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