Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p7
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 7/162)
Character Range: 14692928–14699601

chronic myeloid leukaemia.
                                                                                                         Accelerated phase is defined by the presence of 1 or more of the following
                                                                                                         1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
                                                                                                         2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
                                                                                                         3. Peripheral basophils greater than or equal to 20%; or
                                                                                                         4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
                                                                                                         5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).
C13952              P13952         CN13952          Ustekinumab                                          Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Continuing treatment - balance of supply
                                                                                                         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 for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                         The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
C13955              P13955         CN13955          Ustekinumab                                          Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Initial treatment - initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                         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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                         Patient must have a Mayo clinic score greater than or equal to 6; or
                                                                                                         Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
                                                                                                         The treatment must not exceed a single dose to be administered at week 8 under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         The authority application must be made in writing and must include
                                                                                                         (1) a completed authority prescription