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Filsuvez (birch triterpenes) — Blue Cross Blue Shield of Alabama

wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients age ≥ 6 months

Initial criteria

  • ONE of the following:
  • - The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • - The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  • - The patient has a diagnosis of dystrophic or junctional epidermolysis bullosa confirmed by genetic testing (medical records required) OR
  • - The patient has another FDA labeled indication for the requested agent
  • AND if the patient has an FDA approved indication, then ONE of the following:
  • - The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • - There is support for using the requested agent for the patient’s age for the requested indication
  • AND the patient does NOT have current evidence or a history of squamous cell carcinoma on the area to be treated
  • AND the patient does NOT have an active infection on the area to be treated
  • 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
  • AND the patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated
  • AND the patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization criteria
  • The patient has had clinical benefit with the requested agent
  • The patient does NOT have current evidence or a history of squamous cell carcinoma on the area to be treated
  • The patient does NOT have an active infection on the area to be treated
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or has consulted with a specialist in the area of the patient’s diagnosis
  • The patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 4 months; renewal 12 months