CurrentModa HealthPolicy MODA-0298

Ocrelizumab (Ocrevus) intravenous therapy for Multiple Sclerosis — Coverage Criteria

Policy governing authorization, dosing, and renewal criteria for ocrelizumab (Ocrevus) intravenous therapy for multiple sclerosis for Moda Health members.

Policy Summary

PayerModa Health

PolicyOcrelizumab (Ocrevus) intravenous therapy for Multiple Sclerosis — Coverage Criteria

Policy CodePolicy MODA-0298

Change TypeNo material changes

Effective Date04/25/2017

Next Review DateOct 3, 2023

Key ActionObtain prior authorization documenting the dosing schedule: initial 300 mg IV on day 1 and day 15, then 600 mg IV every 6 months with required documentation of MS diagnosis (ICD-10 G35).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthslength of initial authorization

300→300; 600dosing schedule

G35covered diagnosis code

J2350HCPCS

11CMS entries referenced

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Initial Approval Criteria

Covered when ALL of the following are met

Age and baseline testing: Patient is at least 18 years of age; screened for Hepatitis B prior to initiating treatment and does not have active disease (i.e., positive HBsAg and anti-HBV tests); baseline serum immunoglobulins assessed.

Vaccine and infection precautions: Patient will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation; patient does not have an active infection.

Therapy use: Therapy must be used as single-agent treatment; patient has not received a dose of ocrelizumab or ublituximab within the past 5 months.

Indication-specific: Multiple Sclerosis: Patient has a confirmed diagnosis of multiple sclerosis documented by laboratory report (e.g., MRI) AND either: (A) relapsing form of MS (relapsing-remitting MS, active secondary progressive MS, or clinically isolated syndrome) with inadequate response to an adequate trial of one of interferon beta-1a (Avonex), dimethyl fumarate, fingolimod, or glatiramer acetate unless contraindicated or not tolerated; OR (B) primary progressive MS (PPMS) with patient age <65 and EDSS ≤6.5.

Relapsing MS diagnostic support: Relapsing MS diagnosis consistent with McDonald criteria: either ≥2 clinical attacks OR 1 clinical attack plus MRI or CSF evidence (gadolinium-enhancing and non-enhancing lesions, new T2 lesions, or CSF-specific oligoclonal bands); dissemination in space as specified (≥2 lesions or 1 lesion plus additional MRI/historical evidence).

Active SPMS definition: Active secondary progressive MS (SPMS) defined by EDSS ≥3.0, progression ≥3 months following a relapsing course (EDSS increase criteria) AND either ≥1 relapse in prior 2 years OR MRI activity (gadolinium-enhancing or new/enlarging T2 lesions).

PPMS diagnostic support: Primary progressive MS diagnosis requires ≥1 year of disability progression independent of relapse AND two of: ≥1 qualifying T2-brain lesion, ≥2 spinal cord T2 lesions, or presence of CSF-specific oligoclonal bands.

Renewal Criteria

Renewal covered when ALL of the following are met

Continued eligibility: Patient continues to meet the universal and indication-specific criteria identified in initial approval.

Toxicity: Absence of unacceptable toxicity from the drug (examples include severe infusion reactions, severe infections, progressive multifocal leukoencephalopathy, malignancy, hypogammaglobulinemia, immune-mediated colitis, etc.).

Clinical benefit monitoring: Ongoing monitoring demonstrates clinical benefit: no increase in annualized relapse rate (ARR), no development of ≥2 unequivocally new MRI-detected lesions, and no progression of sustained impairment on measures such as EDSS, timed 25-foot walk (T25-FW), or 9‑hole peg test (9‑HPT).

Note defines inadequate response as ≥1 relapse, ≥2 unequivocally new MRI lesions, or increased disability over one year for those adherent to therapy.

PPMS renewal:

Use of ocrelizumab must be as a single agent therapy. Combination use with other disease-modifying therapies for multiple sclerosis is not permitted.

For Medicare Part B applicability, the policy references CMS guidance and the Medicare Benefit Policy Manual; where applicable NCDs, LCDs, or LCAs apply they must be followed. The policy specifies Medicare Part B Covered Diagnosis Codes: N/A for existing NCD/LCD/LCA entries.

Prior to initiation, patients must be screened for Hepatitis B and must not have active HBV infection (e.g., positive HBsAg or anti-HBV tests). Baseline serum immunoglobulins should be assessed. Patients must not have an active infection and must not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to starting treatment. Additionally, patients must not have received ocrelizumab or ublituximab within the prior 5 months.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is required. Coverage will be provided for 6 months and may be renewed. Initial and continuation dosing limits apply; see dosing schedule and quantity limits below.

Authorization required prior to initiation
Length of approval: 6 months (may be renewed)
HCPCS: J2350 - Injection, ocrelizumab, 1 mg (1 mg = 1 billable unit)

Billing Rule

Dosing Schedule and Quantity Limits

Initial dosing is two 300 mg IV infusions: one on Day 1 and a second 300 mg infusion on Day 15. Subsequent maintenance dosing is 600 mg IV infusion every 6 months (administer first subsequent dose 6 months after the initial series). Quantity limits: 300 mg single‑dose vial — allow 2 vials in the first 2 weeks, then 2 vials per 6 months.

Initial: 300 mg (300 billable units) Day 1 and Day 15
Maintenance: 600 mg (600 billable units) every 6 months
Quantity limit (NDC unit basis): 2 x 300 mg vials in initial 2 weeks; then 2 x 300 mg vials per 6 months

Documentation Required

Required Clinical Documentation and Step Therapy

Ensure required clinical documentation is submitted with the authorization request: diagnosis documentation (MRI, CSF when indicated), baseline labs, and evidence of prior therapies for relapsing MS per step-therapy requirement.

Confirmed diagnosis of MS (ICD-10 G35) with supporting MRI and/or CSF reports when applicable
For relapsing MS: documentation of inadequate response, contraindication, or intolerance to an adequate trial of one listed DMT (interferon beta-1a, dimethyl fumarate, fingolimod, or glatiramer acetate) unless contraindicated
Baseline labs: Hepatitis B screening (HBsAg and anti-HBV) showing no active infection; baseline serum immunoglobulins
Avoid live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation
Documentation of EDSS or other functional measures when indicated for PPMS or renewal

Denial Risk

Potential Denial Triggers

Denial risks: do not initiate or approve if patient has active Hepatitis B, active infection, recent ocrelizumab/ublituximab within past 5 months, is outside age limits where specified, or if required baseline labs/vaccine precautions are missing.

Active Hepatitis B (positive HBsAg/active HBV) — denial risk
Missing HBV screening or baseline immunoglobulins — may result in denial
Use of live vaccines within 4 weeks prior to initiation — denial risk
Prior ocrelizumab or ublituximab within 5 months — not eligible
Lack of documentation of inadequate response to required prior therapies for relapsing MS — may lead to denial

Note

CMS Guidance and Medicare Compliance

Medicare policy compliance: follow the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 and any applicable NCDs, LCDs, or LCAs. Noncompliance with applicable CMS guidance may result in denial for Medicare members.

Reference: https://www.cms.gov/medicare-coverage-database/search.aspx
Medicare Part B covered diagnosis codes: N/A for additional indications in this policy; follow applicable contractor guidance

Note

Provider action highlight: submit complete supporting documentation with the prior authorization request and ensure dosing aligns with the approved schedule and quantity limits. For renewals include evidence of clinical benefit and absence of unacceptable toxicity.

Attach MRI/CSF reports, HBV screening results, baseline immunoglobulins, prior DMT trial documentation (if relapsing MS), and functional assessments (EDSS/T25-FW/9-HPT) when applicable
Confirm dosing units and HCPCS billing (J2350 = 1 mg unit) on claims
Document rationale if skipping step-therapy due to contraindication or intolerance

Definitions

MS phenotype definitions

Relapsing forms (included)Relapsing‑remitting MS (RRMS), active secondary progressive MS (active SPMS), and clinically isolated syndrome (CIS)

Relapsing MS diagnostic basisDiagnosis per McDonald criteria: ≥2 clinical attacks OR 1 clinical attack plus MRI or CSF evidence (dissemination in time and space)

Primary progressive MS (PPMS) criteriaRequires 1 year of disability progression independent of relapse AND two of: ≥1 characteristic T2 brain lesion, ≥2 spinal cord T2 lesions, or CSF‑specific oligoclonal bands

Evidence requiredConfirmed diagnosis documented by laboratory report (e.g., MRI) or CSF as applicable

Active SPMS definition

EDSS thresholdExpanded Disability Status Scale (EDSS) score ≥ 3.0

Progression requirementDisease progression ≥ 3 months following an initial relapsing‑remitting course (defined as EDSS increase of 1.0 if baseline EDSS ≤5.5 or 0.5 if baseline EDSS ≥6)

Activity requirementEither ≥1 relapse in prior 2 years OR MRI evidence of activity (gadolinium‑enhancing or new/enlarging T2 lesions)

Ambulatory requirement for PPMS

Renewal ambulatory requirementFor PPMS renewal, patient must continue to be ambulatory defined as EDSS <7.5

PPMS initial age/EDSS limitsInitial PPMS eligibility also requires age <65 and EDSS ≤6.5 (per indication‑specific criteria)

DocumentationEDSS score must be documented for renewal and monitoring

G35 — Multiple Sclerosis (ICD‑10)

ICD‑10 codeG35

DescriptionMultiple Sclerosis

UseRequired covered diagnosis code for disease‑modifying therapy authorization

OpenPayer

Ocrelizumab (Ocrevus) intravenous therapy for Multiple Sclerosis — Coverage Criteria

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions