Takhzyro (lanadelumab-flyo) — Medical Mutual

Initial criteria

• Patient is age ≥ 2 years; AND
• Patient has HAE confirmed by either: low levels of functional C1-INH protein (below 50% of normal) at baseline OR serum C4 < 14 mg/dL at baseline AND C1-INH < 19.9 mg/dL at baseline; AND
• Medication is prescribed by or in consultation with an allergist, immunologist, hematologist, or physician that specializes in the treatment of HAE or related disorders; AND
• Site of care medical necessity is met

Reauthorization criteria

• Patient has HAE confirmed by either: low levels of functional C1-INH protein (below 50% of normal) at baseline OR serum C4 < 14 mg/dL at baseline AND C1-INH < 19.9 mg/dL at baseline; AND
• Medication is prescribed by or in consultation with an allergist, immunologist, hematologist, or physician that specializes in the treatment of HAE or related disorders; AND
• According to the prescriber, patient has had a favorable clinical response since initiating Takhzyro prophylactic therapy compared with baseline (e.g., decrease in HAE attack frequency, severity, or duration); AND
• If patient is dosing every 2 weeks and has been attack-free for 6 months, dosing must be reduced to every 4 weeks; AND
• Site of care medical necessity is met

Approval duration

1 year initial, 1 year renewal