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