Krystal Biotech Receives Permanent J-code for B-VEC for the Treatment of DEB

Krystal Biotech recently announced that the US Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code, J3401, for beremagene geperpavec (B-VEC/ VYJUVEK), the first FDA-approved treatment for dystrophic epidermolysis bullosa (DEB). J3401 for B-VEC went into effect on January 1, 2024.¹

“The permanent J-code will help ensure efficient and accurate reimbursement of VYJUVEK and further enable us to bring this important treatment to DEB patients in need,” said Krish S. Krishnan, the chairman and CEO at Krystal Biotech, in the news release.

According to the announcement, J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate the billing of treatments that must be administered by a health care professional. J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing. The permanent J-code published by CMS can be found here.¹

B-VEC was approved by the FDA for the treatment of DEB on May 19, 2023. The approval was based on positive data from 2 placebo-controlled clinical trials, GEM 3 (NCT04491604) and GEM1/2 (NCT03536143). B-VEC was granted priority review designation in August 2022, as DEB is a rare and severe skin disease that does not have any other FDA-approved treatment options.²

"Dystrophic epidermolysis bullosa, a rare skin blistering disorder that results from a mutation in gene encoding type VII collagen (COL7A1), places a life-long burden on affected children and their caregivers," said Raj Chovatiya, MD, PhD, assistant professor of dermatology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois, in an interview with Dermatology Times. "Extensive cutaneous blistering follows even the most minor trauma, and repeated cycles of blistering can result in scarring, malignancy, infection, limb loss, and early death. B-VEC is a topical, gene-based therapy that presents a new, innovative approach to treating DEB.”

B-VEC is a non-invasive, topical, redosable gene therapy created to administer 2 copies of the COL7A1 gene when directly applied to DEB wounds. B-VEC treats DEB at the molecular level by giving patients’ cells a template to produce normal COL7 proteins. The FDA granted B-VEC orphan drug designation, fast track designation, pediatric designation, and regenerative medicine advanced therapy for the treatment of DEB.²

References

1. Krystal Biotech receives permanent J-code (J3401) for VYJUVEK. News release. Krystal Biotech. January 4, 2024. Accessed January 4, 2024. https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-receives-permanent-j-code-j3401-vyjuvekr#:~:text=The%20J%2Dcode%20for%20VYJUVEK,Chairman%20%26%20CEO%20at%20Krystal%20Biotech%20.
2. FDA approves first topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa. News release. U.S. Food and Drug Administration. May 19, 2023. Accessed January 4, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa.