Ekterly (sebetralstat) — Medica

Initial criteria

• age ≥ 12 years
• Patient has HAE type I or type II as confirmed by BOTH: 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 (HAE type III) does NOT satisfy this requirement
• 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]
• Patient has had a favorable clinical response with Ekterly treatment (e.g., decrease in duration of HAE attacks, quick onset of symptom relief, complete resolution of symptoms, or decrease in HAE acute attack frequency or severity)
• 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