Clinical Criteria for Hemgenix® (procedure code J1411) effective November 1, 2023

Date: September 26, 2023

Attention: Physicians

Effective date for prior authorization criteria: November 1, 2023

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective November 1 2023, the Texas Health and Human Services (HHSC) will be implementing prior authorization criteria for Hemgenix® (procedure code J1411) for fee-for-service Medicaid. Hemgenix (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated to treat adult patients with Hemophilia B (congenital Factor IX deficiency).

Prior Authorization Requirements:

Coverage will be provided for one dose and may not be renewed

1. Patient is 18 years of age or older AND
2. Patient has confirmed diagnosis (D67) for Hemophilia B (congenital Factor IX deficiency) AND
3. Patient has no history of previously receiving treatment with Hemgenix infusion AND
4. Bleeding disorders not related to Hemophilia B have been ruled out AND
5. Patient has one or more of the following:
   • Currently using Factor IX prophylaxis therapy OR
   • Has a current or historical life-threatening hermorrhage OR
   • Has a history of repeated, serious, or spontaneous bleeding episodes AND
6. Patient has a baseline anti-AAV5 antibody titer of less than or equal to 1:678 AND
7. Patient has been tested and found negative for Factor IX inhibitor titers (if test result is positive, re-test within approximately 2 weeks. If re-test is also positive, Hemgenix should not be given AND
8. Patient has baseline liver function assessed prior to and after therapy AND
   • Documentation includes but not limited to alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin
   • Documentation of hepatic ultrasound and elastography

Monitoring Parameters:

1. Liver transaminase levels must be assessed once weekly for at least three months after Hemgenix infusion to monitor for any signs of potential hepatotoxicity
2. Factor IX activity must be monitored weekly for at least three months post-infusion

Refer to the Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next step for Providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Hemgenix approval.

Note: If request is for a non-FDA approved dose or indication, medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If and when there any updates or changes related to the coverage for Hemgenix, we will promptly communicate those changes to you.

If you have any questions, please email TCHP Pharmacy at: tchppharmacy@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.