Hyftor (sirolimus 0.2% topical gel) — Medica

Initial criteria

• age ≥ 6 years
• Patient has a definitive diagnosis of tuberous sclerosis complex by meeting ONE of the following (a or b): a) Identification of a pathogenic variant in the tuberous sclerosis complex 1 (TSC1) gene or tuberous sclerosis complex 2 (TSC2) gene by genetic testing; OR b) According to the prescriber, clinical diagnostic criteria suggest a definitive diagnosis of tuberous sclerosis complex by meeting either two major features or one major feature with two minor features
• Patient has three or more facial angiofibromas that are at least 2 mm in diameter with redness in each
• Medication is prescribed by or in consultation with a dermatologist or a physician who specializes in the management of patients with tuberous sclerosis complex

Reauthorization criteria

• age ≥ 6 years
• Patient has a definitive diagnosis of tuberous sclerosis complex by meeting ONE of the following (a or b): a) Identification of a pathogenic variant in the tuberous sclerosis complex 1 (TSC1) gene or tuberous sclerosis complex 2 (TSC2) gene by genetic testing; OR b) According to the prescriber, clinical diagnostic criteria suggest a definitive diagnosis of tuberous sclerosis complex by meeting either two major features or one major feature with two minor features
• Patient has responded to Hyftor as evidenced by a reduction in the size and/or redness of the facial angiofibromas, as determined by the prescriber
• Medication is prescribed by or in consultation with a dermatologist or a physician who specializes in the management of patients with tuberous sclerosis complex

Approval duration

Initial: 3 months; Reauthorization: 1 year