Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p27
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 27/161)
Character Range: 13993768–14002612

are not eligible for treatment with this drug.
C13231              P13231         CN13231          Brentuximab vedotin            Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
                                                                                   Patient must not be suitable for ASCT for this condition; or
                                                                                   Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
                                                                                   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
                                                                                   Patient must not receive more than 12 cycles of treatment under this restriction.
                                                                                   The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.
C13236              P13236         CN13236          Vedolizumab                    Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                   Balance of supply - subcutaneous form
                                                                                   Must be treated by a gastroenterologist (code 87); or
                                                                                   Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                   Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                   Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or
                                                                                   Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND
                                                                                   The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available 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.
C13237              P13237         CN13237          Vedolizumab                    Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                   Balance of supply - subcutaneous form
                                                                                   Must be treated by a gastroenterologist (code 87); or
                                                                                   Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                   Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                   Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or
                                                                                   Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND
                                                                                   The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available 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