Ocrelizumab (Ocrevus) (Medicaid Expansion)

Policy ID: ME-I-171-010-02

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 29, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

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).

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 Codes

J2350

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

Diagnosis Codes

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

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-171-010-01

Section: Injections

Effective Date: January 01, 2022

Last Reviewed: November 23, 2021

Archived Date: December 31, 2022

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).

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; and
- Does not have an active Hepatitis B virus infection; and
- Individual will not receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus); and
- The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus).
Primary progressive MS when ALL of the following are met:
- Adults 18 years of age; and
- Individual will not receive a live vaccine for at least four (4) weeks prior to and during treatment with ocrelizumab (Ocrevus); and
- Prescribed by, or in consultation with, a neurologist or provider who specializes in the treatment of MS; and
- A diagnosis of primary progressive multiple sclerosis (PPMS) based on the McDonald criteria:
  - Note: McDonald criteria defined as:
    - One or more years in which neurologic symptoms typical of multiple sclerosis progressively worsen and at least 2 of the following:
      - Evidence of lesion dissemination in space in the brain based on greater than or equal to 1 T2 lesions in at least 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
- Does not have an active Hepatitis B virus infection; and
- The individual has not had a life-threatening infusion reaction to ocrelizumab (Ocrevus).

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) is considered experimental/investigational for any other indication; and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

J2350

Diagnosis Codes

G35

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Links

References (PDF)

Disclaimer

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search

Ocrelizumab (Ocrevus) (Medicaid Expansion)

Description

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer