Tagraxofusp-erzs (Elzonris) (ARCHIVED)

Policy ID: I-207-008

Section: Injections

Effective Date: April 01, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-207-008

Section: Injections

Effective Date: April 01, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

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 two (2) years of age and older.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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 (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:

Documentation of diagnosis of BPDCN; and
Medication prescribed by or in consultation with an oncologist or hematologist; and
Individual is two (2) years of age or older; 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; or

Compendia Sources

Tagraxofusp-erzs (Elzonris) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of tagraxofusp-erzs (Elzonris) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9269

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

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.

Diagnosis Code

C86.4

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-2019

New code C9049 to policy

Internal Medical Policy Committee 5-19-2020

Removed Criteria, and
Added additional notes, and
Updated code to J9269, and
Removed C9049

Internal Medical Policy Committee 5-20-2021 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022 Annual review, no clinical content change

Internal Medical Policy Committee 5-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Removed pre-medication information
Added Compendia sources statement 'Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Updated experimental/investigational statement

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

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.

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