Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p98
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 98/191)
Character Range: 10620063–10634121

blood progenitor cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 8672
                                                                                                                                                                                                                               The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.
C8673               P8673          CN8673           Filgrastim                                                                                                                                                                 Chronic cyclical neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 8673
                                                                                                                                                                                                                               Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND
                                                                                                                                                                                                                               Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics.  or
                                                                                                                                                                                                                               Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.
C8674               P8674          CN8674           Filgrastim                                                                                                                                                                 Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 8674
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                                                                                                               Patient must be at greater than 20% risk of developing febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
C8696               P8696          CN8696           Filgrastim                                                                                                                                                                 Assisting autologous peripheral blood progenitor cell transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 8696
                                                                                                                                                                                                                               The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.
C8734               P8734          CN8734           Adrenaline (epinephrine)                                                                                                                                                   Acute allergic reaction with anaphylaxis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial sole PBS-subsidised supply for anticipated emergency treatment
                                                                                                                                                                                                                               Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis.
C8738               P8738          CN8738           Riluzole                                                                                                                                                                   Amyotrophic lateral sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must be ambulatory; or
                                                                                                                                                                                                                               Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND
                                                                                                                                                                                                                               Patient must not have undergone a tracheostomy; AND
                                                                                                                                                                                                                               Patient must not have experienced respiratory failure.
C8770               P8770          CN8770           Lacosamide                                                                                                                                                                 Intractable partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 8770
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a neurologist; AND
                                                                                                                                                                                                                               The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND
                                                                                                                                                                                                                               The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents.
C8774               P8774          CN8774           Esomeprazole                                                                                                                                                               Gastro-oesophageal reflux disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 8774
                                                                                                                                                                                                                               The treatment must be for initial treatment of symptomatic gastro-oesophageal reflux disease.  or
                                                    Lansoprazole                                                                                                                                                               The treatment must be for the short-term maintenance treatment of gastro-oesophageal reflux disease.