Background

Zevaskyn (prademagene zamikeracel, also known as pz‑cel) is an autologous, cell‑based gene therapy designed for treating chronic wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) — a rare genetic skin disorder characterized by fragile skin and painful, hard-to-heal wounds.

Policy (Criteria)

Zevaskyn (Prademagene Zamikeracel Topical) may be considered MEDICALLY NECESSARY when all of the following criteria have been met:

• Age ≥ 6 years
• Diagnosis of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
• Member has genetic test results confirming biallelic pathogenic mutations in the COL7A1 gene
• Member has clinical manifestations of Recessive Dystrophic Epidermolysis Bullosa (RDEB) (e.g., extensive skin blistering, skin erosions, scarring)
• Member has at least one stage 2 chronic wound that will be treated (open for ≥ 6 months)
• Member does not have an active infection
• Zevaskyn will not be administered to wound(s) that have been previously treated with Zevaskyn
• Zevaskyn will be applied in a surgical health care setting in a qualified wound center by a provider with expertise in wound care in Recessive Dystrophic Epidermolysis (RDEB)
• Maximum of twelve sheets are supplied for a single application
• There is no clinical evidence or history of squamous cell carcinoma in the area that will undergo treatment
• Zevaskyn is not prescribed concurrently with Vyjuvek (beremagene geperpavec-svdt) or Filsuvez (birch triterpenes)

References

1. Zevaskyn Prescribing Information. Abeona Therapeutics Inc. Cleveland, OH. April 2025 ClinicalTrials.gov. NCT04227106. Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). Accessed May 12, 2025.
2. HCPCS Code J3389. (2026). J3389- HCPCS Code for Topical Administtation, prademagene zamikeracel. Hcpcs.codes. https://hcpcs.codes/j-codes/J3889/

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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