sirolimus gel 0.2 % — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. The patient has a diagnosis of tuberous sclerosis complex (TSC) confirmed by ONE of the following:
• A. The patient has two major features OR one major and two minor features of TSC clinical diagnostic criteria (Major features: hypomelanotic macules ≥3, at least 5 mm diameter; angiofibroma ≥3 or fibrous cephalic plaque; ungual fibromas ≥2; shagreen patch; multiple retinal hamartomas; multiple cortical tubers and/or radial migration lines; subependymal nodule ≥2; subependymal giant cell astrocytoma; cardiac rhabdomyoma; lymphangiomyomatosis (LAM); angiomyolipomas ≥2) OR
• B. The patient has a pathogenic variant in the TSC1 gene or TSC2 gene confirmed by genetic testing AND
• 2. The patient has three or more facial angiofibromas AND
• 3. If the patient has an FDA labeled indication, then ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• 4. 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
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. 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
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent.

Approval duration

initial 12 weeks; renewal 12 months