Alemtuzumab (Lemtrada™)

Policy ID: I-9118-007

Section: Injections

Effective Date: April 01, 2021

Revised Date: July 15, 2024

Revision Effective Date: October 01, 2024

Last Reviewed: July 16, 2024

Applies To: Commercial Only

Description

Alemtuzumab (Lemtrada ^TM ) 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.

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

*Preferred brand agents
Avonex ^® (interferon b-1a)
Betaseron ^® (interferon b-1b)
Kesimpta ^® (ofatumumab)
Mavenclad ^® (cladribine)
Mayzent ^® (siponimod) ^b Plegridy ^® (peginterferon b-1a)
Rebif ^® (interferon b-1a)
Vumerity ^® (diroximel fumarate)
Zeposia ^® (ozanimod)

Alemtuzumab (Lemtrada) may be considered medically necessary when the following criteria are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days; or
- The prescriber states that the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of a relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease or active secondary progressive disease AND 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:
      1. The individual has greater than or equal to one (1) gadolinium enhancing lesion on MRI; or
      2. 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 3 MS agents from different drug classes; or
  3. ONE of the following:
    1. The individual has tried and had an inadequate response to TWO preferred generic agent* FDA approved for the treatment of the requested indication; or
    2. The individual has an intolerance or hypersensitivity to TWO 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 FDA approved for the treatment of the requested indication; or
    4. The prescriber has provided information in support of using alemtuzumab (Lemtrada) over ALL preferred generic agents FDA approved for the treatment of the requested indication; or
- The individual has another FDA approved indication and route of administration for alemtuzumab (Lemtrada) ; 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 alemtuzumab (Lemtrada); or
- The prescriber has provided information in support of using alemtuzumab (Lemtrada) for the individual's age and requested indication; and
The individual will be receiving anti-viral prophylaxis for herpetic viral infections; 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 alemtuzumab (Lemtrada) in combination with an additional disease modifying agent (DMA) for the requested indication; and
ONE of the following:
- The individual has NOT received treatment with alemtuzumab (Lemtrada); or
- The individual has received treatment with alemtuzumab (Lemtrada) AND BOTH of the following:
  - The prescriber has provided the number of doses and treatment courses the individual has received; and
  - The individual has NOT received two (2) or more treatment courses with alemtuzumab (Lemtrada).

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

Reauthorization Criteria

Alemtuzumab (Lemtrada) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for alemtuzumab (Lemtrada) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit from treatment with alemtuzumab (Lemtrada); and
The prescriber has provided the number of doses and treatment courses the individual has received; and
The individual has NOT received two (2) or more treatment courses with alemtuzumab (Lemtrada); 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 alemtuzumab (Lemtrada) in combination with another disease modifying agent (DMA) for the requested indication.

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 not recommended for use in individuals with clinically isolated syndrome (CIS) due to its safety profile.

Diagnosis Code

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.

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)

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

ND Committee Review

Internal Medical Policy Committee 3-17-2021

Adopted policy was previously policy number I-118 (same title)

Internal Medical Policy Committee 3-23-2022

Updated wording in criteria, no clinical content change

Internal Medical Policy Committee 9-28-2022 - Effective October 01, 2022

Added Vumerity as a preferred brand agent

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

Added fingolimod as a preferred generic agent, 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
Removed Aubagio and Gilenya from preferred brand agents
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

Internal Medical Policy Committee 7-16-2024 Effective October 01, 2024

Updated preferred agent 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: I-9118-006

Section: Injections

Effective Date: April 01, 2021

Revised Date: August 21, 2023

Revision Effective Date: October 01, 2023

Last Reviewed: September 12, 2023

Archived Date: September 30, 2024

Applies To: Commercial Only

Description

Alemtuzumab (Lemtrada ^TM ) 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.

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

Alemtuzumab (Lemtrada) may be considered medically necessary when the following criteria are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days; or
- The prescriber states that the individual has been treated with alemtuzumab (Lemtrada) within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of a relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease or active secondary progressive disease 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 3 MS agents from different drug classes; or
  - BOTH of the following:
    - 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 FDA approved for the treatment of the requested indication; or
      - The prescriber has provided information in support of using alemtuzumab (Lemtrada) over ALL preferred generic agents FDA approved for the treatment of the requested indication; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE preferred brand agent* FDA approved for the treatment of the requested indication; or
      - The individual has an intolerance or hypersensitivity to ONE preferred brand agent FDA approved for the treatment of the requested indication; or
      - The individual has an FDA labeled contraindication to ALL preferred brand agents FDA approved for the treatment of the requested indication; or
      - The prescriber has provided information in support of using alemtuzumab (Lemtrada) over ALL preferred brand agents FDA approved for the treatment of the requested indication; or
- The individual has another FDA approved indication and route of administration for alemtuzumab (Lemtrada) ;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 alemtuzumab (Lemtrada); or
- The prescriber has provided information in support of using alemtuzumab (Lemtrada) for the individual's age and requested indication; and
The individual will be receiving anti-viral prophylaxis for herpetic viral infections; 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 alemtuzumab (Lemtrada) in combination with an additional disease modifying agent (DMA) for the requested indication; and
ONE of the following:
- The individual has NOT received treatment with alemtuzumab (Lemtrada); or
- The individual has received treatment with alemtuzumab (Lemtrada) AND BOTH of the following:
  - The prescriber has provided the number of doses and treatment courses the individual has received; and
  - The individual has NOT received two (2) or more treatment courses with alemtuzumab (Lemtrada).

Procedure Code

J0202

Reauthorization Criteria

Alemtuzumab (Lemtrada) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for alemtuzumab (Lemtrada) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has an FDA approved indication for alemtuzumab (Lemtrada); and
The individual has had clinical benefit from treatment with alemtuzumab (Lemtrada); and
The individual will be receiving anti-viral prophylaxis for herpetic viral infections; and
The prescriber has provided the number of doses and treatment courses the individual has received; and
The individual has NOT received two (2) or more treatment courses with alemtuzumab (Lemtrada); 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 alemtuzumab (Lemtrada) in combination with another disease modifying agent (DMA) for the requested indication.

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

G35

Professional Statements and Societal Positions Guidelines

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.

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-118 (same title)

Internal Medical Policy Committee 3-23-2022

Updated wording in criteria, no clinical content change

Internal Medical Policy Committee 9-28-2022 - Effective October 01, 2022

Added Vumerity as a preferred brand agent

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

Added fingolimod as a preferred generic agent, 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
Removed Aubagio and Gilenya from preferred brand agents
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

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