Takhzyro (lanadelumab-flyo subcutaneous injection) — Cigna

Initial criteria

• Patient has HAE type I or type II as confirmed by BOTH of the following diagnostic criteria (a and b):
• a) Patient has low levels of functional C1-INH protein (< 50% of normal) at baseline, as defined by the laboratory reference values [documentation required]; AND
• b) Patient has lower than normal serum C4 levels at baseline, as defined by laboratory reference values [documentation required]; AND
• The medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.
• Note: A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement.

Reauthorization criteria

• Patient has a diagnosis of HAE type I or type II [documentation required]; AND
• According to the prescriber, the patient has had a favorable clinical response since initiating Takhzyro prophylactic therapy compared with baseline (i.e., prior to initiating prophylactic therapy); AND
• The medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.
• Note: A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement.

Approval duration

1 year