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CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 57

Assessing the potential population health impact of market authorization of e-cigarettes in the U.S.

MUHAMMAD-KAH R.; PITHAWALLA Y.B.; HANNEL T.; WEI L.; BLACK R.; BRYAN T.; GOGOVA M.
Altria Client Services LLC, Richmond, VA, U.S.A.

When evaluating a Premarket Tobacco Product Application (PMTA) or Modified Risk Tobacco Product Application (MRTPA), the Food and Drug Administration (FDA) employs a Population Health Standard, which requires evaluation of risk and benefit to the population as a whole; including tobacco users and non-users. In the absence of epidemiological data, computational models are valuable tools for predicting the likely impact of introducing a new tobacco product on the U.S. population. Using best modeling practices, we have developed and validated an Agent Based Model that assesses the impact of introducing a new product into a hypothetical population by estimating changes in tobacco use prevalence and premature death prevented for a Modified Case Scenario (where both cigarettes and e-cigarettes have authorization to be marketed in the U.S.) against a Base Case scenario (where cigarettes are the predominately used tobacco product and e-cigarettes do not have authorization to be marketed). The model allows us to integrate information about relative risks between existing and new products, with learnings from published literature, national dataset analyses and consumer perception studies that provide insights about potential behavioral changes, which may occur when a new product is introduced into the market. Survival probabilities of current and former e-cigarette users were determined by combining statistical models with excess relative risks (ERR). Base Case transition probabilities were obtained from nationally representative databases. The Modified Case transitions probabilities were estimated from an analysis of Wave 1 and Wave 2 data from the Population Assessment of Tobacco and Health (PATH) study. Employing these transition probabilities and an ERR value of 0.05 for e-cigarette use compared to smoking, we demonstrate a net benefit to the population of ~600,000 premature deaths prevented, along with a reduction in cigarette smoking prevalence, over the simulation follow-up period. Results from sensitivity analysis will also be discussed.