Orladeyo (berotralstat) — Point32Health

Initial criteria

• Documented diagnosis of hereditary angioedema
• Patient age ≥ 12 years
• Prescribed by or in consultation with an allergist, hematologist, or immunologist
• Documentation that 'on-demand' therapy (e.g., icatibant, Kalbitor, Ruconest, Berinert) did not provide satisfactory control OR access to 'on-demand' therapy is limited

Reauthorization criteria

• Documented diagnosis of hereditary angioedema
• Patient age ≥ 12 years
• Prescribed by or in consultation with an allergist, hematologist, or immunologist
• Documentation of a positive clinical response as evidenced by one of the following: (a) improvement in severity and duration of attacks has been achieved and sustained OR (b) a decrease in attack frequency

Approval duration

12 months