Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p18
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 18/381)
Character Range: 11569081–11578388

positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                                                                    Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
                                                                                                                                                                    The treatment must be in combination with trastuzumab; AND
                                                                                                                                                                    The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                                                                    A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
                                                                                                                                                                    The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug.
                                                                                                                                                                    Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.
C10416              P10416         CN10416          Amoxicillin                                                                                                     Community acquired pneumonia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 10416
                                                                                                                                                                    Patient must have community acquired pneumonia.
C10431              P10431         CN10431          Certolizumab pegol                                                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                    Secukinumab                                                                                                     Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND
                                                                                                                                                                    Must be treated by a rheumatologist.  or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
                                                                                                                                                                    An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following
                                                                                                                                                                    (a) a CRP measurement no greater than 10 mg per L; or
                                                                                                                                                                    (b) a CRP measurement reduced by at least 20% from baseline.
                                                                                                                                                                    If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.
                                                                                                                                                                    The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
C10434              P10434         CN10434          Bimekizumab                                                                                                     Non-radiographic