Hereditary angioedema (HAE) Types 1 or 2 Program in Pharmaceutical Benefits Scheme (PBS) 012-21112939

HAE Types 1 or 2 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 HAE Types 1 or 2 restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Hereditary angioedema Types 1 or 2 - garadacimab or lanadelumab - initial or change authority application (PB325)

Hereditary angioedema Types 1 or 2 - garadacimab - initial grandfather authority application (PB326)

Services Australia website

Hereditary angioedema Types 1 or 2

External website

PBS schedule for:

FAQs from Service Officers

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

Item	Description
1	What is the maximum quantity that can be approved for lanadelumab? The PBS listed quantity is 1. However, an increased quantity can be approved, provided it does not exceed one month’s supply.
2	Does the patient have to be 12 years or older to receive treatment with garadacimab? No. The age restriction only applies to patients applying for lanadelumab.
3	How many scripts are required for initial treatment with garadacimab? Two scripts are required. One for the loading dose (Q2, R0) and one for the balance of initial (Q1, R4) to provide 24 weeks treatment. These can be requested together at the time of the initial approval, or the balance can be requested separately after the initial approval.
4	Can an increased quantity and/or repeats be approved for garadacimab? No. Neither quantity nor repeats can be increased.

Operational Information