Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p28
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 28/161)
Character Range: 14001308–14012803

under Initial treatment - subcutaneous form.  or
                                                                                   The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form.
C13241              P13241         CN13241          Decitabine with cedazuridine   Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND
                                                                                   The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.
                                                                                   The following reports must be documented in the patient's medical records
                                                                                   (a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and
                                                                                   (b) full blood examination report.
C13246              P13246         CN13246          Vorinostat                     Cutaneous T-cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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 PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
C13257              P13257         CN13257          Decitabine with cedazuridine   Myelodysplastic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  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 progressive disease.
                                                                                   Up to 6 cycles will be authorised.
C13258              P13258         CN13258          Decitabine with cedazuridine   Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 13258
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not have progressive disease.
C13259              P13259         CN13259          Brentuximab vedotin            Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
                                                                                   Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; or
                                                                                   Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
                                                                                   Patient must not receive more than 4 cycles of treatment under this restriction.
                                                                                   Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
                                                                                   If the application is submitted through HPOS upload or mail, it must include
                                                                                   (a) a completed authority prescription form; and
                                                                                   (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C13260              P13260         CN13260          Sonidegib                      Metastatic or locally advanced basal cell carcinoma (BCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written 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 PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The condition must remain inappropriate for