Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p218
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 218/312)
Character Range: 16852893–16861268

in the patient being unable to complete a three month course of antibiotics.
                                                                                                                           The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.
                                                                                                                           This restriction is intended for induction dosing only.
                                                                                                                           Details of two completed prescriptions should be submitted with every initial application for this drug.
                                                                                                                           One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.
                                                                                                                           Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C15814              P15814         CN15814          Ganciclovir                                                            Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15814
                                                                                                                           Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.
                                                    Valganciclovir

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).
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 treatment with