icatibant — Blue Cross Blue Shield of Alabama

Preferred products

• icatibant

Initial criteria

• Diagnosis confirmed by mutation in the C1-INH gene altering protein synthesis and/or function OR diagnosis of HAE with normal C1INH (HAE-nI-C1INH) evidenced by ALL of the following:
• - Levels within the normal range for C1-INH antigenic level, C1-INH functional level, and C4 level
• - Repeat blood testing during an attack does not show abnormal lab values indicative of Type 1 or Type 2 HAE
• - ONE of the following: known HAE-causing mutation (e.g., FXII, angiopoietin-1, plasminogen, kininogen-1, myoferlin, heparan sulfate 30-O-sulfotransferase 6 mutation) OR family history of HAE AND documented lack of efficacy of chronic high-dose antihistamine therapy AND corticosteroids
• If FDA labeled indication: patient’s age is within FDA labeling OR supported for use in age
• History of at least ONE of the following: moderate to severe cutaneous attacks (without hives), abdominal attacks, or mild to severe airway swelling attacks (debiliating cutaneous/gastrointestinal symptoms or laryngeal/pharyngeal/tongue swelling)
• Medications known to cause angioedema (ACE inhibitors, estrogens, ARBs, DPP-IV inhibitors, neprilysin inhibitors) have been evaluated and discontinued when appropriate
• Requested agent will be used to treat acute HAE attacks
• If brand Firazyr requested when generic icatibant available: ONE of the following — intolerance or hypersensitivity to the generic, FDA labeled contraindication to the generic, or support for use of brand over generic
• Prescriber is, or has consulted with, a specialist in allergist, immunologist, hematologist, pulmonologist, or medical geneticist
• ONE of the following: requested agent not used in combination with another acute HAE treatment agent (Berinert, Ekterly, Firazyr, icatibant, Kalbitor, Ruconest) OR prescriber documents justification for second acute agent up to 1 month supply in 12 months
• Patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient previously approved for requested agent through prior authorization process
• Prescriber is, or has consulted with, a specialist in allergist or immunologist
• Patient has had clinical benefit with the requested agent
• If brand Firazyr requested when generic icatibant available: ONE of the following — intolerance or hypersensitivity to the generic, FDA labeled contraindication to the generic, or support for use of brand over generic
• Prescriber has communicated with the patient regarding frequency and severity of attacks and verified the patient does not have greater than 1-month supply (sufficient for 2 acute attacks) on-hand
• If patient also uses prophylaxis against HAE, prescriber reduced quantity of acute agent one month after prophylaxis authorization by at least 2 vials or 2 syringes and continues to assess use
• ONE of the following: not used in combination with another acute HAE treatment agent (Berinert, Ekterly, Firazyr, icatibant, Kalbitor, Ruconest) OR prescriber has submitted justification for a second acute agent up to 1 month supply in 12 months
• Patient has no FDA labeled contraindications to the requested agent

Approval duration

6 months (initial); 12 months (first acute agent); up to 1 month (second acute agent)