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Tagraxofusp-erzs (Elzonris)

Section: Injections
Effective Date: October 01, 2019

Description

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.

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.

The use of tagraxofusp-erzs (Elzonris) for the treatment of BPDCN may be considered medically necessary when ALL of the following criteria are met:

  • Documentation of diagnosis of BPDCN; and
  • Medication prescribed by or in consultation with an oncologist or hematologist; and
  • Individual is 2 years of age or older; and
  • Pre-medications administered prior to each tagraxofusp-erzs (Elzonris) infusion including ALL of the following:
    • H1-histamine antagonist; and
    • Acetaminophen; and
    • Corticosteroid; and
    • H2-histamine antagonist; and
  • Prior to first dose of initial treatment cycle, documentation of serum albumin is greater than or equal to 3.2 g/dL; and
  • Initial treatment cycle MUST be administered in an inpatient setting and individual will be monitored for at least 24 hours after last infusion:
    • Subsequent treatment cycles can be administered in appropriate outpatient setting.

The use of tagraxofusp-erzs (Elzonris) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.

Procedure Codes

J9269

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

C86.4