Orladeyo (berotralstat capsules – Biocryst) — Cigna

Initial criteria

• Patient age ≥ 12 years
• Patient has HAE type I or type II confirmed by both of the following: low functional C1-INH protein (< 50% of normal) at baseline [documentation required] AND lower than normal serum C4 levels at baseline [documentation required]
• 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 age ≥ 12 years
• Patient has a diagnosis of HAE type I or type II [documentation required]
• According to the prescriber, patient has had a favorable clinical response since initiating Orladeyo prophylactic therapy compared with baseline (e.g., decreased HAE attack frequency, severity, or duration)
• 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