Filsuvez (birch triterpenes gel) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Diagnosis of dystrophic or junctional epidermolysis bullosa confirmed by genetic testing (medical records required) OR another FDA labeled indication for the requested agent
• If FDA approved indication, then patient's age is within FDA labeling for the requested indication OR there is support for use at that age
• Patient does NOT have current evidence or a history of squamous cell carcinoma on the area to be treated
• Patient does NOT have an active infection on the area to be treated
• Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) OR has consulted with such a specialist
• Patient will NOT be using the requested agent in combination with a gene therapy agent on the area to be treated
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate approval path for BCBS NM Fully Insured or NM HIM members: ALL of the following — patient does NOT have FDA labeled contraindications, requested indication is a rare disease, AND ONE of the following: another FDA labeled indication for the requested agent and route of administration OR another indication supported in compendia for the agent and route of administration
• Alternate approval path for Ohio residents (Fully Insured or HIM Shop (SG) plans): ALL of the following — member resides in Ohio, plan is Fully Insured or HIM Shop, patient does NOT have FDA labeled contraindications, AND ONE of the following: another FDA labeled indication for the requested agent and route of administration OR another indication supported in compendia OR prescriber has submitted two peer-reviewed journal articles supporting use

Reauthorization criteria

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

Approval duration

4 or 12 months (plan specific)