Orladeyo (berotralstat) — United Healthcare

prophylaxis to prevent attacks of hereditary angioedema (HAE)

Preferred products

Haegarda
Takhzyro

Initial criteria

Diagnosis of hereditary angioedema (HAE) as confirmed by one of the following:
a. C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following (per laboratory standard):
(1) C1-INH antigenic level below the lower limit of normal
(2) C1-INH functional level below the lower limit of normal
OR
b. HAE with normal C1 inhibitor levels and one of the following:
(1) Confirmed presence of variant(s) in the gene(s) for factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, and heparan sulfate-glucosamine 3-Osulfotransferase 6
(2) Recurring angioedema attacks that are refractory to high-dose antihistamines with confirmed family history of angioedema
(3) 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 all of the following:
a. Prescribed for the prophylaxis of HAE attacks
AND b. Not used in combination with other approved products indicated for prophylaxis against HAE attacks (i.e., Cinryze, Haegarda, Takhzyro)
AND c. Prescriber attests that patient has experienced attacks of a severity and/or frequency such that they would clinically benefit from prophylactic therapy with Orladeyo
AND d. History of failure to both of the following (document date of trial and list reason for therapeutic failure):
(1) Haegarda (C1 esterase inhibitor, human)
(2) Takhzyro (lanadelumab)
AND 3. Prescribed by one of the following:
1. Immunologist
2. Allergist

Approval duration

12 months