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Bylvay (odevixibat)United Healthcare

Alagille syndrome (ALGS) with moderate to severe pruritus

Initial criteria

  • Diagnosis of Alagille syndrome (ALGS)
  • Confirmation of diagnosis by presence of the JAG1 or Notch2 gene mutation
  • Patient has a serum bile acid concentration above the upper limit of the normal reference range for the reporting laboratory
  • Patient is experiencing moderate to severe pruritis associated with ALGS
  • Patient has had an inadequate response to at least two other conventional treatments for the symptomatic relief of pruritus (e.g., ursodeoxycholic acid, diphenhydramine, cholestyramine, rifampin, naltrexone, sertraline)
  • Prescribed by a gastroenterologist or hepatologist

Reauthorization criteria

  • Documentation of positive clinical response to Bylvay therapy (e.g., reduced serum bile acids, improved pruritis)
  • Prescribed by a gastroenterologist or hepatologist

Approval duration

12 months