birch triterpenes gel 10% — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following: (A) The patient has a diagnosis of dystrophic or junctional epidermolysis bullosa confirmed by genetic testing (medical records required) OR (B) The patient has another FDA labeled indication for the requested agent
• If the patient has an FDA approved indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• 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 such a specialist
• 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

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 such a specialist
• 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

12 months (BCBSIL and BCBSMT); 4 months (other plans)