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Somation Mutation Testing for NSCLC

Medicare Eligibility Criteria

From 1 November 2023, three new pathology items will be included in the MBS to test for genetic variants in patients with non-squamous (or histology not otherwise specified) non-small cell lung cancer. MBS items will include broader actionable gene variants along with fusion genes to access specific therapies relevant to these variants listed on the PBS. 

New items 

73437

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

73438

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

73439

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