Msac application 1173

Safety

 Toxic effects of treatment

 Adverse events from biopsies

 Rate of re-biopsy

Effectiveness

 Progression free survival

 Overall survival

 Objective tumour response rate

 Quality of life

 Comparison of test performance

Cost effectiveness

 Cost per QALY

 Secondary comparator EGFR gene mutation testing and, after presenting with locally advanced or metastatic disease, use of gefitinib in patients with tumours expressing EGFR exon 19 deletions or exon 21 point mutation L858R and use of platinum-based doublet chemotherapy in patients not expressing these EGFR gene mutations and in those whose EGFR gene mutation status is unknown

No agreed reference standard currently available, but comparisons should be made against the specific tests used to generate the evidence to support the effectiveness of gefitinib

Questions
Primary question: is EGFR gene mutation testing and, after presenting with locally advanced or metastatic disease, use of erlotinib or chemotherapy (dependent on mutation status) safe, effective and cost effective compared to no testing and treatment with chemotherapy, in previously untreated patients with non-squamous NSCLC or NSCLC not otherwise classified?
Secondary question: is EGFR gene mutation testing and, after presenting with locally advanced or metastatic disease, use of erlotinib or chemotherapy (dependent on mutation status) safe, effective and cost effective compared to EGFR gene mutation testing and, after presenting with locally advanced or metastatic disease, use of gefitinib or chemotherapy (dependent on mutation status), in previously untreated patients with non-squamous NSCLC or NSCLC not otherwise classified?