CurrentCignaPolicy IP0212

Multiple Sclerosis (Injectable - CD20-Directed Cytolytic Antibody) - Ocrevus

Policy governs prior authorization, coverage criteria, dosing, and exclusions for ocrelizumab (Ocrevus) for treatment of relapsing forms of MS and primary progressive MS for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOcrevus (ocrelizumab) coverage criteria for Multiple Sclerosis

Policy CodePolicy IP0212

Change TypeName updatedosing clarifiedspecialist prescribing requirement added

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that Ocrevus is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to add 'Injectable - CD20-Directed Cytolytic Antibody' and dosing regimens were revised to divide into Initial and Maintenance dosing and allow 'A and/or B'.

Added a specialist prescribing requirement.

Added criteria for patients currently receiving Ocrevus for ≥ 1 year.

2FDA indications

1Approval duration (yrs)

J2350HCPCS

300/600 mgDosing regimens

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Coverage Criteria for Ocrevus (ocrelizumab)

Multiple Sclerosis, Relapsing Forms (FDA-Approved Indication)

Approve for 1 year if the patient meets ONE of the following (relapsing forms):

A: Initial Therapy: Patient is ≥ 18 years of age AND patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease) AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Patients with < 1 year of therapy or restarting therapy should be considered under Initial Therapy

B: Patient currently receiving Ocrevus for ≥ 1 year: Patient is ≥ 18 years of age AND patient has a relapsing form of multiple sclerosis AND patient meets one of the following: (1) experienced a beneficial clinical response as assessed by at least one objective measure (examples include MRI activity [absence or decrease in gadolinium-enhancing lesions or new/enlarging T2 lesions], stabilization or reduced worsening on EDSS, achievement of NEDA-3/4, improvement on FSIQ-RMS, reduction/absence of relapses, improvement/maintenance on 6-minute walk or 12-Item MS Walking Scale, improvement on MSFC, or 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) AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Continuation criteria require demonstration of benefit or stabilization on objective measures or symptoms

Multiple Sclerosis, Primary Progressive (FDA-Approved Indication)

Approve for 1 year if the patient meets BOTH criteria:

Primary Progressive MS approval: Patient is ≥ 18 years of age AND Ocrevus is prescribed by or in consultation with a physician who specializes in the treatment of multiple sclerosis and/or a neurologist

Dosing per policy

Dosing

Dosing (approve the following regimens):

Initial Dosing: 300 mg IV infusion followed 2 weeks later by a second 300 mg IV infusion

Initial dosing regimen; may approve initial and/or maintenance dosing

Maintenance Dosing: 600 mg IV infusion once every 6 months

Maintenance dosing every 6 months

Ocrevus (ocrelizumab) is not medically necessary for any use outside the indications and conditions specified in this policy. Specifically, concurrent use with other disease-modifying agents for multiple sclerosis is considered not medically necessary because these agents are not indicated for combination therapy and additional data are required to determine whether combination use is safe or adds efficacy.

The use of Ocrevus in combination with other disease-modifying multiple sclerosis agents is not medically necessary. These agents are not indicated for concurrent use, and the policy considers such combination therapy outside the scope of covered, medically necessary treatment.

Coding and Reimbursement

Considered Medically Necessary HCPCS CodesHCPCSCovered

J2350

Injection, ocrelizumab, 1 mg

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Ocrevus. Approval is recommended for those who meet the Criteria and Dosing for the listed indications. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. All approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation and diagnosis of patients treated with Ocrevus as well as the monitoring required for adverse events and long-term efficacy, approval requires Ocrevus to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required for Ocrevus (see Policy Statement and Criteria).
Approvals provided for the duration specified in the Coverage Criteria.
Ocrevus must be prescribed by or in consultation with a specialist (e.g., neurologist) experienced in treating the relevant condition.

Documentation Required

Dose Exceptions — Case-by-Case Review

Background

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating autoimmune disease of the central nervous system that typically presents in young adulthood and follows relapsing and/or progressive courses. Clinical phenotypes include relapsing forms (clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS) and primary progressive MS. Ocrelizumab is a CD20‑directed cytolytic antibody indicated for treatment of these FDA‑approved MS indications; coverage under this policy is limited to those indications and to dosing and specialist prescribing requirements described elsewhere in the policy.

Definitions

Relapsing forms of MS — included subtypes

Included subtypeClinically isolated syndrome (CIS)

Included subtypeRelapsing remitting multiple sclerosis (RRMS)

Included subtypeActive secondary progressive multiple sclerosis (active SPMS)