title: 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.
authors.affiliation: Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland. Electronic address: rolf.weitkunat@pmi.com.
authors.forename: Rolf
authors.initials: R
authors.lastname: Weitkunat
authors.affiliation: P N Lee Statistics and Computing Ltd, 17 Cedar Road, Sutton, Surrey SM2 5DA, United Kingdom.
authors.forename: Peter N
authors.initials: PN
authors.lastname: Lee
authors.affiliation: Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.
authors.forename: Gizelle
authors.initials: G
authors.lastname: Baker
authors.affiliation: Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Sponsiello-Wang
authors.affiliation: Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.
authors.forename: Angela M
authors.initials: AM
authors.lastname: González-Zuloeta Ladd
authors.affiliation: Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.
authors.forename: Frank
authors.initials: F
authors.lastname: Lüdicke
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D008875:Middle Aged; D008962:Models, Theoretical; D015995:Prevalence; D012306:Risk; D012907:Smoking / Q000453:epidemiology*; D062789:Tobacco Products / Q000009:adverse effects*; D014029:Tobacco Use Disorder / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
keywords: Attributable risk; Harm reduction; Modeling; Modified Risk Tobacco Product; Smoking