Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p249
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 249/312)
Character Range: 17035353–17043724

by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                                                                                           The condition must be due to age-related macular degeneration (AMD); AND
                                                                                                                           The condition must be diagnosed by optical coherence tomography; OR
                                                                                                                           The condition must be diagnosed by fluorescein angiography; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                           Authority approval for initial treatment of each eye must be sought.
                                                                                                                           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.
C15919              P15919         CN15919          Aflibercept                                                            Diabetic macular oedema (DMO)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                                                                                           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.
                                                                                                                           Authority approval for initial treatment of each eye must be sought.
                                                                                                                           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.
C15924              P15924         CN15924          Dupilumab                                                              Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment 1 - (New patient; or Recommencement of