Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p379
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 379/381)
Character Range: 13815110–13824014

documented in the patient's medical records.
                                                                                                                                                                    If the application is submitted through HPOS upload or mail, it must include
                                                                                                                                                                    (a) a completed authority prescription form; and
                                                                                                                                                                    (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C12982              P12982         CN12982          Larotrectinib                                                                                                   Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a child                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence:
                                                                                                                                                                     (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND
                                                                                                                                                                    The condition must be metastatic disease; or
                                                                                                                                                                    The condition must be both:
                                                                                                                                                                     (i) locally advanced, (ii) unresectable; or
                                                                                                                                                                    The condition must be both:
                                                                                                                                                                     (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                                                                                    Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition;
                                                                                                                                                                    Patient must be/have been under 18 years of age (i.e. prior to their 18th birthday) at treatment initiation with this drug.
                                                                                                                                                                    The authority application 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 of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.
                                                                                                                                                                    All reports must be documented in the patient's medical records.
                                                                                                                                                                    If the application is submitted through HPOS upload or mail, it must include
                                                                                                                                                                    (a) a completed authority prescription form; and
                                                                                                                                                                    (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C12999              P12999         CN12999          Zanubrutinib                                                                                                    Waldenstrom macroglobulinaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.

National Health (Listing of Pharmaceutical Benefits) Instrument 2024

PB 26 of 2024
made under sections 84AF, 84AK, 85, 85A and 88 of