CurrentCignaPolicy IP0705

Ocrevus Zunovo

Cigna coverage policy for Ocrevus Zunovo (subcutaneous ocrelizumab + hyaluronidase) for adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis; describes medical necessity criteria, dosing, coding, and noncovered uses for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyOcrevus Zunovo

Policy CodePolicy IP0705

Change TypeNew policyupdated HCPCS coding

Effective DateMar 15, 2025

Next Review Date

Key ActionPrior authorization required; approve for 1 year when medical necessity criteria for relapsing forms or primary progressive MS are met.

SourceLink

POLICY UPDATE CHANGES

Added new HCPCS code J2351 (injection, ocrelizumab, 1 mg and hyaluronidase-ocsq) effective 04/01/2025 and noted J3590 will be effective until 03/31/2025.

New policy created (Summary of Changes = New policy).

920 mg / 23,000approved dose per administration

every 6 monthsdosing frequency

Adults ≥18age requirement

1 yearauthorization duration

J2351

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Medical Necessity and Coverage Criteria

Multiple Sclerosis, Relapsing Forms (FDA-Approved Indication)

Approve for 1 year if the patient meets ONE of the following (A or B):

Relapsing Forms Approval Pathways

A) Initial Therapy: Patient is ≥ 18 years of age; Documentation the patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease); Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
B) Currently Receiving Ocrevus Zunovo for ≥ 1 Year: Patient is ≥ 18 years of age; Documentation the patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease); Patient meets ONE of the following: (1) experienced a beneficial clinical response when assessed by at least one objective measure (examples include MRI measures, EDSS stabilization, NEDA-3/NEDA-4, FSIQ-RMS, reduction in relapses, improvement/maintenance on 6-minute walk test or MSFC, attenuation of brain volume loss) OR (2) experienced stabilization, slowed progression, or improvement in at least one symptom (e.g., motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, pain/numbness/tingling); Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
See policy for examples of objective measures and symptom improvements.

Multiple Sclerosis, Primary Progressive (FDA-Approved Indication)

Approve for 1 year if the patient meets BOTH of the following (A and B):

Primary Progressive Approval: Patient is ≥ 18 years of age; Medication is prescribed by or in consultation with a physician who specializes in the treatment of multiple sclerosis and/or a neurologist.

Concurrent use of Ocrevus Zunovo with other disease‑modifying agents for multiple sclerosis is not covered. Concurrent use with other disease‑modifying agents used for multiple sclerosis is considered experimental, investigational, or unproven because these agents are not indicated for combination use and additional data are required to determine safety and added efficacy. See the policy appendix for examples of other disease‑modifying therapies that should not be used concurrently.

Any use of Ocrevus Zunovo outside the FDA‑approved indications is considered noncovered. Any other use is considered experimental, investigational, or unproven, and may be denied; the policy will be updated as new published data become available.

Billing, Dosing, and Codes

Considered Medically Necessary when criteria metHCPCSCovered

J2351	Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq (Code effective 04/01/2025)
J3590	Unclassified biologics (Code effective until 03/31/2025)

inv-06: Dose per administration

Dose per administration920 mg ocrelizumab and 23,000 units hyaluronidase administered subcutaneously

Combined product nameOcrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Administration routeSubcutaneous injection

inv-07: Dosing interval

Dosing intervalOnce every 6 months

Authorization durationApprovals typically granted for 1 year when criteria are met

Dosing considerations

Prior Authorization, Documentation, and Noncovered Uses

Prior Authorization

Prior authorization required; 1-year approval and approved dosing

Prior authorization is required. When the patient meets the applicable criteria for relapsing forms or primary progressive multiple sclerosis, approve authorization for 1 year. Dosing: 920 mg ocrelizumab and 23,000 units hyaluronidase administered subcutaneously once every 6 months.

Prior authorization codes: J2351 (effective 04/01/2025) or J3590 (effective until 03/31/2025) as applicable.

Step Therapy

Concurrent DMTs are not allowed (not covered)

Concurrent use of Ocrevus Zunovo with other disease‑modifying therapies for multiple sclerosis is considered experimental, investigational, or unproven and is not covered. See the policy appendix for examples of other DMTs.

Appendix lists examples of other DMTs (e.g., Avonex, Kesimpta, Ocrevus IV, Lemtrada, etc.).

Clinical Background

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating autoimmune disease of the central nervous system with relapsing and progressive courses. Ocrevus Zunovo is a CD20‑directed cytolytic antibody indicated for adults with relapsing forms of MS (which include clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS) and for primary progressive MS.

Definitions of Key Terms

inv-13: Relapsing forms of multiple sclerosis

Included conditionsClinically isolated syndrome

Included conditionsRelapsing‑remitting multiple sclerosis (RRMS)

Included conditionsActive secondary progressive multiple sclerosis

inv-14: Primary progressive MS

DefinitionPrimary progressive multiple sclerosis is characterized by steady progression of symptoms over time

Regulatory statusIncluded as an FDA‑approved indication for Ocrevus Zunovo

Typical onset pattern