Prior Authorization Criteria for High-Cost Clinician Administered Drugs (HCCAD) Aucatzyl and Lenmeldy

Effective date: July 1, 2025

Call to action: Texas Children’s Health Plan (TCHP) would like to make providers aware of updates to the prior authorization criteria for High-Cost Clinician Administered Drugs (HCCAD) Aucatzyl and Lenmeldy.

Aucatzyl

• On July 1, 2025, Aucatzyl will become a benefit of Medicaid and CHIP. HHSC requires prior authorization for Aucatzyl (procedure code Q2058) for Medicaid and CHIP, effective for dates of service on or after August 1, 2025.
• Aucatzyl (obecabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated to treat adult clients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
• Health and Human Services (HHSC) will reimburse Aucatzyl as non-risk and designated as a high-cost clinician-administered drug (HCCAD). The HHSC-approved clinical prior authorization is mandatory for TCHP and all other MCOs.

Lenmeldy

• On July 1, 2025, Lenmeldy, will become a benefit of Medicaid and CHIP. HHSC requires prior authorization for Lenmeldy (procedure code J3391) for Medicaid and CHIP, effective for dates of service on or after August 1, 2025.
• Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of clients with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ), or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy.
• HHSC will reimburse Lenmeldy as non-risk and designated it as a high-cost clinician-administered drug. The HHSC-approved clinical prior authorization is mandatory for TCHP and all other MCOs.

Aucatzyl Prior Authorization Requirements

• Prior authorization approval for a one-time, split dose Aucatzyl (obecabtagene autoleucel) Q2058 infusion therapy will be considered when all the following criteria are met:
• The client is 18 years and older;
• There is a confirmed diagnosis of relapsed or refractory B-cell precursor ALL (diagnosis code: C91.00, C91.02);
• The client has adequate cardiac, hepatic, pulmonary, and renal function;
• A bone marrow blast assessment was conducted and result from a sample obtained to start lymphodepleting chemotherapy;
• The client does not have a clinically significant active infection or inflammatory disorder;
• The client has been screened and does not have active/latent Hepatitis B virus, active Hepatitis C virus, or human immunodeficiency virus (HIV); and
• The client has not received prior CAR-T therapy.
• Aucatzyl (obecabtagene autoleucel), Q2058 is limited to one transfusion treatment per lifetime.

Required Monitoring Parameters

• TCHP and all other MCOs must require providers to monitor the client for the parameters listed below following Aucatzyl (obecabtagene autoleucel) treatment:
• Signs and symptoms of cytokine release syndrome (CRS);
• Signs and symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS) and other acute toxicities; and
• Signs of cytopenias (e.g., anemia, neutropenia, thrombocytopenia) and secondary malignancies.

Resource: Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual for the current HCCADs list and more details on the clinical policy and prior authorization requirements.

Lenmeldy Prior Authorization Requirements

Prior authorization approval for a one-time Lenmeldy (atidarsagene autotemcel) J3391 infusion therapy will be considered when all the following criteria are met:

• The client is 7 years and younger OR is between the ages 7 to 17 years with onset of symptoms less than 7 years;
• The client has a documented biochemical and molecular diagnosis of one of the following forms of metachromatic leukodystrophy (diagnosis code: E75.25):
  • Pre-symptomatic late infantile
  • Pre-symptomatic early juvenile (PSEJ)
  • Early symptomatic early juvenile
• MLD diagnosis is confirmed by:
  • Biochemical testing indicating Arylsulfatase A (ARSA) activity below normal range,
  • Genetic testing confirming two disease causing ARSA alleles, and
  • If ARSA mutations are present, a 24-hour urine collection showing elevated sulfatide levels.
• The client is a candidate for and has not previously received hematopoietic stem cell gene therapy (HSCT); and
• The client will not take prophylactic HIV anti-retroviral medications for at least one month prior to mobilization, or for the expected duration of time needed for the elimination of medications

Lenmeldy (atidarsagene autotemcel), J3391 is limited to one transfusion treatment per lifetime.

Required Monitoring Parameters

TCHP and all other MCOs must require providers to monitor the client for the parameters listed below following Lenmeldy (atidarsagene autotemcel) treatment:

• Signs and symptoms of encephalitis, thrombocytopenia and/or serious infection;
• Signs and symptoms of veno-occlusive disease including liver function tests during the first month post Lenmeldy infusion; and
• Life-long hematologic malignancies, including a complete blood count (with differential) annually and integration site analysis, as warranted, for at least 15 years after treatment.

Next step for Providers: Providers should share this communication with their staff.

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

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