Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p24
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 24/31)
Character Range: 80432–84574

be the sole PBS-subsidised therapy for this condition; AND
                 Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

         (c)           insert in numerical order after existing text:
   C14770        Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                             Compliance with Authority Required procedures
                 Initial treatment - 3 weekly treatment regimen
                 The treatment must be in addition to complete surgical resection; AND
                 Patient must have a WHO performance status of 1 or less; AND
                 The treatment must be the sole PBS-subsidised therapy for this condition; AND
                 Patient must not have received prior PBS-subsidised treatment for this condition; AND
                 The treatment must commence within 12 weeks of complete resection; AND
                 Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).
   C14786        Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                    Compliance with Authority Required procedures
                 Continuing treatment - 3 weekly treatment regimen
                 Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing.
                 Patient must not have experienced disease recurrence; AND
                 The treatment must be the sole PBS-subsidised therapy for this condition; AND
                 Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).

     [111]           Schedule 4, Part 1, entry for Ustekinumab
     insert in numerical order after existing text:
   C14758  P14758     Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                      Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                      Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                      Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
                      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)].
                      To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted between 8 and 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                      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 has experienced a serious adverse reaction