Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p14
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 14/38)
Character Range: 37318–41443

Code "C14829"
[107] Schedule 4, Part 1, omit entry for Circumstances Code "C15049"
[108] Schedule 4, Part 1, omit entry for Circumstances Code "C15050"
[109] Schedule 4, Part 1, omit entry for Circumstances Code "C15055"
[110] Schedule 4, Part 1, omit entry for Circumstances Code "C15056"
[111] Schedule 4, Part 1, omit entry for Circumstances Code "C15062"
[112] Schedule 4, Part 1, entry for Circumstances Code "C15303"
omit entry for Circumstances Code "C15303" and substitute:
C15303  P15303  CN15303  Tafamidis  Transthyretin amyloid cardiomyopathy                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                    Second and subsequent PBS-subsidised prescriptions for this drug
                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                    Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND
                                    The treatment must be ceased where the patient's heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND
                                    The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device.
                                    Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.
                                    Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no).
                                    If 'no', continued PBS subsidy is available.
                                    If 'yes', continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent.
                                    Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available.

[113] Schedule 4, Part 1, entry for Circumstances Code "C15456"
omit entry for Circumstances Code "C15456" and substitute:
C15456  P15456  CN15456  Midazolam  Generalized convulsive status epilepticus                                                          Compliance with Authority Required procedures
                                    Continuing treatment
                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.

[114] Schedule 4, Part 1, entry for Circumstances Code "C15457"
omit entry for Circumstances Code "C15457" and substitute:
C15457  P15457  CN15457  Midazolam  Generalized convulsive status epilepticus                                                                                                                          Compliance with Authority Required procedures
                                    Initial treatment
                                    Patient must have been assessed to be at significant risk of status epilepticus; AND
                                    Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years.
                                    Patient must be at least one year of age.
                                    The treatment must initiated by a specialist physician experienced in the treatment of epilepsy.

[115] Schedule 4, Part 1, entry for Circumstances Code "C15560"
(a) omit from