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BackgroundMost 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.DesignRandomised two-group trial.Setting/participantsColorado QuitLine callers who smoked 16–20 cigarettes per day at enrolment and who were eligible for and agreed to receive free NRT.InterventionProvision 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 measuresPoint abstinence (7 and 30 day) and prolonged abstinence (6 month) from tobacco use.ResultsOverall, 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.ConclusionsA 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 numberNCT01889771.

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.).

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. 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. 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. 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.

Background Hospitalized smokers often quit smoking, voluntarily or involuntarily; most relapse soon after discharge. Extended follow-up counseling can help prevent relapse. However, it is difficult for hospitals to provide follow-up and smokers rarely leave the hospital with quitting aids (for example, nicotine patches). This study aims to test a practical model in which hospitals work with a state cessation quitline. Hospital staff briefly intervene with smokers at bedside and refer them to the quitline. Depending on assigned condition, smokers may receive nicotine patches at discharge or extended quitline telephone counseling post-discharge. This project establishes a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions in a rigorous randomized trial. Methods/design This randomized clinical trial (N = 1,640) tests the effect of two interventions on long-term quit rates of hospitalized smokers in a 2 x 2 factorial design. The interventions are (1) nicotine patches (eight-week, step down program) dispensed at discharge and (2) proactive telephone counseling provided by the state quitline after discharge. Subjects are randomly assigned into: usual care, nicotine patches, telephone counseling, or both patches and counseling. It is hypothesized that patches and counseling have independent effects and their combined effect is greater than either alone. The primary outcome measure is thirty-day abstinence at six months; a secondary outcome is biochemically validated smoking status. Cost-effectiveness analysis is conducted to compare each intervention condition (patch alone, counseling alone, and combined interventions) against the usual care condition. Further, this study examines whether smokers’ medical diagnosis is a moderator of treatment effect. Generalized linear (binomial) mixed models will be used to study the effect of treatment on abstinence rates. Clustering is accounted for with hospital-specific random effects. Discussion If this model is effective, quitlines across the U.S. could work with interested hospitals to set up similar systems. Hospital accreditation standards related to tobacco cessation performance measures require follow-up after discharge and provide additional incentive for hospitals to work with quitlines. The ubiquity of quitlines, combined with the consistency of quitline counseling delivery as centralized state operations, make this partnership attractive. Trial registration Smoking cessation in hospitalized smokers NCT01289275. Date of registration February 1, 2011; date of first patient August 3, 2011.

Background: The aim of this study was to evaluate and compare the cost-effectiveness of varenicline with nicotine replacement therapy (NRT) for smoking cessation in four European countries (Belgium, France, Sweden and the UK). Methods: Markov simulations, using the Benefits of Smoking Cessation on Outcomes (BENESCO) model, were performed. We simulated the incidence of four smoking-related morbidities: lung cancer, chronic obstructive pulmonary disease, coronary heart disease and stroke. The model computes quality-adjusted life-years gained and incremental cost-effectiveness ratios. Incremental cost-utility ratios were calculated, adopting a lifetime perspective. Efficacy data were obtained from a randomized open-label trial: Week 52 continuous abstinence rates were 26.1% for varenicline and 20.3% for NRT. Results: The analyses imply that for countries analysed, smoking cessation using varenicline versus NRT was associated with reduced smoking-related morbidity and mortality. The number of morbidities avoided, per 1000 smokers attempting to quit, ranged from 9.7 in Belgium to 6.5 in the UK. The number of quality-adjusted life-years gained, per 1000 smokers, was 23 (Belgium); 19.5 (France); 29.9 (Sweden); and 23.7 (UK). In all base-case simulations (except France), varenicline dominated (more effective and cost saving) NRT regarding costs per quality-adjusted life-year gained; for France the incremental cost-effectiveness ratio was 2803. Conclusion: This cost-effectiveness analysis demonstrated that since varenicline treatment was more effective, the result was increased healthcare cost savings in Belgium, Sweden and the UK. Our results suggest that funding varenicline as a smoking cessation aid is justifiable from a healthcare resource allocation perspective.

Introduction: An employer-based cost-benefit analysis for varenicline versus bupropion was conducted using clinical outcomes from a recently published trial. Methods: A decision tree model was developed based on the net benefit of treatment to produce a nonsmoker at 1 year. Sensitivity analyses were conducted based on quit rates with placebo and varenicline and the cost of varenicline. Results: Estimated 12-month employer cost savings per non-smoking employee were $540.60 for varenicline, $269.80 for bupropion SR generic, $150.80 for bupropion SR brand, and $81.80 for placebo. Varenicline was more cost beneficial than placebo, which had quit rates of 16.9% or less. The quit rate with varenicline would have to be ≤ 16.9% to lose cost benefit over bupropion SR generic. Conclusions: The economic benefit of varenicline is improved over bupropion, despite the increased initial cost of varenicline. (J Occup Environ Med. 2007;49:453—460)

IntroductionE-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.MethodsAn 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.ResultsHealth 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.ConclusionsThe 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.

Background Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective. Methods This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline. Discussion The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation. Trial Registration (clinicaltrials.gov): NCT00775944

Background: Varenicline acts as a partial agonist/antagonist with affinity and selectivity for α 4 β 2 nicotinic acetylcholine receptors. This activity at the nicotine-receptor level may help patients achieve smoking cessation by reducing cravings/withdrawal symptoms and smoking satisfaction. Objective: This article reviews the literature on the pharmacologic properties, therapeutic efficacy, and tolerability of varenicline for smoking cessation. Methods: Pertinent controlled clinical trials, meta-analyses, meeting abstracts, case reports, and review articles published in English between 1966 and May 2008 were identified through searches of MEDLINE and OVID using the terms varenicline, smoking, tobacco cessation, and CP 526555. Results: Eight clinical trials were identified that compared ≤12 weeks of varenicline treatment with placebo and/or bupropion sustained release (SR); one of the trials reported follow-up data to 24 weeks, and the remainder reported data to 52 weeks. During treatment with oral varenicline titrated to 1 mg BID, CO-confirmed 4-week continuous quit rates/continuous abstinence rates (CQRs/CARs) in weeks 9 through 12 ranged from 43.9% (odds ratio [OR] = 3.85 [95% CI, 2.69–5.50; P < 0.001 vs placebo]; OR = 1.90 [95% CI, 1.38–2.62; P < 0.001 vs bupropion SR]) to 65.4% (OR = 2.98 [95% CI, 1.78–4.99; P < 0.001 vs placebo]). In 4 of these trials, varenicline 1 mg BID was associated with significantly higher CQRs/CARs compared with placebo at week-52 follow-up, ranging from 21.9% ( P < 0.001) to 34.6% ( P = 0.036). One trial reported a significantly higher CAR at 52 weeks with varenicline compared with bupropion SR (23.0% vs 14.6%, respectively; P = 0.004), and another reported a significantly higher CAR at 52 weeks with varenicline compared with nicotine replacement therapy (25.9% vs 19.8%, respectively; P = 0.040). In a relapse-prevention study that included a 12-week extension period for participants who were abstinent after the initial 12 weeks of treatment, CARs were significantly improved at 24 weeks with varenicline relative to placebo (70.5% vs 49.6%, respectively; OR = 2.48; 95% CI, 1.95–3.16; P < 0.001). Treatment with varenicline was generally well tolerated in study populations with no major comorbidities. In a pooled analysis of 2 Phase III trials, the most commonly reported adverse events (AEs) with varenicline, bupropion SR, and placebo were nausea (28.8%, 9.9%, and 9.1%, respectively), insomnia (14.2%, 21.5%, and 12.6%), and headache (14.2%, 11.1%, and 12.4%). In a pooled analysis of 2 identically designed Phase III trials, bupropion SR was associated with the highest overall rates of discontinuation due to all-cause AEs compared with varenicline and placebo (13.9%, 9.5%, and 8.2%, respectively) and due to AEs considered related to study drug (12.1%, 7.9%, and 6.4%). In double-blind clinical trials of varenicline, nausea was the most frequently reported AE (16.3%–41.9%). Varenicline treatment should begin 7 days before the proposed smoking quit date; dose titration is recommended to minimize dose-related nausea. Based on postmarketing reports of serious AEs in vareniclinetreated patients, caution is recommended when operating vehicles or heavy machinery. Patient education and monitoring for potential AEs are also recommended, particularly in patients with a history of psychiatric illness. Conclusions: Varenicline has a unique mechanism of action compared with other first-line options for smoking cessation. Available clinical-trial data support its use as an effective and generally well-tolerated therapy for smoking cessation in healthy adult smokers, although there is a need for further efficacy and safety evaluation in the general population, particularly those with comorbid conditions.

Patients with Crohn's disease (CD) who smoke are at a higher risk of flaring and requiring surgery. Cost-effectiveness studies of funding smoking cessation programs are lacking. Thus, we performed a cost-utility analysis of funding smoking cessation programs for CD. A cost-utility analysis was performed comparing five smoking cessation strategies: No Program, Counseling, Nicotine Replacement Therapy (NRT), NRT+Counseling, and Varenicline. The time horizon for the Markov model was 5 years. The health states included medical remission (azathioprine or antitumor necrosis factor (anti-TNF), dose escalation of an anti-TNF, second anti-TNF, surgery, and death. Probabilities were taken from peer-reviewed literature, and costs (CAN$) for surgery, medications, and smoking cessation programs were estimated locally. The primary outcome was the cost per quality-adjusted life year (QALY) gained associated with each smoking cessation strategy. Threshold, three-way sensitivity, probabilistic sensitivity analysis (PSA), and budget impact analysis (BIA) were carried out. All strategies dominated No Program. Strategies from most to least cost effective were as follows: Varenicline (cost: $55,614, QALY: 3.70), NRT+Counseling (cost: $58,878, QALY: 3.69), NRT (cost: $59,540, QALY: 3.69), Counseling (cost: $61,029, QALY: 3.68), and No Program (cost: $63,601, QALY: 3.67). Three-way sensitivity analysis demonstrated that No Program was only more cost effective when every strategy's cost exceeded approximately 10 times their estimated costs. The PSA showed that No Program was the most cost-effective <1% of the time. The BIA showed that any strategy saved the health-care system money over No Program. Health-care systems should consider funding smoking cessation programs for CD, as they improve health outcomes and reduce costs.