Etranacogene dezaparvovec (Hemgenix) (Medicaid Expansion)

Policy ID: ME-I-9027-002-01

Section: Injections

Effective Date: August 01, 2023

Last Reviewed: July 26, 2023

Applies To: Medicaid Expansion Only

Description

Etranacogene dezaparvovec (Hemgenix®) is a one-time gene replacement therapy indicated for the prevention of bleeding episodes in adult individuals with moderate-severe to severe hemophilia B. Hemophilia B is an X-linked genetic disorder characterized by a deficiency in clotting factor IX (FIX) resulting in impaired clotting. Severity of hemophilia B is determined based off the amount of FIX in the blood plasma.

Etranacogene dezaparvovec (Hemgenix) is an adeno-associated virus (AAV) gene therapy composed of a recombinant AAV5 (rAAV5) vector with the FIX Padua transgene. Expression of this transgene in liver cells yields functional human clotting FIX-Padua which is then secreted into circulation.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Etranacogene dezaparvovec (Hemgenix ) may be considered medically necessary when an individual meets the following criteria:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
The requested medication must be prescribed by, or in consult with, a hematologist at a dose of 2 x10^13 genome copies (gc) per kg of body weight; and
The date of the individual's last appointment with a Hemophilia Treatment Center must be within the past year; and
The contact information for Hemophilia Treatment Center must be provided; and
The individual was assigned male at birth; and
The individual must currently be treated with routine Factor IX prophylaxis therapy for at least 6 months; and
The individual must have had a life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes; and
The individual must be negative for Factor IX inhibitor titers within the previous 30 days.

The use of e tranacogene dezaparvovec (Hemgenix ) 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

J1411

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.

Diagnosis Code

D67

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Adopted Medicaid Expansion specific 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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