Berinert (C1 esterase inhibitor [human]) — United Healthcare
Treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks
Preferred products
- Ruconest (C1 esterase inhibitor [recombinant])
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 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
- 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) (i.e., no family history) (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., Firazyr, Ruconest)
- AND
- Submission of medical records documenting a history of failure, contraindication, or intolerance to Ruconest (C1 esterase inhibitor [recombinant])
- AND
- Prescribed by an Immunologist or Allergist
Reauthorization criteria
- Documentation of positive clinical response to Berinert 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., Firazyr, Ruconest)
- AND
- Prescribed by an Immunologist or Allergist
Approval duration
12 months