Vyjuvek™ (beremagene geperpavec-svdt)

Covered: Vyjuvek is authorized for topical treatment of open, clean, adequately granulated/vascularized wounds in patients ≥6 months with genetically confirmed dystrophic epidermolysis bullosa (pathogenic COL7A1); it is not covered for patients <6 months, without COL7A1 confirmation, for closed or infected wounds, wounds lacking adequate granulation/vascularization, or when squamous cell carcinoma has not been considered. Key requirements: initial and renewal approvals (up to 6 months) require a dermatologist or wound care specialist prescribing/consult, documentation of genetic testing and DEB clinical features, wound assessments (baseline and follow‑up showing decreased wound size for reauthorization and that the target wound remains open), once‑weekly topical dosing within age limits (0.8 mL weekly for 6 months–<3 yrs; 1.6 mL weekly for ≥3 yrs).

"Treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene (FDA‑approved indication)."