CurrentCareSourcePolicy N/A

Multiple Sclerosis - Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) Utilization Management Medical Policy

This policy governs prior authorization, coverage criteria, dosing, and prescribing requirements for Ocrevus Zunovo (subcutaneous ocrelizumab + hyaluronidase) for adults with relapsing forms of multiple sclerosis and primary progressive MS; it applies to CareSource medical benefit coverage decisions.

Policy Summary

PayerCareSource

PolicyMultiple Sclerosis - Ocrevus Zunovo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation that medication is prescribed by or in consultation with a neurologist or MS specialist and that criteria for indication and age are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard approval duration

920 mgapproved dose per administration

q6 monthsdosing interval

≥18minimum patient age

2024-10-02policy reviewed on

Policy Summary

PayerCareSource

PolicyMultiple Sclerosis - Ocrevus Zunovo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation that medication is prescribed by or in consultation with a neurologist or MS specialist and that criteria for indication and age are met.

SourceLink

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Coverage Criteria for Ocrevus Zunovo

COVERAGE CRITERIA

Covered when the following FDA-approved indication criteria are met

Indication

Relapsing Forms - Initial Therapy: Patient is ≥ 18 years of age AND has a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing remitting MS, active secondary progressive MS) AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
Approve for 1 year
Relapsing Forms - Continued Therapy: Patient is ≥ 18 years AND has a relapsing form of MS AND patient experienced benefit OR stabilization/slowed progression or improvement in at least one objective measure or symptom (examples: clinical response on an objective measure; stabilization or reduced MRI activity such as decreased gadolinium-enhancing lesions or fewer new/enlarging T2 lesions; EDSS stabilization; achievement of NEDA-3/NEDA-4; improvement on functional scales; reduced relapses; attenuation of brain volume loss) AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
Approve for 1 year
Primary Progressive MS: Patient is ≥ 18 years of age AND has a diagnosis of primary progressive multiple sclerosis AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
Approve for 1 year

Dosing and Administration: Dosing: 920 mg/23,000 units (920 mg ocrelizumab and 23,000 units hyaluronidase) administered subcutaneously once every 6 months

Typical approval duration: 1 year

Concurrent use of Ocrevus Zunovo with other disease-modifying therapies for multiple sclerosis is not recommended. The policy specifies that these agents are not indicated for combination use and that additional data are required to determine safety and added efficacy when used together. Requests for coverage when Ocrevus Zunovo is used concurrently with other disease-modifying MS agents will not be recommended for approval, and coverage is likewise not recommended for circumstances that are not explicitly listed in the Recommended Authorization Criteria.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended for medical benefit coverage of Ocrevus Zunovo. Approvals are provided for the durations noted in the FDA-Approved Indications (typically 1 year) and may be extended if the patient continues to meet the Criteria and Dosing in this policy. Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Ocrevus Zunovo, the medication must be prescribed by or in consultation with a physician who specializes in the condition treated (for example, a neurologist).

Approvals typically limited to 1 year; reauthorization requires documentation that patient continues to meet criteria and has clinical benefit or disease stabilization.
Doses or regimens outside this policy considered case-by-case by clinician review.

Denial Risk

Concurrent Agent Restriction

Ocrevus Zunovo should not be used concurrently with other disease-modifying therapies (DMTs) for multiple sclerosis. These agents are generally not indicated for combination use; additional data are required to determine safety and additive efficacy. See Appendix for examples of other DMTs. Concurrent administration with other DMTs is a basis for non‑coverage.

Concurrent use with other disease-modifying agents for multiple sclerosis is not recommended and may trigger denial.
Appendix lists examples of other DMTs (e.g., Aubagio, Avonex, Kesimpta, Ocrevus IV, Tecfidera, Tysabri, etc.).

Documentation Required

Required Prescriber and Clinical Documentation

Prescriber must be a neurologist or a physician who specializes in the treatment of multiple sclerosis, or the request must document consultation with such a specialist. Required clinical documentation at time of prior authorization request includes: patient age, specific MS diagnosis (relapsing forms or primary progressive as applicable), prior MS treatments and response, objective measures of clinical benefit or disease activity (examples: MRI findings, relapse history, EDSS or other validated functional scales, NEDA status), and proposed dosing schedule. For continuation/reauthorization, provide documentation of clinical response, stabilization, or objective evidence of disease control since initiation.

Required: Prescriber specialty (neurologist or MS specialist) or documented consultation.
Required: Patient age (must be ≥18 years) and specific MS phenotype.
Required: Prior treatment history and rationale for Ocrevus Zunovo.
Required: Objective measures of response or disease activity (MRI, relapse frequency, EDSS, NEDA, functional tests).
For reauthorization: documentation of continued benefit or disease stabilization.

Background

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating autoimmune disease of the central nervous system that affects approximately 1,000,000 people in the United States. The disease typically presents between ages 20 and 40 and manifests in several courses: relapsing forms (including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS) and primary progressive MS, the latter representing roughly 10–15% of patients and characterized by steady symptomatic progression without initial relapses. Ocrevus Zunovo is indicated for adults with relapsing forms of MS and primary progressive MS.

Definitions

Relapsing forms of MS — definition and policy notes

TermRelapsing forms of MS

IncludesClinically isolated syndrome; relapsing remitting MS; active secondary progressive MS

Age requirementPatient must be ≥ 18 years for approval under this policy

Prescriber requirementMedication must be prescribed by or in consultation with a neurologist or MS specialist

Approval durationApprove for 1 year when criteria are met

Primary progressive MS — definition and prevalence

TermPrimary progressive MS

DefinitionA steady progression of symptoms over time without initial relapses

PrevalenceRepresents approximately 10–15% of patients with MS

Typical onsetGenerally diagnosed in patients near the upper end of typical onset age (around 40 years)

Prescriber and age requirementPatient must be ≥ 18 years and medication prescribed by or in consultation with a neurologist or MS specialist