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Prior Authorization Criteria and Age Limitation Updates for CAD Enzyme Replacement Therapy Effective October 1, 2026

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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).

For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.