Fluticasone Propionate With Formoterol Fumarate DihydrateFlutiform

5.1 The PBAC did not recommend amending the current Authority Required (STREAMLINED) listing of fluticasone/formoterol to a Restricted Benefit listing. The PBAC reaffirmed its March 2018 recommendation to increase the restriction level to Authority Required (STREAMLINED) for all ICS/LABA FDC inhalers to encourage prescribers to consider first line treatment with ICS alone in asthma management.PSD · Nov 2018

5.2 The PBAC recalled that the March 2018 recommendation was made following its consideration of the findings of the Evaluation Report of the 2014 Asthma in Children Review. The PBAC did not accept the minor submissions claim that fluticasone/formoterol should not be covered by PBAC decisions from the Asthma in Children Review as it is not TGA or PBS-indicated for use in children below 12 years of age.PSD · Nov 2018

4.6 The minor submission argued that fluticasone/formoterol was not included in the Terms of Reference for the Asthma in Children Review, as it is not TGA nor PBS- indicated for use in children below 12 years of age and hence should not be covered by the subsequent DUSC review or PBAC decisions that directly arise from the review.PSD · Nov 2018

4.7 The minor submission and pre-PBAC response argued the PBS listings should be separated into adult/adolescent (≥ 12 years) and children’s PBS items (4 to 12 years) where necessary and change the restriction level for items that are indicated for use in children only. The PBAC noted that term ‘children’ was used in relation to patients aged 0 to 18 years of age in the Asthma in Children Review.PSD · Nov 2018