Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p179
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 179/312)
Character Range: 16578642–16585004

that the patient should be treated with this pharmaceutical benefit on this occasion.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           (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)
                                                                                                                           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.
C15490              P15490         CN15490          Selumetinib                                                            Neurofibromatosis type 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient must have plexiform neurofibroma(s) (PN) that is causing/likely to cause at least one of: (i) significant symptoms/morbidity, (ii) disability, (iii) disfigurement, (iv) impairment of normal body function; AND
                                                                                                                           Patient must have PN for which complete resection cannot be performed; AND
                                                                                                                           Patient must have either a: (i) Karnofsky, (ii) Lansky Performance Score of at least 70%.
                                                                                                                           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.
                                                                                                                           Patient must be aged between 2 to 18 years; AND
                                                                                                                           Patient must be able to swallow the whole capsule form of this drug.
                                                                                                                           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 each strength requested. Up to a maximum of 5 repeats will be authorised.
                                                                                                                           Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.
                                                                                                                           For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:
                                                                                                                           1. head and neck PN that can compromise the airway or great vessels;
                                                                                                                           2. paraspinal PN that can cause myelopathy;
                                                                                                                           3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;
                                                                                                                           4. PN that can result in major deformity or significant disfiguring (e.g. orbital