Andembry (garadacimab) — Medica

Initial criteria

• Patient is age ≥ 12 years; AND
• Patient has HAE type I or type II as confirmed by BOTH of the following diagnostic criteria: 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]; AND
• 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]; AND
• According to the prescriber, patient has had a favorable clinical response since initiating Andembry prophylactic therapy compared with baseline (e.g., decrease in HAE acute attack frequency, severity, or duration); AND
• 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