Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p170
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 170/312)
Character Range: 16515023–16521409

with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
                                                                                                                           The following must be stated at the time of application and documented in the patient's medical records:
                                                                                                                           (i) the qualifying Dutch Lipid Clinic Network Score; or
                                                                                                                           (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
                                                                                                                           One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
                                                                                                                           (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
                                                                                                                           (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
                                                                                                                           (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
                                                                                                                           Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
C15445              P15445         CN15445          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 15445
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed 24 weeks under this restriction per authority application.
                                                                                                                           Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR
                                                                                                                           Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached 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