Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p151
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 151/161)
Character Range: 14601477–14609085

with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.
                                                                                   The assessment of response must be documented in the patient's medical records.
                                                                                   Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
                                                                                   This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
C13880              P13880         CN13880          Sapropterin                    Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                   First continuing treatment
                                                                                   Must be treated by a metabolic physician; or
                                                                                   Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
                                                                                   Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND
                                                                                   Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.
                                                                                   Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.
                                                                                   Dietary phenylalanine intake must be maintained at a constant level.
C13885              P13885         CN13885          Sapropterin                    Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                   Initial treatment - responsiveness testing
                                                                                   Must be treated by a metabolic physician; AND
                                                                                   Patient must be untreated with this drug; or
                                                                                   Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND
                                                                                   Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or
                                                                                   Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND
                                                                                   The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age.  or
                                                                                   The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.
                                                                                   Dietary phenylalanine intake must be maintained at a constant level.
                                                                                   Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.
C13886              P13886         CN13886          Calcitonin salmon              Hypercalcaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                   The treatment must be initiated in a hospital; AND
                                                                                   The treatment must be for a patient who cannot tolerate