Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p140
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 140/312)
Character Range: 16346704–16354777

sole PBS-subsidised systemic anti-cancer therapy for this condition.
                                                                                                                           Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the word 'cancelled'; where (i)/(ii) has occurred.
                                                                                                                           PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
C15311              P15311         CN15311          Dapagliflozin                                                          Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15311
                                                    Empagliflozin                                                          The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND
                                                                                                                           The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin.
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.
C15321              P15321         CN15321          Pioglitazone                                                           Diabetes mellitus type 2

C15326              P15326         CN15326          Apremilast                                                             Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 15326
                                                                                                                           Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; OR
                                                                                                                           Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; OR
                                                                                                                           Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND
                                                                                                                           The condition must have caused significant interference with quality of life; AND
                                                                                                                           Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) deucravacitinib.
                                                                                                                           Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR
                                                                                                                           Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; OR
                                                                                                                           Must be treated by a general practitioner where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           For patients who do not demonstrate an adequate response to apremilast, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'.
                                                                                                                           This assessment must be documented in the patient's medical records.
C15329              P15329         CN15329          Osimertinib                                                            Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment as