Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p242
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 242/312)
Character Range: 16992568–17000401

received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2024; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The condition must have been untreated with drug treatment at the time of the first dose of this drug; OR
                                                                                                                           Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL at the time of receiving non-PBS-subsidised treatment with this drug for this condition; 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
                                                                                                                           The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                                                                           For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the next relevant treatment phase.
                                                                                                                           There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).
C15894              P15894         CN15894          Avacopan                                                               Anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           Induction treatment
                                                                                                                           The condition must be severe granulomatosis with polyangiitis; OR
                                                                                                                           The condition must be severe microscopic polyangiitis; AND
                                                                                                                           The condition must be active at the time of the first prescription for this drug per treatment cycle; AND
                                                                                                                           Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease; AND
                                                                                                                           Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug's approved Product Information; AND
                                                                                                                           Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction.
                                                                                                                           A prescriber may apply for more than one induction treatment for their patient
C15902              P15902         CN15902          Bimekizumab                                                            Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           An adequate response to treatment is