Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p175
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 175/312)
Character Range: 16549711–16557334

condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND
                                                                                                                           The condition must be metastatic disease; OR
                                                                                                                           The condition must be both: (i) locally advanced, (ii) unresectable; OR
                                                                                                                           The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND
                                                                                                                           Patient must have received prior systemic treatment for this disease; OR
                                                                                                                           Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND
                                                                                                                           The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND
                                                                                                                           Patient must not receive more than 3 months of treatment under this restriction.
                                                                                                                           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 (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.
                                                                                                                           (c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies.
                                                                                                                           All reports 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).
C15469              P15469         CN15469          Beclometasone with formoterol                                          Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 15469
                                                                                                                           Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR
                                                                                                                           Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR
                                                                                                                           Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.
                                                                                                                           Patient must be at least 18 years of age.
C15471              P15471         CN15471          Nivolumab                                                              Resectable non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 15471
                                                                                                                           The condition must be at