Filsuvez™
Drug - Filsuvez™ (birch triterpenes) [Chiesi USA]
January 2025
Therapeutic area - Dystrophic epidermolysis bullosa
Initial approval criteria
- Age ≥ 6 months; AND
- Diagnosis of dystrophic or junctional epidermolysis bullosa (EB) as confirmed by one of the following (medical records required):
- Immunofluorescence mapping (IFM); OR
- Transmission electron microscopy (TEM); OR
- Genetic testing; AND
- The patient does NOT have current evidence or a history of squamous cell carcinoma in the area that will undergo treatment; AND
- The patient does NOT have an active infection in the area that will undergo treatment; AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
- Initial approval is for 4 months
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient must have clinical benefit with use; AND
- Patient has not experienced any treatment-restricting adverse effects (e.g., local or systemic hypersensitivity).
- Renewal approval is for 6 months
Quantity limits
- 30 tubes per 30 days. If a supply of more than 30 tubes per 30 days is required, provide the following information at time of request:
-
- Estimated affected area size; 1 tube covers the same area as a business envelop (4 1/8” X 9 ½”)l; AND
- Frequency of application or wound dressing
Questions?
Provider Call Center (844) 575-7887