Emapalumab-lzsg (Gamifant®) is an interferon gamma blocking antibody for the treatment of newborn and older individuals with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.
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.
Emapalumab (Gamifant) may be considered medically necessary in individuals newborn and older when ALL of the following criteria are met:
The use of emapalumab-lzsg (Gamifant) for any other indication is considered experimental/investigation and therefore non-covered. Scientific evidence does not support its use for any other indications.
Note: Emapalumab (Gamifant) is not indicated for the treatment of secondary HLH.
Note: Prior to emapalumab (Gamifant) administration, individual should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to individuals who are at risk for TB or known to have positive purified protein derivative (PPD) test result or positive interferon gamma release assay. Individuals should also be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to emapalumab (Gamifant) administration. During treatment, individuals should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every two weeks and as clinically indicated.
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.