Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p91
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 91/381)
Character Range: 12112646–12122193

be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C11835              P11835         CN11835          Progesterone                                                                                                    Prevention of preterm birth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 11835
                                                                                                                                                                    Patient must have a singleton pregnancy; AND
                                                                                                                                                                    Patient must have at least one of:
                                                                                                                                                                     (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND
                                                                                                                                                                    The treatment must be administered no earlier than at 16 weeks gestation.
C11836              P11836         CN11836          Sapropterin                                                                                                     Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                    Pre-conception through to when pregnancy first becomes known
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND
                                                                                                                                                                    Must be treated by a metabolic physician; or
                                                                                                                                                                    Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
                                                                                                                                                                    Patient must not be undergoing treatment with this drug under this Treatment phase, following completion of this authority application, for more than 13 cumulative months (assuming 1 month consists of 30 days); AND
                                                                                                                                                                    Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously);
                                                                                                                                                                    Patient must be actively trying to conceive.
C11852              P11852         CN11852          Adalimumab                                                                                                      Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient)
                                                                                                                                                                    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)]; or
                                                                                                                                                                    Must be treated by a paediatrician; or
                                                                                                                                                                    Must be treated by a specialist paediatric gastroenterologist; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                                                                                    Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                                                                                    Patient must have failed to achieve an