Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p84
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 84/476)
Character Range: 1317912–1324196

treatment phase for this condition; AND
                                                                                                                                            Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
                                                                                                                                            Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
                                                                                                                                            Patient must not receive more than 80 weeks of eculizumab treatment in total under this restriction; OR
                                                                                                                                            Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
                                                                                                                                            Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
                                                                                                                                            Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
                                                                                                                                            Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
                                                                                                                                            A treatment response is defined as:
                                                                                                                                            (1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
                                                                                                                                            (2) One of the following:
                                                                                                                                            a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
                                                                                                                                            b) an eGFR within +/- 25% from baseline; or
                                                                                                                                            c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
                                                                                                                                            PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
                                                                                                                                            A treatment failure is defined as a patient who is:
                                                                                                                                            (1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
                                                                                                                                            (2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
                                                                                                                                            The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
                                                                                                                                            The authority application must be in writing and must include all of the following:
                                                                                                                                            (1) A completed authority prescription form(s);
                                                                                                                                            (2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
                                                                                                                                            (3) A measurement of body weight at the time of application;
                                                                                                                                            (4)