211Real-World Data Assessment Plan for a Heat-Not-Burn Tobacco Product: Proof of Concept

Focus of Presentation Real-world data (RWD) is readily available in Japan through multiple sources. Considering the crucial need to substantiate the beneficial effects of switching from cigarette smoking to heat-not-burn (HNB) products, both at the individual and population levels, the use of RWD seems a viable option. For instance, ecological studies using RWD have assessed the impact of population-level interventions such as smoking bans and their effects on smoking-related diseases and their endpoints As a proof of concept, ecological analyses were performed to assess the rates of chronic obstructive pulmonary disease (COPD) exacerbations and acute Ischemic Heart Disease (IHD) hospitalizations before and after the introduction of and HNB product in the Japanese market. Findings Hospital admissions associated with ICD codes for COPD and IHD from 2008 to 2019—5 years before and 4 years after the introduction of the target HNB product in the Japanese market—were retrieved from the MDV database. Referrals were below those predicted from pre-launch trends. Conclusions The use of RWD in assessment of HNB products is viable for ecological studies with the well-known caveats. Their use in exposure-specific studies will become feasible once the systematic collection of exposure to tobacco products and use history is guaranteed. This will greatly increase the range and robustness of the evidence base. Key messages The use of RWD is a practical way of assessing the impact of HNB products in the population as a whole.