Date: February 27, 2024
Attention: All Providers
Prior authorization effective date: February 1, 2024
URGENT PATIENT SAFETY NOTICE:
Sarepta suspends the drug, ELEVIDYS (HCPCS code J1413) for Non-ambulatory patients with Duchene muscular dystrophy due to patient safety concerns including risk for acute liver failure and death. Providers should halt the administration of ELEVIDYS for non-ambulatory clients while an enhanced immunosuppressive regimen is evaluated. Click here to learn more. |
Call to action: The purpose of this communication is to inform providers that on January 1, 2024, Elevidys became a benefit of Medicaid and CHIP. Texas Health and Human Services Commission (HHSC) requires prior authorization for Elevidys (procedure code J1413) for Medicaid and CHIP, effective February 1, 2024.
Elevidys is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory pediatric clients ages 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
Prior Authorization Requirements:
Coverage will be provided for one dose and may not be renewed
- Patient is 4 through 5 years of age; AND
Patient has a confirmed diagnosis of Duchenne muscular dystrophy confirming BOTH of the following:
- Mutation in the DMD gene between exons 1-17 and/or 59-71 (ICD 10 – 71.01); AND
- Mutation is not a deletion in exon 8 or exon 9 in the DMD gene; AND
- Patient is ambulatory and not wheelchair-bound (able to walk with or without assistance) confirmed via documentation; AND
- Patient is not on concomitant DMD antisense oligonucleotide therapy (e.g., golodirsen, casimersen, viltolarsen, eteplirsen, etc.); AND
- Patient does not have an elevated anti-AAVrh74 total binding titer > 1400; AND
- Patient does not have current infection; AND
- Patient’s liver function test should be document prior and post infusion; AND
- Patient’s platelet count and troponin-I level be obtained prior to infusion; AND
- Patient has never received Elevidys treatment (J1413) in their lifetime
Monitoring parameters:
- Liver function should be monitored upon initiation of therapy and continued on a weekly schedule for the first 3 months after Elevidys infusion due to the possibility of acute serious liver injury.
- Troponin–l level should be monitored weekly for the first month after treatment with Elevidys.
Next step for Providers: Providers should 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.
Note: If request is for a non-FDA approved dose or indication, 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 and when there any updates or changes related to the coverage for Elevidys, we will promptly communicate those changes to you.
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.
