scholarly journals A Computational Model for Assessing the Population Health Impact of Introducing a Modified Risk Claim on an Existing Smokeless Tobacco Product

2019 ◽  
Vol 16 (7) ◽  
pp. 1264 ◽  
Author(s):  
Raheema Muhammad-Kah ◽  
Yezdi Pithawalla ◽  
Edward Boone ◽  
Lai Wei ◽  
Michael Jones ◽  
...  
Keyword(s):  
Smokeless Tobacco ◽  
Computational Models ◽  
Transition Probabilities ◽  
Health Impact ◽  
Tobacco Product ◽  
Sensitivity Analyses ◽  
Relative Risk Ratio ◽  
Base Case ◽  
Net Benefit ◽  
Premature Deaths

Computational models are valuable tools for predicting the population effects prior to Food and Drug Administration (FDA) authorization of a modified risk claim on a tobacco product. We have developed and validated a population model using best modeling practices. Our model consists of a Markov compartmental model based on cohorts starting at a defined age and followed up to a specific age accounting for 29 tobacco-use states based on a cohort members transition pathway. The Markov model is coupled with statistical mortality models and excess relative risk ratio estimates to determine survival probabilities from use of smokeless tobacco. Our model estimates the difference in premature deaths prevented by comparing Base Case (“world-as-is”) and Modified Case (the most likely outcome given that a modified risk claim is authorized) scenarios. Nationally representative transition probabilities were used for the Base Case. Probabilities of key transitions for the Modified Case were estimated based on a behavioral intentions study in users and nonusers. Our model predicts an estimated 93,000 premature deaths would be avoided over a 60-year period upon authorization of a modified risk claim. Our sensitivity analyses using various reasonable ranges of input parameters do not indicate any scenario under which the net benefit could be offset entirely.

scholarly journals Modeling the Population Health Impact of ENDS in the U.S.

2021 ◽  
Vol 45 (3) ◽  
pp. 588-610
Author(s):  
Rasmus Wissmann ◽  
Changhua Zhan ◽  
Kenneth D'Amica ◽  
Shivaani Prakash ◽  
Yingying Xu
Keyword(s):  
Population Health ◽  
Health Benefit ◽  
Population Level ◽  
Health Impact ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Premature Deaths ◽  
Key Population ◽  
The Us ◽  
Health Model

Objectives: Our objective was to improve understanding of the population health impact of electronic nicotine delivery systems (ENDS) availability in the US via computational modeling. Methods: We present an agent-based population health model (PHM) that simulates annual smoking, ENDS use, and associated mortality for individual agents representing the US population, both adults and youth, between 2000 and 2100. Model transitions were derived from key population surveys and a large longitudinal study of JUUL purchasers. The mortality impact of ENDS is modeled as excess risk relative to smoking. Outcomes are compared between a cigarettes-only Base Case and a Modified Case where ENDS are introduced in 2010. Model validation demonstrates that the PHM simulates population-level behavior and outcomes realistically. Results: The availability of ENDS in the US is projected to reduce smoking and prevent 2.5 million premature deaths by 2100 in the Modified Case. Sensitivity analyses show that a significant population health benefit occurs under all plausible scenarios. Conclusions: Our results suggest the availability of ENDS is likely to result in a significant health benefit to the US population as a whole, after accounting for both beneficial and harmful uses.

Estimating the Public Health Impact from Introducing Tobacco-Free Nicotine Pouches Into the US

2021 ◽  
Author(s):  
Peter N Lee ◽  
John S Fry ◽  
Tryggve Ljung
Keyword(s):  
Smoking Status ◽  
Health Impact ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Initiation Rate ◽  
Individual Parameter ◽  
Product Use ◽  
The Us ◽  
Current Product

Abstract BackgroundFor smokers not intending to quit, switching to a reduced-risk nicotine product should be healthier than continuing smoking. We estimate the health impact, over the period 2000-2050, of introducing into the US the nicotine pouch ZYN. ZYN’s toxicant profile and method of use is like that for Swedish snus, a product with known health effects much less than smoking. MethodsOur modelling approach is similar to others developed for estimating potential effects of new tobacco products. It starts with a simulated cohort of 100,000 individuals in the year 2000 subdivided by age, sex, and smoking status (including years since quitting). They are followed annually accounting for births, net immigrations, deaths and product use changes, with follow-up carried out in the Base Case (ZYN not introduced) and Modified Case (ZYN introduced). Using informed assumptions about initiation, quitting and switching rates, distributions of the population over time are then constructed for each Case, which are used to estimate product-related mortality based on assumptions about the relative risk according to product use. ResultsWhereas in both Base and Modified Cases, the prevalence of any current product use is predicted to decline from about 22% to 10% during follow-up, in the Modified Case about 25% of current users use ZYN by 2050, about a quarter being dual users and the rest ZYN-only users. Over the 50 years, deaths at ages 35-84 from product use among the 100,000 are estimated as 249 less in the Modified than the Base Case, equivalent to about 700,000 less deaths in the whole US. Sensitivity analyses varying individual parameter values confirm the benefits of switching to ZYN, which increase as either the switching rate to ZYN increases or the initiation rate of ZYN relative to smoking increases. Even assuming the reduction in excess mortality risk using ZYN use is 20% of that from smoking rather than the 3.5% assumed in the main analyses, the reduction in product-related deaths would still be 213, or about 600,000 in the US. ConclusionsAlthough such model-based estimates are subject to uncertainties, the results suggest that introducing ZYN could substantially reduce smoking-attributable deaths.

scholarly journals Title: “Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product”

2019 ◽  
Author(s):  
Smilja Djurdjevic ◽  
Laszlo Pecze ◽  
Rolf Weitkunat ◽  
Frank Luedicke ◽  
John Fry ◽  
...  
Keyword(s):  
Smoking Prevalence ◽  
Transition Probabilities ◽  
Health Impact ◽  
European Countries ◽  
Sensitivity Analyses ◽  
Mortality Data ◽  
Published Data ◽  
Advantages And Disadvantages ◽  
Prevalence Estimates

Abstract Background We have developed an approach for modelling the health impact of introducing new smoke-free tobacco products. We wished to compare its estimates with those of alternative approaches, when applied to snus, used in Sweden for many years.Methods Modelling was restricted to men aged 30-79 years for 1980-2009 and to four smoking-related diseases. Mortality data were extracted for Sweden and other European countries. Published data provided Swedish prevalence estimates for combinations of never/former/current smoking and snus use, and smoking prevalence estimates for other European countries. Approach 1 compares mortality in Sweden and in other countries with a smoking prevalence similar to Sweden’s prevalence of combined smoking/snus use. Approaches 2 and 3 compare mortality in Sweden with hypothetical mortality had snus users smoked. Approach 3 uses our health impact model, individuals starting with the tobacco prevalence of Sweden in 1980. Tobacco histories during 30-year follow-up were then estimated using transition probabilities, with risk derived using a negative exponential model. Approach 2 uses annual tobacco prevalence estimates coupled with estimates of relative risk of current and former smokers regardless of history. The main applications of Approaches 2 and 3 assume that only smoking affects mortality, though sensitivity analyses using Approach 3 allow for risk to vary in snus users and dual users.Results Using Approach 2, estimated mortality increases in Sweden in 1980-2009 had snus not been introduced were: lung cancer 8,786; COPD 1,781; IHD 10,409; stroke 1,720. The main Approach 3 estimates were similar (7,931; 1,969; 12,501; 1,901). They decreased as risk in snus users and dual users increased. Approach 1 estimates differed wildly (77,762; 32,538; 77,438; 76,946), remaining very different following correction for differences between Sweden and the comparison countries in non-smoking-related disease mortality.Conclusions Approach 1 is unreliable, accounting inadequately for non-tobacco factors affecting mortality. Approaches 2 and 3 provide reasonably similar approximate estimates of the mortality increase had snus not been available, but have differing advantages and disadvantages. Only Approach 3 considers tobacco history, but develops histories using tobacco transition probabilities, which is possibly less reliable than using estimated tobacco prevalences at each follow-up year.

scholarly journals Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Smilja Djurdjevic ◽  
Laszlo Pecze ◽  
Rolf Weitkunat ◽  
Frank Luedicke ◽  
John Fry ◽  
...  
Keyword(s):  
Smoking Prevalence ◽  
Transition Probabilities ◽  
Health Impact ◽  
European Countries ◽  
Sensitivity Analyses ◽  
Mortality Data ◽  
Published Data ◽  
Advantages And Disadvantages ◽  
Prevalence Estimates

Abstract Background We have developed an approach for modelling the health impact of introducing new smoke-free tobacco products. We wished to compare its estimates with those of alternative approaches, when applied to snus, used in Sweden for many years. Methods Modelling was restricted to men aged 30–79 years for 1980–2009 and to four smoking-related diseases. Mortality data were extracted for Sweden and other European countries. Published data provided Swedish prevalence estimates for combinations of never/former/current smoking and snus use, and smoking prevalence estimates for other European countries. Approach 1 compares mortality in Sweden and in other countries with a smoking prevalence similar to Sweden’s prevalence of combined smoking/snus use. Approaches 2 and 3 compare mortality in Sweden with hypothetical mortality had snus users smoked. Approach 3 uses our health impact model, individuals starting with the tobacco prevalence of Sweden in 1980. Tobacco histories during 30-year follow-up were then estimated using transition probabilities, with risk derived using a negative exponential model. Approach 2 uses annual tobacco prevalence estimates coupled with estimates of relative risk of current and former smokers regardless of history. The main applications of Approaches 2 and 3 assume that only smoking affects mortality, though sensitivity analyses using Approach 3 allow for risk to vary in snus users and dual users. Results Using Approach 2, estimated mortality increases in Sweden in 1980–2009 had snus not been introduced were: lung cancer 8786; COPD 1781; IHD 10,409; stroke 1720. The main Approach 3 estimates were similar (7931, 1969; 12,501; 1901). They decreased as risk in snus users and dual users increased. Approach 1 estimates differed wildly (77,762, 32,538; 77,438; 76,946), remaining very different following correction for differences between Sweden and the comparison countries in non-smoking-related disease mortality. Conclusions Approach 1 is unreliable, accounting inadequately for non-tobacco factors affecting mortality. Approaches 2 and 3 provide reasonably similar approximate estimates of the mortality increase had snus not been available, but have differing advantages and disadvantages. Only Approach 3 considers tobacco history, but develops histories using tobacco transition probabilities, which is possibly less reliable than using estimated tobacco prevalences at each follow-up year.

scholarly journals Identification of the Most Cost-effective Position of Vedolizumab Among the Available Biologic Drugs for the Treatment of Ulcerative Colitis

2020 ◽  
Vol 14 (5) ◽  
pp. 575-587
Author(s):  
Frank I Scott ◽  
Michelle Luo ◽  
Yash Shah ◽  
Karen Lasch ◽  
Ravy K Vajravelu ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Transition Probabilities ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Effective Strategy ◽  
Markov Modelling ◽  
Necrosis Factor Alpha ◽  
Cost Effective Strategy ◽  
Steroid Dependent

Abstract Background and Aims There are limited data on the most cost-effective sequencing of biologics for ulcerative colitis [UC]. Methods We used Markov modelling to identify the most cost-effective position for vedolizumab among biologics for steroid-dependent UC, with a base-case of a 35-year-old male. We assessed three treatment algorithms, with vedolizumab use: prior to an initial anti-tumour necrosis factor alpha [anti-TNFα] and azathioprine [Algorithm 1]; prior to a second anti-TNF and azathioprine [Algorithm 2]; and prior to colectomy [Algorithm 3]. The initial anti-TNF could be either infliximab or adalimumab. Transition probabilities, costs, and quality-adjusted life-year estimates were derived from published estimates, Medicare, and the Nationwide Inpatient Sample. Primary analyses included 100 trials of 100 000 individuals over 1 year, with a willingness-to-pay threshold of US$100,000. Multiple sensitivity analyses were conducted to assess our findings. Results From a population perspective, when both infliximab and adalimumab are available, vedolizumab was preferred as the first biologic if ≥14% of initial anti-TNF use was adalimumab. If infliximab is the primary biologic, vedolizumab use after infliximab [Algorithm 2] and prior to adalimumab was the most cost-effective strategy. All models were sensitive to biologic pricing. Conclusions This simulation demonstrated that the most cost-effective strategy in UC depends on the proportion of patients using adalimumab as the initial anti-TNF. If adalimumab was ≥14%, vedolizumab was preferred as the first biologic. When only infliximab was available for first-line therapy, the most cost-effective position of vedolizumab was prior to cycling to adalimumab.

scholarly journals Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product

2019 ◽  
Author(s):  
Peter Lee ◽  
Smilja Djurdjevic ◽  
Laszlo Pecze ◽  
Rolf Weitkunat ◽  
Frank Luedicke ◽  
...  
Keyword(s):  
Smoking Prevalence ◽  
Transition Probabilities ◽  
Health Impact ◽  
European Countries ◽  
Sensitivity Analyses ◽  
Mortality Data ◽  
Published Data ◽  
Advantages And Disadvantages ◽  
Prevalence Estimates

Abstract Background We have developed an approach for modelling the health impact of introducing new smoke-free tobacco products. We wished to compare its estimates with those of alternative approaches, when applied to snus, used in Sweden for many years. Methods Modelling was restricted to men aged 30-79 years for 1980-2009 and to four smoking-related diseases. Mortality data were extracted for Sweden and other European countries. Published data provided Swedish prevalence estimates for combinations of never/former/current smoking and snus use, and smoking prevalence estimates for other European countries. Approach 1 compares mortality in Sweden and in other countries with a smoking prevalence similar to Sweden’s prevalence of combined smoking/snus use. Approaches 2 and 3 compare mortality in Sweden with hypothetical mortality had snus users smoked. Approach 3 uses our health impact model, individuals starting with the tobacco prevalence of Sweden in 1980. Tobacco histories during 30-year follow-up were then estimated using transition probabilities, with risk derived using a negative exponential model. Approach 2 uses annual tobacco prevalence estimates coupled with estimates of relative risk of current and former smokers regardless of history. The main applications of Approaches 2 and 3 assume that only smoking affects mortality, though sensitivity analyses using Approach 3 allow for risk to vary in snus users and dual users. Results Using Approach 2, estimated mortality increases in Sweden in 1980-2009 had snus not been introduced were: lung cancer 8,786; COPD 1,781; IHD 10,409; stroke 1,720. The main Approach 3 estimates were similar (7,931; 1,969; 12,501; 1,901). They decreased as risk in snus users and dual users increased. Approach 1 estimates differed wildly (77,762; 32,538; 77,438; 76,946), remaining very different following correction for differences between Sweden and the comparison countries in non-smoking-related disease mortality. Conclusions Approach 1 is unreliable, accounting inadequately for non-tobacco factors affecting mortality. Approaches 2 and 3 provide reasonably similar approximate estimates of the mortality increase had snus not been available, but have differing advantages and disadvantages. Only Approach 3 considers tobacco history, but develops histories using tobacco transition probabilities, which is possibly less reliable than using estimated tobacco prevalences at each follow-up year.

scholarly journals Estimating the Population Health Impact of Recently Introduced Modified Risk Tobacco Products: A Comparison of Different Approaches

2020 ◽  
Author(s):  
Peter N Lee ◽  
David Abrams ◽  
Annette Bachand ◽  
Gizelle Baker ◽  
Ryan Black ◽  
...  
Keyword(s):  
Population Health ◽  
Transition Probabilities ◽  
Model Development ◽  
Health Impact ◽  
Epidemiological Studies ◽  
Tobacco Product ◽  
Smoking Habits ◽  
Frequency Of Use ◽  
Life Years ◽  
Beneficial Impact

Abstract Introduction Various approaches have been used to estimate the population health impact of introducing a Modified Risk Tobacco Product (MRTP). Aims and Methods We aimed to compare and contrast aspects of models considering effects on mortality that were known to experts attending a meeting on models in 2018. Results Thirteen models are described, some focussing on e-cigarettes, others more general. Most models are cohort-based, comparing results with or without MRTP introduction. They typically start with a population with known smoking habits and then use transition probabilities either to update smoking habits in the “null scenario” or joint smoking and MRTP habits in an “alternative scenario”. The models vary in the tobacco groups and transition probabilities considered. Based on aspects of the tobacco history developed, the models compare mortality risks, and sometimes life-years lost and health costs, between scenarios. Estimating effects on population health depends on frequency of use of the MRTP and smoking, and the extent to which the products expose users to harmful constituents. Strengths and weaknesses of the approaches are summarized. Conclusions Despite methodological differences, most modellers have assumed the increase in risk of mortality from MRTP use, relative to that from cigarette smoking, to be very low and have concluded that MRTP introduction is likely to have a beneficial impact. Further model development, supplemented by preliminary results from well-designed epidemiological studies, should enable more precise prediction of the anticipated effects of MRTP introduction. Implications There is a need to estimate the population health impact of introducing modified risk nicotine-containing products for smokers unwilling or unable to quit. This paper reviews a variety of modeling methodologies proposed to do this, and discusses the implications of the different approaches. It should assist modelers in refining and improving their models, and help toward providing authorities with more reliable estimates.

scholarly journals Cost-effectiveness of a proportionate universal offer of free exercise: Leeds Let’s Get Active

2020 ◽  
Author(s):  
Paolo Candio ◽  
David Meads ◽  
Andrew J. Hill ◽  
Laura Bojke
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Transition Probabilities ◽  
Markov Chain Model ◽  
Adult Population ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Chain Model ◽  
The Cost

Abstract Objectives To assess the cost-effectiveness of a proportionate universal programme to reduce physical inactivity (Leeds Let’s Get Active) in adults. Methods A continuous-time Markov chain model was developed to assess the cost implications and QALY gains associated with increases in physical activity levels across the adult population. An ordered logistic model was specified to estimate the effectiveness of the Leeds Let’s Get Active programme and derive transition probabilities between physical activity categories. A parametric survival analysis approach was applied to estimate the decay of intervention effect over time. Baseline model data were obtained from previous economic models, population-based surveys and other published literature. A cost-utility analysis was conducted from a health care sector perspective over the programme duration (39 months). Scenario and probabilistic sensitivity analyses were performed to test the robustness of cost-effectiveness results. Results 51,874 adult residents registered to the programme and provided baseline data, 19.5% of which were living in deprived areas. Under base case assumptions, Leeds Let’s Get Active was found to be likely to be cost-effective. However, variations in key structural assumptions showed sensitivity of the results. Conclusions Evidence from this study suggests that a universal offer of access to free off-peak leisure centre-based exercise that targets hard to reach groups can provide good value for money. Further data collection is needed to reduce the uncertainty surrounding the decision.

scholarly journals Title: “Using data on snus use in Sweden to compare different modelling approaches to estimate the population health impact of introducing a smoke-free tobacco product”

2019 ◽  
Author(s):  
Smilja Djurdjevic ◽  
Laszlo Pecze ◽  
Rolf Weitkunat ◽  
Frank Luedicke ◽  
John Fry ◽  
...  
Keyword(s):  
Smoking Prevalence ◽  
Transition Probabilities ◽  
Health Impact ◽  
European Countries ◽  
Sensitivity Analyses ◽  
Mortality Data ◽  
Published Data ◽  
Advantages And Disadvantages ◽  
Prevalence Estimates

Abstract Background We have developed an approach for modelling the health impact of introducing new smoke-free tobacco products. We wished to compare its estimates with those of alternative approaches, when applied to snus, used in Sweden for many years.Methods Modelling was restricted to men aged 30-79 years for 1980-2009 and to four smoking-related diseases. Mortality data were extracted for Sweden and other European countries. Published data provided Swedish prevalence estimates for combinations of never/former/current smoking and snus use, and smoking prevalence estimates for other European countries. Approach 1 compares mortality in Sweden and in other countries with a smoking prevalence similar to Sweden’s prevalence of combined smoking/snus use. Approaches 2 and 3 compare mortality in Sweden with hypothetical mortality had snus users smoked. Approach 3 uses our health impact model, individuals starting with the tobacco prevalence of Sweden in 1980. Tobacco histories during 30-year follow-up were then estimated using transition probabilities, with risk derived using a negative exponential model. Approach 2 uses annual tobacco prevalence estimates coupled with estimates of relative risk of current and former smokers regardless of history. The main applications of Approaches 2 and 3 assume that only smoking affects mortality, though sensitivity analyses using Approach 3 allow for risk to vary in snus users and dual users.Results Using Approach 2, estimated mortality increases in Sweden in 1980-2009 had snus not been introduced were: lung cancer 8,786; COPD 1,781; IHD 10,409; stroke 1,720. The main Approach 3 estimates were similar (7,931; 1,969; 12,501; 1,901). They decreased as risk in snus users and dual users increased. Approach 1 estimates differed wildly (77,762; 32,538; 77,438; 76,946), remaining very different following correction for differences between Sweden and the comparison countries in non-smoking-related disease mortality.Conclusions Approach 1 is unreliable, accounting inadequately for non-tobacco factors affecting mortality. Approaches 2 and 3 provide reasonably similar approximate estimates of the mortality increase had snus not been available, but have differing advantages and disadvantages. Only Approach 3 considers tobacco history, but develops histories using tobacco transition probabilities, which is possibly less reliable than using estimated tobacco prevalences at each follow-up year.

scholarly journals Cost-Effectiveness of Remdesivir Plus Supportive Care for Patients with COVID-19 in Iran

2021 ◽  
Author(s):  
Mohammad Tasavon Gholamhoseini ◽  
Reza Goudarzi ◽  
Vahid Yazdi-Feyzabadi ◽  
Mohammad Hossein Mehrolhassani ◽  
Meysam Yousefi
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Supportive Care ◽  
Purchasing Power Parity ◽  
Transition Probabilities ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Power Parity ◽  
System Perspective

Abstract Background: Remdesivir is a medication used for moderate to severe Coronavirus disease 2019 (COVID-19) patients with favorable effects. However, it is an expensive medication. Therefore, the present study aimed to assess the cost-effectiveness of remdesivir plus supportive care (SC) for COVID-19 patients in Iran.Methods: Markov model was used to compare costs and quality-adjusted life-days (QALDs) of remdesivir+SC and SC for patients with COVID-19. The model simulated a cycle length of one day and a 30-day time horizonin TreeAge 2020 software. The costs from the healthcare system perspective were obtained from Afzalipour hospital as a referral hospital for the hospitalization of COVID-19 patients in Kerman, Iran. All the costs were converted to 2018 purchasing power parity (PPP) US dollars. Utility values were derived from published sources. The results were presented as an incremental cost-effectiveness ratio (ICER) at a willingness-to-pay (WTP) threshold of three times the Gross Domestic Product per capita of Iran. Both deterministic and probabilistic sensitivity analyses were performed.Results: The base-case results showed that the treatment of COVID-19 patients with remdesivir+SC had a cost of 8795 PPP US dollars for 21.13 QALD gained. The SC alone cost 8637 PPP US dollars with a gain of 20.20 QALD. Our findings demonstrated that at a WTP threshold of 159 PPP US dollars per QALD, remdesivir+SC was not cost-effective with an ICER of 168 PPP US dollars per QALD. Deterministic sensitivity analysis indicated ICER to be sensitive to the transition probabilities and costs. Probabilistic sensitivity analysis revealed that remdesivir+SC was cost-effective at a WTP of 159 PPP US dollars per QALD in 47% of iterations.Conclusions: Our findings demonstrated thatremdesivir+SC is not cost-effective, compared to SC alone. Considering the lack of studies on the effectiveness of remdesivir, the findings should be interpreted with caution. Further evaluations are recommended to determine the efficacy and effectiveness of remdesivir in COVID-19 patients.

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