A novel approach to assess the population health impact of introducing a Modified Risk Tobacco Product

Abstract

Based on the Food and Drug Administration's Modified Risk Tobacco Product (MRTP) Application draft guideline, Philip Morris International (PMI) has developed a Population Health Impact Model to estimate the reduction in the number of deaths over a period following the introduction of an MRTP. Such a model is necessary to assess the effect that its introduction would have on population health, given the lack of epidemiological data available prior to marketing authorization on any risks from MRTPs. 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 the smoking of conventional cigarettes (CCs), together with an estimate of exposure from the MRTP relative to that from CCs, and allows the exploration of possible scenarios regarding the effect of MRTP introduction on the prevalence of CC and MRTP use, individually and in combination. By comparing mortality attributable in a scenario where the MRTP is introduced with one where it is not, the model can estimate the mortality attributable to CCs and the MRTP, as well as the reduction in the deaths attributable to the introduction of the MRTP.

Assessing the Likelihood and Magnitude of a Population Health Benefit Following the Market Introduction of a Modified‐Risk Tobacco Product: Enhancements to the Dynamic Population Modeler, DPM(+1)

“…Alternative analytic frameworks have been suggested for assessing the population benefit or harm that may result from specified shifts in tobacco exposure patterns. In particular, some researchers have suggested models that employ a framework whereby simulations start with a cross‐sectional population of mixed ages, genders, and tobacco use status (never users, former users by years since quitting, and current users) . Each age in the cross‐sectional population represents a distinct birth cohort, which is followed over time (based on calendar year and age), with new members added through births and existing members removed through deaths.…”

“…In particular, some researchers have suggested models that employ a framework whereby simulations start with a cross-sectional population of mixed ages, genders, and tobacco use status (never users, former users by years since quitting, and current users). (20)(21)(22) Each age in the cross-sectional population represents a distinct birth cohort, which is followed over time (based on calendar year and age), with new members added through births and existing members removed through deaths. While such models purport to predict future mortality under the assumption that an MRTP is introduced during the follow-up period, following a cross-sectional population over time to assess population health in this manner is unnecessarily complex, with great input requirements, and raises methodological questions.…”

Modeling the Population Health Impact of Introducing a Modified Risk Tobacco Product into the U.S. Market

“…The methodology of the PHIM has been described in detail [Weitkunat et al 2015] and is summarized below. It was designed to assess the population-level health impact of marketing a cMRTP as a function of the risk or toxicity of the product to the individual user and the product use prevalence distribution in the population.…”

“…The population health impact is then derived by subtracting the numbers under the alternative scenario from those under the null scenario. As equal population size is assumed under both scenarios, an adjustment can be made for the decrease in death rates in the alternative scenario [Weitkunat et al 2015;Lee et al 2017]. However, the simulations presented in this paper do not use this adjustment, as it had a small effect and did not affect the overall picture.…”

“…PMI has developed the PHIM to quantify, in the absence of epidemiological data, the effect that marketing a cMRTP may have on the health of the population as a whole [Weitkunat et al 2015; Lee et al 2017]. This activity is accompanied by an increasing number of publications on alternative modeling approaches for estimating the population health impact following changes in the nicotine and tobacco product landscape [Bachand and Sulsky 2013;Vugrin et al 2015; Hill and Camacho 2017; Poland and Teischinger 2017].…”