Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p101
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 101/161)
Character Range: 14338181–14347287

quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
                                                                                   Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (a) a completed authority prescription form; and
                                                                                   (b) 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)
                                                                                   A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
                                                                                   Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.
C13402              P13402         CN13402          Aflibercept                    Diabetic macular oedema (DMO)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 13402
                                                                                   Continuing treatment
                                                    Faricimab                      Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND
                                                    Ranibizumab                    The treatment must be as monotherapy; or
                                                                                   The treatment must be in combination with laser photocoagulation; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
C13406              P13406         CN13406          Aflibercept                    Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 13406
                                                                                   Continuing treatment
                                                    Faricimab                      Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   The condition must be due to age-related macular degeneration (AMD); AND
                                                    Ranibizumab                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.
C13411              P13411         CN13411          Cemiplimab                     Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first:
                                                                                    (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
C13412              P13412         CN13412          Nintedanib                     Progressive fibrosing Interstitial lung disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Must be treated by a medical practitioner who is either:
                                                                                    (i) a