Prior Authorization Criteria and Age Limitation Updates for CAD Enzyme Replacement Therapy

Date: October 6, 2026

Attention: Providers

Effective date: October 1, 2026

Call to action: Texas Children’s Health Plan (TCHP) would like to make providers aware that effective for dates of service on or after October 1, 2026, prior authorization will be required for clinician-administered drugs (CADs) tividenofusp alfa-eknm (Avlayah) (procedure code J1757) and pegzilarginase-nbln (Loargys) (procedure code J1818). Texas Medicaid will also update the age limits for galsulfase (Naglazyme), imiglucerase (Cerezyme), and taliglucerase alfa (Elelyso).

Prior Authorization Criteria

Prior authorization requests for tividenofusp alfa-eknm (Avlayah) and pegzilarginase-nbln (Loargys) must be submitted on the Special Medical Prior Authorization (SMPA) Request Form.

The Texas Medicaid & Healthcare Partnership (TMHP) may approve prior authorization for tividenofusp alfa-eknm (Avlayah) (procedure code J1757) and pegzilarginase-nbln (Loargys) (procedure code J1818) if they are requested for the following indications:

• Tividenofusp alfa-eknm (Avlayah) is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) in presymptomatic or symptomatic pediatric clients weighing at least five kilograms before advanced neurologic impairment (diagnosis code E761).
• Pegzilarginase-nbln (Loargys) is indicated to treat hyperargininemia in clients who are 2 years of age or older with arginase 1 deficiency (ARG1-D) in conjunction with dietary protein restriction (diagnosis code E7221).

Age Limitation Updates

• Galsulfase (Naglazyme) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for clients who are 5 years of age or older with mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome) and may be reimbursed with diagnosis code E7629.
• Imiglucerase (Cerezyme) is indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric clients with a confirmed diagnosis of Type 1 Gaucher disease (diagnosis code E7522).
• Taliglucerase alfa (Elelyso) is indicated for long-term ERT for adult and pediatric clients who are 4 years of age or older with Type 1 Gaucher disease (diagnosis code E7522).

Next step for Providers: Providers should share this communication with other prescribers. 

If you have any questions, please email Provider Relations at providerrelations@texaschildrens.org.

For access to all provider alerts www.texaschildrenshealthplan.org/provideralerts.