Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p73
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 73/312)
Character Range: 15890411–15897123

with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised
                                                                                                                           Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
                                                                                                                           Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
C14788              P14788         CN14788          Acalabrutinib                                                          Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Treatment of relapsed/refractory disease
                                                    Ibrutinib                                                              The condition must have relapsed or be refractory to at least one prior therapy; AND
                                                                                                                           The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND
                                                    Zanubrutinib                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND
                                                                                                                           Patient must be undergoing treatment through this treatment phase listing for the first time (initial treatment).  or
                                                                                                                           Patient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent.
C14801              P14801         CN14801          Ustekinumab                                                            Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                                           The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND
                                                                                                                           Must be treated by a gastroenterologist (code 87).  or
                                                                                                                           Must be treated by a consultant physician [internal