Xuriden — Medical Mutual

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 variant 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 (i.e. megaloblastic anemia, immunodeficiency, developmental delays, and failure to thrive); AND
• b) First-degree family relative (i.e., parent or sibling) with hereditary orotic aciduria; AND
• c) Urinary orotic acid level above the normal reference range for the reporting laboratory; AND
• Xuriden is prescribed by, or in consultation with, a metabolic specialist, geneticist, or physician specializing in the condition being treated.

Reauthorization criteria

• Response to therapy is required for continuation of therapy unless otherwise noted.

Approval duration

1 year