Primary hyperoxaluria type 1 (PH1) Program in Pharmaceutical Benefits Scheme (PBS) 012-25090506

PH1 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 PH1 restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Primary hyperoxaluria type 1 - lumasiran - initial authority application (PB389)

Primary hyperoxaluria type 1 - lumasiran - initial grandfather authority application (PB391)

Primary hyperoxaluria type 1 - lumasiran - continuing authority application (PB390)

Services Australia website

Primary hyperoxaluria type 1

External website

PBS schedule for Primary hyperoxaluria type 1

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 lumasiran to treat PH1? No.
2	Can quantity and repeats of PBS-subsidised lumasiran be increased for the treatment of PH1? No increase in the maximum number of 5 vials and 2 repeats may be authorised for initial treatment; no increase in the maximum number of 5 vials and 1 repeat may be authorised for continuing treatments. At the time of the authority application, prescribers should request the appropriate number of vials based on the patient's weight, as per the Therapeutic Goods Administration (TGA) approved Product Information.
3	Are questions and answers (Q&A) attached to relevant restrictions of PH1 available in the National Drug Reference Database (NDRD)? No. PH1 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).