Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p82
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 82/191)
Character Range: 10438679–10450713

trace elements formula                                                                                                                              Dietary management of conditions requiring a highly restrictive therapeutic diet
                                                                                                                                                                                                                               Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
                                                                                                                                                                                                                               Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations;
                                                                                                                                                                                                                               Patient must be aged 3 years or older.
C7280               P7280          CN7280           Eribulin                                                                                                                                                                   Advanced (unresectable and/or metastatic) liposarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 7280
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not develop progressive disease while being treated with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
C7289               P7289          CN7289           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
                                                                                                                                                                                                                               The treatment must be as systemic monotherapy (other than methotrexate);
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a dermatologist.
C7346               P7346          CN7346           Alectinib                                                                                                                                                                  Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                    Brigatinib                                                                                                                                                                 The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                    Ceritinib                                                                                                                                                                  Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

C7362               P7362          CN7362           Mannitol                                                                                                                                                                   Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 7362
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must be intolerant or inadequately responsive to dornase alfa;
                                                                                                                                                                                                                               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