Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p9
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 9/162)
Character Range: 14703125–14712521

of 90 mg and no repeats.
                                                                                                         Details of the accepted toxicities including severity can be found on the Services Australia website.
C13958              P13958         CN13958          Upadacitinib                                         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
                                                                                                         The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of:
                                                                                                          (i) the quantity per dispensing, (ii) repeat prescriptions; AND
                                                                                                         The treatment must provide no more than the balance of 24 weeks treatment.
C13959              P13959         CN13959          Upadacitinib                                         Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Dose modification
                                                                                                         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 be undergoing existing PBS-subsidised treatment with this therapy.
C13966              P13966         CN13966          Memantine                                            Moderately severe Alzheimer disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 13966
                                                                                                         Continuing
                                                                                                         Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND
                                                                                                         Patient must demonstrate a clinically meaningful response to the initial treatment; AND
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                         Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
                                                                                                         Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
                                                                                                         Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
                                                                                                         Clinically meaningful response to treatment is demonstrated in the following areas
                                                                                                         Patient's quality of life including but not limited to level of independence and happiness;
                                                                                                         Patient's cognitive function including but not limited to memory, recognition and interest in environment;
                                                                                                         Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour.
C13967              P13967         CN13967          Naltrexone                                           Alcohol dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 13967
                                                                                                         The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence/controlled consumption.
C13972              P13972         CN13972          Lenvatinib                                           Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13972
                                                                                                         Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this