Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p25
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 25/30)
Character Range: 77784–83021

cancer, and has at least 4 positive lymph nodes; AND
                                       The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word 'cancelled' where (i)/ (ii) has occurred; AND
                                       The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND
                                       The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab.
                                       Retain all pathology imaging and investigative test results in the patient's medical records.
                                       Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).
C16241  P16241  CN16241  Olaparib      Metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                       Continuing treatment
                                       Patient must have received previous PBS-subsidised treatment with this drug in the metastatic setting; AND
                                       The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                       Patient must not have developed disease progression while receiving treatment with this drug for this condition.
C16242  P16242  CN16242  Somatropin    Severe growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                       Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
                                       Must be treated by an endocrinologist; AND
                                       Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child;
                                       Patient must have a mature skeleton.
                                       Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.
                                       The authority application must be in writing and must include:
                                       Details of the proposed prescription; AND
                                       A completed Severe Growth Hormone Deficiency supporting information form.
C16243  P16243  CN16243  Somatropin    Severe growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                       Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
                                       Must be treated by an endocrinologist; AND
                                       Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
                                       Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
                                       Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or
                                       Patient must have current or historical evidence of