Does J2351 require prior authorization?

Yes, J2351 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J2351?

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

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`J2351`, Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq

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.
Ocrelizumab (Ocrevus®) or ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo™) may be considered medically necessary for the treatment of adults with relapsing forms of MS (including CIS, RRMS, active SPMS) or PPMS, AND HBV negative, no active infection, not in combination with another MS DMD, not with live vaccines; immunizations at least 4 weeks prior to initiation.
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: For initial therapy, all of the following: o Diagnosis of primary progressive multiple sclerosis (PPMS); and o Patient is not receiving Ocrevus or Ocrevus Zunovo in combination with any of the following: [...]
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.

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-193159, Ocrelizumab (Ocrevus) and Ocrelizumab hya-ocsq (Ocrevus Zunovo)

MULTI

MODA-CUSTOM-MODA-MPS-OCREVUS-SQ-B4B3F7E9BC, Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

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

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)

BCBSOK-RX501.085, Ocrelizumab or Ocrelizumab and Hyaluronidase-ocsq

BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care

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

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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J2351, Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq