Provider Alert! Coverage of Vyjuvek (procedure code J3401) Begins January 2024; Prior Authorization Effective February 2024

Date: December 6, 2023

Attention: All Providers

Prior Authorization Effective Date: February 1, 2024

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that on January 1, 2024, Vyjuvek will become a benefit of Medicaid and CHIP. Texas Health and Human Services Commission (HHSC) will require prior authorization for Vyjuvek (procedure code J3401) for Medicaid and CHIP, effective February 1, 2024.

Vyjuvek is the first U.S. Food and Drug Administration (FDA) approved topical gene therapy that delivers new COL7A1 genes directly to dystrophic epidermolysis bullosa (DEB) skin wounds to promote wound healing.

Length of authorization: 6 months

Criteria for initial approval:

1. Patient is at least 6 months of age or older; AND
2. Patient has a confirmed documentation of BOTH of the following:
   1. Confirmed diagnosis of dystrophic epidermolysis bullosa (DEB); diagnosis code Q81.2 AND
   2. Genetic test confirming patient has a mutation in the collagen type VII alpha 1 chain (COL7A1) gene; AND
3. Patient does not have current evidence or history of squamous cell carcinoma or active infection in the area requiring Vyjuvek application; AND
4. Patient (female of childbearing age) has confirmed negative pregnancy status

Criteria for continuation of therapy:

1. Patient has met all initial requirements for initial approval and is currently being treated with Vyjuvek with no adverse reactions; AND
2. Patient has experienced positive clinical response as documented by ANY of the following
   1. Reduction in the number of wounds; OR
   1. Reduction in wound size; OR
   1. Increase in granulation tissue; OR
   1. Complete wound closure ; AND
3. Patient has not experienced any complications while being treated with Vyjuvek

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

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, indication, or age 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 Vyjuvek, 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.