Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p166
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 166/191)
Character Range: 11184233–11193858

has proven ineffective.
C9591               P9591          CN9591           Dornase alfa                                                                                                                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9591
                                                                                                                                                                                                                               Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or
                                                                                                                                                                                                                               Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or
                                                                                                                                                                                                                               Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or
                                                                                                                                                                                                                               Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy;
                                                                                                                                                                                                                               Patient must be less than 5 years of age.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
                                                                                                                                                                                                                               Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.
C9592               P9592          CN9592           Dornase alfa                                                                                                                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9592
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND
                                                                                                                                                                                                                               Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
                                                                                                                                                                                                                               Patient must be 5 years of age or older.
                                                                                                                                                                                                                               Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.
C9593               P9593          CN9593           Mannitol                                                                                                                                                                   Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9593
                                                                                                                                                                                                                               The treatment must be in combination with dornase alfa; AND
                                                                                                                                                                                                                               Patient must be inadequately responsive to dornase alfa; AND
                                                                                                                                                                                                                               Patient must have trialled hypertonic saline for this condition;
                                                                                                                                                                                                                               Patient must be 6 years of age or older.
                                                                                                                                                                                                                               Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
                                                                                                                                                                                                                               Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable