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A test of tumour tissue that is derived from a new sample from a patient with locally advanced (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who has progressed on or after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The test is to be requested by a specialist or consultant physician, to determine if the requirements relating to EGFR T790M gene status for access to osimertinib under the Pharmaceutical Benefits Scheme are fulfilled.

Fee: $397.35 Benefit: 75% = $298.05 85% = $337.75

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A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)  to detect variants in at least EGFR, BRAF, KRAS and MET exon 14 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); and

(b)  to detect the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2 and NTRK3; and

          (i)   to determine access to specific therapies relevant to these variants listed on the PBS; or

         (ii)   determine if the requirements relating to EGFR, ALK and ROS1 status for access immunotherapies listed on the PBS are fulfilled; and

(c)  not associated with a service to which item 73438, 73439, 73337, 73341, 73344, 73436 or 73351 applies

Fee: $1,247.00 Benefit: 75% = $935.25 85% = $1,148.30

(See para PN.7.15 of explanatory notes to this Category)

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A DNA-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to detect variants in at least EGFR, BRAF, KRAS and MET exon 14; and

(b)   to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); or

(c)   to determine if the requirements relating to EGFR status for access to immunotherapies listed on the PBS are fulfilled; and

(d)   not associated with a service to which item 73437, 73337, 73436 or 73351 applies

Fee: $682.35 Benefit: 75% = $511.80 85% = $583.65

(See para PN.7.15 of explanatory notes to this Category)

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A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer and with documented absence of activating variants of the EGFR gene, KRAS, BRAF and MET exon14, requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to determine the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS) are fulfilled; or

(b)   to determine if the requirements relating to ALK and ROS1 status for access to immunotherapies listed on the PBS are fulfilled; and

(c)   not associated with a service to which item 73437, 73341, 73344 or 73351 applies

Fee: $682.35 Benefit: 75% = $511.80 85% = $583.65

(See para PN.7.15 of explanatory notes to this Category)

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