Does J2350 require prior authorization?

Yes, J2350 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J2350?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J2350`, Injection, ocrelizumab, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Documented diagnosis of one of the FDA-approved indications: relapsing forms of MS (clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease) or primary progressive MS.
Documentation of patient age (≥18 years).
Evidence that Ocrevus or Ocrevus Zunovo is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis (prescriber specialty/consultation notes).
For re-authorization (relapsing forms): documentation showing the individual has been receiving Ocrevus or Ocrevus Zunovo for at least 12 months.
For re-authorization (relapsing forms): objective evidence of beneficial clinical response or stabilization as described: 'stabilization or reduced worsening in disease activity as evaluated by magnetic resonance imaging [MRI], stabilization or reduced worsening on the Expanded Disability Status Scale [EDSS] score, achievement in criteria for No Evidence of Disease Activity-3 [NEDA-3] or NEDA-4, improvement on the fatigue symptom and impact questionnaire-relapsing multiple sclerosis [FSIQ-RMS] scale, reduction or absence of relapses, improvement or maintenance on the six-minute walk test or 12-Item Multiple Sclerosis Walking Scale, improvement on the Multiple Sclerosis Functional Composite [MSFC] score, and/or attenuation of brain volume loss' OR documentation of 'stabilization, slowed progression, or improvement in at least one symptom (e.g., motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation)'.
Prescribing/dosing information consistent with recommended dosing: (Ocrevus) 'initial dose is 300 mg intravenous infusion, followed 2 weeks later by a second 300 mg intravenous infusion. Subsequent maintenance doses are 600 mg intravenous infusion once every 6 months.' (Ocrevus Zunovo) '920 mg / 23,000 units (920 mg ocrelizumab and 23,000 units of hyaluronidase) administered as a single 23 mL subcutaneous injection in the abdomen over approximately 10 minutes every 6 months.'

Key Coverage Criteria

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Primary progressive MS, in adults.
Indication: Ocrevus and Ocrevus Zunovo are indicated for treatment of relapsing forms of MS (including CIS, RRMS, active SPMS) in adults, and treatment of primary progressive MS in adults.
Ocrevus (ocrelizumab) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) are proven for primary progressive multiple sclerosis. Ocrevus and Ocrevus Zunovo are medically necessary for the treatment of primary progressive multiple sclerosis (PPMS) when all of the following criteria are met.
Ocrevus or Ocrevus Zunovo dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization is for no more than 12 months
Relapsing-remitting multiple sclerosis (RRMS) in adults (age >= 18) without concurrent use of another disease-modifying agent, with regimen consistent with FDA approved dosing.

20 Active Policies

ARKBLUE-OCRELIZUMAB-E-G-OCREVUS-AND-OCRELIZUMAB-WITH-HYA-A1B73589F2, Ocrelizumab (e.g., Ocrevus) and Ocrelizumab with Hyaluronidase (e.g., Ocrevus Zunovo)

FLORIDA_BLUE-FLBLUE-OCRELIZUMAB-OCREVUSTM-AND-OCREVUS-ZUNOVO-3C06EF13F1, Ocrelizumab (Ocrevus) and Ocrevus Zunovo

BCBSLA-00559-331CD47078, 00559 ocrelizumab (Ocrevus) ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo)

HEALTHPARTNERS-CC-ENTRY-194059, Ocrelizumab (Ocrevus) – Minnesota Health Care Programs

MULTI

HEALTHPARTNERS-CC-ENTRY-193159, Ocrelizumab (Ocrevus) and Ocrelizumab hya-ocsq (Ocrevus Zunovo)

MULTI

BCBSND-OCRELIZUMAB-OCREVUS-E9B55D14C2, Ocrelizumab Ocrevus

BCBSNJ-DRUGS-150-32F9539D1A, Ocrelizumab (Ocrevus)

HEALTHNET_OR-HNOR-OCRELIZUMAB-OCREVUS-OCRELIZUMAB-HYALURONIDASE-OCSQ-OCREV-85A0E068BD, Ocrelizumab (Ocrevus), Ocrelizumab/Hyaluronidase-ocsq (Ocrevus Zunovo); CP.PHAR.335

MODA-OCREVUS-BBDE047008, Ocrevus (ocrelizumab)

IBX-MEDICARE-ADVANTAGE-MA08-088E-C18DBFB75A, Ocrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)

IBX-COMMERCIAL-08-01-38E-52B98DD968, Ocrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)

UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

SUREST-POL-SUREST-ocrevus-ocrelizumab, Ocrevus (Ocrelizumab) and Ocrevus Zunovo (Ocrelizumab and Hyaluronidase-Ocsq)

AMERIHEALTH-COMMERCIAL-08-01-38E-3F9E746FE3, Ocrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-088E-34BF4BA987, Ocrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)

BCBSTN-6e907f0afc, Multiple Sclerosis Products:(Ocrelizumab [Ocrevus], Ocrelizumab and Hyaluronidase-ocsq [Ocrevus Zunovo], Ublituximab-xiiy [Briumvi])

EVICORE-MEDICAL_DRUG-25E4B43CDDD7, Ocrevus (ocrelizumab) Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

OSCAR-OCRELIZUMAB-OCREVUS-OCREVUS-ZUNOVO-PG235-VER-D23B934EA2, Ocrelizumab (Ocrevus, Ocrevus Zunovo) (PG235, Ver. 6)

UHC-COMM-MD-OCREVUS-OCRELIZUMAB-AND-OCREVUS-ZUNOVO-O-2CE5382E65, Ocrevus (Ocrelizumab) and Ocrevus Zunovo (Ocrelizumab and Hyaluronidase-Ocsq) – Community Plan Medical Benefit Drug Policy

UHC-POL-ocrevus-ocrelizumab, Ocrevus (Ocrelizumab) and Ocrevus Zunovo (Ocrelizumab and Hyaluronidase-Ocsq)

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J2350, Injection, ocrelizumab, 1 mg