Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.

INTRODUCTION: We describe the development and pilot testing of the experimental tobacco and nicotine product marketplace (ETM)-a method for studying tobacco and nicotine product (TNP) choices and use behavior in a standardized way. AIMS AND METHODS: The ETM resembles an online store populated with TNPs. Surveillance activities and data from a US representative survey and consumer reports were used to determine the most popular TNPs for inclusion in the ETM. Standardized information and videos demonstrating how to use the TNPs were provided. To test the feasibility of using the ETM, smokers (n = 119) underwent monitoring of usual brand cigarette smoking and other TNP use (Baseline Phase) followed by access to the ETM (ETM Phase) that included their usual brand cigarettes, e-cigarettes, moist snuff, snus, and nicotine replacement therapy. During the ETM Phase, participants were provided points based on their baseline TNP consumption to exchange for TNPs in the ETM. Participants were advised to exchange points for enough TNPs to last until their next visit and to refrain from using TNPs not obtained in the ETM. A subset of the participants (n = 62) completed a survey on their experience with the ETM. RESULTS: The majority of the participants stated they were comfortable with navigating the ETM (97%), it was easy to determine product characteristics (89%), and they were satisfied with the products included in the marketplace (85%). CONCLUSIONS: The ETM was well received by the vast majority of the participants and can be utilized by researchers to investigate a variety of TNP policy and regulatory science research questions. IMPLICATIONS: Patterns of TNP use are complex due to greater availability, marketing, and promotion of a diverse array of TNPs. Innovative methods are needed to experimentally study TNP choices and patterns. Through describing the development of the ETM, we provide researchers with a tool that can be readily adapted to studying a variety of phenomena challenging public health.

Examining effects of unit price on preference for reduced nicotine content cigarettes and smoking rate.

Cigarette preference increases as a function of greater nicotine content, but manipulating cost can shift preference. The aims of the present study are to model whether (1) the behavioral-economic metric unit price (cost/reinforcer magnitude) accounts for preference shifts and (2) whether preference shifts toward reduced nicotine content are associated with smoking reductions. In a multisite study between 2015 and 2016, 169 daily smokers from vulnerable populations completed two concurrent-choice conditions examining preference for smoking normal (15.8 mg/g) and reduced (0.4 mg/g) nicotine content cigarettes. In Condition 1, both products were available at 10 responses/choice. In Condition 2, availability of the 0.4 mg/g dose remained at 10 responses/choice while the 15.8 mg/g dose was available on a progressive-ratio (PR) schedule wherein response cost increased following each choice. Unit prices were calculated by dividing dose by response requirement. Results were analyzed using ANOVA and binomial tests (p < .05). Participants preferred the 15.8 over 0.4 mg/g dose in Condition 1, but shifted preference to the 0.4 mg/g dose in Condition 2 (p < .001) immediately before the point in the PR progression where unit price for 15.8 dose exceeded unit price for the 0.4 dose (p < .001). This shift was associated with a reduction in smoking (p < .001). The unit price of nicotine appears to underpin cigarette product preference and may provide a metric for predicting preference and potentially impacting it through tobacco regulations. These results also demonstrate that reduced compared to normal nicotine content cigarettes sustain lower smoking rates discernible even under acute laboratory conditions and in vulnerable populations.

Behavioral Economic Purchase Tasks to Estimate Demand for Novel Nicotine/tobacco Products and Prospectively Predict Future Use: Evidence From The Netherlands.

INTRODUCTION: The demand for alternative nicotine/tobacco products is not well established. This paper uses a behavioral economic approach to test whether smokers have differential demand for conventional factory-made, electronic, and very low nicotine content cigarettes (FMCs/ECs/VLNCs) and uses the prospective cohort design to test the predictive validity of demand indices on subsequent use of commercially available FMCs and ECs. METHODS: Daily smokers (≥16 years) from the Netherlands completed an online survey in April 2014 (N = 1215). Purchase tasks were completed for FMCs, ECs, and VLNCs. Participants indicated the number of cigarettes they would consume in 24 h, across a range of prices (0-30 euro). The relationship between consumption and price was quantified into four indices of demand (intensity, Pmax, breakpoint, and essential value). A follow-up survey in July 2015 measured FMC and EC use. RESULTS: At baseline, greater demand was observed for FMCs relative to ECs and VLNCs across all demand indices, with no difference between ECs and VLNCs. At follow-up, greater baseline FMC demand (intensity, essential value) was associated with lower quit rates and higher relapse. EC demand (Pmax, breakpoint, essential value) was positively associated with any EC use between survey waves, past 30 day EC use, and EC purchase between waves. CONCLUSIONS: Smokers valued FMCs more than ECs or VLNCs, and FMCs were less sensitive to price increases. Demand indices predicted use of commercially available products over a 15 month period. To serve as viable substitutes for FMCs, ECs and VLNCs will need to be priced lower than FMCs. IMPLICATIONS: Purchase tasks can be adapted for novel nicotine/tobacco products as a means to efficiently quantify demand and predict use. Among current daily smokers, the demand for ECs and VLNCs is lower than FMCs.

The Effect of Price on the Consumption of Reduced Nicotine Cigarettes.

BACKGROUND: Price affects the demand for cigarettes, indicating that smokers, perhaps especially lower income smokers, may choose low nicotine cigarettes (LNC) if they were commercially available and cost less than fully nicotinized conventional cigarettes. The present study tests the hypothesis that smokers will prefer purchasing LNCs at a lower price point than conventional cigarettes given a fixed budget. METHOD: A laboratory-based, within-subject, 3 (nicotine level) × 3 (price) factorial design provided smokers opportunities to purchase standard (0.7 per mg tobacco), moderately reduced (0.3 mg), and very low-nicotine (0.03 mg). Spectrum research cigarettes according to an escalating price structure (low-nicotine costing the least, high-nicotine costing the most) given a fixed, laboratory-provided "income." Participants were 20 overnight-abstinent smokers who previously smoked and rated each of the three cigarettes. RESULTS: Overall, smokers rated LNCs as less satisfying compared with standard nicotine cigarettes (SNC), t(18) = -5.40, p < .001. In the free-choice session, subjects were more likely to choose LNC that cost less compared with SNC that cost more, even after an 8-hour abstinence period, F(2, 19) = 4.32, p = .03. Those selecting LNC or moderate nicotine cigarettes after abstinence smoked more cigarettes per day, t(17) = 2.40, p = .03 and had higher dependence scores on the HONC, t(18) = 2.21, p = .04 that those selecting SNC. CONCLUSION: The results indicate that smokers' response to price points when purchasing cigarettes may extend to LNC if these were commercially available. Differential cigarette prices based on nicotine content may result in voluntary selection of less addicting products. IMPLICATIONS: The Food and Drug Administration has proposed a rule that would reduce nicotine content in commercially available cigarettes. However, it is not known how smokers may respond in an environment where products of differing nicotine content and of differing prices are available. This study demonstrates that price may be an important factor that could lead smokers to select reduced nicotine products voluntarily, even if those products are rated as inferior or less satisfying.

Estimating Demand and Cross-Price Elasticity for Very Low Nicotine Content (VLNC) Cigarettes Using a Simulated Demand Task.

Introduction: Very Low Nicotine Content (VLNC) cigarettes might be useful as part of a tobacco control strategy, but relatively little is known about their acceptability as substitutes for regular cigarettes. We compared subjective effects and demand for regular cigarettes and VLNC cigarettes, and estimated cross-price elasticity for VLNC cigarettes, using simulated demand tasks. Method: Forty New Zealand smokers sampled a VLNC cigarette and completed Cigarette Purchase Tasks to indicate their demand for regular cigarettes and VLNC cigarettes at a range of prices, and a cross-price task indicating how many regular cigarettes and VLNC cigarettes they would purchase at 0.5x, 1x, and 2x the current market price for regular cigarettes, assuming the price of VLNC cigarettes remained constant. They also rated the subjective effects of the VLNC cigarette and their usual-brand regular cigarettes. Results: Cross-price elasticity for VLNC cigarettes was estimated as 0.32 and was significantly positive, indicating that VLNC cigarettes are partially substitutable for regular cigarettes. VLNC cigarettes were rated as less satisfying and psychologically rewarding than regular cigarettes, but this was unrelated to demand or substitutability. Conclusion: VLNC cigarettes are potentially substitutable for regular cigarettes. Their availability may reduce tobacco consumption, nicotine intake and addiction; making it easier for smokers to quit. Implications: VLNC cigarettes share the behavioral and sensory components of smoking while delivering negligible levels of nicotine. Although smokers rated VLNCs as less satisfying than regular cigarettes, smokers said they would increase their consumption of VLNCs as the price of regular cigarettes increased, if VLNCs were available at a lower price. This suggests that VLNCs are partially substitutable for regular cigarettes. VLNCs can be part of an effective tobacco control strategy, by reducing nicotine dependence and improving health and financial outcomes for smokers.

Differences in the design and sale of e-cigarettes by cigarette manufacturers and non-cigarette manufacturers in the USA.

BACKGROUND: Three categories of e-cigarette brands have emerged within the US market: e-cigarette brands developed by cigarette manufacturers, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation. In the absence of federal regulatory oversight of e-cigarettes, we assessed differences in e-cigarette products and sales practices across these categories. METHODS: Brand websites for top-selling e-cigarette brands from each of these categories were examined in October of 2015 to compare website access restrictions, online sales practices and products sold, including e-cigarette model type (eg, 'cigalike' vs advanced systems) and options available (eg, flavoured, nicotine free). RESULTS: Website access to brands developed by cigarette manufacturers was restricted to users aged 21 years or older, and one website required user registration. In addition, these brands were exclusively reusable/rechargeable 'cigalikes.' Limited flavour options were available for these products, and nicotine-free options were not sold. In contrast, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation generally required website visitors to be 18, offered a nicotine-free option, and most offered disposable products and an array of flavoured products (eg, fruit/candy flavours). CONCLUSIONS: This exploratory study finds differences in e-cigarette products and sales practices across these three e-cigarette brand categories, with brands developed by cigarette manufacturers adopting a particularly distinctive product and sales strategy. Anticipated regulation of e-cigarettes in the USA may be influencing these product and sales decisions.

Consumer preferences for electronic cigarettes: results from a discrete choice experiment.

INTRODUCTION: E-cigarettes present a formidable challenge to regulators given their variety and the rapidly evolving nicotine market. The current study sought to examine the influence of e-cigarette product characteristics on consumer perceptions and trial intentions among Canadians. METHODS: An online discrete choice experiment was conducted with 915 Canadians aged 16 years and older in November 2013. An online commercial panel was used to sample 3 distinct subpopulations: (1) non-smoking youth and young adults (n=279); (2) smoking youth and young adults (n=264) and (3) smoking adults (n=372). Participants completed a series of stated-preference tasks, in which they viewed choice sets with e-cigarette product images that featured different combinations of attributes: flavour, nicotine content, health warnings and price. For each choice set, participants were asked to select one of the products or indicate 'none of the above' with respect to the following outcomes: interest in trying, less harm and usefulness in quitting smoking. The attributes' impact on consumer choice for each outcome was analysed using multinomial logit regression. RESULTS: Health warning was the most important attribute influencing participants' intentions to try e-cigarettes (42%) and perceived efficacy as a quit aid (39%). Both flavour (36%) and health warnings (35%) significantly predicted perceptions of product harm. CONCLUSIONS: The findings indicate that consumers make trade-offs with respect to e-cigarette product characteristics, and that these trade-offs vary across different subpopulations. Given that health warnings and flavour were weighted most important by consumers in this study, these may represent good targets for e-cigarette regulatory frameworks.

Randomised trial of two nicotine patch protocols distributed through a state quitline.

BACKGROUND: Most telephone quitlines provide free nicotine replacement therapy (NRT). An 8-week course is recommended, but few users complete it. Information is needed to help quitlines distribute NRT cost-effectively. DESIGN: Randomised two-group trial. SETTING/PARTICIPANTS: Colorado QuitLine callers who smoked 16-20 cigarettes per day at enrolment and who were eligible for and agreed to receive free NRT. INTERVENTION: Provision of 4-week versus 8-week NRT supply; the 8-week supply was shipped in halves and required participants to request the second half (split-shipment protocol). Enrolment occurred during March 2010-February 2011, follow-up concluded in November 2011, and analysis was performed in 2012. MAIN OUTCOME MEASURES: Point abstinence (7 and 30 day) and prolonged abstinence (6 month) from tobacco use. RESULTS: Overall, 1495 study participants were enrolled and 57.7% completed follow-up. Abstinence rates did not differ significantly between study conditions: 13.8% versus 12.4% in 4-week versus 8-week arms, respectively, (30-day point abstinence, non-respondents treated as smokers). NRT duration was similar in both groups, due in part to purchase of additional patches in the 4-week group. About one-third of the 8-week group requested the full 8-week supply and had higher abstinence rates. Cost per quit was lower in the 4-week (compared to 8-week) group. CONCLUSIONS: A randomised trial did not find worse cessation outcomes among quitline users who received half the minimum recommended course of NRT, but offering the full recommended course using a split-shipment protocol may be reasonably cost-effective and supportive of NRT adherers. TRIAL REGISTRATION NUMBER: NCT01889771.

Quantifying how smokers value attributes of electronic cigarettes.

INTRODUCTION: Rates of electronic cigarette (e-cigarette) use have increased quickly among US adults (3.3% in 2010 to 8.5% in 2013) and youth (4.5% in 2013 to 13.4% in 2014). As state and local governments consider regulatory policies, understanding what smokers believe about e-cigarettes and how they value e-cigarettes is important. METHODS: Using data from a convenience sample of Florida adult smokers (N=765), we investigated the value smokers place on specific attributes of e-cigarettes (availability of flavours, effectiveness of e-cigarettes as a cessation aid, healthier alternative to regular cigarettes, ability to use e-cigarettes in public places) by asking smokers how much they would be willing to pay for e-cigarettes with and without each of these attributes. RESULTS: For cigarette-only and dual users, losing the ability to use an e-cigarette as a quit aid and losing the harm reduction of an e-cigarette significantly reduced the price respondents were willing to pay for an e-cigarette. For cigarette-only users, not being able to use an e-cigarette indoors and losing flavours also significantly reduced the price respondents were willing to pay for an e-cigarette. CONCLUSION: Our results suggest that smokers value multiple attributes of e-cigarettes. Our valuation measures also appear to align with smokers' beliefs about e-cigarettes.

Cost-Effectiveness of Nicotine Patches for Smoking Cessation in Pregnancy: A Placebo Randomized Controlled Trial (SNAP).

INTRODUCTION: Smoking during pregnancy is the most important, preventable cause of adverse pregnancy outcomes including miscarriage, premature birth, and low birth weight with huge financial costs to the National Health Service. However, there are very few published economic evaluations of smoking cessation interventions in pregnancy and previous studies are predominantly U.S.-based and do not present incremental cost-effectiveness ratios (ICER). A number of studies have demonstrated cost-effectiveness of nicotine replacement therapy (NRT) in the general population, but this has yet to be tested among pregnant smokers. METHODS: A cost-effectiveness analysis was undertaken alongside the smoking, nicotine, and pregnancy trial to compare NRT patches plus behavioral support to behavioral support alone, for pregnant women who smoked. RESULTS: At delivery, biochemically verified quit rates were slightly higher at 9.4% in the NRT group compared to 7.6% in the control group (odds ratio = 1.26, 95% CI = 0.82-1.96), at an increased cost of around £90 per participant. Higher costs in the NRT group were mainly attributable to the cost of NRT patches (mean = £46.07). The incremental cost-effectiveness ratio associated with NRT was £4,926 per quitter and a sensitivity analysis including only singleton births yielded an ICER of £4,156 per quitter. However, wide confidence intervals indicated a high level of uncertainty. CONCLUSIONS: Without a specific willingness to pay threshold, and due to high levels of statistical uncertainty, it is hard to determine the cost-effectiveness of NRT in this population. Furthermore, future research should address compliance issues, as these may dilute any potential effects of NRT, thus reducing the cost-effectiveness.

A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

BACKGROUND: Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters. METHODS: A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26. RESULTS: Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n = 145) and 13.9% (n = 95), respectively; odds ratio (OR) = 1.64, 95% confidence interval (CI) 1.23-2.18; p = 0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n = 109) and 10.1% (n = 69), respectively; OR = 1.68, 95% CI 1.21-2.33; p = 0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n = 46) and 5.6% (n = 38), in the full coverage and no coverage groups, respectively; OR = 1.19, 95% CI 0.76-1.87; p = 0.439. CONCLUSIONS: In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).

Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant.

INTRODUCTION: Telephone tobacco quitlines are effective and are widely used, with more than 500,000 U.S. callers in 2010. This study investigated the clinical effectiveness and cost-effectiveness of 3 different quitline enhancements: combination nicotine replacement therapy (NRT), longer duration of NRT, and counseling to increase NRT adherence. METHODS: In this study, 987 quitline callers were randomized to a combination of quitline treatments in a 2 × 2 × 2 factorial design: NRT duration (2 vs. 6 weeks), NRT type (nicotine patch only vs. patch plus nicotine gum), and standard 4-call counseling (SC) versus SC plus medication adherence counseling (MAC). The primary outcome was 7-day point-prevalence abstinence (PPA) at 6 months postquit in intention-to-treat (ITT) analyses. RESULTS: Combination NRT for 6 weeks yielded the highest 6-month PPA rate (51.6%) compared with 2 weeks of nicotine patch (38.4%), odds ratios [OR] = 1.71 (95% confidence interval [CI]:1.20-2.45). A similar result was found for 2 weeks of combination NRT (48.2%), OR = 1.49 (95% CI: 1.04-2.14) but not for 6 weeks of nicotine patch alone (46.2%), OR = 1.38 (95% CI: 0.96-1.97). The MAC intervention effect was nonsignificant. Cost analyses showed that the 2-week combination NRT group had the lowest cost per quit ($442 vs. $464 for 2-week patch only, $505 for 6-week patch only, and $675 for 6-week combination NRT). CONCLUSIONS: Combination NRT for 2 or 6 weeks increased 6-month abstinence rates by 10% and 13%, respectively, over rates produced by 2 weeks of nicotine patch when offered with quitline counseling. A 10% improvement would potentially yield an additional 50,000 quitters annually, assuming 500,000 callers to U.S. quitlines per year.

Medicinal nicotine nonuse: smokers' rationales for past behavior and intentions to try medicinal nicotine in a future quit attempt.

INTRODUCTION: Nicotine replacement therapy (NRT) is a proven smoking cessation treatment. Previous research has reported low rates of NRT use among quit attempters. This study analyzed population-level nonuse rates and reasons for not using NRT. METHODS: Data were from the 2008 adult Colorado Tobacco Attitudes and Behaviors Survey (TABS), a population-based, random-digit-dialed telephone survey (n = 14,156). Primary measures were past NRT nonuse and future intentions regarding NRT use among current smokers intending to quit. Multiple logistic regression was used to identify reasons for past NRT nonuse associated with intention to use NRT in the future, adjusted for factors known to influence NRT use. RESULTS: Nearly, 80% of 1,095 current smokers who intended to quit had never used NRT. The most common reasons for nonuse were belief that "willpower" alone is sufficient for cessation (21.5%), perceived lack of NRT effectiveness (15.6%), and cost (14.3%). Willpower was more widely reported among Hispanics than Anglos (36.9% vs. 14.7%) and nondaily versus daily smokers (30.4% vs. 12.5%). Most previous NRT nonusers reported they would use cold turkey (65.2%) in their next quit attempt; NRT was the next most common choice (15.0%). In multivariate analysis, smokers identifying cost or willpower as a reason for previous nonuse had significantly lower odds of planning to use NRT in a future quit attempt. CONCLUSIONS: The majority of smokers have never used NRT and do not plan to use it in the future. Cost and belief in willpower alone are significant barriers to using NRT in future smoking cessation attempt.

The regulation of nicotine in the United Kingdom: how nicotine gum came to be a medicine, but not a drug.

This article explores the utility of actor-network theory (ANT) as a tool for socio-legal research. ANT is deployed in a study of the evolution of divided regulatory responsibility for tobacco and medicinal nicotine (MN) products in the United Kingdom, with a particular focus on how the latter came to be regulated as a medicine. We examine the regulatory decisions taken in the United Kingdom in respect of the first MN product: a nicotine-containing gum developed in Sweden, which became available in the United Kingdom in 1980 as a prescription-only medicine under the Medicines Act 1968. We propose that utilizing ANT to explore the development of nicotine gum and the regulatory decisions taken about it places these decisions into the wider context of ideas about tobacco control and addiction, and helps us to understand better how different material actors acted in different networks, leading to very different systems of regulation.

One-year outcomes and a cost-effectiveness analysis for smokers accessing group-based and pharmacy-led cessation services.

INTRODUCTION: An observational study examining 1-year follow-up of clients of two National Health Service smoking cessation services in Glasgow was used to inform a cost-effectiveness analysis. One service involved 7 weeks of group-based support (n = 411) and the other consisted of up to 12 weeks of one-to-one counseling with pharmacists (n = 1,374). Pharmacological aids to quitting (e.g., nicotine replacement therapy) were available to all clients. METHODS: Quit rates were calculated for each service at 52 weeks after the quit date, and these were used for an economic evaluation of both the annual and the lifetime cost-effectiveness of the pharmacy- and group-based interventions in comparison with a baseline "self-quit" scenario. The annual cost-effectiveness model established the incremental cost per 52-week quitter, while a Markov model was developed for the lifetime analysis to estimate the potential lifetime outcomes in terms of cost per quality-adjusted life years (QALY) gained, to account for the benefits quitters will receive in terms of extended life years and improvements in quality of life from smoking cessation. RESULTS: The proportion of carbon monoxide-validated quitters from both services combined fell from 22.5% at 4-week follow-up to 3.6% at 52 weeks. The group service achieved a higher quit rate (6.3%) than the pharmacy service (2.8%) but was more intensive and required greater overhead costs. The lifetime analysis resulted in an incremental cost per QALY of £4,800 for the group support and £2,600 for pharmacy one-to-one counseling. CONCLUSIONS: Despite disappointing 1-year quit rates, both services were considered to be highly cost-effective.

Genetic predispositions moderate the effectiveness of tobacco excise taxes.

BACKGROUND: Tobacco consumption is one of the leading causes of preventable death. In this study, we analyze whether someone's genetic predisposition to smoking moderates the response to tobacco excise taxes. METHODS: We interact polygenic scores for smoking behavior with state-level tobacco excise taxes in longitudinal data (1992-2016) from the US Health and Retirement Study (N = 12,058). RESULTS: Someone's genetic propensity to smoking moderates the effect of tobacco excise taxes on smoking behavior along the extensive margin (smoking vs. not smoking) and the intensive margin (the amount of tobacco consumed). In our analysis sample, we do not find a significant gene-environment interaction effect on smoking cessation. CONCLUSIONS: When tobacco excise taxes are relatively high, those with a high genetic predisposition to smoking are less likely (i) to smoke, and (ii) to smoke heavily. While tobacco excise taxes have been effective in reducing smoking, the gene-environment interaction effects we observe in our sample suggest that policy makers could benefit from taking into account the moderating role of genes in the design of future tobacco control policies.

State medicaid coverage for tobacco-dependence treatments --- United States, 2009.

Medicaid enrollees have nearly twice the smoking rates (37%) of the general adult population (21%), and smoking-related medical costs are responsible for 11% of Medicaid expenditures. In 2008, the Public Health Service released clinical practice guidelines recommending comprehensive coverage of effective tobacco-dependence medications and counseling by health insurers. Healthy People 2010 established a clear objective for Medicaid programs to cover all Food and Drug Administration--approved medications and counseling for tobacco cessation. To monitor progress toward that objective, the Center for Health and Public Policy Studies at the University of California, Berkeley, in collaboration with CDC, surveyed Medicaid programs in the 50 states and the District of Columbia (DC) to document their 2009 tobacco-dependence treatment coverage and found that 47 programs offered coverage. Only eight state programs offered coverage of all recommended pharmacotherapy and counseling for all Medicaid enrollees, and 16 programs reported coverage for fee-for-service enrollees that differed from that provided for Medicaid managed-care enrollees. Among the 33 programs that covered at least one combination therapy, the nicotine patch plus bupropion slow release (SR) was the one combination covered by all. The Affordable Care Act mandates Medicaid coverage of tobacco-dependence treatments for pregnant women, beginning October 1, 2010. Coverage of pharmacotherapy for all Medicaid enrollees will be enhanced by January 2014, when states no longer may exclude tobacco-dependence cessation drugs from covered benefits. Monitoring the extent to which Medicaid programs place limitations on these treatments can help in evaluating accessibility of tobacco-dependence treatments to Medicaid enrollees.

Evaluation of cost-utility of varenicline compared with existing smoking cessation therapies in South Korea.

OBJECTIVE: This study aimed to evaluate the cost-effectiveness of varenicline compared with the other smoking cessation interventions, bupropion, nicotine replacement therapy (NRT), and willpower. METHODS: The Benefits of Smoking Cessation on Outcomes model was modified to reflect major smoking-related diseases in Korea. Transitional probabilities, resource utilization, and costs were obtained from Korean public data. The analysis was carried out from a societal perspective for the lifetime period. Also, series of sensitivity analyses, including probabilistic sensitivity analysis, were performed. RESULTS: With the exclusion of bupropion, which is subject to extended dominance, the incremental cost-effectiveness ratio (ICER) for varenicline versus NRT was analyzed as $US4809 per quality-adjusted life-year (QALY) during the lifetime. The results of sensitivity analysis are quite stable across most of the included parameters. The acceptability curves showed that the probability of varenicline being cost-effective was 83.3% at the willingness to pay of $US15,000. CONCLUSIONS: Even though the maximum willingness to pay for a QALY has not officially been defined, varenicline can be regarded as cost-effective because the ICER is at the 24.0% level of per capital gross domestic product, which is an implicit reference for decision-making in Korea.