Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p59
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 59/381)
Character Range: 11883256–11893388

or
                                                                                                                                                                    Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for:
                                                                                                                                                                     (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.
                                                                                                                                                                    Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.
C11360              P11360         CN11360          Indacaterol with mometasone                                                                                     Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11360
                                                                                                                                                                    Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;
                                                                                                                                                                    Patient must be aged 12 years or over.
C11370              P11370         CN11370          Esomeprazole                                                                                                    Complex gastro-oesophageal reflux disease (GORD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control
                                                                                                                                                                    Must be treated by a gastroenterologist; or
                                                                                                                                                                    Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND
                                                                                                                                                                    The treatment must be:
                                                                                                                                                                     (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND
                                                                                                                                                                    Patient must have symptoms inadequately controlled with each of:
                                                                                                                                                                     (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control.  or
                                                                                                                                                                    Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for:
                                                                                                                                                                     (2) maintenance treatment.  or
                                                                                                                                                                    Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for:
                                                                                                                                                                     (3) re-establishment of symptom control.  or
                                                                                                                                                                    Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for:
                                                                                                                                                                     (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.
                                                                                                                                                                    Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.
C11374              P11374         CN11374          Dupilumab                                                                                                       Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or resuming treatment of the whole body
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND
                                                                                                                                                                    Patient must have achieved an adequate response within the first 16 weeks of treatment; or
                                                                                                                                                                    Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or
                                                                                                                                                                    Patient must have temporarily ceased treatment for reasons other than lack of response