CurrentViva HealthPolicy IC-0298

Ocrevus (ocrelizumab) (Intravenous) — Coverage Criteria

This policy governs prior authorization, dosing, and coverage criteria for intravenous ocrelizumab (Ocrevus) for members receiving treatment for multiple sclerosis within Viva Health's commercial lines.

Policy Summary

PayerViva Health

PolicyOcrevus (ocrelizumab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0298

Change TypeNo material change

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization valid for 12 months and document contraindication/intolerance/failure to one generic disease-modifying agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuth duration

300 mg x2Initial dose

600 mg q6mMaintenance

J2350HCPCS

Age ≥18; EDSS ≤6.5Eligibility limits

Coverage Criteria for Ocrevus (ocrelizumab)

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Coverage Criteria — Initial and Universal Requirements

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Member has a confirmed diagnosis of multiple sclerosis (MS) documented by appropriate diagnostic testing (e.g., MRI).
MS Type
- Relapsing form of MS (e.g., relapsing-remitting MS [RRMS], active secondary progressive MS [SPMS], or clinically isolated syndrome [CIS]).
- Primary progressive MS (PPMS).
Member is less than 65 years of age (for PPMS patients).
Applies when diagnosis is primary progressive MS.
Member has an Expanded Disability Status Scale (EDSS) score ≤ 6.5.
Patient must have a contraindication, intolerance, or failure to ONE generic disease-modifying agent prior to consideration of Ocrevus; OR documentation supporting FDA/compendia indication that bypasses step requirement.
Evidence of prior therapy failure or intolerance should be provided in medical record.
Member has been screened for Hepatitis B virus (HBV) prior to initiating treatment and does not have active disease (i.e., negative HBsAg and appropriate anti-HBV testing).
Baseline serum immunoglobulins have been assessed prior to initiation of therapy.
Member does NOT have any FDA-labeled contraindications to ocrelizumab.
Member does not have an active infection.
Member will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation of treatment.
Live vaccine exclusion applies to administration within 4 weeks before starting therapy and during treatment.
Member will have baseline and periodic monitoring of liver function tests (ALT, AST), alkaline phosphatase, and bilirubin during therapy.
Used as single-agent therapy (not in combination with other disease-modifying agents).
Member has not received a dose of ocrelizumab or ublituximab within the past 5 months.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J2350

Injection, ocrelizumab, 1 mg; 1 billable unit = 1 mg

NDCNDC

50242-0150-xx

Ocrevus 300 mg/10 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

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

Ambulatory definition (PPMS)

Ambulatory definition for PPMSEDSS score < 7.5

ContextApplies to members with primary progressive multiple sclerosis (PPMS) for continued coverage consideration

Source guidanceUsed as the criterion for continued ambulatory status during renewal assessments

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required and, when approved, is valid for 12 months (365 days) for initial requests and for each renewal thereafter. Providers must request renewal prior to PA expiration to avoid gaps in coverage.

Initial PA validity: 12 months (365 days).
Renewal PA validity: 12 months (365 days) per renewal.

Step Therapy

Step Therapy Requirement

A trial, contraindication, intolerance, or failure of ONE generic disease-modifying therapy (DMT) is required before approval of the requested agent.

Documented trial of ONE generic DMT, or documentation of contraindication, intolerance, or therapeutic failure to that agent.

Denial Risk

Triggers for Denial

Requests may be denied if required prior trials or exclusionary conditions are not met. Verify documentation for prior DMT trial and screen for active infections or other contraindications before submission.

Missing documentation of trial, contraindication, intolerance, or failure of ONE generic DMT.
Active Hepatitis B infection (positive HBsAg and/or anti-HBV consistent with active disease).
Any FDA-labeled contraindication to the requested agent.
Active infection at time of request.
Member received a dose of ocrelizumab or ublituximab within the past 5 months (must be >5 months since prior dose).

Documentation Required

Required Clinical Documentation

Clinical documentation must confirm the diagnosis and support medical necessity; include relevant imaging/laboratory reports and appropriate ICD-10 codes.

Confirmed diagnosis of multiple sclerosis supported by MRI or other diagnostic reports.
Appropriate ICD-10 code from Appendix 1 (e.g., G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D).
Documentation of screening for Hepatitis B and baseline serum immunoglobulins.
Baseline and periodic liver function tests (ALT, AST, alkaline phosphatase, bilirubin) as applicable.

Background

Ocrelizumab is an anti-CD20 monoclonal antibody approved for treatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. Clinical monitoring for patients receiving ocrelizumab includes baseline and periodic assessment of liver function tests (ALT, AST, alkaline phosphatase, bilirubin) and surveillance for infections. Patients should be screened for Hepatitis B prior to initiation and must avoid live vaccines during treatment and for 4 weeks prior to initiation.