Multiple Sclerosis (Injectable - CD20-Directed Cytolytic Antibody) - Ocrevus Intravenous
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Defines prior authorization, coverage criteria, dosing, and exclusions for ocrelizumab (Ocrevus) intravenous infusion for treatment of primary progressive MS and relapsing forms of MS for Cigna-administered plans.
Added a specialist prescribing requirement.
Added criteria for a patient currently receiving Ocrevus for ≥ 1 year.
Age requirement for Multiple Sclerosis, Relapsing Forms lowered from ≥ 18 years to ≥ 10 years; for patients < 18 years, weight must be ≥ 25 kg.
Dosing for relapsing forms and primary progressive MS was divided into Initial Dosing and Maintenance Dosing and wording changed to allow A and/or B regimens to be approved.
Added a definition of documentation.
Coverage Criteria for Ocrevus (ocrelizumab)
Initial and Continuation Therapy Criteria
Ocrevus is medically necessary when ONE of the following criteria is met (1 or 2):
Primary Progressive MS
- Primary Progressive criteria: A. Patient is ≥ 18 years of age; AND B. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
Relapsing Forms of MS
- Initial Therapy: i. Age/weight criteria; ii. Patient has a relapsing form of multiple sclerosis; iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
i. Age/weight: Patient is ≥ 10 years of age; if patient is < 18 years of age, patient weighs ≥ 25 kg. Examples of relapsing forms include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- Patient Currently Receiving Ocrevus for ≥ 1 Year: i. Age/weight criteria; ii. Patient has a relapsing form of multiple sclerosis; iii. Patient experienced a beneficial clinical response assessed by at least one objective measure OR experienced stabilization, slowed progression, or improvement in at least one symptom; iv. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
Objective measures include MRI lesion activity, EDSS, NEDA-3/NEDA-4, relapse reduction, MSFC, 6-minute walk, or attenuation of brain volume loss.
Dosing
Approved dosing when criteria are met:
Approve initial and/or maintenance dosing as appropriate (A and/or B).
For pediatric patients meeting the age and weight criteria.
Follow the specified initial and maintenance dosing regimens when authorizing therapy.
Revised coverage criteria highlights
Policy-level criteria revisions and additions
Revised from prior requirement of ≥ 18 years.
This change permits both regimens to be approved concurrently when appropriate.
Continuation requires documentation of benefit or stabilization as defined in the policy; exact continuation details are in the dosing/criteria sections.
This specialist requirement was added as a policy revision and applies to initial and continuation approvals.
Concurrent administration of Ocrevus (ocrelizumab) with other disease‑modifying agents used for multiple sclerosis is considered not medically necessary. The policy states these agents are not indicated for use in combination and refers to the Appendix for example agents that should not be combined with Ocrevus.
The policy revision history notes removal of certain Appendix items and plan‑specific preferred product requirements. Specifically, the policy records removal of Extavia from the Appendix and removal of Individual and Family Plans preferred product references in prior revisions; the Appendix still lists multiple disease‑modifying agents as examples (see Appendix for the current list).
Use of Ocrevus for any indication not listed in the policy is considered not medically necessary. This includes concurrent use with other multiple sclerosis disease‑modifying therapies, which the policy explicitly identifies as not medically necessary.
Coding and Dosing Summary
| J2350 | Injection, ocrelizumab, 1 mg |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required for Ocrevus
Prior authorization is required for benefit coverage of Ocrevus; approvals are recommended for patients who meet the Criteria and Dosing and are provided for the duration noted (typically 1 year). Requests for doses outside the dosing documented in this policy will be considered case-by-case by a clinician.
- Approval durations (typically 1 year) applied when criteria are met.
- Requests for non-standard doses reviewed case-by-case by Medical Director or Pharmacist.
Specialist prescribing requirement for authorization
Prior authorization requires that Ocrevus be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; policy revisions explicitly added this specialist prescribing requirement.
- Specialist requirement applies to both Primary Progressive MS and Relapsing Forms criteria where prescribing clinician must be a neurologist or MS specialist.
- Operationally enforced at prior authorization review.
No step therapy required
No step therapy requirements are specified in this policy section.
No explicit step therapy stated
The policy text does not state any explicit step therapy protocols or required trial of alternative agents in these chunks.
Required documentation for prior authorization
Prior authorization requests must include evidence that the patient meets the policy Criteria and Dosing and documentation that Ocrevus is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.
- Clinical evidence supporting relevant indication (e.g., age/weight, relapsing form or primary progressive criteria).
- Confirmation of prescribing clinician specialty or documented consultation with a neurologist/MS specialist.
Policy adds definition of documentation
The policy added a definition of 'documentation' to guide submissions; providers should follow the newly defined documentation requirements when submitting prior authorization requests.
- Refer to the policy's definition of documentation for acceptable supporting records when preparing submissions.
Denial triggers: missing codes or not‑medically‑necessary uses
Claims submitted without covered diagnosis or procedure codes, or for uses listed as not medically necessary (for example, concurrent use with other disease‑modifying MS agents), will be denied.
- Ensure billing uses the covered diagnosis/procedure codes listed in the policy (claims lacking covered codes will be denied).
- Do not submit claims for uses explicitly listed as not medically necessary, such as concurrent use with other MS disease‑modifying therapies.
Potential denial if pediatric age/weight or dosing criteria not met
Potential denial risk if the patient does not meet the revised age or weight requirements for relapsing forms (age must be ≥10 years; if <18 years, patient must weigh ≥25 kg) or if dosing does not conform to the updated initial and maintenance dosing regimens.
- For Relapsing Forms: patient must be ≥10 years old; patients <18 years must weigh ≥25 kg.
- Dosing must follow the policy's Initial and Maintenance Dosing regimens (deviations may lead to denial or case-by-case review).
Definitions and Key Terms
Background
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system that can follow relapsing or progressive courses. Ocrevus (ocrelizumab) is a CD20‑directed cytolytic antibody indicated for treatment of primary progressive MS and relapsing forms of MS; pediatric relapsing‑remitting MS is addressed for patients aged ≥ 10 years who meet the policy’s weight criteria. The policy specifies approved dosing regimens when clinical criteria are met (for adults and for pediatric weight bands) and requires prior authorization and specialist involvement (prescribed by or in consultation with a neurologist or physician who specializes in MS). Recent revisions lowered the minimum age for relapsing forms to ≥ 10 years and added a weight requirement of ≥ 25 kg for patients under 18, split dosing into Initial and Maintenance regimens, and added continuation criteria for patients currently receiving Ocrevus for ≥ 1 year.
Policy Revision History
Added a definition of documentation to clarify required supporting materials for prior authorization submissions.
Operational requirement added that Ocrevus be prescribed by or in consultation with a neurologist or physician who specializes in MS.
Removed Individual and Family Plans preferred product (administrative update).
Removed Individual and Family Plans preferred product (administrative update).
Dosing for relapsing forms and primary progressive MS divided into Initial and Maintenance dosing; wording changed to allow A and/or B regimens to be approved and 'up to' language added before milligram quantities.
Policy name updated to include 'intravenous'; policy statement added; documentation requirements removed; conditions-not-covered statement updated; Extavia removed from the Appendix.
Policy text updated to add 'up to' dosing language and to record earlier dosing/name changes (administrative entry dated 07/02/2026 in revision log).
Lowered minimum age for relapsing forms from ≥18 to ≥10 years and added weight requirement that patients <18 years must weigh ≥25 kg; marked as effective date of the current policy.
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