Skip to navigation Skip to content

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

Expand/Collapse all sectionsExpand all


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