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SajazirUnited Healthcare

acute attacks of hereditary angioedema (HAE)

Initial criteria

  • Diagnosis of hereditary angioedema (HAE) confirmed by ONE of the following:
  • EITHER C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) documented by ONE of:
  • • C1-INH antigenic level below the lower limit of normal
  • • C1-INH functional level below the lower limit of normal
  • OR HAE with normal C1 inhibitor levels AND ONE of:
  • • 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 refractory to high-dose antihistamines with confirmed family history of angioedema
  • • Recurring angioedema attacks refractory to high-dose antihistamines with unknown background de-novo mutation(s) (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., Berinert, Kalbitor, or Ruconest)
  • AND Prescribed by an Immunologist OR Allergist
  • Age ≥ 18 years

Reauthorization criteria

  • Documentation of positive clinical response to icatibant 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., Berinert, Kalbitor, or Ruconest)
  • AND Prescribed by an Immunologist OR Allergist

Approval duration

12 months