Date: July 24, 2024
Attention: All Providers
Effective Date: September 1, 2024
URGENT PATIENT SAFETY NOTICE: Providers should halt the administration of ELEVIDYS for non-ambulatory clients while an enhanced immunosuppressive regimen is evaluated. |
Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that Texas Health and Human Services Commission (HHSC) updated the prior authorization criteria for Elevidys (procedure code J1413), a benefit of Medicaid and CHIP, as the result of a recent review by the FDA. The update is effective September 1, 2024, for fee-for-service Medicaid clients.
Elevidys (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory and non-ambulatory clients 4 years of age and older with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene.
The prior authorization criteria for delandistrogene moxeparvovec-rokl (Elevidys) was previously for ambulatory clients ages 4 to 5 years. With the FDA update, Elevidys is currently approved for clients ages 4 years and older, whether ambulatory or non-ambulatory. The clinical policy and prior authorization criteria have been updated accordingly.
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.
Next step for Providers: Providers should share this update with their staff.
Resources:
If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.
For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.