The use of Comparative Effectiveness Research (CER) is intended to help patients and providers make sound health care and treatment decisions. However, little is known about the impact of CER on financial incentives for medical innovation and, ultimately, the health of future generations. Using a microsimulation approach, we analyze the impacts of potential CER policies on biomedical innovation and population health in the United States and Europe. METHODS: We selected three clinical scenarios that reflect broad trends for assessing the impacts of CER policies on innovation returns: growth in personalized medicine; increasing demand for head-to-head trials; and changes in size and complexity of trials. We estimated the impact on development costs, revenue, and the timing of returns (lags between development, approval, and reimbursement coverage). These scenario-specific impacts were then generalized to the US and European markets, and a range of estimated effects of CER policies were compiled. We simulated the impact of changes in current innovation incentives on producer output and the health of future populations in year 2060 using the Future Elderly Model (FEM). RESULTS: Under most scenarios, CER policies would have negative impacts on innovation, and lead to substantial reductions in population life expectancy. Population life expectancy was estimated to be reduced by 14.1% (range, 9.0% to 15.6%) by 2060 due to CER policies related to trends in personalized medicine, 4.4% (-8.1% to +5.5%) related to active comparators, and 7.4% (-11.4% to +10.2%) related to increased trial complexity. Only with multiple innovation-friendly assumptions (such as trial cost reductions, relatively high price increases, and large market size growth driven by personalized medicine), do CER policies generate increases in innovation output and corresponding social value. CONCLUSIONS: The potential long-run consequences of CER on innovation and future health calls for careful consideration of CER policies that encourage and incentivize innovation.
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