Sajazir — United 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