PBS updates

Ocaliva (Obeticholic acid)

obeticholic acid 5 mg tablet, 30 · ORAL · PBS code 12630R

STREAMLINED

What it costs

AU$3631 PBS-determined price per 30 units

Most patients pay only the standard PBS co-payment, not the full price above — up to AU$25.00 per script (general) or AU$7.70 (concession/Safety Net) in 2026. The figure above is what the PBS pays the pharmacy; the Australian Government subsidises the rest. Always confirm the current amount with your pharmacist.

  • • First listed on the PBS: 2021-09-01.
  • • Repeats: 5.
  • • PBS program: GE.
Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

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

Primary biliary cholangitis (previously known as Primary biliary cirrhosis)


Continuing treatment


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 continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the 'Initial treatment' listing, (ii) 'Grandfather' arrangements; 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 elafibranor; AND

Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.

The improvement in the qualifying laboratory reading(s) has/have been documented in the patient's medical records.

Sponsor: Amdipharm Mercury (Australia) Pty Limited ABN 91 118 106 684

Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.