Alemtuzumab (LemtradaTM) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of individuals with relapsing forms of multiple sclerosis (MS).
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:
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
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.
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:
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.