Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p255
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 255/312)
Character Range: 17070591–17077282

conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                           Where four initial doses of vedolizumab (at weeks 0, 2, 6 and 10) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (4 weeks after the fourth dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
C15936              P15936         CN15936          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
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                                                                                           Must be treated by a gastroenterologist; OR
                                                                                                                           Must be treated by a surgeon with expertise in the upper gastrointestinal tract.
                                                                                                                           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 2 packs 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.
C15937              P15937         CN15937          Bimekizumab                                                            Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received this drug as their most