Filsuvez (birch triterpenes) topical gel — United Healthcare

Dystrophic epidermolysis bullosa (DEB)

Initial criteria

age ≥ 6 months
Diagnosis of dystrophic epidermolysis bullosa (DEB) OR junctional epidermolysis bullosa (JEB)
Submission of medical records confirming a genetic mutation associated with DEB or JEB (COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)
At least one partial thickness wound that meets ALL: 10–50 cm2 in size AND present for ≥ 3 weeks AND adequate granulation tissue AND excellent vascularization AND no evidence of active wound infection AND no evidence/history of basal or squamous cell carcinoma (SCC)
Prescribed by or in consultation with a dermatologist with expertise in treatment of epidermolysis bullosa (EB)
Not used in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

Documentation of positive clinical response to Filsuvez therapy (e.g., complete wound closure, reduction in wound size, decrease in procedural pain, less frequent dressing changes, decreased total body wound burden)
Wound(s) being treated meet ALL: adequate granulation tissue AND excellent vascularization AND no evidence of active wound infection AND no evidence/history of basal or squamous cell carcinoma (SCC)
Prescribed by or in consultation with a dermatologist with expertise in treatment of epidermolysis bullosa (EB)
Not used in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

12 months