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.
Original Effective Date April 1, 2019
Internal Medical Policy Committee 5-19-2020 Added code J9210, removed code C9050
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.