Fibrodysplasia ossificans progressiva (FOP) Program in Pharmaceutical Benefits Scheme (PBS) 012-25080655

FOP 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 FOP restriction and item codes

Contact details

PBS Complex Drugs Programs

Form

Fibrodysplasia ossificans progressiva - palovarotene - chronic treatment authority application (PB387)

Services Australia website

Fibrodysplasia ossificans progressiva

External website

PBS schedule for fibrodysplasia ossificans progressiva

FAQs from Service Officers

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

Item	Description
1	Is there an age restriction for patients applying for PBS-subsidised chronic treatment of FOP? Yes. Female patients must be aged at least 8 years and male patients must be aged at least 10 years.
2	Can patients apply to continue PBS-subsidised treatment of FOP? FOP is PBS-subsidised for chronic treatment and flare-up (acute) treatment instead of initial and continuing treatment as for other conditions. If the patient starts to experience a flare-up or is at high risk of a flare-up after the chronic treatment has been approved, they should begin flare-up (acute) treatment which is Authority Required (Streamlined). No authority approval is required from us for the listed quantity and repeats.
3	Can quantity and repeats of PBS-subsidised palovarotene be increased for chronic treatment of FOP? No increase in the maximum number of 5 repeats may be authorised. An appropriate combination of packs must be requested based on the age and weight of the patient, adequate for 4 weeks according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested.
4	Are questions and answers (Q&A) attached to relevant restrictions of FOP available in the National Drug Reference Database (NDRD)? No. FOP authority applications are assessed by Dynamic Q&A in the Online PBS Authorities (OPA) system. For troubleshooting see Resources > Dynamic Question and Answers (DQA) resources in Dosage calculators and charts for Pharmaceutical Benefits Scheme (PBS).
5	Can patients get multiple approvals for different strength for chronic treatment of FOP? Yes. Patients can get multiple approvals for different strength listed for chronic treatment of FOP. A separate authority prescription form must be completed for each strength requested.