1.9.1. Drugs affecting biliary composition and flow

Restrictions:
For the dissolution of cholesterol gallstones in the gall bladder and for the treatment of primary billiary cirrhosis (PBC), provided there is no decompensated hepatic cirrhosis. It is restricted to specialist initiation.

Restrictions:
Restricted to specialist initiation for primary biliary cholangitis (primary biliary cirrhosis) in patients for whom alternative treatment options are not tolerated or where there has been an inadequate response. Alternative treatments include the off-label use of bezafibrate in combination with ursodeoxycholic acid.

Restrictions:
Restricted to specialist use for the treatment of progressive familial intrahepatic cholestasis.
Prescribing Notes:
Odevixibat may be prescribed within the ultra-orphan pathway while further evidence on its effectiveness is generated. In 2025, the SMC will evaluate the medicine for routine use in NHS Scotland. This medicine is part of the national Ultra-Orphan Risk Share Scheme.