Firazyr — Blue Cross Blue Shield of New Mexico

Preferred products

• icatibant

Initial criteria

• Diagnosis of HAE due to C1INH deficiency (Type 1 or Type 2) confirmed by laboratory measurements (decreased C4, C1-INH protein, and C1-INH function levels for Type 1; decreased C4 and C1-INH function with normal or elevated protein for Type 2) OR confirmed by mutation in the C1-INH gene altering protein synthesis and/or function OR diagnosis of HAE with normal C1INH confirmed by normal levels of C1-INH protein, function, and C4 and mutation in one of [FXII, Plasminogen, Angiopoietin-1, Kininogen-1, Heparan sulfate 3-O-sulfotransferase 6, Myoferlin] OR diagnosis of HAE-U confirmed by an HAE specialist (medical records required)
• If patient has FDA labeled indication, age is within label OR there is support for use for patient's age for indication
• Medications known to cause angioedema (ACE inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate
• Requested agent will be used to treat acute HAE attacks
• If request is for brand Firazyr when generic icatibant is available, ONE of: (A) member in BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties; OR (B) stable on brand agent; OR (C) inadequate response to generic; OR (D) generic discontinued due to lack of efficacy or adverse event; OR (E) intolerance/hypersensitivity to generic not expected with brand; OR (F) FDA labeled contraindication to generic not expected with brand; OR (G) generic expected to be ineffective or create adherence barriers or worsen comorbidity; OR (H) generic not in best interest (medical necessity); OR (I) another drug in same class discontinued due to lack of efficacy or AE; OR (J) support for brand over generic
• Prescriber is a specialist (allergist, immunologist) or has consulted one
• Patient will not use requested agent in combination with another agent for acute HAE attacks (Berinert, Ekterly, Firazyr, icatibant, KALBITOR, RUCONEST)
• Patient has no FDA labeled contraindications to requested agent
• Alternate approval paths: BCBS MT Fully Insured or MT HIM – patient <18 years, no contraindications, indication supported by two major peer-reviewed publications, and age supported by two such publications; OR BCBS NM Fully Insured or NM HIM – no contraindications, indication is a rare disease, and either another FDA labeled indication or compendia support or submission of two peer-reviewed journal articles supporting proposed use (non-oncology compendia DrugDex 1,2A,2B or AHFS-DI supportive; oncology compendia NCCN 1 or 2A, AHFS-DI supportive, DrugDex 1,2A,2B, Clinical Pharmacology supportive, LexiDrugs level A, or peer-reviewed literature)

Reauthorization criteria

• Previously approved through plan’s prior authorization process
• Prescriber is a specialist (allergist, immunologist) or has consulted one
• Patient has had clinical benefit with requested agent
• If brand Firazyr requested with available generic icatibant, same brand over generic criteria as initial apply
• Prescriber has verified patient does not have >1 month supply (sufficient for 2 acute HAE attacks) on hand
• Patient will not use requested agent with another agent for acute HAE attacks (Berinert, Ekterly, Firazyr, icatibant, KALBITOR, RUCONEST)
• Patient has no FDA labeled contraindications to requested agent

Approval duration

initial 6–12 months (plan-specific); renewal 12 months