolicyOcrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase) coverage

Policy CodePolicy CS2O25DOOS6W

Change TypeApplication update; ICD-10 edits; Administrative archive

Effective DateOct 1, 2025

Next Review Date

Key ActionProviders must document positive clinical response to therapy to support continuation authorization.

POLICY UPDATE CHANGES

Policy application updated to add Arizona as a state where this Medical Benefit Drug Policy does not apply and directs to state Medicaid clinical policy.

Applicable ICD-10 diagnosis codes were updated to add G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D and removed G35 supporting information.

Previous policy version CS2O25DOO56V archived.

2Covered Indications (MS types: PPMS, Relapsing forms)

3Unproven / Not Medically Necessary Indications

6→12Auth durations (initial → continuation months)

Coverage Summary

This policy covers Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab + hyaluronidase) for the treatment of primary progressive multiple sclerosis (PPMS) and relapsing forms of multiple sclerosis under a covered_with_criteria approach, with specific authorization durations and exclusion criteria detailed in the policy scope. The policy now excludes Arizona from its application and directs users to the state Medicaid clinical policy for that state. For full scope, see the policy coverage criteria and application sections.

Initial Therapy Criteria

Primary Progressive Multiple Sclerosis - Initial therapy (Medically Necessary)

Ocrevus or Ocrevus Zunovo are proven and medically necessary for the treatment of primary progressive multiple sclerosis (PPMS) when ALL of the following criteria are met:

ALL of the following

Diagnosis of primary progressive multiple sclerosis (PPMS)
Disease modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide)
listed as context requirement
Patient is not receiving Ocrevus/Ocrevus Zunovo in combination with ANY of the following
- B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy)
- 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

Relapsing Forms of Multiple Sclerosis - Initial therapy (Medically Necessary)

Ocrevus or Ocrevus Zunovo are proven and medically necessary for the treatment of relapsing forms of multiple sclerosis when ALL of the following criteria are met:

ALL of the following

Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses)
Disease modifying therapy (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide)
Patient is not receiving Ocrevus/Ocrevus Zunovo in combination with ANY of the following
- B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy)
- Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

Primary Progressive Multiple Sclerosis - Initial authorization duration

Initial authorization is for no more than 6 months

Continuation Therapy Criteria

Primary Progressive Multiple Sclerosis - Continuation therapy (Medically Necessary)

For continuation of therapy, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to Ocrevus or Ocrevus Zunovo therapy
Disease modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide)
listed as context requirement
Patient is not receiving Ocrevus/Ocrevus Zunovo in combination with ANY of the following
- B-cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ublituximab-xiiy)

Not Medically Necessary / Unproven Indications

Ocrevus or Ocrevus Zunovo are unproven and not medically necessary for the treatment of the following:

ANY of the following

Rheumatoid arthritis
Lupus nephritis
Systemic lupus erythematosus

Applicable Codes

HCPCS - J-codes (drug administration units)HCPCSCovered

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

ICD-10-CM diagnosis codes (relevant MS subtypes)ICD-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

Provider Actions

Prior Authorization

Initial authorization periods

Initial authorization for Ocrevus or Ocrevus Zunovo is limited to no more than 6 months for both primary progressive MS (PPMS) and relapsing forms of MS; continuation authorizations are limited to no more than 12 months.

J2350
J2351

Documentation Required

Required documentation for continuation

Providers must document positive clinical response to Ocrevus or Ocrevus Zunovo therapy to support continuation authorization.

Documentation of positive clinical response to Ocrevus or Ocrevus Zunovo therapy

Clinical Evidence

24% / 25%ORATORIO primary endpoint: 12-week CDP reduced 24%; 24-week CDP reduced 25% vs placebo

~46-47%OPERA pooled result: ARR reduced ~46–47% vs interferon beta-1a; 12- and 24-week CDP reduced 40%

Phase 3 trials demonstrated efficacy: the ORATORIO trial in PPMS showed a 24% reduction in 12-week confirmed disability progression (and 25% reduction in 24-week) versus placebo, while the OPERA I/II trials in relapsing MS showed an approximate 46–47% reduction in annualized relapse rate versus interferon beta-1a and a 40% reduction in 12- and 24-week confirmed disability progression in pooled analyses. Safety summaries note similar overall adverse event rates versus comparators in MS trials, but prior studies in other diseases (e.g., rheumatoid arthritis, lupus nephritis) identified infection safety signals that limited development and use.

Background & Definitions

Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. It is FDA-indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) and for primary progressive multiple sclerosis (PPMS). Key Phase 3 trials include ORATORIO (PPMS) and OPERA I/II (relapsing forms of MS).

Revision History

10/01/2025addedLatest

Application section updated to add Arizona as a state where this Medical Benefit Drug Policy does not apply and directs to the state's Medicaid clinical policy.

10/01/2025revised

Applicable ICD-10 diagnosis codes updated: Added G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D; removed G35 supporting information.

10/01/2025archived

Previous policy version CS2O25DOO56V archived.