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