UnitedHealthcare Ocrevus Coverage Update Prior Auth

Coverage Criteria

Primary Progressive Multiple Sclerosis (PPMS)

Covered when ALL of the following are met

PPMS Initial Therapy: Diagnosis of primary progressive multiple sclerosis (PPMS); patient is not receiving Ocrevus or Ocrevus Zunovo in combination with 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); dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 months.

PPMS Continuation Therapy: Patient has previously received 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 disease-modifying therapy, B-cell targeted therapy, or lymphocyte trafficking blockers (examples as above); dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months.

Relapsing Forms of Multiple Sclerosis (RMS)

Covered when ALL of the following are met

RMS Initial Therapy: 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 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); dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 months.

RMS Continuation Therapy: Patient has previously received 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 disease-modifying therapy, B-cell targeted therapy, or lymphocyte trafficking blockers (examples as above); dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months.

Ocrevus and Ocrevus Zunovo are designated as unproven and not medically necessary for the treatment of lupus nephritis, rheumatoid arthritis, and systemic lupus erythematosus based on clinical trial experience and safety findings.

The source chunks reviewed do not provide an alternate coverage pathway or member-specific exclusions within this policy text; when determining coverage for indications not explicitly addressed, reference the member-specific benefit plan document and any applicable federal or state mandates, as the member-specific plan governs in the event of a conflict.

Summary of uses identified as not medically necessary / unproven: clinical trial data and policy language indicate that ocrelizumab is considered unproven and not medically necessary for lupus nephritis (Phase 3 BELONG study terminated early due to an imbalance in serious and opportunistic infections), for rheumatoid arthritis (clinical program discontinued because the benefit–risk profile was unfavorable, with infection safety signals), and for systemic lupus erythematosus.

Although the policy text lists specific unproven or not medically necessary indications, the provided chunks do not contain separate, explicit statutory-style not medically necessary declarations beyond the listed statements; providers should rely on the policy language and member-specific plan documents when making coverage determinations.

Coding

HCPCS CodesHCPCS

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

ICD-10 CodesICD-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

inv-09: Study dosing interval — 600 mg every 24 weeks

Study dosing interval600 mg every 24 weeks

Study population (ORATORIO)732 patients randomized to receive 600 mg IV or placebo every 24 weeks

Study population (OPERA I/II)OPERA I and OPERA II used 600 mg every 24 weeks vs interferon beta-1a

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document the diagnosis (PPMS or relapsing forms of MS), confirm dosing is consistent with FDA‑approved labeling, show absence of concurrent excluded therapies (disease‑modifying therapies, B‑cell targeted therapies, or lymphocyte‑trafficking blockers), and include dosing documentation. Initial authorizations are for up to 12 months.

Diagnosis documented: primary progressive MS (PPMS) or relapsing forms of MS
Dosing consistent with FDA labeling
Initial authorization ≤ 12 months

Note

Prior Authorization Governed by Member Plan

Authorization decisions must reference the member's specific benefit plan and any applicable federal or state mandates. This policy assists interpretation but the member-specific benefit plan governs in the event of conflict.

Check member-specific benefit plan document
Follow applicable federal/state mandates

Initial Therapy

Initial authorization requirements

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

Continuation Therapy

Continuation authorizations require prior receipt and documented positive clinical response and are limited to 12 months

Continuation requirements: Previously received 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 disease-modifying therapy, B-cell targeted therapy, or lymphocyte trafficking blockers (examples include interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide, rituximab, belimumab, ofatumumab, ublituximab-xiiy, alemtuzumab, mitoxantrone); dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months.

Step Therapy / Sequencing

Policy element	Requirement
Step therapy approach	No mandated prior-failure sequence is specified. The policy requires that the patient not be receiving Ocrevus or Ocrevus Zunovo in combination with other disease-modifying therapies, B‑cell targeted therapies, or lymphocyte trafficking blockers rather than requiring failure of specific alternative agents.
Concurrent therapy exclusion	Patient must not be receiving Ocrevus or Ocrevus Zunovo in combination with disease‑modifying therapies (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide), B‑cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ublituximab‑xiiy), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone).
Initial therapy requirement	Diagnosis of PPMS or relapsing forms of MS and dosing per FDA‑approved labeling; initial authorization for no more than 12 months (policy does not require prior trial/failure of other MS agents).
Continuation therapy requirement	Previously received Ocrevus or Ocrevus Zunovo with documentation of positive clinical response and not receiving excluded concurrent therapies; authorization for no more than 12 months.

Site of Care

Billing Rule

Infusion center site‑of‑care — follow Site of Care policy

For site‑of‑care considerations when administering Ocrevus or Ocrevus Zunovo in an infusion center, follow the Provider Administered Drugs - Site of Care policy.

See the referenced Site of Care policy for applicable site‑of‑care rules and potential site restrictions.

Background

Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Depletion of CD20-expressing B cells is believed to reduce inflammatory demyelination and subsequent axonal damage in multiple sclerosis while largely sparing B-cell stem cells and plasma cells, which may help preserve other immune functions.

Definitions

inv-19: CD20-positive B cells — definition and role; targeted by ocrelizumab

DefinitionCD20-positive B cells: a subset of immune B cells expressing CD20 implicated in the pathogenesis of multiple sclerosis

Role in MSThought to contribute to myelin and axonal damage leading to disability in multiple sclerosis

Therapeutic targetOcrelizumab selectively binds CD20 on these B cells, depleting CD20-expressing B cells while sparing stem cells and plasma cells

inv-20: third-party utilization management criteria referenced for benefit administration — InterQual

Referenced third-party criteriaInterQual criteria

PurposeUsed by UnitedHealthcare to assist in administering health benefits and coverage determinations

Coding & Billing Highlights

HCPCS CodesHCPCS

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

Revision History

2026-01-01revisionLatest

Updated References section and archived previous policy version 2025D0056O.

2026-01-01administrative

Archived prior policy version 2025D0056O (non‑clinical update referencing updated references).

OpenPayer

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