sirolimus gel — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of tuberous sclerosis complex (TSC) confirmed by ONE of the following: (A) Two major features OR one major and two minor features of TSC clinical diagnostic criteria OR (B) Pathogenic variant in the TSC1 or TSC2 gene confirmed by genetic testing
• The patient has three or more facial angiofibromas
• If the patient has an FDA labeled indication, then ONE of the following: (A) Patient age is within FDA labeling for the requested indication OR (B) There is support for use in the patient’s age for the requested indication
• 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 does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or has consulted with such a specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months