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Progressive familial intrahepatic cholestasis (PFIC) Program in Pharmaceutical Benefits Scheme (PBS) 012-25120137



This document outlines details of PBS-subsidised odevixibat for patients with progressive familial intrahepatic cholestasis (PFIC).

PFIC and listing dates

PFIC is a rare genetic disorder that causes progressive liver disease, which typically leads to liver failure. Odevixibat is used to treat the chronic severe itching (pruritis) that patients experience from this condition.

Listing date: odevixibat - 1 January 2026.

See Written Authority Required Drugs for more details.

Treatment specifics

Initial treatment

Patients initiate treatment at a dose of 40 micrograms/kg/day for up to 3 months. Patients will progress to the next treatment phase depending on their response to treatment.

Dose Modification (where dose escalation occurs during initial treatment)

If an adequate clinical response has not been achieved after at least 1 month and up to 3 months of initial treatment, the dose may be increased to 120 micrograms/kg/day (maximum of 7,200 micrograms per day) through the dose modification treatment phase. This will be for up to a total period of 6 months from the date of treatment commencement with odevixibat.

Continuing Treatment (where dose escalation occurs during continuing treatment)

If an adequate clinical response is unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment, the dose may be increased to 120 micrograms/kg/day (maximum of 7,200 micrograms per day) through the continuing treatment phase.

Enquiries

Transfer enquiries about prescription arrangements to PBS Complex Drugs Programs and choose the option relevant to the condition treated.

The Resources page contains:

  • application forms
  • contact details
  • FAQs from Service Officers
  • restriction and item codes
  • the PBS schedule
  • Services Australia websites link

Online Pharmaceutical Benefits Scheme (PBS) Authorities System (OPA System)

Processing an existing Authority request in the Pharmaceutical Benefits Scheme (PBS)

Processing and National Demand Allocation (PaNDA)

Processing Complex Authority Required Listings

Processing Delayed Assessment requests in the Pharmaceutical Benefits Scheme (PBS)

Processing new Authority requests in the Pharmaceutical Benefits Scheme (PBS)

Written Authority Required Drugs