Msac application 1173

Outcomes for safety and effectiveness evaluation

The health outcomes, upon which the comparative clinical performance of EGFR gene mutation testing to determine eligibility for treatment with erlotinib as a first-line therapy in patients with locally advanced or metastatic NSCLC will be measured, are:

Effectiveness

 Progression free survival

 Overall survival

 Objective tumour response rate

 Quality of life

 Comparison of test performance

Comparison of test performance

In a consideration of EGFR gene mutation testing, available test options and combination test strategies (e.g. PCR amplification and sequencing with or without HRM pre-screening) should be identified and a comparative assessment performed. Comparison should be made to the EGFR gene mutation testing methods used in clinical trials where there is evidence supporting

the co-dependent EGFR test and erlotinib treatment (i.e. EURTAC and OPTIMAL trials). If a reference or gold standard test becomes available, then a comparative assessment should refer to that standard. As currently there is no reference standard available, the decision analytic will not be able to take into account the rates of false positive and false negative results generated by EGFR gene mutation testing.
A comparative assessment should consider the method of testing, analytic performance of the tests, and also include a consideration of the collection and handling methods of samples for the test to assess the impact of inadequate samples and re-sampling.