sirolimus gel 0.2% — Blue Cross Blue Shield of Montana

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]; Minor features: 'confetti' skin lesions, dental enamel pits [≥3], intraoral fibromas [≥2], retinal achromic patch, multiple renal cysts, nonrenal hamartomas, sclerotic bone lesions) OR
• B. The patient has a pathogenic variant in the TSC1 gene or TSC2 gene confirmed by genetic testing
• 2. The patient has three or more facial angiofibromas
• 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 OR
• B. There is support for using the requested agent for the patient’s age for the requested indication
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with such a specialist
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate criteria for Ohio residents (Fully Insured or HIM Shop plans): BOTH of the following:
• A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
• B. ONE of the following:
• 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. The patient has another indication supported in compendia for the requested agent and route of administration OR
• 3. The prescriber has submitted TWO peer-reviewed published clinical studies supporting the proposed use as generally safe and effective per accepted compendia guidelines (DrugDex level 1, 2A, or 2B; AHFS-DI narrative text supportive; NCCN 1 or 2A; or equivalent)

Reauthorization criteria

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

Approval duration

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