Orladeyo — Medical Mutual

Initial criteria

• Patient is age ≥ 12 years; AND
• The patient has HAE as confirmed by the following criteria (i or ii): i) Patient has low levels of functional C1-INH protein (below 50% of normal) at baseline, as defined by the laboratory reference values; OR ii) Patient has lower than normal serum C4 levels (< 14 mg/dL) at baseline, as defined by the laboratory reference values AND lower than normal C1-INH levels (< 19.9 mg/dL) at baseline, as defined by the laboratory reference values; AND
• The medication is prescribed by or in consultation with an allergist, immunologist, hematologist or a physician that specializes in the treatment of HAE or related disorders

Reauthorization criteria

• Patient is age ≥ 12 years; AND
• The patient has HAE as confirmed by the following criteria (i or ii): i) Patient has low levels of functional C1-INH protein (below 50% of normal) at baseline, as defined by the laboratory reference values; OR ii) Patient has lower than normal serum C4 levels (< 14 mg/dL) at baseline, as defined by the laboratory reference values AND lower than normal C1-INH levels (< 19.9 mg/dL) at baseline, as defined by the laboratory reference values; AND
• The medication is prescribed by or in consultation with an allergist, immunologist, hematologist or a physician that specializes in the treatment of HAE or related disorders; AND
• According to the prescriber, the patient has had a favorable clinical response since initiating Orladeyo prophylactic therapy compared with baseline (i.e., prior to initiating prophylactic therapy). Examples include decrease in HAE acute attack frequency, decrease in HAE attack severity, or decrease in duration of HAE attacks

Approval duration

1 year initial, 1 year reauth