Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p325
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 325/476)
Character Range: 2933182–2940045

AND
                                                                                                                                            Patient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; AND
                                                                                                                                            Patient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy.
                                                                                                                                            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.
                                                                                                                                            This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
                                                                                                                                            Evidence of active and progressing TMA is defined by the following:
                                                                                                                                            (1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:
                                                                                                                                            (i) presence of schistocytes on blood film;
                                                                                                                                            (ii) low or absent haptoglobin;
                                                                                                                                            (iii) lactate dehydrogenase (LDH) above normal range; or
                                                                                                                                            (2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and
                                                                                                                                            (3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
                                                                                                                                            (a) kidney impairment as demonstrated by one or more of the following:
                                                                                                                                            (i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;
                                                                                                                                            (ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;
                                                                                                                                            (iii) a sCr of greater than the age-appropriate ULN in paediatric patients;
                                                                                                                                            (iv) a renal biopsy consistent with aHUS;
                                                                                                                                            (b) onset of TMA-related neurological impairment;
                                                                                                                                            (c) onset of TMA-related cardiac impairment;
                                                                                                                                            (d) onset of TMA-related gastrointestinal impairment;
                                                                                                                                            (e) onset of TMA-related pulmonary impairment.
                                                                                                                                            Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.
                                                                                                                                            The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.
                                                                                                                                            Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for 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