Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p26
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 26/30)
Character Range: 82701–87122

for this condition as a child; AND
                                       Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or
                                       Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or
                                       Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre;
                                       Patient must have a mature skeleton.
                                       Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.
                                       The authority application must be in writing and must include:
                                       Details of the proposed prescription; AND
                                       A completed Severe Growth Hormone Deficiency supporting information form; AND
                                       Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.
C16249  P16249  CN16249  Imatinib      Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16249
                                       Maintenance of first complete remission
                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition; or
                                       Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND
                                       The condition must be expressing the Philadelphia chromosome; or
                                       The condition must have the transcript BCR-ABL; AND
                                       Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                       Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose. or
                                       Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.
                                       Conditions for PBS-subsidy beyond 24 months of treatment
                                       On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring that
                                       1) The condition is expressing the Philadelphia chromosome,
                                       2) Measurable residual disease (MRD) is present,
                                       3) MRD has been confirmed in at least one of (i) marrow, (ii) peripheral blood,
                                       4) MRD has been confirmed within the preceding months of this authority application,
                                       5) MRD has been ascertained by at least one of (i) a molecular method, (ii) flow cytometry,
                                       6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.
                                       For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm