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

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)

Initial treatment

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

Must be treated by a medical practitioner 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 an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, 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 a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or

Patient must have 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 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.