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Berinert (C1 esterase inhibitor [human])United Healthcare

Treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks

Preferred products

  • Ruconest (C1 esterase inhibitor [recombinant])

Initial criteria

  • Diagnosis of hereditary angioedema (HAE) as confirmed by one of the following:
  • C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following (per laboratory standard):
  • C1-INH antigenic level below the lower limit of normal OR C1-INH functional level below the lower limit of normal
  • OR
  • HAE with normal C1 inhibitor levels and one of the following:
  • Confirmed presence of variant(s) in the gene(s) for factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, or heparan sulfate-glucosamine 3-O-sulfotransferase 6
  • Recurring angioedema attacks that are refractory to high-dose antihistamines with confirmed family history of angioedema
  • Recurring angioedema attacks that are refractory to high-dose antihistamines with unknown background de-novo mutation(s) (i.e., no family history) (HAE-unknown)
  • AND
  • Prescribed for the acute treatment of HAE attacks
  • AND
  • Not used in combination with other products indicated for the acute treatment of HAE attacks (e.g., Firazyr, Ruconest)
  • AND
  • Submission of medical records documenting a history of failure, contraindication, or intolerance to Ruconest (C1 esterase inhibitor [recombinant])
  • AND
  • Prescribed by an Immunologist or Allergist

Reauthorization criteria

  • Documentation of positive clinical response to Berinert therapy
  • AND
  • Prescribed for the acute treatment of HAE attacks
  • AND
  • Not used in combination with other products indicated for the acute treatment of HAE attacks (e.g., Firazyr, Ruconest)
  • AND
  • Prescribed by an Immunologist or Allergist

Approval duration

12 months