Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p253
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 253/312)
Character Range: 17057768–17067045

treatment available under the above restriction.
                                                                                                                           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)].
C15927              P15927         CN15927          Icosapent ethyl                                                        Established atherosclerotic cardiovascular disease with hypertriglyceridaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 15927
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           The treatment must be co-administered with a HMG CoA reductase inhibitor (statin), unless the patient is contraindicated to statins or has developed statin related adverse events necessitating withdrawal of statin treatment.
C15928              P15928         CN15928          Aflibercept                                                            Diabetic macular oedema (DMO)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
                                                                                                                           Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication for the same eye prior to 1 October 2024; AND
                                                                                                                           Patient must have visual impairment due to diabetic macular oedema; AND
                                                                                                                           Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
                                                                                                                           The condition must be diagnosed by optical coherence tomography; OR
                                                                                                                           The condition must be diagnosed by fluorescein angiography; AND
                                                                                                                           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.
                                                                                                                           The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
                                                                                                                           (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
                                                                                                                           If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                           (a) details of the proposed prescription; 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).
                                                                                                                           All reports must be documented in the patient's medical records.
C15931              P15931         CN15931          Vedolizumab                                                            Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment with subcutaneous form
                                                                                                                           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