Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p177
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 177/312)
Character Range: 16563798–16570464

with this pharmaceutical benefit on this occasion.
                                                                                                                           Vision threatening disease is defined as at least 1 of the following:
                                                                                                                           (a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;
                                                                                                                           (b) A 2-step increase in anterior chamber cells or vitreous haze;
                                                                                                                           (c) New retinal vasculitis;
                                                                                                                           (d) New retinal or choroidal lesions;
                                                                                                                           (e) Other signs of disease progression including visual field changes or electroretinogram changes
                                                                                                                           A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria:
                                                                                                                           (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or
                                                                                                                           (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or
                                                                                                                           (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or
                                                                                                                           (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)
                                                                                                                           Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient's medical record.
                                                                                                                           The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease.
                                                                                                                           If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                           (i) details of the proposed prescription; and
                                                                                                                           (ii) 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).
C15477              P15477         CN15477          Selumetinib                                                            Neurofibromatosis type 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must be tolerating treatment; AND
                                                                                                                           Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment with this drug.
                                                                                                                           Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.
                                                                                                                           At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for