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.

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.

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
• Individual has had an inadequate response to two or more preferred medications indicated for the treatment of MS; and
• Individual has HIV-negative status; and
• Alemtuzumab (Lemtrada) is not to be used in combination with other disease modifying therapies (DMTs); and
• Individual receives appropriate vaccinations, concomitant prophylaxis, and pre-infusion medications:
  • High dose corticosteroids prior to infusion and for first 3 days of each treatment course; and
  • Anti-viral prophylaxis for herpetic viral infections; and
  • Completion of any necessary immunizations at least 6 weeks prior to treatment with alemtuzumab (Lemtrada), with no live vaccines administered concurrent or within 6 weeks prior to treatment.

Preferred agents:

Aubagio (teriflunomide)
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Copaxone (glatiramer)
glatiramer
Gilenya (fingolimod)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon beta-1a)
Rebif (interferon beta-1a)
Tecfidera (dimethyl fumarate)

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

Procedure Codes

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.
• Patients 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 patients are authorized before infusing alemtuzumab (Lemtrada).
• Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions.

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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

NA