Orladeyo (berotralstat) — Medica

Hereditary Angioedema (HAE) due to C1 Inhibitor (C1-INH) deficiency – prophylaxis

Initial criteria

Patient is age ≥ 12 years
Patient has HAE type I or type II as confirmed by BOTH of the following: 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

Patient is age ≥ 12 years
Patient has a diagnosis of HAE type I or type II [documentation required]
Diagnosis of HAE with normal C1-INH (HAE type III) does NOT satisfy this requirement
According to the prescriber, the patient has had a favorable clinical response since initiating Orladeyo 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

1 year