Alemtuzumab (Lemtrada) (Medicaid Expansion)

Policy ID: ME-I-118-008-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 16, 2024

Revision Effective Date: December 01, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Alemtuzumab (Lemtrada) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of individuals with relapsing 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.

Alemtuzumab (Lemtrada) may be considered medically necessary for the treatment of relapsing-remitting forms of MS when ALL of the following criteria 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
The individual has failed at least a three (3)-month trial of two or more of the following as indicated for the treatment of MS:
- ublituximab-xiiy (Briumvi);
- ofatumumab (Kesimpta);
- ocrelizumab (Ocrevus);
- natalizumab (Tysabri); and
Alemtuzumab (Lemtrada) is not to be used in combination with other disease modifying therapies (DMTs) for MS; and
The has completed necessary immunizations at least six (6) weeks prior to treatment with Alemtuzumab (Lemtrada), with no live vaccines administered concurrent or within six (6) weeks prior to treatment.

Reauthorization Criteria

The individual has documented positive clinical response (e.g., confirmed delay or improvement of disability progression, reduction in T2 lesion volume) ; and
The prescriber is a neurologist the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual is not receiving alemtuzumab (Lemtrada) in combination with another disease modifying therapy for MS ; and
Subsequent treatment is 12 months after the last dose of prior alemtuzumab (Lemtrada) course

The use of alemtuzumab (Lemtrada) 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

J0202

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.

NOTE: Alemtuzumab (Lemtrada) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program called the LEMTRADA REMS Program, because of the risks of autoimmunity, infusion reactions, and malignancies.

NOTE: Alemtuzumab (Lemtrada) is not recommended for use in individuals with clinically isolated syndrome (CIS) due to its safety profile

Diagnosis Code

Covered Diagnosis Code for Procedure Code J0202

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

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

Updated initial criteria, and
Updated reauthorization criteria, and
Added note about CIS, and
Moved REMS information under Professional Statements and Societal Positions Guidelines, and
Updated experimental/investigational statement

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

Updated initial criteria

Internal Medical Policy Committee 11-19-2024 Effective December 1, 2024

Updated criteria to remove 'The individual has HIV-negative status' based on the DHHS PDL Version 2024.6

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-118-008-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 20, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Archived Date: November 30, 2024

Applies To: Medicaid Expansion Only

Description

Alemtuzumab (Lemtrada) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of individuals with relapsing forms of multiple sclerosis (MS).

Criteria

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

Alemtuzumab (Lemtrada) may be considered medically necessary for the treatment of relapsing-remitting forms of MS when ALL of the following criteria 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
The individual has failed at least a three (3)-month trial of two or more of the following as indicated for the treatment of MS:
- ublituximab-xiiy (Briumvi);
- ofatumumab (Kesimpta);
- ocrelizumab (Ocrevus);
- natalizumab (Tysabri); and
The individual has HIV-negative status; and
Alemtuzumab (Lemtrada) is not to be used in combination with other disease modifying therapies (DMTs) for MS; and
The has completed necessary immunizations at least six (6) weeks prior to treatment with Alemtuzumab (Lemtrada), with no live vaccines administered concurrent or within six (6) weeks prior to treatment.

Reauthorization Criteria

The individual has documented positive clinical response (e.g., confirmed delay or improvement of disability progression, reduction in T2 lesion volume) ; and
The prescriber is a neurologist the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual is not receiving alemtuzumab (Lemtrada) in combination with another disease modifying therapy for MS ; and
Subsequent treatment is 12 months after the last dose of prior alemtuzumab (Lemtrada) course

Procedure Code

J0202

NOTE: Alemtuzumab (Lemtrada) is not recommended for use in individuals with clinically isolated syndrome (CIS) due to its safety profile

Diagnosis Code

Covered Diagnosis Code for Procedure Code J0202

G35

Professional Statements and Societal Positions Guidelines

Alemtuzumab (Lemtrada) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program called the LEMTRADA REMS Program, because of the risks of autoimmunity, infusion reactions, and malignancies.

Notable requirements of the LEMTRADA REMS Program include the following:

Prescribers must be certified with the program, by enrolling and completing training.
Individuals must enroll in the program and comply with ongoing monitoring requirements.
Pharmacies must be certified with the program and must only dispense to certified healthcare facilities that are authorized to receive alemtuzumab (Lemtrada).
Healthcare facilities must enroll in the program and verify that individuals are authorized before infusing alemtuzumab (Lemtrada). Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions.

ND Committee Review

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

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

Updated initial criteria, and
Updated reauthorization criteria, and
Added note about CIS, and
Moved REMS information under Professional Statements and Societal Positions Guidelines, and
Updated experimental/investigational statement

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

Updated initial criteria

Medical Policies Quick Search

Alemtuzumab (Lemtrada) (Medicaid Expansion)

Description

Policy Application

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer