Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p60
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 60/476)
Character Range: 1150536–1157398

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 treatment with this drug including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score.
                                                                                                                                            Must be treated by a nephrologist; OR
                                                                                                                                            Must be treated by a medical practitioner in consultation with a nephrologist.
                                                                                                                                            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 5 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.
                                                                       C15227                                                               Moderate to severe pruritus (itching) associated with chronic kidney disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                                            Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND
                                                                                                                                            Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply was commenced, the patient: (i) was on optimised haemodialysis; (ii) was on haemodialysis for at least 3 months; (iii) had a condition confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; (iv) had experienced itch that persists for at least 6 weeks despite best supportive care; (v) had a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) of more than 4 at baseline; AND
                                                                                                                                            Patient must have demonstrated an adequate response to the most recent non-PBS-subsidised treatment with this drug for this condition, including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score.
                                                                                                                                            Must be treated by a nephrologist.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            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 5 repeats will be authorised. No more than 4 doses per week will be authorised