Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p15
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 15/38)
Character Range: 41132–45273

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 the column headed "Listed Drug": Carmellose
(b) omit from the column headed "Listed Drug": Carmellose with glycerin
[116] Schedule 4, Part 1, omit entry for Circumstances Code "C15622"
[117] Schedule 4, Part 1, omit entry for Circumstances Code "C15623"
[118] Schedule 4, Part 1, entry for Circumstances Code "C15640"
(a) omit from the column headed "Listed Drug": Carmellose
(b) omit from the column headed "Listed Drug": Carmellose with glycerin
[119] Schedule 4, Part 1, omit entry for Circumstances Code "C15654"
[120] Schedule 4, Part 1, omit entry for Circumstances Code "C15739"
[121] Schedule 4, Part 1, omit entry for Circumstances Code "C15756"
[122] Schedule 4, Part 1, entry for Circumstances Code "C15818"
omit entry for Circumstances Code "C15818" and substitute:
C15818  P15818  CN15818  Trastuzumab emtansine  Early HER2 positive breast cancer                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                Initial adjuvant treatment
                                                The treatment must be prescribed within 12 weeks after surgery; AND
                                                Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
                                                Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND
                                                The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
                                                The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
                                                Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
                                                (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.
                                                The pathology report must be documented in the patient's medical records.
                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                (i) details of the proposed prescription; and
                                                (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

[123] Schedule 4, Part 1, entry for Circumstances Code "C15819"
omit entry for Circumstances Code "C15819" and substitute:
C15819  P15819  CN15819  Trastuzumab emtansine  Early HER2 positive breast cancer                                                                                                                         Compliance with Authority Required procedures
                                                Continuing adjuvant treatment
                                                Patient must have previously received PBS-subsidised