Dystrophic epidermolysis bullosa (DEB) is a condition caused by mutations in gene COL7A in which skin becomes fragile and prone to blistering. For people with DEB, any injury or friction on the skin can lead to the formation of painful blisters.
In mild cases, blisters form on the hands, feet, knees, and elbows. In more severe cases, the blisters become more widespread and can lead to vision loss, scarring, and other medical problems. Severe generalized recessive dystrophic epidermolysis (RDEB, severe generalized) is the classic form and also the most severe. Infants born with this condition suffer from blistering and skin loss, along with extreme scarring after the blisters heal. Individuals with RDEB, severe generalized also have an increased risk of squamous cell carcinoma.
The gene therapy Vyjuvek was initially approved May 19, 2023, for individuals six (6) months of age and older with DEB with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Vyjuvek is mixed into a gel, and a healthcare provider administers it once a week directly into the wound until it is fully healed.
On September 15, 2025, the United States Food and Drug Administration expanded the approval of Vyjuvek to allow it to be given from birth. In addition, patients and their caregivers can apply Vyjuvek and manage their dressing changes at home.
The wholesale acquisition cost of Vyjuvek is $25,230 per vial and the average patient will use 26 vials per year. Thus the estimated annual cost of treating one patient is projected to be $655,980.
For more information about how DEB and its treatment may affect your plan, please contact your Summit ReSources care specialist.
Article written by Stacy Schumacher, RN, BSN, CMCN, Managed Care Specialist. The following sources were used as reference material for this article:
https://medlineplus.gov/genetics/condition/dystrophic-epidermolysis-bullosa/#inheritance
https://www.siia.org/files/resource_library_files/CGT_Overview_and_Resources_2025_Rev_8_25.pdf