This document outlines details of PBS-subsidised odevixibat for patients with progressive familial intrahepatic cholestasis (PFIC).
For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.
On this page:
Progressive familial intrahepatic cholestasis (PFIC) quick reference
Delayed assessment
Written/Health professional online services (HPOS) applications
Progressive familial intrahepatic cholestasis (PFIC) quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial PB392 form | Written Electronic S85: odevixibat | No | OPA | Patients between 6 months and 17 years, inclusive, or diagnosed under 18 years must be treated by: - a gastroenterologist experienced in the management of PFIC
- a hepatologist experienced in the management of PFIC
Patients diagnosed after 18 years must be treated by: - a specialist hepatologist experienced in the management of PFIC
| Yes - delayed assessment due to DMPQ (cost) |
Dose modification | Telephone Electronic S85: odevixibat | No | OPA | Patients between 6 months and 17 years, inclusive, or diagnosed under 18 years must be treated by: - a gastroenterologist experienced in the management of PFIC
- a hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
Patients diagnosed after 18 years must be treated by: - a specialist hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
| Yes |
Continuing | Telephone Electronic S85: odevixibat | No | OPA | Patients between 6 months and 17 years, inclusive, or diagnosed under 18 years must be treated by: - a gastroenterologist experienced in the management of PFIC
- a hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
Patients diagnosed after 18 years must be treated by: - a specialist hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
| Yes |
Recommencement | Telephone Electronic S85: odevixibat | No | OPA | Patients between 6 months and 17 years, inclusive, or diagnosed under 18 years must be treated by: - a gastroenterologist experienced in the management of PFIC
- a hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
Patients diagnosed after 18 years must be treated by: - a specialist hepatologist experienced in the management of PFIC
- a medical practitioner under the supervision of a specialist experienced in the management PFIC
| Yes |
Delayed assessment
Table 2: this table lists the details of what to check for the delayed assessment applications.
Initial Authority requests (for different strengths) will go to Awaiting Assessment status.
Scenario | OPA information | Action |
Initial approval - processing when strength A is requested | Check any OPA reason codes | Proceed with approval/rejection No further action required - automated response is sent to prescriber |
Initial approval for second application when strength B is requested on the same day | Check any OPA reason codes Rejection code (RC) 817 appears after assessment result has been overridden to approved or rejected | Check patient history for approval of another strength on the same day. RC817 can be ignored if the application is for a different strength to make up the dose as part of the same application (max dose 7200mcg/day) Proceed with approval/rejection No further action required - automated response is sent to prescriber |
Initial application for a strength that has already been previously approved | RC817 appears after assessment is made | Proceed with rejection |
Written/Health professional online services (HPOS) applications
Table 3
Scenario | OPA information | Action |
Initial approval - processing when strength A is requested | Check any OPA reason codes | Proceed with approval/rejection |
Initial approval for second script when strength B is requested | Check any OPA reason codes Rejection code (RC) 817 appears, and assessment result is a rejection | Override the RC817 if the second strength is to make up the dose as part of the same application (max dose 7200mcg/day) |
Initial application for a strength that has already been previously approved | RC817 appears, and assessment result is a rejection | Do not override RC817 as the application should be rejected unless the prescriber has indicated that the previous approval has been lost or not used |
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