Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p203
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 203/381)
Character Range: 12868987–12879737

medical records; AND
                                                                                                                                                                    The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD:
                                                                                                                                                                     (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder; AND
                                                                                                                                                                    Must be treated by a haematologist; or
                                                                                                                                                                    Must be treated by a medical physician working under the supervision of a haematologist; AND
                                                                                                                                                                    Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed.  or
                                                                                                                                                                    Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
                                                                                                                                                                    Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.
C12590              P12590         CN12590          Olaparib                                                                                                        Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
                                                                                                                                                                    The treatment must not be subsidised in combination with:
                                                                                                                                                                     (i) chemotherapy, (ii) a novel hormonal drug; AND
                                                                                                                                                                    The condition must have progressed following prior treatment that included a novel hormonal drug for this condition (metastatic/non-metastatic disease); AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    Patient must be undergoing treatment with this drug for the first time.
C12594              P12594         CN12594          Siltuximab                                                                                                      Idiopathic multicentric Castleman disease (iMCD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                                                                    Must be treated by a haematologist.  or
                                                                                                                                                                    Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                                                    Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.
C12598              P12598         CN12598          Olaparib                                                                                                        Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not be subsidised in combination with:
                                                                                                                                                                     (i) chemotherapy, (ii) a novel hormonal drug.
C12599              P12599         CN12599          Tiotropium                                                                                                      Severe asthma
                                                                                                                                                                    Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of:
                                                                                                                                                                     (i) receiving optimised asthma