OBJECTIVES: Introduce the Population Health Impact Model (PHIM) developed by Phillip Morris International, used to assess the population health impact of introducing Reduced-Risk Products (RRP)* in different markets where such products are already, or may be, marketed based on the FDA Modified Risk Tobacco Product Application (MRTPA) guidelines. The model assesses the effect that its introduction would have on population health, given the lack of epidemiological data on any risks from RRPs available prior to marketing authorization.

METHODS: The model is based on publicly available data on smoking prevalence and on the relationships between smoking-related disease-specific mortality and various aspects of cigarette smoking, together with an estimate of exposure from the RRP relative to that from cigarettes, and allows the exploration of possible scenarios regarding the effect of RRP introduction on the prevalence of cigarette and RRP use, individually and in combination. By comparing attributable mortality in a scenario where the RRP is introduced with one where it is not, the model estimates the mortality attributable to cigarette smoking and RRP use and the reduction in the deaths attributable to the introduction of the RRP, due to lung cancer, ischemic heart disease, stroke, and COPD. Predictions are based on hypothetical populations (historical period 1990–2010).

RESULTS: Results have been used in the FDA MRTPA for the U.S. and regulatory applications. The model predictions are validated with ext. data available at that time point and are continuously updated.

CONCLUSIONS: The predictions completed to date demonstrate that in addition to existing tobacco control efforts, an introduction of an RRP can further reduce the overall population health impact in countries with different smoking habits and different RRP uptake.

*"RRP": Term PMI uses to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking.