Filsuvez (birch triterpenes) topical gel — Point32Health

Initial criteria

• Documented diagnosis of one of the following as confirmed by genetic testing: dystrophic epidermolysis bullosa (pathogenic variant of COL7A1 gene) OR junctional epidermolysis bullosa (pathogenic variant of LAMA3, LAMB3, LAMC2, COL17A, ITGA6, ITGB4, or ITGA3)
• Age ≥ 6 months
• Previous trial and failure or contraindication to standard wound therapy
• Member has at least one recurrent or chronic partial-thickness wound AND ALL of the following: 10–50 cm² in surface area; present for at least 3 weeks; adequate granulation tissue and excellent vascularization; wound has no evidence of active wound infection
• Member does not have history or current evidence of squamous cell carcinoma in the area that will undergo treatment
• Prescribed by or in consultation with a dermatologist with expertise in the treatment of DEB or JEB
• Member is not currently on Vyjuvek (beremagene geperpavec-svdt topical gel)

Reauthorization criteria

• Clinical documentation confirming that Filsuvez is providing clinical benefit (e.g., decrease in wound size, increase in granulation tissue, decrease in pain severity)
• Prescribed by or in consultation with a dermatologist with expertise in the treatment of DEB or JEB
• Documentation that the wound to be treated is clean in appearance with adequate granulation tissue, has excellent vascularization, and does not appear infected
• Member does not have current evidence of squamous cell carcinoma in the area that will undergo treatment
• Member is not currently on Vyjuvek (beremagene geperpavec-svdt topical gel)

Approval duration

6 months initial, 6 months reauth