Medical Drug Criteria (MDC) 

Policy Num:      P1.002.027
Policy Name:    Zevaskyn (prademagene zamikeracel) 
Policy ID:          [P1.002.027] [Ac L M+ P+ ]

Last Review:   March 3, 2026
Next Review:   September 20, 2026
 

Zevaskyn (prademagene zamikeracel) 

Summary

ZEVASKYN is composed of autologous cells isolated from skin punch biopsies of patients with mutations in the collagen type VII alpha 1 chain (COL7A1) gene and which have been transduced ex vivo with a replicationincompetent retroviral vector (RVV) containing the full-length COL7A1 gene. The resulting gene-modified cell sheets express functional collagen VII (C7) protein. ZEVASKYN is manufactured using human- and animalderived reagents. 

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare and severe mucocutaneous fragility disorder due to mutations in the COL7A1 gene encoding collagen VII, the major constituent of anchoring fibrils essential for epithelial adhesion. RDEB is characterized by unremitting blistering, chronic painful wounds and fibrotic scarring that results in hand and foot pseudosyndactyly, microstomia, and esophageal strictures. RDEB complications include nutritional compromise, chronic anemia, failure to thrive, delayed puberty, osteoporosis, and renal involvement. In addition, early onset cutaneous squamous cell carcinomas (cSCC) represent the first cause of premature death. Despite recent progress in wound care, disease management still relies on symptomatic and preventive measures. No clinical practice guidelines specifically focused on the care of RDEB are currently available.¹

Policy Statements

Zevaskyn (prademagene zamikeracel) is considered medically necessary for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Policy Guidelines

None. 

DOSAGE/ADMINISTRATION

Recommended Dose

For autologous topical application on wounds only.  

• The recommended dose of ZEVASKYN is based on the surface area of the wound(s).  
• ZEVASKYN is supplied as single-dose cellular sheets each measuring 41.25 cm2 (5.5 cm x 7.5 cm) and consisting of patient's own viable, gene-modified cells that contain functional copies of the COL7A1 gene, which express collagen 7 (C7) protein.  
• One sheet of ZEVASKYN covers an area of 41.25 cm2.  
• Up to twelve ZEVASKYN sheets may be manufactured from the patient biopsies and supplied for potential use. 

REQUIRED MEDICAL INFORMATION

ZEVASKYN is to be prepared by the manufacturer in an appropriate healthcare setting for surgical application by a qualified healthcare provider.  

ZEVASKYN should be stored at room temperature (15-25°C) until application.

Apply all selected sheets in a single surgical session. 

EXCLUSION CRITERIA

There is no exclusion criteria. 

Warnings and Precautions

• Hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application.
• Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN.
• Transmission of Infectious Agents may occur because ZEVASKYN is manufactured using human- and bovine-derived reagents. 

BENEFIT APPLICATION

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity. 

Based on benefits or contract language, ZEVASKYN (prademagene zamikeracel), may be considered either a pharmacy or a medical benefit. 

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

None available. 

Practice Guidelines and Position Statements

No Interqual Criteria Applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

References

1. El Hachem, M., Diociaiuti, A., Bonamonte, D. et al. Taking care of patients with recessive dystrophic epidermolysis bullosa from birth to adulthood: a multidisciplinary Italian Delphi consensus. Orphanet J Rare Dis 20, 128 (2025). https://doi.org/10.1186/s13023-025-03635-1

2. ZEVASKYN^TM (prademagene zamikeracel) [package insert]. (2025). Zevaskyn - HCP | For the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Wounds. https://zevaskynhcp.com/

Codes

Policy History