Andembry (garadacimab subcutaneous injection – CSL Behring) — Cigna

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 as defined by laboratory reference values [documentation required]; AND lower than normal serum C4 levels at baseline as defined by laboratory reference values [documentation required]; AND
• A diagnosis of HAE with normal C1-INH (HAE type III) does NOT satisfy this requirement; 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
• A diagnosis of HAE with normal C1-INH (HAE type III) does NOT satisfy this requirement; AND
• According to the prescriber, the patient has had a favorable clinical response since initiating Andembry prophylactic therapy compared with baseline (e.g., decrease in HAE acute attack frequency, attack 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