CurrentCapital BlueCrossPolicy N/A

Ocrevus (ocrelizumab) prior authorization request

This document is the Capital BlueCross prior authorization form and clinical criteria checklist for requesting OCREVUS (ocrelizumab) for members; it governs submission requirements and medical necessity criteria for providers seeking approval for initiation or continuation of therapy.

Policy Summary

PayerCapital BlueCross

PolicyOcrevus (ocrelizumab) prior authorization request

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the preauthorization form and provide required documentation, including HBV screening and baseline labs, and fax to 866-805-4150.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Preauth requiredPrior authorization status

HBV screenUniversal screening requirement

EDSS thresholdsEDSS reference

Payment not guaranteedAuthorization limitation

Coverage Criteria for Ocrevus (ocrelizumab)

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Initial therapy - MS

Covered when ALL of the following are met for Multiple Sclerosis:

Confirmed diagnosis: Patient has a confirmed diagnosis of multiple sclerosis (MS) documented by laboratory report (e.g., MRI).

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MS phenotype: Patient has a relapsing form of MS (relapsing-remitting MS [RRMS], active secondary progressive MS [SPMS], or clinically isolated syndrome [CIS]) OR has primary progressive MS (PPMS) meeting PPMS-specific criteria.

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PPMS-specific criteria: If PPMS: patient is less than 65 years AND has an Expanded Disability Status Scale (EDSS) score < 6.5.age <65; EDSS <6.5

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Renewal criteria

Renewal covered when ALL of the following are met:

Tolerability: Patient has absence of unacceptable toxicity from the drug (examples include severe infusion reactions, severe infections, progressive multifocal leukoencephalopathy, or malignancy).

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Clinical response assessment: Continuous monitoring indicates a beneficial response OR, if inadequate response, the definition of inadequate response is not met after sufficient therapy duration.

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Definition of inadequate response: Inadequate response in an adherent patient receiving therapy for sufficient time is defined as > 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a one-year period.>1 relapse OR ≥2 new MRI lesions OR increased disability over 1 year

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All patients must be screened for hepatitis B virus (HBV) prior to initiation of ocrelizumab. The policy requires documentation that the patient "has been screened for the presence of Hepatitis B virus (HBV) prior to initiating treatment AND does not have active disease." Active HBV infection is a contraindication to starting therapy and should preclude initiation until appropriately managed.

Requests for ocrelizumab for an off‑label indication must include supporting documentation in accordance with Medical Policy 2.103. The preauthorization form explicitly asks whether the drug is being requested for an off‑label indication and directs providers to include any applicable documentation from MP 2.103 when "Yes" is selected; lack of this documentation may result in the request not meeting medical necessity.

Coding and Clinical Scores

HCPCS (to be specified on form)HCPCS

HCPCS code(s):

HCPCS codes to be provided on form (not specified in document)

Diagnosis codes (to be specified on form)ICD-10

Diagnosis code(s):

Diagnosis codes to be provided on form (not specified in document)

EDSS thresholds for PPMS (initiation and renewal)

PPMS initiation EDSS thresholdEDSS score < 6.5 required for initial (new) PPMS requests

PPMS renewal ambulatory requirementPatient must continue to be ambulatory defined as EDSS score < 7.5 for continuation/renewal

Source context for thresholdsEDSS thresholds are specified on the form under PPMS and Multiple Sclerosis sections

Provider Requirements, Submission, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for ocrelizumab (OCREVUS). Submit a completed preauthorization form and all required clinical documentation prior to infusion or administration. Note: prior authorization approval is not a guarantee of payment; benefits and eligibility will be verified at claim adjudication and claims may still be denied.

Fax completed form to: 866.805.4150 (toll free)
Prior authorization is required before administration
Prior authorization is not a guarantee of payment; claims adjudication applies

Documentation Required

Submission and Documentation

Complete the preauthorization form with all required submission fields. Provide requesting and rendering provider details (names, addresses, NPI, telephone, secure fax), site of service, HCPCS and diagnosis code(s), medication name/strength/dose/frequency, quantity requested, route of administration, indication, initial start date and anticipated next administration date, and whether this is a new start, continuation, or reinitiation. Indicate if the prescriber is a specialist or consulted a specialist.

Required fields: member information, requesting provider, rendering provider (if different), NPI, site of service, HCPCS code(s), ICD-10 diagnosis code(s), medication requested, indication, dosing (dose, strength, frequency), quantity requested, start/end dates, and prior authorization reason (new, continuation, reinitiation)
If requesting for late-stage metastatic disease (Stage IV), reference MP 2.373 for cancer-stage guidance

Documentation Required

Supporting Clinical Documentation

Include supporting clinical documentation demonstrating medical necessity: prior medication trials and failures (with reasons for discontinuation such as intolerance, hypersensitivity, or inadequate response), documentation of dose changes, specialist consultation notes, and any relevant testing or imaging results. For reauthorization or continuation requests, include prior treatment dates and response information.

List previous medications tried, strengths, and documentation of failure or intolerance
Attach specialist consultation notes when applicable
Document any dose changes and clinical rationale

Documentation Required

Prior Authorization and Required Testing

Required testing must be documented prior to initiating therapy: screen for Hepatitis B virus (HBV) and document that the patient does not have active disease; obtain baseline serum immunoglobulins; confirm the patient does not have an active infection; and document vaccine status (patient will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation). Also confirm the patient has not received a dose of ocrelizumab or ublituximab within the past 5 months when applicable.

HBV screening: documented and negative for active disease
Baseline serum immunoglobulins assessed
No active infection documented
No live or live-attenuated vaccines within 4 weeks prior to initiation
No ocrelizumab or ublituximab dose within past 5 months (when applicable)

Note

Off-label and Cancer Stage Guidance

Off-label requests must include supporting documentation per Medical Policy 2.103, including rationale and literature or guideline support. For requests involving metastatic or late-stage (Stage IV) cancer, follow MP 2.373 for step therapy and cancer-stage-specific requirements; include documentation of disease stage and any relevant oncology specialist input.

If drug is requested for an off-label indication, include documentation per MP 2.103
For late-stage metastatic disease (Stage IV), include documentation and follow MP 2.373 guidance

Denial Risk

Payment Not Guaranteed / Denial Risk

Prior authorization approval alone does not guarantee payment. Claims will be processed according to the member's benefits, eligibility, and applicable billing rules at the time of claim adjudication. Submitting thorough documentation reduces risk of denial but does not eliminate the need for correct coding and coverage verification.

Prior authorization is not a guarantee of payment; benefits and eligibility will apply at claim adjudication
Ensure accurate coding and that site-of-service and billing comply with policy requirements

Background

Ocrelizumab (OCREVUS) is an infused monoclonal antibody indicated for treatment of multiple sclerosis. It is used for relapsing forms of MS — including relapsing‑remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS) — and for primary progressive MS (PPMS). Clinical monitoring of response typically includes relapse frequency, MRI activity, and functional measures such as the Expanded Disability Status Scale (EDSS), Timed 25‑Foot Walk, and 9‑Hole Peg Test.

Definitions and Scoring

Relapsing forms of multiple sclerosis

Relapsing-Remitting MS (RRMS)Listed on the form as a relapsing form of MS eligible under relapsing disease criteria

Active Secondary Progressive MS (active SPMS)Included on the form as an example of relapsing disease phenotype (active SPMS)

Clinically Isolated Syndrome (CIS)CIS is listed on the form as a relapsing form of MS

Primary progressive MS (PPMS) criteria

Age requirement for PPMS (initial)Patient must be less than 65 years for initial PPMS requests

EDSS requirement for PPMS (initial)EDSS score < 6.5 required at initial request

EDSS requirement for PPMS (renewal)For continuation, patient must remain ambulatory with EDSS < 7.5

Policy Summary

PayerCapital BlueCross

PolicyOcrevus (ocrelizumab) prior authorization request

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the preauthorization form and provide required documentation, including HBV screening and baseline labs, and fax to 866-805-4150.

SourceLink

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