Cost-Effectiveness Analysis of Smoking Cessation Interventions in the United Kingdom Accounting for Major Neuropsychiatric Adverse Events.

OBJECTIVES: Smoking is a leading cause of death worldwide. Cessation aids include varenicline, bupropion, nicotine replacement therapy (NRT), and e-cigarettes at various doses (low, standard and high) and used alone or in combination with each other. Previous cost-effectiveness analyses have not fully accounted for adverse effects nor compared all cessation aids. The objective was to determine the relative cost-effectiveness of cessation aids in the United Kingdom. METHODS: An established Markov cohort model was adapted to incorporate health outcomes and costs due to depression and self-harm associated with cessation aids, alongside other health events. Relative efficacy in terms of abstinence and major adverse neuropsychiatric events was informed by a systematic review and network meta-analysis. Base case results are reported for UK-licensed interventions only. Two sensitivity analyses are reported, one including unlicensed interventions and another comparing all cessation aids but removing the impact of depression and self-harm. The sensitivity of conclusions to model inputs was assessed by calculating the expected value of partial perfect information. RESULTS: When limited to UK-licensed interventions, varenicline standard-dose and NRT standard-dose were most cost-effective. Including unlicensed interventions, e-cigarette low-dose appeared most cost-effective followed by varenicline standard-dose + bupropion standard-dose combined. When the impact of depression and self-harm was excluded, varenicline standard-dose + NRT standard-dose was most cost-effective, followed by varenicline low-dose + NRT standard-dose. CONCLUSION: Although found to be most cost-effective, combined therapy is currently unlicensed in the United Kingdom and the safety of e-cigarettes remains uncertain. The value-of-information analysis suggested researchers should continue to investigate the long-term effectiveness and safety outcomes of e-cigarettes in studies with active comparators.

Estimating the public economic consequences of introducing varenicline smoking cessation therapy in South Korea using a fiscal analytic framework.

BACKGROUND AND AIMS: Smoking gives rise to many cross-sectorial public costs and benefits for government. Costs arise from increased healthcare spending and work-related social benefits, while smoking itself provides significant revenue for government from tobacco taxes. To better understand the public economic impact of smoking and smoking cessation therapies, this study developed a government perspective framework for assessing smoking-attributable morbidity and mortality and associated public costs. This framework includes changes in lifetime tax revenue and health costs, as well as changes in tobacco tax revenue, from fewer smokers. METHODS: A modified generational accounting framework was developed to assess relationships between smoking-attributable morbidity and mortality and public economic consequences of smoking, including lifetime tax revenue gains/losses, government social transfers, and health spending. Based on the current prevalence of smoking in South Korean males, a cohort model was developed for smokers, former-smokers, and never-smokers. The model simulated the lifetime discounted fiscal transfers for different age cohorts in 5 year age bands, and the return on investment (ROI) from smoking cessation therapy. RESULTS: Former smokers are estimated to generate higher lifetime earnings and direct tax revenues and lower lifetime healthcare costs due to the reduction of smoking-attributable mortality and morbidity compared to smokers, even after accounting for reduced tobacco taxes paid. Based on the costs of public investments in varenicline, this study estimated a ROI from 1.4-1.7, depending on treatment age, with higher ROI in younger cohorts, with an average ROI of 1.6 for those aged less than 65. CONCLUSIONS: This analysis suggests that reductions in smoking can generate positive public economic benefits for government, even after accounting for lost tobacco tax revenues. The results described here are likely applicable to countries having similar underlying smoking prevalence, comparable taxation rates, and social benefit protection provided to individuals with smoking-related conditions.

Using PICO Methodology to Answer Questions About Smoking in COPD Patients. / Preguntas y respuestas relacionadas con tabaquismo en pacientes con EPOC. Aplicación de metodología con formato PICO.

The ALAT and SEPAR Treatment and Control of Smoking Groups have collaborated in the preparation of this document which attempts to answer, by way of PICO methodology, different questions on health interventions for helping COPD patients to stop smoking. The main recommendations are: (i)moderate-quality evidence and strong recommendation for performing spirometry in COPD patients and in smokers with a high risk of developing the disease, as a motivational tool (particularly for showing evidence of lung age), a diagnostic tool, and for active case-finding; (ii)high-quality evidence and strong recommendation for using intensive dedicated behavioral counselling and drug treatment for helping COPD patients to stop smoking; (iii)high-quality evidence and strong recommendation for initiating interventions for helping COPD patients to stop smoking during hospitalization with improvement when the intervention is prolonged after discharge, and (iv)high-quality evidence and strong recommendation for funding treatment of smoking in COPD patients, in view of the impact on health and health economics.

Estimated Budget Impact of Adopting the Affordable Care Act's Required Smoking Cessation Coverage on United States Healthcare Payers.

INTRODUCTION: Despite abundant information on the negative impacts of smoking, more than 40 million adult Americans continue to smoke. The Affordable Care Act (ACA) requires tobacco cessation as a preventive service with no patient cost share for all FDA-approved cessation medications. Health plans have a vital role in supporting smoking cessation by managing medication access, but uncertainty remains on the gaps between smoking cessation requirements and what is actually occurring in practice. This study presents current cessation patterns, real-world drug costs and plan benefit design data, and estimates the 1- to 5-year pharmacy budget impact of providing ACA-required coverage for smoking cessation products to understand the fiscal impact to a US healthcare plan. METHODS: A closed cohort budget impact model was developed in Microsoft Excel® to estimate current and projected costs for US payers (commercial, Medicare, Medicaid) covering smoking cessation medicines, with assumptions for coverage and smoking cessation product utilization based on current, real-world national and state-level trends for hypothetical commercial, Medicare, and Medicaid plans with 1 million covered lives. A Markov methodology with five health states captures quit attempt and relapse patterns. Results include the number of smokers attempting to quit, number of successful quitters, annual costs, and cost per-member per-month (PMPM). RESULTS: The projected PMPM cost of providing coverage for smoking cessation medications is $0.10 for commercial, $0.06 for Medicare, and $0.07 for Medicaid plans, reflecting a low incremental PMPM impact of covering two attempts ranging from $0.01 for Medicaid to $0.02 for commercial and Medicare payers. CONCLUSION: The projected PMPM impact of covering two quit attempts with access to all seven cessation medications at no patient cost share remains low. Results of this study reinforce that the impact of adopting the ACA requirements for smoking cessation coverage will have a limited near-term impact on health plan's budgets. FUNDING: Pfizer Inc.

Smoking Cessation in Pulmonary Care Subjects: A Mixed Methods Analysis of Treatment-Seeking Participation and Preferences.

BACKGROUND: African-American smokers experience disproportionate COPD morbidity. As a front-line COPD behavioral management strategy, smoking cessation is less prevalent among African-American smokers. Identifying barriers and predictors to smoking cessation in this population is important to bridging this disparity. METHODS: In this study, the predictors of enrollment and attendance to a 3-session urban hospital smoking cessation program were examined. A retrospective chart review was conducted for all pulmonary clinic patients who smoked and were referred to the cessation program between June 2013 and May 2014. Demographic, smoking behavior, cardiopulmonary, and health status variables were extracted (N = 253). Second, a qualitative assessment of the beliefs and barriers for smoking cessation and physical activity were examined in a sub-sample of the population (n = 41). RESULTS: One-hundred forty-seven of the pulmonary subjects (58%) enrolled in the cessation program, and 40 attended all sessions (16% of the total sample). Participants with COPD (odds ratio = 4.65, P = .030), or had a mother who had cancer (odds ratio = 4.49, P = .027), were more likely to attend the program. Qualitatively, pulmonary care patients who wanted to quit smoking and be more physically active cited: strong beliefs about the inability to engage in these behaviors, belief that quitting and increased activity might exacerbate poor health, and an inability to obtain pharmacotherapy as barriers to adopting these behaviors. CONCLUSIONS: Smoking cessation program attendance in this sample of mostly African-American smokers was poor. Increased knowledge about cessation benefits and access to full-course pharmacotherapy, particularly in those without a COPD diagnosis and who do not have a maternal history of cancer, may be high-priority targets to promote cessation program uptake in this population. Increased knowledge and access to safe forms of physical activity may also be beneficial.

Re-treatment with varenicline is a cost-effective aid for smoking cessation.

OBJECTIVE: One quit attempt with varenicline has been found to be a cost-effective smoking cessation intervention. The purpose of this study was to analyze varenicline's cost-effectiveness in patients who relapse during or after the first treatment. A comparison was made between re-treatment schema with varenicline and re-treatment schema with bupropion, NRT and unaided cessation, and treatment once with varenicline in a Finnish context. METHODS: The two-quit version of BENESCO Markov model was used to follow a cohort of smokers making up to two quit attempts over a lifetime. The abstinence rates of the interventions were derived from a Cochrane review. Gender- and age-specific data on the incidence and prevalence of five smoking-related diseases were included in the model. Quality-adjusted life-years, total expected costs, and the lifetime cumulative incidence of smoking-related morbidities and mortality were the primary outcomes evaluated. RESULTS: The study cohort comprised 116,533 smokers who were willing to make a quit attempt. In the lifetime simulation, re-treatment with varenicline yielded 6,150-20,250 extra quitters, depending on the comparator. Among these quitters it was possible to prevent 899-2,972 additional cases of smoking-related diseases, and 395-1,307 deaths attributable to smoking. Re-treatment with varenicline resulted in cost savings of up to 54.9 million Euros. Re-treatment with varenicline dominated all the other smoking cessation interventions used in the analysis. Sensitivity analysis supported the robustness of the base case results. LIMITATIONS: The analysis did not consider adverse events, and included only five major smoking-related diseases, which is a conservative approach, and probably leads to under-estimation of cost-effectiveness of cessation interventions. Furthermore, assumptions of constant relative risks for smoking-related diseases for each smoking status and the proxy values used as efficacy estimates of second quit attempts for other interventions than varenicline are limitations. CONCLUSIONS: A second quitting effort with varenicline is economically justifiable.

Analysis of Driving Factors of Willingness to Use and Willingness to Pay for Existing Pharmacological Smoking Cessation Aids Among Young and Middle-Aged Adults in Germany.

BACKGROUND: Smoking cessation is a challenging task with a high risk of relapse. Depending on the choice of medication and duration of therapy, the costs of using a smoking cessation aid can be high. Additionally, these costs are not covered by health insurance in Germany. Information on willingness to use (WTU) and willingness to pay (WTP) for smoking cessation aids is valuable for developing different smoking cessation strategies. OBJECTIVES: The study analyses WTU and WTP for three pharmacological smoking cessation aids (nicotine replacement therapy (NRT), bupropion and varenicline) among young and middle-aged adults in Germany and attempts to determine their major driving factors. METHODS: Two cross-sectional internet-based surveys of smokers over 18 years of age were conducted in 2014 and 2015 in Germany. Respondents were asked about smoking-related issues and WTU and WTP for each therapy. The contingent valuation method with payment cards was used to measure WTP. Descriptive statistics, logistical regression and accelerated failure-time regression models were performed. RESULTS: The total sample size is 505. Half of the respondents are willing to use NRT and one-third are willing to use bupropion and/or varenicline. WTU induces positive WTP; however, the magnitude of WTP is beneath the market price. WTU significantly increases with a higher addiction level and if smokers have previously heard about the therapy. CONCLUSION: This study indicates different points to be considered for policy development. Promotion information and improving awareness about medication aids might increase WTU, and development of monetary incentives for young smokers could create a better chance for successful smoking cessation.

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.

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 analysis of clinical smoking cessation interventions in Thailand.

AIMS: Clinical smoking cessation interventions have been found typically to be highly cost-effective in many high-income countries. There is a need to extend this to low- and middle-income countries and undertake comparative analyses. This study aimed to estimate the incremental cost-effectiveness ratio of a range of clinical smoking cessation interventions available in Thailand. METHODS: Using a Markov model, cost-effectiveness, in terms of cost per quality-adjusted life years (QALY) gained, from a range of interventions was estimated from a societal perspective for males and females aged 40 years who smoke at least 10 cigarettes per day. Interventions considered were: counselling in hospital, phone counselling (Quitline) and counselling plus nicotine gum, nicotine patch, bupropion, nortriptyline or varenicline. An annual discounting rate of 3% was used. Probabilistic sensitivity analyses were conducted and a cost-effectiveness acceptability curve (CEAC) plotted. Comparisons between interventions were conducted involving application of a 'decision rule' process. RESULTS: Counselling with varenicline and counselling with nortriptyline were found to be cost-effective. Hospital counselling only, nicotine patch and bupropion were dominated by Quitline, nortriptyline and varenicline, respectively, according to the decision rule. When compared with unassisted cessation, probabilistic sensitivity analysis revealed that all interventions have very high probabilities (95%) of being cost-saving except for nicotine replacement therapy (NRT) patch (74%). CONCLUSION: In middle-income countries such as Thailand, nortriptyline and varenicline appear to provide cost-effective clinical options for supporting smokers to quit.

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.

Nicotine replacement therapy, tobacco products, and electronic cigarettes in pharmacies in St. Louis, Missouri.

OBJECTIVES: To compare availability of nicotine replacement therapy (NRT), tobacco products, and electronic cigarettes (e-cigarettes) in pharmacies in St. Louis, MO. DESIGN: Cross-sectional study, on-site store audits of 322 pharmacies. SETTING: St. Louis, MO. PARTICIPANTS: 242 eligible community pharmacies located in the study area. INTERVENTION: Pharmacies were visited by trained research assistants who conducted a 5- to 10-minute store audit using a paper-based data collection tool. MAIN OUTCOME MEASURES: Availability, accessibility, and pricing of NRT as a function of neighborhood poverty rate and proportion of black residents as well as availability of tobacco products and e-cigarettes. RESULTS: NRT availability decreased as neighborhood poverty rate increased (P = 0.02). Availability without pharmacy personnel assistance also decreased with increasing poverty rate (r = -0.19; 95% CI = -0.06, -0.31) and higher percentage of black residents (r = -0.18; 95% CI = -0.06, -0.31). Prices were lower in neighborhoods with higher poverty rates (P = 0.02) and a higher percentage of black residents (P = 0.03). E-cigarettes were available in 43% of pharmacies, and their availability and price did not differ by poverty rate or percentage of black residents. CONCLUSION: Low access to NRT might perpetuate smoking disparities in disadvantaged and racially diverse neighborhoods. Study data support policies to ensure equal NRT access to reduce disparities.

Funding a smoking cessation program for Crohn's disease: an economic evaluation.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Health-care systems should consider funding smoking cessation programs for CD, as they improve health outcomes and reduce costs.

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.

Effectiveness of pharmacotherapy in behavioural therapeutic smoking cessation programmes.

BACKGROUND: In 2011, pharmacotherapy as a part of smoking cessation treatment was reimbursed through the basic health insurance in the Netherlands. We examine the (cost)-effectiveness of pharmacotherapy added to behavioural therapy. METHODS: An observational study was conducted using data from the suppliers of the smoking cessation programmes together with information on costs from health insurance company Achmea. National suppliers, general practitioners and healthcare centres offered four different programmes. (i) Behavioural support (=therapy); (ii) Behavioural support combined with nicotine replacement therapy (NRT); (iii) Behavioural support combined with smoking cessation aids (=medication) (SCA); (iv) Behavioural support combined with NRT and SCA. The primary independent variable was the programme type, and the primary outcome was whether someone quitted smoking. To examine the effectiveness of the different programmes logistic regression and logistic multilevel analyses were performed. Bootstrapping was used to evaluate cost-effectiveness. RESULTS: The results indicate that behavioural support combined with SCA has more quitters than the reference programme of behavioural support alone, and it also seems the most cost-effective programme for general practitioners and healthcare centres. Behavioural therapy combined with NRT had also more quitters, although the difference with the reference programme was smaller. CONCLUSION: Behavioural support combined with SCA seems the most successful programme. However, as we performed an observational study, firm conclusions about the differences in effectiveness between the programme types cannot be made. Future research should consider the type of smoker (smoking history, amount of cigarettes per day).

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.).

Association of out-of-pocket pharmacy costs with adherence to varenicline.

BACKGROUND: Varenicline, a nicotinic acetylcholine receptor partial agonist, is a pharmacotherapy indicated for smoking cessation treatment. To date, no research has examined the relationship between out-of-pocket (OOP) expense and varenicline adherence among Medicare beneficiaries. OBJECTIVES: To (a) characterize medication utilization patterns of varenicline among Medicare members newly initiated on varenicline and (b) examine the relationship between member OOP expense and varenicline medication adherence. METHODS: In this retrospective cohort study, pharmacy claims data were used to identify Medicare Advantage Prescription Drug Plan (MAPD) members newly initiated on varenicline. Demographic and clinical characteristics, varenicline medication utilization patterns, and pharmacy costs (total and varenicline-specific) were determined for members included in the study. Varenicline adherence was measured by calculating the proportion of days covered (PDC) over a period of 84 days (12 weeks) after initiation. Multiple regression analysis was used to examine the relationship between varenicline OOP cost and varenicline medication utilization, while controlling for sociodemographic characteristics, clinical factors, and nonvarenicline pharmacy costs. RESULTS: A total of 15,452 MAPD members were included in the analysis. Mean (SD) subject age was 62.6 (10.0) years; 21.1% (n = 3,256) were dual eligible; and 33.0% (n = 5,106) received a low-income subsidy. Mean (SD) initial varenicline treatment episode duration was 50.8 (37.8) days, with a mean (SD) varenicline days' supply of 47.8 (32.6) obtained by members during the initial treatment episode. Mean (SD) PDC was 0.51 (0.24), and 14.9% (n = 2,302) of members were classified as adherent to treatment (PDC ≥ 0.80). Greater varenicline OOP expense was significantly associated with lower PDC (regression coefficient = -0.058, P less than 0.001) and significantly associated with lower odds of receiving a refill for varenicline (odds ratio 0.594, 95% CI: 0.540-0.655, P less than 0.001). CONCLUSIONS: Among Medicare beneficiaries newly initiated on varenicline, medication adherence was suboptimal, and greater OOP cost was associated with lower adherence and lower odds of refilling varenicline.

What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation.

BACKGROUND: Tobacco smoking is one of the leading causes of deaths worldwide. Nearly one-fifth of adults in the UK regularly smoke cigarettes. The ill-health associated with smoking costs the NHS over £3B every year. A number of pharmacological interventions are available that can help people to quit smoking. These include nicotinic receptor partial agonists such as varenicline or cytisine. Varenicline is a synthetic product licensed for use in the UK, while cytisine is derived naturally from the seeds of the plant Cytisus laborinum L. (golden rain acacia). OBJECTIVES: To review the evidence on the clinical effectiveness and safety of cytisine from smoking cessation compared with varenicline; to develop an economic model to estimate the cost-effectiveness of cytisine and varenicline; and to provide recommendations based on value of information analyses as to whether or not a head-to-head trial of cytisine and varenicline would represent effective use of resources. DATA SOURCES: Efficacy and adverse events data were sourced from a recent Cochrane review. These data were supplemented with an updated search of twelve electronic databases, including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library, for the period from December 2011 to January 2013. The review included randomised controlled trials (RCTs) of adult smokers attempting to quit using varenicline or cytisine. Further interventions were considered (placebo, nicotine replacement therapy, bupropion) to allow an indirect comparison between varenicline and cytisine. The primary outcome was abstinence at a minimum of 6 months' follow-up. Secondary outcomes were common adverse events such as abnormal dreams, headache, nausea, insomnia and serious adverse events. REVIEW METHODS: A systematic review and network meta-analysis of the clinical evidence was undertaken. A random-effects model was used to allow for heterogeneity between studies. The economic model structure was based on a published model. Probabilistic sensitivity analyses were undertaken to estimate the treatment expected to be most cost-effective given current information. Formal expected value of perfect information, perfect partial information and of sample information were performed. RESULTS: Twenty-three (RCTs) were included in the systematic review, comprising a total of 10,610 participants. Twenty-one trials of varenicline of differing dosing schedules and two trials of cytisine at standard dose met the inclusion criteria. No head-to-head trials comparing varenicline with cytisine were identified. The methodological quality of the studies was judged to be moderate to good. Cytisine was more efficacious than placebo [hazard ratio (HR) 4.27, 95% credible interval (CrI) 2.05 to 10.05], as was standard-dose varenicline (HR 2.58, 95% Crl 2.16 to 3.15). Standard-dose varenicline treatment was associated with significantly higher rates of headache, insomnia and nausea than placebo; there was no significant difference in the rates of abnormal dreams. There were no significant differences in the rates of headache or nausea between cytisine and placebo; data were identified for neither abnormal dreams nor insomnia. Using expected values, cytisine is anticipated to dominate varenicline, in that it produces more quality-adjusted life-years at a lower associated cost. This occurred in approximately 90% of the scenarios performed. However, owing to the large number of people who wish to quit smoking (estimated to be 3 million over a 10-year period), the implications of making an incorrect decision is large. The expected value of sample information indicated that conducting a head-to-head trial of cytisine and varenicline was worthwhile, and that 1000 smokers per arm was an appropriate number to recruit. CONCLUSIONS: On the basis of the evidence included in this review, varenicline and cytisine are both effective interventions to aid smoking cessation when compared with placebo. Cytisine is estimated to be both more clinically effective and cost-effective than varenicline. However, there is uncertainty in the decision, and a head-to-head trial of cytisine and varenicline would appear to be an effective use of resources. STUDY REGISTRATION: The study was registered as PROSPERO CRD42012003455. FUNDING DETAILS: The National Institute for Health Research Health Technology Assessment programme.