Vyjuvek™ (beremagene geperpavec-svdt)

Vyjuvek is covered only for topical treatment of open, clean, adequately granulated/vascularized wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) when a pathogenic COL7A1 mutation is documented and there is no evidence or clinical suspicion of squamous cell carcinoma; excluded are closed wounds, infected or poorly granulated/vascularized wounds, wounds with suspected/known SCC, use without documented COL7A1 mutation, or for diagnoses other than DEB. Key requirements: initial and renewal approvals (each up to 6 months) require dermatologist or wound‑care specialist prescribing/consultation, documentation of genetic testing and DEB clinical features, wound assessments and baseline/follow‑up measurements showing the target wound remains open and has decreased in size for reauthorization, and adherence to once‑weekly topical dosing with age‑based weekly limits (<3 years: 2×10^9 PFU/1 mL; ≥3 years: 4×10^9 PFU/2 mL).

"Clinical notes describing adequate granulation tissue and vascularization of the target wound."