Ocrevus vs Ocrevus Zunovo access guide

Ocrevus (ocrelizumab, Genentech/Roche) was the first anti-CD20 monoclonal antibody approved for both relapsing forms of multiple sclerosis (RMS) and primary progressive MS (PPMS). In September 2024, the FDA approved Ocrevus Zunovo — a subcutaneous formulation combining 920 mg ocrelizumab with 23,000 units of hyaluronidase-ocsq — giving patients and providers a ~10-minute twice-yearly injection alternative to the standard IV infusion.

Both products carry the same active drug, same twice-yearly dosing interval, and same indication scope. But the route of administration changes the billing path, the site-of-care logistics, the prior authorization workflow, and the payer switching friction. This guide covers those differences for MS access teams.

Short answer

FDA approval and clinical evidence

Ocrevus IV

Ocrevus was approved in March 2017 based on two pivotal Phase III trials (OPERA I and OPERA II) demonstrating superior reduction in annualized relapse rate vs interferon beta-1a in RMS, and the ORATORIO trial demonstrating delayed disability progression in PPMS. Over 350,000 patients have been treated globally.

Ocrevus Zunovo (SC)

Ocrevus Zunovo was approved September 13, 2024, based on the Phase III OCARINA II trial (NCT05232825), which enrolled 236 patients with RMS or PPMS. Key findings:

• Non-inferior pharmacokinetics: AUC geometric mean ratio (GMR) for Ocrevus Zunovo vs Ocrevus IV was 1.29 (90% CI: 1.23–1.35) at Week 12

• Disease suppression: 97% suppression of relapse activity and 97% suppression of MRI lesions through 48 weeks

• Safety: consistent with IV Ocrevus, with the exception of injection-site reactions (49% after first injection; all mild or moderate; none led to discontinuation)

• Patient satisfaction: >92% of participants reported being satisfied or very satisfied with SC administration

HCPCS coding and billing

Ocrevus IV and Ocrevus Zunovo SC have separate permanent HCPCS codes. Using the wrong code will result in claim denial.

Ocrevus IV — J2350

• J2350: Injection, ocrelizumab, 1 mg (effective January 1, 2018)

• Billing: 300 units for each initial 300 mg infusion; 600 units for each 600 mg maintenance infusion

• NDC: 50242-0150-xx (300 mg/10 mL single-dose vial)

• Administration CPT: 96413 (IV infusion, up to 1 hour, initial) + 96415 (each additional hour)

• ICD-10-CM codes (effective October 2025): G35.A (RRMS), G35.B0–B2 (PPMS), G35.C0–C1 (SPMS), G35.D (MS unspecified)

Ocrevus Zunovo SC — J2351

• J2351: Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq (effective April 1, 2025)

• Billing: 920 units per dose

• NDC: 50242-0554-01 (920 mg ocrelizumab + 23,000 units hyaluronidase/23 mL single-dose vial)

• Administration CPT: 96401 (SC/IM chemotherapy administration, non-hormonal anti-neoplastic)

• Home injection codes: G0089 (initial, per 15 minutes), G0069 (subsequent, per 15 minutes)

• JZ modifier: required for Medicare Part B claims (single-dose vial, zero waste)

Medicare reimbursement

According to BuyandBill.com (Q2 2026 data):

• Ocrevus Zunovo ASP: logged pricing, Medicare co-insurance at 19.831%

• Medicare co-insurance amount: approximately $9.28 per HCPCS unit

• APC payment limit: $46.794 per unit

Payer coverage criteria

Both Ocrevus IV and Ocrevus Zunovo share the same clinical coverage criteria across most payers, with the key difference that separate PAs are typically required for each formulation.

UnitedHealthcare

UHC covers both products under its Commercial Medical Benefit Drug Policy (effective January 1, 2026). Criteria:

• RMS: diagnosis of relapsing forms of MS, age 18+, EDSS ≤6.5, prescribed by neurologist or MS specialist

• PPMS: diagnosis of PPMS, age 18+, no requirement for prior DMT failure

• No concurrent DMTs: cannot be combined with other disease-modifying therapies (interferon, dimethyl fumarate, glatiramer, natalizumab, fingolimod, cladribine, siponimod, teriflunomide)

• No concurrent anti-CD20 or B-cell therapies: rituximab, belimumab, ofatumumab, ublituximab

• Reauthorization: documented clinical benefit — reduced relapse rate, stabilized/improved EDSS, reduced MRI lesion activity, or symptomatic improvement (motor, fatigue, vision, bowel/bladder, spasticity, gait)

• Ocrevus Zunovo specific: initial authorization for no more than 6 months; continuation for up to 12 months with documented response

Molina Healthcare

Molina covers both formulations under its Drug and Biologic Coverage Criteria (Policy C11250-A). Site-of-care requirements apply for both IV and SC — restricted to non-hospital facility-based locations per Molina's Site of Care program.

Community Health Plan of Washington

Covers Ocrevus (300 mg IV × 2 initial; 600 mg IV q6mo) and Ocrevus Zunovo (920 mg SC q6mo). Initial approval for 1 year. Reauthorization requires documentation of clinical benefit.

Blue Cross Blue Shield plans

BCBSTX, Blue Shield of California, and South Carolina Blue Cross cover both Ocrevus and Ocrevus Zunovo under their medical benefit drug policies. J2350 and J2351 are both listed as applicable codes. Many BCBS plans require the parent code G35 to be avoided in favor of the specific sub-code (G35.A, G35.B1, etc.).

Site-of-care and administration logistics

Ocrevus IV

• Requires an infusion center or clinic with IV infrastructure

• First dose is split across two appointments (300 mg each, 2 weeks apart), each requiring pre-medication and post-infusion observation

• Subsequent doses: single 600 mg IV infusion every 6 months (~3.5 hours including preparation and observation)

• Site-of-care edits (UHC, Molina, others) may require non-hospital outpatient settings

Ocrevus Zunovo SC

• ~10-minute subcutaneous injection in the abdomen by a healthcare professional

• No split first dose — single 920 mg injection from the start

• No dilution, no IV supplies needed

• Can be administered in settings without IV infrastructure (doctor's office, clinic)

• Genentech notes this can expand treatment access to centers with IV constraints

• Pre-medication (corticosteroid and antihistamine) is still recommended per the label

Switching between formulations

Genentech explicitly supports parity coverage for both products. However, switching between Ocrevus IV and Ocrevus Zunovo requires:

1. Separate prior authorization: Ocrevus and Ocrevus Zunovo require separate benefit investigations and PAs

2. No automatic conversion: payers treat these as distinct products with different HCPCS codes

3. Billing alignment: confirm the correct HCPCS code (J2350 for IV, J2351 for SC) before claim submission

4. Field Reimbursement Manager support: Genentech provides FRMs to help navigate evolving payer policies for Ocrevus Zunovo

Payer switching friction and parity status

Genentech has committed to parity coverage to preserve patient and provider choice. As of the Genentech Access and Reimbursement Reference Guide:

• Medicare FFS established its Ocrevus Zunovo policy at the time of approval

• National payers covering Ocrevus Zunovo at parity with Ocrevus IV include UHC, Cigna, Anthem BCBS, and Humana, along with multiple regional payers

• Separate PAs are required because the products have different NDCs and HCPCS codes

• Some plans have not yet updated policies to include Ocrevus Zunovo — FRMs can identify these gaps

Genentech Access Solutions and patient support

Access Solutions

Genentech Access Solutions provides:

• Benefits investigation: confirms coverage, PA requirements, and benefit channel for both IV and SC

• Prior authorization assistance: helps submit and track PA requests

• Appeals support: provides sample appeal letters and clinical documentation guidance

• Field Reimbursement Managers (FRMs): dedicated staff to help practices navigate payer policies for both formulations

Patient assistance

• Genentech Patient Foundation: provides free medicine to eligible patients who are uninsured, have government insurance, or have commercial insurance with affordability gaps

• Co-pay assistance: commercially insured patients may be eligible for co-pay support (terms apply; not valid for Medicare/Medicaid)

• Contact: 1-866-4ACCESS (1-866-422-2377)

Coding resources

Genentech provides a Coding and Billing Guide with example CMS-1500 and UB-04 claim forms for both J2350 and J2351, including NDC crosswalks, CPT administration codes, and JW/JZ modifier guidance.

Documentation checklist for PA submission

1. ICD-10-CM codes: G35.A (RRMS), G35.B0–B2 (PPMS), G35.C0–C1 (active SPMS), G35.D (MS unspecified) — avoid using parent code G35 alone; many payers reject it

2. Diagnosis documentation: McDonald criteria (2024 revision) fulfillment, MRI findings, clinical history of relapses

3. EDSS score: baseline and follow-up scores; most plans require EDSS ≤6.5 for initial approval

4. Prior DMT history: list all prior disease-modifying therapies, start/stop dates, and reasons for discontinuation — though Ocrevus/Ocrevus Zunovo may be used as first-line therapy

5. HBV screening: negative HBsAg and anti-HBc required before initiation

6. Vaccination status: confirm no live vaccines during treatment; update vaccinations before starting

7. Formulation-specific: specify whether requesting Ocrevus IV (J2350) or Ocrevus Zunovo SC (J2351)

8. Specialist attestation: prescribed by or in consultation with a neurologist or MS specialist

9. Reauthorization: document clinical benefit — reduced relapse rate, improved/stabilized EDSS, MRI improvement, or symptomatic improvement

Key takeaways for access teams

• Ocrevus IV and Ocrevus Zunovo SC share indications and clinical criteria but require separate PAs and different HCPCS codes (J2350 vs J2351). Using the wrong code will deny the claim.

• Ocrevus Zunovo eliminates the split first dose and reduces administration time to ~10 minutes, but it still requires a healthcare professional for injection.

• Both formulations route through medical benefit. The acquisition and reimbursement process is the same, but the coding differs.

• Parity coverage is established at most national payers (UHC, Cigna, Anthem BCBS, Humana), but regional payers may still be updating policies.

• Site-of-care edits apply to both formulations: confirm the approved place of service before scheduling.

• Genentech Field Reimbursement Managers can help identify payer policy gaps and navigate the separate PA requirements.

Sources

• FDA. Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) Prescribing Information. NDA 761371. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761371s000lbl.pdf

• FDA. Ocrevus (ocrelizumab) Prescribing Information. BLA 761053. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

• Genentech. FDA Approves Ocrevus Zunovo Press Release. September 13, 2024. gene.com/media/press-releases/15036

• Roche. FDA Approves Ocrevus Zunovo. September 16, 2024. roche.com/media/releases/med-cor-2024-09-16

• Genentech. Ocrevus Access and Reimbursement Reference Guide. ocrevus-hcp.com

• Genentech. Ocrevus and Ocrevus Zunovo Coding and Billing Guide. ocrevus-hcp.com

• UnitedHealthcare. Ocrevus (Ocrelizumab) and Ocrevus Zunovo Commercial Medical Benefit Drug Policy. 2026D0056P. Effective 01/01/2026. uhcprovider.com

• Molina Healthcare. Ocrevus (ocrelizumab) Drug and Biologic Coverage Criteria. C11250-A. molinahealthcare.com

• Community Health Plan of Washington. Ocrelizumab Clinical Coverage Criteria. PM142. chpw.org

• Blue Cross Blue Shield of Texas. Ocrelizumab Medical Policy. RX501.085. medicalpolicy.bcbstx.com

• Blue Cross Blue Shield of South Carolina. Ocrelizumab (Ocrevus) and Ocrevus Zunovo. CAM 170. southcarolinablues.com

• Blue Shield of California. Ocrevus Zunovo Coverage Information. blueshieldca.com

• BuyandBill.com. Ocrevus Zunovo J2351 Code and Cost Information. buyandbill.com

• Neighborhood Health Plan of Rhode Island. Ocrevus IV and SC Coverage Policy. nhpri.org

• OHSU Health Services. Ocrevus (ocrelizumab) IV Policy. OHSU HEALTHSERVICES-0298. ohsu.edu

• UHC Community Plan. Medical Policy Update Bulletin January 2025 — Ocrevus Zunovo criteria. uhcprovider.com