Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p27
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 27/42)
Character Range: 96106–100425

be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
                                      Patient must be 12 years of age or older.
                                      This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
                                      The authority application must be in writing and must include:
                                      (1) a completed authority prescription; and
                                      (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
                                      (3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
                                      (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.

    [18]       Schedule 3, entry for Ravulizumab
         insert in numerical order after existing text:
   C14744     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Switch from PBS-subsidised eculizumab (all phases) - loading dose
              Patient must have previously received PBS-subsidised eculizumab under the 'Initial treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised eculizumab under the 'Continuing treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised eculizumab under the 'Extended continuing treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised eculizumab under the 'Continuing recommencement of treatment' restriction for this condition; AND
              Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
              Patient must not receive more than 2 weeks of treatment under this restriction.
              Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
              Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
              Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
              This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
              The application must indicate the most recent treatment phase that the patient is switching from.
              For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.
              Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
              The authority application must be in writing and must include all of the following:
              (1) A completed authority prescription form(s);
              (2) A completed authority application form