Ocrelizumab (Ocrevus) (Medicaid Expansion)

Policy ID: ME-I-171-010-05

Section: Injections

Effective Date: January 01, 2022

Revised Date: March 06, 2025

Revision Effective Date: April 01, 2025

Last Reviewed: March 11, 2025

Applies To: Medicaid Expansion Only

Description

Ocrelizumab (Ocrevus ^(R) ) and ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo ^TM ) are CD20-directed cytolytic antibodies indicated for relapsing or primary progressive forms of multiple sclerosis (MS).

Ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo) is a combination of ocrelizumab and hyaluronidase in a subcutaneous formulation that is given by a healthcare professional. These two products are different formulations and cannot be used interchangeably.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Ocrevus or Ocrevus Zunovo may be considered medically necessary for the treatment of EITHER of the following conditions:

Relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, when ALL of the following are met:
- Adults 18 years of age or older; and
- A diagnosis of relapsing forms of multiple sclerosis as defined by an MRI of the brain showing abnormalities consistent with MS; and
- Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS; or
Primary progressive MS when ALL of the following are met:
- ONE of the following:
  - Evidence of lesion dissemination in space in the brain based on greater than or equal to one (1) T2 lesions in at least one (1) area characteristic for MS periventricular, juxtacortical, or infratentorial; Gadolinium enhancement of lesions is not required; or
  - Evidence of lesion dissemination in space in the spinal cord based on greater than or equal to 2 T2 lesions in the cord (Gadolinium enhancement of lesions is not required); or
  - A documented history or presence of an elevated CSF IgG index or CSF oligoclonal band; and
- One (1) or more years in which neurologic symptoms typical of MS progressively worsen and at least TWO of the following:
  - The individual is 18 years of age or older; and
  - Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS.

Reauthorization Criteria

The individual has an FDA approved indication for Ocrevus or Ocrevus Zunovo; and
The individual has had clinical benefit from treatment with Ocrevus or Ocrevus Zunovo; and
The prescriber is a neurologist or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using Ocrevus or Ocrevus Zunovo in combination with an additional disease modifying agent (DMA).

Ocrevus or Ocrevus Zunovo for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J2350

J2351

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

G35

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-19-2024 Effective January 01, 2025

Annual review no clinical content change

Internal Medical Policy Committee 03-11-2025 Effective April 01, 2025

Added new code J2351 for Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq)

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: ME-I-171-010-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 24, 2024

Revision Effective Date: January 01, 2025

Last Reviewed: November 19, 2024

Archived Date: March 31, 2025

Applies To: Medicaid Expansion Only

Description

Ocrelizumab (Ocrevus ^(R) ) is a CD20-directed cytolytic antibody indicated for relapsing or primary progressive forms of multiple sclerosis (MS).

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Ocrelizumab (Ocrevus) may be considered medically necessary for the treatment of EITHER of the following conditions:

Relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, when ALL of the following are met:
- Adults 18 years of age or older; and
- A diagnosis of relapsing forms of multiple sclerosis as defined by an MRI of the brain showing abnormalities consistent with MS; and
- Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS; or
Primary progressive MS when ALL of the following are met:
- ONE of the following:
  - Evidence of lesion dissemination in space in the brain based on greater than or equal to one (1) T2 lesions in at least one (1) area characteristic for MS periventricular, juxtacortical, or infratentorial; Gadolinium enhancement of lesions is not required; or
  - Evidence of lesion dissemination in space in the spinal cord based on greater than or equal to 2 T2 lesions in the cord (Gadolinium enhancement of lesions is not required); or
  - A documented history or presence of an elevated CSF IgG index or CSF oligoclonal band; and
- One (1) or more years in which neurologic symptoms typical of MS progressively worsen and at least TWO of the following:
  - The individual is 18 years of age or older; and
  - Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS.

Reauthorization Criteria

The individual has an FDA approved indication for ocrelizumab (Ocrevus); and
The individual has had clinical benefit from treatment with ocrelizumab (Ocrevus); and
The prescriber is a neurologist or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using ocrelizumab (Ocrevus) in combination with an additional disease modifying agent (DMA).

Ocrelizumab (Ocrevus) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J2350

Diagnosis Code

G35

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-19-2024 Effective January 01, 2025

Annual review no clinical content change

Medical Policies Quick Search

Ocrelizumab (Ocrevus) (Medicaid Expansion)

Description

Policy Application

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer