Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p70
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 70/162)
Character Range: 15018460–15023872

treatment is not considered as a treatment failure.
                                                                                                         A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C14195              P14195         CN14195          Tocilizumab                                          Active giant cell arteritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment
                                                                                                         Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND
                                                                                                         Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND
                                                                                                         Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or
                                                                                                         Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or
                                                                                                         Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND
                                                                                                         Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND
                                                                                                         Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or
                                                                                                         Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or
                                                                                                         Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND
                                                                                                         The treatment must be in combination with a tapering course of corticosteroids; AND
                                                                                                         The treatment must not exceed 52 weeks in total including initial and continuing applications;
                                                                                                         Patient must be aged 50 years or older.
                                                                                                         Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.
                                                                                                         The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include
                                                                                                         (a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and
                                                                                                         (b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L