Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p378
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 378/381)
Character Range: 13806940–13815862

must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
C12979              P12979         CN12979          Amifampridine                                                                                                   Lambert-Eaton myasthenic syndrome (LEMS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    The condition must not be any of:
                                                                                                                                                                     (i) myasthenia gravis, (ii) Guillain-Barre syndrome; AND
                                                                                                                                                                    Must be treated by a prescriber type identifying as at least one of the following:
                                                                                                                                                                     (i) a clinical immunologist, (ii) a neurologist, (iii) a medical practitioner working under the direct supervision of one of these mentioned specialists.
C12981              P12981         CN12981          Larotrectinib                                                                                                   Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     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 a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date); or
                                                                                                                                                                    The condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (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 at least 18 years of age.
                                                                                                                                                                    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.
                                                                                                                                                                    (b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.
                                                                                                                                                                    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