Orladeyo — CareFirst (Caremark)

Initial criteria

• Requested medication will not be used in combination with any other medication used for the prophylaxis of HAE attacks
• Member has C1 inhibitor deficiency or dysfunction as confirmed by laboratory testing AND meets one of the following: C1 inhibitor (C1‑INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test OR normal C1‑INH antigenic level and a low C1‑INH functional level (functional C1‑INH less than 50% or below the lower limit of normal as defined by the laboratory performing the test)
• OR Member has normal C1 inhibitor as confirmed by laboratory testing AND meets one of the following: Member has an F12, angiopoietin‑1, plasminogen, kininogen‑1 (KNG1), heparan sulfate‑glucosamine 3‑O‑sulfotransferase 6 (HS3ST6), or myoferlin (MYOF) gene mutation as confirmed by genetic testing OR Member has a documented family history of angioedema and the angioedema was refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg per day or equivalent) for at least one month
• Other causes of angioedema have been ruled out (e.g., ACE‑inhibitor induced angioedema, angioedema related to an estrogen‑containing drug, allergic angioedema)
• Prescribed by or in consultation with a prescriber who specializes in the management of HAE
• Documentation submitted includes C1 inhibitor functional and antigenic protein levels and, if applicable, gene mutation testing and chart notes on family history and antihistamine trial

Reauthorization criteria

• Member continues to meet all requirements in the coverage criteria section
• Member has experienced a significant reduction in frequency of attacks (e.g., ≥ 50%) since starting treatment
• Member has reduced the use of medications to treat acute attacks since starting treatment

Approval duration

12 months