SA restriction and item codes
Do not share this attachment externally. See Freedom of Information – Information Publication Scheme.
PBS SA restriction and item codes
Contact details
PBS Complex Drugs Programs
Forms
Severe allergic asthma paediatric - dupilumab or omalizumab - initial or recommencement authority application form (PB188)
Severe asthma paediatric - dupilumab - initial grandfather authority application form (PB386)
Severe asthma paediatric - change or continuing authority application form (PB385)
Severe asthma - adolescent and adult - initial or recommencement after 12 months break authority application form (PB075)
Severe asthma - adolescent and adult - continuing authority application form (PB076)
Severe asthma - adolescent and adult - change authority application form (PB285)
Services Australia website
Severe asthma
External website
PBS schedule for Severe asthma
ACQ-5 assessment form
The ACQ-5 assessment form is owned by a third party.
Prescribers can locate this form by contacting Novartis Medical Information.
FAQs for Service Officers
Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.
Item | Description |
1 | When the prescriber writes the eosinophils as 0.3, how is this entered in OPA? The eosinophil count is entered in OPA as 300. Prescribers may use different units to those written in the restriction. Other examples include: - 1.1 is entered as 1100, and
- 0.15 is entered as 150
|
2 | Are patients able to swap between dupilumab 200mg and dupilumab 300mg? No. Swapping between 200mg and 300mg strengths is not permitted. The respective strengths are PBS approved for different patient cohorts. |
3 | What is the correct process when the ACQ-5 is done after the date of prescribing and OPA is rejecting with reason code 812? Confirm all other answers are correct using the appropriate Q+As resources. Override the rejection for an ACQ-5 that is: - dated after date of prescribing or on and before date of lodgement
- not future dated (ACQ-5 is not after the date of lodgement)
|
4 | If a patient has a break in therapy and wishes to continue with the same agent, can this be approved? The prescriber must submit a continuing request including, an ACQ-5 assessment conducted within 4 weeks of the last dose of biological medicine. There is no requirement on a continuing application for the ACQ-5 to be current. |
5 | If a script is written for the omalizumab syringe, can the pharmacy supply the pen formulation? Yes, for adult and adolescent patients, the pen and syringe form types are equivalent for the purposes of substitution by the pharmacy. Substitution is not permitted if the prescription is written using a PBS streamlined item code. |
6 | Can a paediatric patient be approved for the omalizumab pen formulation? No, the omalizumab pen device is not intended for use in children below 12 years. For children below 12 years, the omalizumab syringe is the appropriate form for this population. The pen device is not PBS listed for paediatric patients and pharmacies cannot substitute for the pen. |
7 | When a paediatric patient turns 12 years, do they have to requalify as an initial adolescent/adult patient? No, when a patient turns 12 years, they can: - continue on the same medication under the continuing adolescent/adult item code, or
- change to one of the medications that are only available for adolescent and adult patients
There is no requirement to requalify as an initial patient. |
8 | Can a patient be approved for the dupilumab pen after they turn 12 years? No, only the dupilumab syringe is PBS listed for adolescent/adult patients. Even if the patient was receiving the pen under the paediatric criteria, only the syringe form can be approved after they turn 12 years under the continuing restriction. A change application is not required for a change of form type or age criteria. |