Cost effectiveness analysis and impact assessment

Deliverable of a European Project funded by Horizon 2020. This deliverable reports the results of the Task 6.1 Impact assessment and cost effectiveness analysis, in terms of impact on the health care systems and on the society at large of the adoption (use) of the SMARTool platform. Our analysis is focused on two key diagnostic modules: Pre-Imaging Module (PIM) and Non-invasive Fractional Flow Reserve (SmartFFR). We have based our work on two phases: an analysis of the evidence (to structure the problem, and identify relevant processes and variables) and the building of an economic model - Markov-based decision analysis (to compare an alternative strategy with the SMARTool approach). The former phase is the basis for the latter. The evidence analysis has been performed by collecting data from literature (a systematic review on the different pre-test probability scores/models adopted all over the world, a selection of papers to extract transition probabilities adopted in the Markov model), by analysing costs of the procedures adopted in the Italian National Healthcare System as well as in other EU healthcare systems of Consortium partners and collecting data from SMARTool cohort in terms of prevalence of Coronary Artery Disease (CAD), drugs used for the medical treatment of CAD and sensitivity and specificity of SMARTool PIM. The second phase is aimed to build and run the economic model based on more than 40 variables. By running the model, we have compared two main diagnostic strategies: SMARTool strategy, based on the use of SMARTool PIM, Coronary Computed Tomography Angiography (CCTA) and SmartFFR vs EU Strategy based on the use of the updated Diamond and Forrester model, CCTA and Invasive Coronary Angiography (ICA). We have developed a Markov-based decision analysis model of diagnosis, treatment, costs, and outcomes, measured by quality-adjusted life years (QALYs). Although limited to the key diagnostic modules PIM and SmartFFR of the entire platform, it must be acknowledged that these two modules constitute the real gatekeepers of the whole SMARTool CDSS for non-invasive CCTA imaging and invasive ICA procedure respectively: CCTA and ICA, also according to the recent NICE guidelines for the management of stable angina, are the clue clinical decisions to be taken in suspected stable CAD management. Based on our analysis, the cost of the SMARTool Strategy is estimated equal to 3,815EUR with an effectiveness of of 14.488 QALYs and a C/E ratio of 263 euros per QALY. Its comparator, the EU strategy, has a cost of 4,453EUR and an effectiveness of 14.504 QALYs with a C/E ratio of 307 euros per QALY. The incremental C/E ratio (from SMARTool to EU strategy) is 38,724 euros per QALY gained. Although none of the two strategies can be considered dominant when compared with the other, it must be underlined (as reported in Figure 7 and Table 8) that SMARTool adoption implies a small loss in effectiveness (0.016 QUALYs) but a significant reduction of costs. Overall, the SMARTool Strategy has resulted the one with the best cost/effectiveness ratio (263 vs. 307EUR/QALYs for SMARTool and EU respectively).