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Haegarda (C1 esterase inhibitor, human)United Healthcare

Routine prophylaxis to prevent hereditary angioedema (HAE) attacks

Preferred products

  • Cinryze
  • Orladeyo
  • Takhzyro

Initial criteria

  • Diagnosis of hereditary angioedema (HAE) confirmed by one of the following:
  • C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) 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; OR recurring angioedema attacks refractory to high-dose antihistamines with confirmed family history of angioedema; OR recurring angioedema attacks refractory to high-dose antihistamines with unknown background de-novo mutation(s) (HAE-unknown)
  • Prescribed for the prophylaxis of HAE attacks
  • Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Orladeyo, Takhzyro)
  • Prescriber attests that patient has experienced attacks of severity and/or frequency such that prophylactic therapy with Haegarda is clinically beneficial
  • Prescribed by an Immunologist OR Allergist
  • Patient age ≥ 6 years

Reauthorization criteria

  • Documentation of positive clinical response to Haegarda therapy
  • Reduction in utilization of on-demand therapies used for acute attacks (e.g., Berinert, Firazyr, Ruconest) as determined by claims information, while on Haegarda therapy
  • Prescribed for the prophylaxis of HAE attacks
  • Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Orladeyo, Takhzyro)
  • Prescribed by an Immunologist OR Allergist

Approval duration

12 months