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DrugsBylvay™ (odexvixibat) [Albireo Pharma, Inc.]

April 2022

Therapeutic area - Bile Salts

Initial approval criteria

  • Patient is at least 3 months old AND
  • Patient has a molecular diagnosis of progressive familial intrahepatic cholestasis (PFIC) type 1 or 2 AND
  • Patient does not have ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3) AND
  • Patient is experiencing moderate to severe pruritus associated with PFIC AND
  • Patient has serum bile acid concentration above the upper limit of normal AND
  • Patient does not have any of the following:
    • Cirrhosis OR
    • Portal hypertension OR
    • Prior hepatic decompensation event (e.g., variceal hemorrhage, ascites, and hepatic encephalopathy) AND
  • Bylvay is prescribed by or in consultation with a hepatologist or gastroenterologist AND
  • Patient has failed an adequate trial, or is intolerant to, or has a contraindication to at least 1 conventional treatment for the symptomatic relief of pruritis (e.g., ursodeoxycholic acid [ursodiol], cholestyramine, rifampin, naloxone, naltrexone, antihistamine)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet initial approval criteria AND
  • Patient has documented positive response to Bylvay therapy (e.g., reduced serium bile acids, improved pruritis)
  • Renewal approval is for 12 months

Quantity limits

  • 6 mg per day
  • Patient’s weight (in kg) must be submitted at time of request
  • In order to minimize waste, reasonable efforts must be taken to ensure dosing follows weight guidelines presented in FDA-approved label


Bylvay is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3).


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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