Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p134
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 134/381)
Character Range: 12392675–12400561

be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated; AND
                                                                                                                                                                    Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or
                                                                                                                                                                    Patient must have experienced an intolerance to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND
                                                                                                                                                                    Patient must not have/be each of:
                                                                                                                                                                     (i) severe liver disease, (ii) immunocompromised; AND
                                                                                                                                                                    Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of:
                                                                                                                                                                     (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or
                                                                                                                                                                    Patient must have a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or
                                                                                                                                                                    Patient must have abnormal readings of at least one of:
                                                                                                                                                                     (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.
C12096              P12096         CN12096          High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate                 Ketogenic diet
                                                                                                                                                                    Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of:
                                                                                                                                                                     (i) a metabolic physician, (ii) a neurologist; AND
                                                                                                                                                                    Patient must have intractable seizures requiring treatment with a ketogenic diet.  or
                                                                                                                                                                    Patient must have a glucose transport protein defect.  or
                                                                                                                                                                    Patient must have pyruvate dehydrogenase deficiency.
C12098              P12098         CN12098          Adalimumab                                                                                                      Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                    Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                                                    Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
                                                                                                                                                                    To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4