Berinert — Highmark

Preferred products

• generic icatibant

Initial criteria

• age ≥ 5 years for Berinert; age ≥ 12 years for Ekterly; age ≥ 18 years for Firazyr/Sajazir (icatibant); age ≥ 13 years for Ruconest
• Medication is used for the treatment of acute HAE attacks and not for prophylactic treatment
• Prescribed by or in consultation with an allergist, immunologist, or a provider who specializes in hereditary angioedema
• Low C4 ≤ 14 mg/dL or below lab normal range AND either (C1INH antigenic level ≤ 19 mg/dL or below lab normal range) OR (normal antigenic C1INH ≥ 19 mg/dL with functional C1INH < 50% or below lab normal range)
• History of at least one symptom of moderate or severe angioedema attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea/vomiting, painful facial distortion) in absence of concomitant hives or angioedema-causing medication
• Medications known to cause angioedema (e.g., ACE inhibitors, estrogens, ARBs) evaluated and discontinued when appropriate
• Not on two acute therapies simultaneously (e.g., Berinert, Ekterly, Firazyr, Kalbitor, or Ruconest)
• For Berinert or Ruconest: if age ≥ 18 years, therapeutic failure, contraindication, or intolerance to plan-preferred generic icatibant AND prescriber submits member's weight
• For Ekterly if age ≥ 18 years: either therapeutic failure, contraindication, or intolerance to plan-preferred generic icatibant OR documentation member is unable to use self-administered injection due to (diagnosed needle phobia via psychiatric evaluation) OR (physical/cognitive impairment causing high risk of inappropriate administration)
• For brand Firazyr: therapeutic failure or intolerance to generic icatibant

Reauthorization criteria

• Member has experienced a decrease in frequency of HAE attacks from baseline OR significant improvement in severity or duration of attacks from baseline
• If brand Firazyr requested: therapeutic failure or intolerance to generic icatibant

Approval duration

up to 12 months