![]() ![]() Patients who had a positive test result with the new biomarker had the same treatment response, as patients with PD-L1 ≥ 50% who are currently treated with immunotherapy in clinical practice. Patients who had a negative test result were treated with first-line immunotherapy combined with PDCT and second-line single agent chemotherapy, because this is still believed to be best possible treatment strategy in case no actionable target is found. This is because it is believed that patients who benefit from immunotherapy will not need the addition of chemotherapy in the first line to experience the most health gain. In “WGS-based biomarker for immunotherapy” (scenario 2), it was assumed that patients who had a positive test result for the new biomarker for immunotherapy would receive first-line immunotherapy, followed by second-line PDCT. This was assumed because the on-label targeted therapies would most likely also concern new drugs. Furthermore, on-label treatment costs and serious adverse events (SAEs) were assumed to be comparable with those of the latest generation targeted therapies that are currently being used in clinical practice. For the treatment response on overall survival (OS) and progression-free survival (PFS) of these first-line on-label targeted therapies, the same proxy was used as in the base model in case of missing survival data. In “WGS results used for treatment selection” (scenario 1), it was assumed that on-label targets were treated with first-line targeted therapies, followed by second-line chemotherapy (in case of disease progression), because most on-label actionable targets are currently treated with this strategy. and M.P.) who witnessed the complete lifecycle of the scenarios and model creation and are listed in the Appendix C in Supplemental Materials found at. These assumptions were discussed with clinical oncology experts (J.M. Model assumptions were made because several model parameters relevant to the scenarios were unknown. The scenario ‘WGS based biomarker for immunotherapy’ (scenario 2) had influence on the biomarker for immunotherapy, PD-L1, in the decision-tree of the model and consequently the treatment decision regarding immunotherapy. The scenarios ‘WGS results used for treatment selection’ (scenario 1) and ‘off-label drug approval for WGS results’ (scenario 3) had influence on the actionable targets found in the decision-tree of the model and consequently the treatment decision regarding on- and off-label targeted therapy. The scenarios concerned alternative future developments of the strategy ‘WGS as a diagnostic test’ of the base-model. The diagnostic strategies ‘SoC’ and ‘WGS as a molecular diagnostic test’ of the initial cost-effectiveness analysis represented the base-model of current research. The right part (circles) indicated the state transition model which simulates disease progression. The left part (rounded rectangles) indicates the decision-tree representing the diagnostic pathway. Increase of 15.0% of physicians that offer WGS to their patientsįigure 1 General structure of the base-model with indications where the scenarios apply. Off-label targets are identified by WGS in 5.0% of the patients. New biomarker: “off-label targets,” added to the decision tree Off-label drug prescription is allowed outside clinical trials to target actionable targets identified by WGS. Increase of 10.0% of patients who prefer WGS over SoCģ. Increase of 10.0% of physicians that offer WGS to their patients New biomarker predicts treatment response in 20.0% of the patients. It is prevalent in 20.0% of patients with advanced lung cancer. PD-L1 replaced with new biomarker for immunotherapy based on WGS New biomarker based on WGS becomes available that predicts treatment response to immunotherapy. 12/2016: Making Choices on the Journey to Universal Health Care Coverage: From Advocacy to Analysisįor change in costs, we used the suggested percental change between the status quo and the scenario parameter values.2/2017: “Mapping Studies” In Cost-Utility Analyses: New Recommendations From ISPOR Task Force.2/2017: ISPOR Releases New Task Force Recommendations for the Development of Clinician-Reported Outcome Assessments. ![]()
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