CurrentUnitedHealthcarePolicy 2025D0056N

Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Defines UnitedHealthcare medical necessity criteria, applicable codes, and coverage stance for use of Ocrevus and Ocrevus Zunovo for primary progressive and relapsing forms of multiple sclerosis, and lists indications considered unproven/not medically necessary. Applies to Community Plan populations.

Policy Summary

PayerUnitedHealthcare

PolicyOcrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Policy CodePolicy 2025D0056N

Change TypeNo material change

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation per criteria; authorizations limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PPMS & relapsingmedically necessary indications

Lupus nephritis, RA, SLEnot medically necessary

12 monthsauth duration

J2350, J2351, G35reference codes

Coverage Criteria for Ocrevus and Ocrevus Zunovo

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PPMS 6 Initial Therapy

Covered when ALL of the following are met for primary progressive multiple sclerosis (PPMS):

PPMS Initial Therapy: Diagnosis of primary progressive multiple sclerosis (PPMS)

PPMS Initial Therapy: Patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any of the following: 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)

PPMS Initial Therapy: Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling

PPMS Initial Therapy: Initial authorization is for no more than 12 months<=12 months

PPMS 6 Continuation Therapy

PPMS 6 Continuation of therapy covered when ALL of the following are met:

PPMS Continuation: Patient has previously received treatment with Ocrevus or Ocrevus Zunovo

PPMS Continuation: Documentation of positive clinical response to Ocrevus or Ocrevus Zunovo therapy

PPMS Continuation: Patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any of the following: 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)

PPMS Continuation: Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months

Relapsing MS 6 Initial Therapy

Covered when ALL of the following are met for relapsing forms of multiple sclerosis (initial therapy):

Relapsing Initial: Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses)

Relapsing Initial: Patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any of the following: 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)

Relapsing Initial: Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling

Relapsing Initial: Initial authorization is for no more than 12 months

Relapsing MS 6 Continuation Therapy

Relapsing forms 6 Continuation of therapy covered when ALL of the following are met:

Relapsing Continuation: Patient has previously received treatment with Ocrevus or Ocrevus Zunovo

Relapsing Continuation: Documentation of positive clinical response to Ocrevus or Ocrevus Zunovo therapy

Relapsing Continuation: Patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any of the following: disease modifying therapy, B cell targeted therapy, or lymphocyte trafficking blockers

Relapsing Continuation: Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months<=12 months

Use of Ocrevus (ocrelizumab) or Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for indications outside of multiple sclerosis is considered unproven and not medically necessary. Clinical trial experience and safety findings have informed this stance: a Phase 3 study in Class 3/4 lupus nephritis (BELONG) was terminated early because of an imbalance in serious and opportunistic infections among ocrelizumab-treated patients, despite numerically higher overall response rates versus placebo in the truncated analysis; patients continued into safety follow-up. (See BELONG trial results and safety signal.)

Ocrelizumab development programs in rheumatoid arthritis were discontinued after the manufacturer concluded the benefit-to-risk profile was not favorable; clinical trials identified an infection safety signal including serious and fatal infections and opportunistic infections. Observational data in systemic lupus erythematosus include limited reports of ocrelizumab use in small subgroups, but do not establish efficacy or an acceptable safety profile sufficient to support routine coverage.

Ocrevus and Ocrevus Zunovo are explicitly listed as unproven and not medically necessary for the treatment of lupus nephritis, rheumatoid arthritis, and systemic lupus erythematosus.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq). Initial authorizations and continuations are limited to a maximum duration of 12 months. Providers must ensure dosing follows FDA‑approved labeling and submit authorization requests through the payer's prior authorization process.

Initial and continuation authorizations: ≤ 12 months
Dosing must align with FDA‑approved labeling
Submit prior authorization via UnitedHealthcare operational channels

Prior Authorization

Concurrent Therapy Restriction

Concurrent use of Ocrevus or Ocrevus Zunovo with other disease‑modifying therapies, B‑cell targeted therapies, or lymphocyte trafficking blockers is not permitted. Examples include, but are not limited to, interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide, rituximab, belimumab, ofatumumab, ublituximab, alemtuzumab, and mitoxantrone. Providers must confirm the patient is not receiving any listed concurrent therapies at the time of request and during authorization.

Do not combine with disease‑modifying therapies (e.g., interferon beta, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide)
Do not combine with B‑cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ublituximab)
Do not combine with lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

Documentation Required

Required Documentation for Continuation

For continuation of therapy, documentation is required to demonstrate prior receipt of Ocrevus or Ocrevus Zunovo and evidence of a positive clinical response. Submit clinical notes that document treatment history and response, objective measures of disease stability or improvement (e.g., relapse frequency, EDSS score changes, MRI findings where applicable), and confirmation that dosing remains consistent with FDA labeling.

Evidence patient previously received Ocrevus or Ocrevus Zunovo
Documentation of positive clinical response (e.g., decreased relapse rate, stabilization/improvement in EDSS, MRI evidence)
Confirmation dosing aligns with FDA‑approved labeling
Confirmation patient is not receiving prohibited concurrent therapies

OpenPayer

Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Coverage Criteria for Ocrevus and Ocrevus Zunovo

Applicable Codes

Provider Actions and Authorization Requirements

Background

Definitions

J2350	Injection, ocrelizumab, 1 mg.
J2351	Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq
G35	Multiple sclerosis