Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p129
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 129/162)
Character Range: 15321696–15328059

weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.
C14471              P14471         CN14471          Dapagliflozin                                        Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 14471
                                                                                                         Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
                                                    Empagliflozin                                        Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND
                                                                                                         Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND
                                                                                                         Patient must have documented evidence of at least one of the following:
                                                                                                          (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND
                                                                                                         Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.
C14483              P14483         CN14483          Adalimumab                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
                                                    Baricitinib                                          Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Etanercept                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or
                                                                                                         Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
                                                    Tocilizumab                                          Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND
                                                    Tofacitinib                                          Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                    Upadacitinib                                         Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
                                                                                                         Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced