Hereditary Angioedema (HAE), Treatment and Prophylaxis
Clinical coverage policy for selected C1-esterase inhibitor and kallikrein inhibitor products for treatment and prophylaxis of hereditary angioedema (HAE), governing UnitedHealthcare benefit determinations and provider authorization requirements.
Specifies which drug products the policy refers to and separates self-administered injections as pharmacy benefit.
Defines medical necessity criteria for Berinert, Ruconest, and Kalbitor for treatment of acute HAE attacks including diagnostic and prescriber requirements.
States Cinryze is not medically necessary in Medical Necessity Plans but is proven for prophylaxis in Non-Medical Necessity Plans.
Revised coverage criteria for initial therapy for Berinert, Ruconest, and Kalbitor to add allowance for coverage when the patient has recurring angioedema attacks refractory to high-dose antihistamines with unknown de-novo mutation(s) (HAE-unknown).
Replaced criterion listing specific genes with an expanded list including variant(s) in factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, and heparan sulfate-glucosamine 3-O-sulfotransferase 6.
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