Nitisinone products (Harliku, Nityr, Orfadin, generic nitisinone)
UnitedHealthcare prior authorization/medical necessity policy for nitisinone products (Harliku™, Nityr®, Orfadin®, and generic nitisinone) governing initial authorization and reauthorization criteria for alkaptonuria (AKU) and hereditary tyrosinemia type 1 (HT-1), prescriber requirements, combination-product restrictions, and authorization duration.
New program established (2/2026).
Educational note added to AKU reauthorization section (4/2026).
Coverage Summary
UnitedHealthcare’s prior authorization/medical necessity policy covers nitisinone products (Harliku™, Nityr®, Orfadin®, and generic nitisinone) for the treatment of alkaptonuria (AKU) and hereditary tyrosinemia type 1 (HT-1). Initial and reauthorization criteria specify diagnostic, laboratory/genetic, and prescriber requirements. Approvals are issued for 12 months. Prescriptions must be from or in consultation with a metabolic disease specialist (required for HT-1) or a rheumatologist (acceptable for AKU). The requested nitisinone product must not be used in combination with another nitisinone product; combination use will not meet criteria.
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