Cystic fibrosis (CF) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051113

CF 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 CF restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Cystic fibrosis - ivacaftor - initial authority application (PB120)

Cystic fibrosis - ivacaftor - continuing authority application (PB126)

Cystic fibrosis - lumacaftor+ivacaftor or tezacaftor+ivacaftor - initial authority application (PB243)

Cystic fibrosis - lumacaftor+ivacaftor or tezacaftor+ivacaftor - continuing authority application (PB244)

Cystic fibrosis - elexacaftor+tezacaftor+ivacaftor - initial authority application (PB286)

Cystic fibrosis - elexacaftor+tezacaftor+ivacaftor - continuing authority application (PB287)

Services Australia website

Cystic fibrosis

External websites

PBS schedule for Cystic fibrosis

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 a patient change PBS-subsidised medication? There is no change restriction. To access another medication, an initial application must be submitted for the relevant drug as each medication has slightly different PBS criteria.
2	If a prescriber has written a script for Symdeko® for a quantity of 56; however, the PBS listed quantity is 1. Can this request be approved? Yes, as each pack has 56 tablets, and the PBS listed quantity is 1 pack. Key in OPA as quantity 1 with a dose of 1 every 28 days. An approved with changes letter does not need to be sent.
3	If a prescriber has written a script for Trikafta® tablets for a quantity of 84 or 56+28; however, the PBS listed quantity is 1. Can this request be approved? Yes, as each pack has 84 tablets (split into 56 morning tablets and 28 night tablets), and the PBS listed quantity is 1 pack. Key in OPA as quantity 1 with a dose of 1 every 28 days. An approved with changes letter does not need to be sent.
4	If a prescriber has written a script for Trikafta® granules for a quantity of 56 or 28+28; however, the PBS listed quantity is 1. Can this request be approved? Yes, as each pack has 56 sachets (split into 28 morning granules and 28 night granules), and the PBS listed quantity is 1 pack. Key in OPA as quantity 1 with a dose of 1 every 28 days. An approved with changes letter does not need to be sent.
5	The Q&As ask if the patient is concomitantly receiving CYP3A4 inhibitors, CYP3A4 inducers or IV antibiotics but this is not asked on the application form as a specific question, how should this question be answered? The application form instructs prescribers to provide details of these treatments if applicable. If the box is left blank or nil/none written, the Q&A can be answered as No. Only where a medication has been listed in the box should the question be answered as YES and the details completed in the following question.