Document ID: chunk:federal_register_of_legislation:F2024L01542:reg:52:p2
Version: federal_register_of_legislation:F2024L01542
Segment Type: reg
Provision Reference: reg 52 (pt 2/6)
Character Range: 7359–11546

Maximum quantity: 1; Maximum repeats: 11]
          1.            insert in numerical order in the column headed "Circumstances": C14729 C14735
          2.            insert in numerical order in the column headed "Purposes": P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328
 1.                Schedule 2, omit entry for Daunorubicin with cytarabine
 2.                Schedule 2, entry for Vedolizumab [Maximum quantity: 1; Maximum repeats: 2]
     insert in numerical order in the column headed "Circumstances": C16169 C16170 C16181 C16216 C16217
 1.                Schedule 3, omit entry for Daunorubicin with cytarabine
 2.                Schedule 3, omit entry for Nivolumab with relatlimab
 3.                Schedule 3, entry for Vedolizumab
     insert in numerical order after existing text:
   C16169     Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
              Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)
              Patient must have received insufficient therapy with this drug under the Initial 1 treatment (new patient) restriction to complete 14 weeks of treatment; OR
              Patient must have received insufficient therapy with this drug under the Initial 2 treatment (recommencement of treatment after a break in biological medicine) to complete 14 weeks of treatment; AND
              The treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases.
              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)].
   C16170     Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
              Initial 2 treatment (Recommencement of treatment after a break in biological medicine)
              Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
              Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition; AND
              Patient must not receive more than 14 weeks of treatment under this restriction.
              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)].
              The treatment must be initiated in combination with standard of care antibiotic.
              The assessment of a patient's response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.
              Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient