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Vyjuvek (beremagene geperpavec-svdt topical gel)Medica

Dystrophic epidermolysis bullosa (DEB) with pathogenic variant in the COL7A1 gene

Initial criteria

  • Patient is age ≥ 6 months; AND
  • Diagnosis is confirmed by genetic testing showing a pathogenic variant in the collagen type VII alpha 1 chain (COL7A1) gene [documentation required]; AND
  • Patient has at least one clinical feature of dystrophic epidermolysis bullosa (e.g., blistering, wounds, scarring) [documentation required]; AND
  • Patient has one or more open wound(s) that will be treated (target wound[s]); AND
  • Target wound(s) meet ALL of the following according to the prescriber: (a) Target wound(s) is clean in appearance and does not appear infected; AND (b) Target wound(s) has adequate granulation tissue and vascularization; AND (c) Squamous cell carcinoma has been considered for the target wound(s); AND
  • Medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Reauthorization criteria

  • According to the prescriber, the target wound(s) remains open; AND
  • According to the prescriber, the target wound(s) has decreased in size from baseline; AND
  • Medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Approval duration

6 months