Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p198
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 198/312)
Character Range: 16725931–16733928

for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
C15754              P15754         CN15754          Tiotropium                                                             Severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 15754
                                                                                                                           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 respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists.
                                                                                                                           Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
                                                                                                                           Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; OR
                                                                                                                           Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
                                                                                                                           Patient must be aged 6 to 17 years inclusive.
                                                                                                                           Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative
C15755              P15755         CN15755          Budesonide with formoterol                                             Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 15755
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR
                                                                                                                           Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR
                                                                                                                           Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.
                                                                                                                           Patient must be aged 12 years or over.
C15757              P15757         CN15757          Cabozantinib                                                           Stage IV renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 15757
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for maintenance treatment
                                                                                                                           Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2024; AND
                                                                                                                           Patient must have had a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i)