Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received treatment with this drug for this PBS indication prior to 1 November 2025; AND

Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or

Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND

Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or

Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND

Patient must not be undergoing concurrent treatment with obeticholic acid; AND

Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or

Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND

Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND

Patient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or

Patient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or

Patient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or

Patient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or

Patient must have had inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug; AND

Patient must be at least 18 years of age.

Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.