Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p59
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 59/476)
Character Range: 1140188–1152134

with Authority Required procedures ‑ Streamlined Authority Code 9590
                                                                                                                                            Patient must have thalassaemia major; AND
                                                                                                                                            Patient must be one in whom desferrioxamine therapy has proven ineffective.
                                                                       C9623                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9623
                                                                                                                                            Patient must have thalassaemia major; AND
                                                                                                                                            Patient must be unable to take desferrioxamine therapy.
Desferrioxamine                                                        C6394                                                                Disorders of erythropoiesis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 6394
                                                                                                                                            The condition must be associated with treatment‑related chronic iron overload.
                                                                       C9696                                                                Disorders of erythropoiesis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 9696
                                                                                                                                            The condition must be associated with treatment‑related chronic iron overload.
Difelikefalin                                                          C15171                                                               Moderate to severe pruritus (itching) associated with chronic kidney disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be on optimised haemodialysis; AND
                                                                                                                                            Patient must be on haemodialysis for at least 3 months; AND
                                                                                                                                            The condition must be confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; AND
                                                                                                                                            Patient must have experienced itch that persists for at least 6 weeks despite best supportive care; AND
                                                                                                                                            Patient must have a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) baseline score of more than 4; AND
                                                                                                                                            Patient must not receive more than 12 weeks of treatment under this restriction.
                                                                                                                                            Must be treated by a nephrologist.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Prescriber must exclude any other causes of pruritus which include any of the following:
                                                                                                                                            (i) drug/dialysis related (e.g., opioid-related pruritus);
                                                                                                                                            (ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;
                                                                                                                                            (iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; liver disease; polycythaemia vera/leukemia/lymphoma; hypothyroidism; uncontrolled diabetes).
                                                                                                                                            Best supportive care for patients with chronic kidney disease-associated pruritus is not limited to but includes:
                                                                                                                                            (i) optimisation of dialysis;
                                                                                                                                            (ii) skin hydration and nutrition (with the use of moisturiser, emollients, barrier creams or oils);
                                                                                                                                            (iii) patient education on the importance of avoiding or minimising scratching.
                                                                                                                                            Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.
                                                                                                                                            At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 2 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.
                                                                       C15211                                                               Moderate to severe pruritus (itching) associated with chronic kidney disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have demonstrated an adequate response to