Natalizumab (Medicaid Expansion)

Policy ID: ME-I-85-020-05

Section: Injections

Effective Date: January 01, 2022

Revised Date: March 05, 2025

Revision Effective Date: April 01, 2025

Last Reviewed: March 11, 2025

Applies To: Medicaid Expansion Only

Description

Natalizumab (Tysabri ^(R) ) is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab (Tysabri) contains human framework regions and the complementarity determining regions of a murine antibody that binds to a 4-integrin.

Natalizumab-sztn (Tyruko®) is the biosimilar to natalizumab (Tysabri).

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.

Natalizumab may be considered medically necessary when the following criteria is met:

Multiple Sclerosis (MS)

As monotherapy for relapsing forms of MS when ALL of the following are met:

A diagnosis of relapsing forms of MS 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
Individual has had anti-JCV antibody testing prior to initiating treatment with natalizumab and annually thereafter; and
The individual will NOT be using natalizumab in combination with an additional disease modifying agent (DMA) for MS.

Crohn's Disease (CD)

As therapy for inducing and maintaining clinical response and remission in individuals 18 years of age and older with moderately to severely active CD with evidence of inflammation when ALL of the following are met:

A diagnosis of CD; and
Prescribed by or in consultation with a gastroenterologist or provider who specializes in the treatment of CD; and
The individual will NOT be using natalizumab in combination with an additional disease modifying agent (DMA) for CD.

Reauthorization Criteria

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

The use of natalizumab 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

J2323

Q5134

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 Codes

Covered Diagnosis Codes for Procedure Code J2323 and Q5134

G35

K50.00

K50.10

K50.80

K50.90

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

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

Added preferred products, and
Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Effective January 1, 2024

Removed trial agents criteria for MS

Internal Medical Policy Committee 3-19-2024 Effective April 01, 2024

Added natalizumab-sztn (Tyruko), Q5134, to the policy

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

Updated Crohn's Disease initial criteria required based on the DHHS PDL Version 2025.2

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-85-020-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: March 18, 2024

Revision Effective Date: April 01, 2024

Last Reviewed: March 19, 2024

Archived Date: March 31, 2024

Applies To: Medicaid Expansion Only

Description

Natalizumab-sztn (Tyruko®) is the biosimilar to natalizumab (Tysabri).

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.

Natalizumab may be considered medically necessary when the following criteria is met:

Multiple Sclerosis (MS)

As monotherapy for relapsing forms of MS when ALL of the following are met:

A diagnosis of relapsing forms of MS 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
Individual has had anti-JCV antibody testing prior to initiating treatment with natalizumab and annually thereafter; and
The individual will NOT be using natalizumab in combination with an additional disease modifying agent (DMA) for MS.

Crohn's Disease (CD)

A diagnosis of CD; and
Prescribed by or in consultation with a gastroenterologist or provider who specializes in the treatment of CD; and
The individual has failed a three (3)-month trial of vedolizumab (Entyvio), as evidenced by paid claims or printouts; and
The individual will NOT be using natalizumab in combination with an additional disease modifying agent (DMA) for CD.

Reauthorization Criteria

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

Procedure Codes

J2323

Q5134

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J2323 and Q5134

G35

K50.00

K50.10

K50.80

K50.90

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

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

Added preferred products, and
Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Effective January 1, 2024

Removed trial agents criteria for MS

Internal Medical Policy Committee 3-19-2024 Effective April 01, 2024

Added natalizumab-sztn (Tyruko), Q5134, to the policy

Medical Policies Quick Search

Natalizumab (Medicaid Expansion)

Description

Policy Application

Criteria

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J2323 and Q5134

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J2323 and Q5134

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer