Tagraxofusp-erzs (Elzonris™) is a first in class CD123-directed cytotoxin composed of recombinant human interleukin-3 and truncated diphtheria toxin fusion protein that inhibits protein synthesis for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in individuals 2 years of age and older.
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.
The use of tagraxofusp-erzs (Elzonris) for the treatment (e.g., first-line therapy, as treatment induction, continuation after induction, or for relapsed/refractory disease if not already used) of BPDCN may be considered medically necessary when ALL of the following criteria are met:
The use of tagraxofusp-erzs (Elzonris) for any other indication is considered experimental/investigational and therefore non-covered as the published peer reviewed literature does not support its efficacy or safety for any other indications.
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.
Note: To reduce the risk of development of capillary leak syndrome, prior to the first dose of the initial treatment cycle serum albumin should be greater than or equal to 3.2 g/dL.
Pre-medications are recommended to be administered prior to each tagraxofusp-erzs (Elzonris) infusion includingthe following:
Original Effective Date April 1, 2019
Internal Medical Policy Committee 7-2019 New code C9049 added to policy
Internal Medical Policy Committee 5-19-2020 Criteria removed, additional notes added, code updated to J9269 and C9049 removed
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.