Haegarda — Medica

Initial criteria

• 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

Reauthorization criteria

• Patient has a diagnosis of HAE type I or type II [documentation required] (HAE with normal C1‑INH does NOT satisfy this requirement)
• According to the prescriber, patient has had a favorable clinical response since initiating Haegarda prophylactic therapy compared with baseline (e.g., decrease in HAE acute 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