Xuriden (uridine triacetate oral granules) — Medica

Initial criteria

• Patient has hereditary orotic aciduria confirmed by at least ONE of the following (i or ii):
• i. Molecular genetic testing confirming biallelic pathogenic variants in the UMPS gene; OR
• ii. Clinical diagnosis supported by ALL of the following (a, b, and c):
• a) At least one clinical manifestation consistent with orotic aciduria type 1 (e.g., megaloblastic anemia, immunodeficiency, developmental delays, failure to thrive); AND
• b) First-degree family relative (parent or sibling) with hereditary orotic aciduria; AND
• c) Urinary orotic acid level above the normal reference range for the reporting laboratory; AND
• Medication is prescribed by, or in consultation with, a metabolic specialist, geneticist, or physician specializing in the condition being treated.

Approval duration

1 year