Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p146
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 146/312)
Character Range: 16380453–16386861

2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                           Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
                                                                                                                           A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
                                                                                                                           A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.
                                                                                                                           At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                           The following information must be provided at the time of application and must be documented in the patient's medical records:
                                                                                                                           (a) if applicable, details of maintenance oral corticosteroid dose; and
                                                                                                                           (b) a completed Asthma Control Questionnaire (ACQ-5) score.
C15362              P15362         CN15362          Tafamidis                                                              Transthyretin amyloid cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                           First PBS-subsidised prescription for this drug
                                                                                                                           The condition must have documented evidence of transthyretin precursor protein present; AND
                                                                                                                           Patient must have experienced at least one episode of hospitalisation that was a direct result of heart failure; OR
                                                                                                                           Patient must have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement; AND
                                                                                                                           Patient must have/have had New York Heart Association class I heart failure at the time of commencing this drug; OR
                                                                                                                           Patient must have/have had New York Heart Association class II heart failure at the time of commencing this drug; AND
                                                                                                                           Patient must have an end-diastolic interventricular septal wall thickness of at least 12 mm on imaging; AND
                                                                                                                           Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2.
                                                                                                                           Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.
                                                                                                                           Applications for authorisation of initial