Ocrelizumab (Ocrevus)

Policy ID: I-9171-005

Section: Injections

Effective Date: April 01, 2021

Revised Date: August 21, 2023

Revision Effective Date: October 01, 2023

Last Reviewed: September 12, 2023

Applies To: Commercial Only

Description

Ocrelizumab (Ocrevus®) 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.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

*Preferred generic agents
dimethyl fumarate
fingolimod
glatiramer
Glatopa (glatiramer)
teriflunomide

Ocrelizumab (Ocrevus) may be considered medically necessary when the following criteria are met:

ONE of the following:
- Information has been provided that the individual has been treated with ocrelizumab (Ocrevus) within the past 210 days; or
- The prescriber states the individual has been treated with ocrelizumab (Ocrevus) within the past 210 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of a relapsing form of multiple sclerosis (MS) AND BOTH of the following:
  1. ONE of the following:
    1. The individual has a diagnosis of clinically isolated syndrome (CIS) AND ALL of the following:
      1. The individual had a single event that lasted at least 24 hours; and
      2. The event was not due to fever or infection; and
      3. The individual has MS-like brain lesion(s) confirmed by magnetic resonance imaging (MRI); or
    2. The individual has a diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS); and
  2. ONE of the following:
    1. The individual has highly active MS disease activity AND BOTH of the following:
      1. The individual has greater than or equal to two (2) relapses in the previous year; and
      2. ONE of the following:
        
        The individual has greater than or equal to one (1) gadolinium enhancing lesion on MRI; or
        The individual has a significant increase in T2 lesion load compared with a previous MRI; or
    2. The individual has been treated with at least three (3) MS agents form different drug classes; or
    3. ONE of the following:
      1. The individual has tried and had an inadequate response to ONE preferred generic agent* FDA approved for the treatment of the requested indication; or
      2. The individual has an intolerance or hypersensitivity to ONE preferred generic agent FDA approved for the treatment of the requested indication; or
      3. The individual has an FDA labeled contraindication to ALL preferred generic agents that are FDA approved for the treatment of the requested indication; or
      4. The prescriber has provided information in support of using ocrelizumab (Ocrevus) over ALL preferred generic agents FDA approved for the treatment of the requested indication; or
- The individual has a diagnosis of primary progressive multiple sclerosis (PPMS); or
- The individual has another FDA approved indication for ocrelizumab (Ocrevus); and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for ocrelizumab (Ocrevus); or
- The prescriber has provided information in support of using ocrelizumab (Ocrevus) for the individual's age and requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (i.e., 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 another disease modifying agent (DMA) for the requested indication.

The use of 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

Reauthorization Criteria

Ocrelizumab (Ocrevus) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for ocrelizumab (Ocrevus) through Blue Cross Blue Shield of North Dakota's precertification process; and
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 specialist in the area of the individual's diagnosis (e.g., 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 another disease modifying agent (DMA) for the requested indication.

Procedure Code

J2350

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

MS Disease Modifying Agents drug classes

Class

Class Drug Agents

CD20 monoclonal antibody

CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

CD52 monoclonal antibody

CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

Fumarates

Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

Glatiramer

Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

IgG4k monoclonal antibody

IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

Interferons

Interferons

AVONEX*Interferon beta-1a injection

Interferons

BETASERON*Interferon beta-1b injection

Interferons

EXTAVIA*Interferon beta-1b injection

Interferons

PLEGRIDY*Peginterferon beta-1a injection

Interferons

REBIF*Interferon beta-1a injection

Purine antimetabolite

Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

Pyrimidine synthesis inhibitor

Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

Sphingosine 1-phosphate (SIP) receptor modulator

Sphingosine 1-phosphate (SIP) receptor modulator

GILENYA*Fingolimod HCl Cap

Sphingosine 1-phosphate (SIP) receptor modulator

MAYZENT*Siponimod Fumarate Tab

Sphingosine 1-phosphate (SIP) receptor modulator

PONVORY*Ponesimod Tab

Sphingosine 1-phosphate (SIP) receptor modulator

TASCENSO*fingolimod lauryl sulfate tablet disintegrating

Sphingosine 1-phosphate (SIP) receptor modulator

ZEPOSIA*Ozanimod capsule

Agents NOT to be used Concomitantly (subject to change)

MS Disease Modifying Agents
Aubagio (teriflunomide)
Avonex (interferon b-1a)
Bafiertam (monomethyl fumarate)
Betaseron (interferon b-1b)
Briumvi (ublituximab-xiiy)
Copaxone (glatiramer)
Dimethyl fumarate
Extavia (interferon b-1b)
fingolimod
Gilenya (fingolimod)
Glatopa (glatiramer)
Glatiramer
Kesimpta (ofatumumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon b-1a)
Ponvory (ponesimod)
Rebif (interferon b-1a)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)a
Vumerity (diroximel fumarate)
Zeposia (ozanimod)

ND Committee Review

Internal Medical Policy Committee 3-17-2021 Adopted policy was previously policy number I-171 (same title)

Internal Medical Policy Committee 3-23-2022 Update criteria wording, removed preferred brand agent step

Internal Medical Policy Committee 11-29-2022 - Effective December 01, 2022

Added fingolimod as a preferred generic agent, and
Removed hepatitis B criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy; and
Added Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

Internal Medical Policy Committee 3-23-2023 Effective April 03, 2023

Added teriflunomide as a preferred generic agent
Updated Agents NOT to be used Concomitantly list and MS Disease Modifying Agents drug classes table

Internal Medical Policy Committee 9-12-2023 Effective October 01, 2023

Added Glatopa as a preferred generic agent

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: I-9171-004

Section: Injections

Effective Date: April 01, 2021

Revised Date: March 16, 2023

Revision Effective Date: April 01, 2023

Last Reviewed: March 23, 2023

Archived Date: September 30, 2023

Applies To: Commercial Only

Description

Ocrelizumab (Ocrevus®) 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.

*Preferred generic agents
dimethyl fumarate
fingolimod
glatiramer
teriflunomide

Ocrelizumab (Ocrevus) may be considered medically necessary when the following criteria are met:

ONE of the following:
- Information has been provided that the individual has been treated with ocrelizumab (Ocrevus) within the past 210 days; or
- The prescriber states the individual has been treated with ocrelizumab (Ocrevus) within the past 210 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of a relapsing form of multiple sclerosis (MS) AND BOTH of the following:
  - ONE of the following:
    - The individual has a diagnosis of clinically isolated syndrome (CIS) AND ALL of the following:
      - The individual had a single event that lasted at least 24 hours; and
      - The event was not due to fever or infection; and
      - The individual has MS-like brain lesion(s) confirmed by magnetic resonance imaging (MRI); or
    - The individual has a diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS); and
  - ONE of the following :
    - The individual has highly active MS disease activity AND BOTH of the following:
      - The individual has greater than or equal to two (2) relapses in the previous year; and
      - ONE of the following:
        
        The individual has greater than or equal to one (1) gadolinium enhancing lesion on MRI; or
        The individual has a significant increase in T2 lesion load compared with a previous MRI; or
    - The individual has been treated with at least three (3) MS agents form different drug classes; or
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE preferred generic agent* FDA approved for the treatment of the requested indication; or
      - The individual has an intolerance or hypersensitivity to ONE preferred generic agent FDA approved for the treatment of the requested indication; or
      - The individual has an FDA labeled contraindication to ALL preferred generic agents that are FDA approved for the treatment of the requested indication; or
      - The prescriber has provided information in support of using ocrelizumab (Ocrevus) over ALL preferred generic agents FDA approved for the treatment of the requested indication; or
- The individual has a diagnosis of primary progressive multiple sclerosis (PPMS); or
- The individual has another FDA approved indication for ocrelizumab (Ocrevus); and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for ocrelizumab (Ocrevus); or
- The prescriber has provided information in support of using ocrelizumab (Ocrevus) for the individual's age and requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (i.e., 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 another disease modifying agent (DMA) for the requested indication.

Procedure Codes

J2350

Reauthorization Criteria

Ocrelizumab (Ocrevus) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for ocrelizumab (Ocrevus) through Blue Cross Blue Shield of North Dakota's precertification process; and
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 specialist in the area of the individual's diagnosis (e.g., 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 another disease modifying agent (DMA) for the requested indication.

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

MS Disease Modifying Agents drug classes

Class

Class Drug Agents

CD20 monoclonal antibody

CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

CD52 monoclonal antibody

CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

Fumarates

Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

Glatiramer

Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

IgG4k monoclonal antibody

IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

Interferons

Interferons

AVONEX*Interferon beta-1a injection

Interferons

BETASERON*Interferon beta-1b injection

Interferons

EXTAVIA*Interferon beta-1b injection

Interferons

PLEGRIDY*Peginterferon beta-1a injection

Interferons

REBIF*Interferon beta-1a injection

Purine antimetabolite

Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

Pyrimidine synthesis inhibitor

Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

Sphingosine 1-phosphate (SIP) receptor modulator

Sphingosine 1-phosphate (SIP) receptor modulator

GILENYA*Fingolimod HCl Cap

Sphingosine 1-phosphate (SIP) receptor modulator

MAYZENT*Siponimod Fumarate Tab

Sphingosine 1-phosphate (SIP) receptor modulator

PONVORY*Ponesimod Tab

Sphingosine 1-phosphate (SIP) receptor modulator

TASCENSO*fingolimod lauryl sulfate tablet disintegrating

Sphingosine 1-phosphate (SIP) receptor modulator

ZEPOSIA*Ozanimod capsule

Agents NOT to be used Concomitantly (subject to change)

ND Committee Review

Internal Medical Policy Committee 3-17-2021 Adopted policy was previously policy number I-171 (same title)

Internal Medical Policy Committee 3-23-2022 Update criteria wording, removed preferred brand agent step

Internal Medical Policy Committee 11-29-2022 - Effective December 01, 2022

Added fingolimod as a preferred generic agent, and
Removed hepatitis B criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy; and
Added Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

Internal Medical Policy Committee 3-23-2023 Effective April 03, 2023

Added teriflunomide as a preferred generic agent
Updated Agents NOT to be used Concomitantly list and MS Disease Modifying Agents drug classes table

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