Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p20
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 20/191)
Character Range: 9668010–9683037

for the week prior to radiotherapy; AND
                                                                                                                                                                                                                               Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
C4796               P4796          CN4796           Exemestane                                                                                                                                                                 Metastatic (Stage IV) breast cancer
                                                                                                                                                                                                                               The condition must be hormone receptor positive; AND
                                                                                                                                                                                                                               The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                                                                                                                                                                                                               Patient must be receiving PBS-subsidised everolimus concomitantly for this condition;
                                                                                                                                                                                                                               Patient must not be pre-menopausal.
C4812               P4812          CN4812           Everolimus                                                                                                                                                                 Metastatic (Stage IV) breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                                                                               The condition must be hormone receptor positive; AND
                                                                                                                                                                                                                               The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                                                                                                                                                                                                               The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
                                                                                                                                                                                                                               The treatment must be in combination with exemestane;
                                                                                                                                                                                                                               Patient must not be pre-menopausal.
C4824               P4824          CN4824           Olsalazine                                                                                                                                                                 Ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 4824
                                                                                                                                                                                                                               Patient must have had a documented hypersensitivity reaction to a sulphonamide.  or
                                                                                                                                                                                                                               Patient must be intolerant to sulfasalazine.
C4837               P4837          CN4837           Everolimus                                                                                                                                                                 Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously been issued with an authority prescription for this drug; AND
                                                                                                                                                                                                                               Patient must not have disease progression; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
                                                                                                                                                                                                                               Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug.
C4861               P4861          CN4861           Everolimus                                                                                                                                                                 Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be symptomatic (despite somatostatin analogues); or
                                                                                                                                                                                                                               Patient must have disease progression; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
                                                                                                                                                                                                                               Disease progression must be documented in the patient's medical records.
                                                                                                                                                                                                                               Patients who have developed progressive disease on sunitinib are not eligible to receive PBS-subsidised everolimus.
                                                                                                                                                                                                                               Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.
C4862               P4862          CN4862           Sunitinib                                                                                                                                                                  Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be symptomatic (despite somatostatin analogues); or
                                                                                                                                                                                                                               Patient must have disease progression; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
                                                                                                                                                                                                                               Disease progression must be documented in the patient's medical records.
                                                                                                                                                                                                                               Patients who have developed progressive disease on everolimus are not eligible to receive PBS-subsidised sunitinib for this condition.
                                                                                                                                                                                                                               Patients who have developed intolerance to everolimus of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.
C4872               P4872          CN4872           Hydrocortisone                                                                                                                                                             Ulcerative colitis

                                                    Prednisolone

C4877               P4877          CN4877           Pamidronic acid                                                                                                                                                            Symptomatic Paget disease of bone

                                                    Risedronic acid

C4878               P4878          CN4878           Mesalazine                                                                                                                                                                 Acute episode of mild to moderate ulcerative proctitis

C4888               P4888          CN4888           Mesalazine                                                                                                                                                                 Acute episode of mild