Takhzyro (lanadelumab-flyo) — Medica

Initial criteria

• Patient has HAE type I or type II as confirmed by BOTH of the following diagnostic criteria: low levels of functional C1-INH protein (< 50% of normal) at baseline [documentation required]; AND lower than normal serum C4 levels at baseline [documentation required]
• Diagnosis of HAE with normal C1-INH (also known as type III) does NOT qualify
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Reauthorization criteria

• Patient has a diagnosis of HAE type I or type II [documentation required]
• According to the prescriber, the patient has had a favorable clinical response since initiating Takhzyro prophylactic therapy compared with baseline (e.g., decreased frequency, severity, or duration of HAE attacks)
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Approval duration

1 year