sirolimus gel 0.2% — Blue Cross Blue Shield of Texas

Initial criteria

• Diagnosis of tuberous sclerosis complex (TSC) confirmed by either (A) two major features OR one major and two minor features of TSC clinical diagnostic criteria OR (B) a pathogenic variant in the TSC1 or TSC2 gene confirmed by genetic testing
• Patient has three or more facial angiofibromas
• If patient has FDA labeled indication, then EITHER (A) patient’s age is within FDA labeling for the indication OR (B) there is support for using the requested agent for the patient’s age
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) OR prescriber has consulted with such a specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient was 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 a specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Initial 12 weeks (BCBSIL: 12 months); Renewal 12 months