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Clinical Criteria Implementation for Enzyme Replacement Hormonal Therapy Agents effective May 1, 2024

Date: April 18, 2024

Attention: All Providers

Effective Date: May 1, 2024

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective May 1, 2024, the Texas Health and Human Services (HHSC) will implement clinical prior authorizations to Adzynma (procedure code C9167) and Pombiliti (procedure code J1203) to the Enzyme Replacement Therapy (ERT) policy.

Prior Authorization Requirements 

Apadamtase alfa (Adzynma), procedure code C9167 is indicated to treat the following: 

  • Pediatric and adult clients for prophylactic or on-demand ERT for congenital thrombotic thrombocytopenic purpura (cTTP)
  • No age restrictions
  • Restricted to diagnosis code D6942

Cipaglucosidase alfa-atga (Pombiliti) procedure code J1203 is indicated to treat the following:

  • Adult clients with Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) who weigh over 40 kilograms, are not improving on current ERT
  • Restricted to age 18 or older
  • Restricted to diagnosis code E7402

Next steps for providers: Providers are strongly encouraged to follow the guidance as specified above. Prescribers should share this communication with their staff. Providers must stay up-to-date on the latest restrictions and indications for these agents to ensure appropriate use and maximize patient outcomes. Provider must submit documentation (such as office chart notes, lab results, other pertinent clinical information, etc.) supporting that the member has met all appropriate criteria for medication approval.

Note: If request is for a dose or indication that is not approved by the U.S. Food and Drug Administration (FDA), 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 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.