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

PFIC restriction and item codes

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$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.png$ PBS PFIC restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Progressive familial intrahepatic cholestasis - odevixibat - initial authority application (PB392)

Services Australia website

Progressive familial intrahepatic cholestasis - Health professionals - Services Australia

External website

PBS schedule for progressive familial intrahepatic cholestasis

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	Can scripts for multiple strengths be approved at the same time? Yes. Prescribers may need to request multiple strengths to achieve the required dose. Scripts must be approved for the number of capsules required for one month treatment up to the maximum listed repeats (approve in multiples of 30). OPA may reject with an 817 reason code, this can be ignored providing all other PBS criteria has been met and the request is for a different strength.
2	Is there a maximum dose for this condition? Yes, the maximum dose is 7200mcg per day.
3	How is dose modification approved if it is required during the initial treatment phase? Approval can be given under the dose modification restriction if: the patient has not had an adequate response between one and three months following the commencement of treatment, and the prescriber needs to escalate the dose to 120mcg/kg/day
4	How is dose modification approved if it is required during the continuing treatment phase? If the patient is unable to maintain a previously demonstrated response at 40 mcg/kg/day in the continuing treatment phase, then the prescriber can escalate the dose to 120mcg/kg/day under the continuing restriction. Note: the OPA system will reject if treatment is requested using the dose modification restriction after a continuing request has been approved. If dose modification is required for these patients, it must be done under the continuing restriction.