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Ruconest (C1 esterase inhibitor [recombinant])United Healthcare

Acute treatment of hereditary angioedema (HAE) attacks

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
  • • 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) (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, Firazyr)
  • AND Prescribed by an immunologist or allergist

Reauthorization criteria

  • Documentation of positive clinical response to Ruconest 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, Firazyr)
  • AND Prescribed by an immunologist or allergist

Approval duration

12 months