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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

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