Posters

      Population health impact model to estimate the effect of introducing modified risk tobacco products on mortality

      Sponsiello-Wang, Z.; Lee, P. N.; Baker, G.; Gonzalez-Zuloeta Ladd, A. M.; Lüdicke, F.; Weitkunat, R.
      Conference date
      Feb 27, 2015
      Conference name

      Society for Research on Nicotine and Tobacco (SRNT) 2015
      Link to more information
      Topic
      Summary

      According to the 2012 Food and Drug Administration (FDA)’s Modified Risk Tobacco Product (MRTP) draft guidance, there is an inherent difficulty in making premarket assessments of the effect of introducing an MRTP on the population as a whole. FDA therefore encourages the development and application of innovative analytical methods to make preliminary estimates of the potential effects including modeling. Philip Morris International is developing a Population Health Impact Model to assess the effect that the introduction of a MRTP would have on the population. The modeling approach uses available smoking prevalence and disease-specific mortality data as well as relative risk (RR) estimates for the most common smoking related diseases from epidemiological studies. Calculations rely on generally acknowledged methods and it is a goal to reduce the number of necessary assumptions to a minimum. The model will consist of two major components, the Prevalence (P) and Epidemiological (E) Risk Component. The P-Component uses a state-transition Monte Carlo microsimulation model to estimate changes in the distribution of smoking habits (combustible cigarette (CC) and/or MRTP) occurring in a hypothetical population of a given size over a defined period, separately for a scenario where the MRTP is introduced and a scenario where it is not. The E-Component uses estimates of the RRs of smoking-related diseases for current smokers compared to never smokers and for former smokers by time quit to estimate the number of smoking-attributable deaths. The MRTP-related risk reduction quantification will be based on a comprehensive risk assessment integrating evidence on non-clinical and clinical research. Using an estimate of the exposure from the MRTP relative to CCs and smoking cessation, the model compares smoking-attributable deaths under each scenario to derive the estimated reduction in smoking-attributable mortality associated with the introduction of a MRTP.

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      Reduced Risk Products ("RRPs”) is the term we use 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 continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.