Bylvay™

Drugs - Bylvay™ (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

Background

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).

Questions?

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