The Lifetime Health and Economic Burden of Smokeless Tobacco use in Bangladesh, India, and Pakistan: Results From ASTRAMOD.

INTRODUCTION: Under the current policy landscapes, the lifetime health and economic burden of smokeless tobacco (ST) products, consumed by over 297 million ST users in South Asia, is unknown. The aim of this study was to estimate the lifetime health effects and costs attributable to current and future ST use in Bangladesh, India, and Pakistan where the majority of ST users live. AIMS AND METHODS: We developed a Markov-based state-transition model (ASTRAMOD) to predict the lifetime costs of treatment of four diseases (oral, pharyngeal, esophageal cancers, and stroke) and disability-adjusted life years (DALYs), attributable to the current and future use of ST under existing ST policy scenario. Country-specific Global Adult Tobacco Surveys, life tables, and meta-analyses of South Asian and South East Asian studies were used to populate the model. A probabilistic sensitivity analysis evaluated the uncertainty in model predictions. RESULTS: If there were no change in the current ST policies, the lifetime ST-attributable treatment costs would be over US$19 billion in India, over US$1.5 billion in Bangladesh, and over US$3 billion in Pakistan. For all countries, the attributable costs are higher for younger cohorts with costs declining with increasing age for those over 50. The model predicted that a typical 15-year-old male adoloscent would gain 0.07-0.18 life years, avert 0.07-0.19 DALYs, and generate a cost-savings of US$7-21 on healthcare spending if ST policies were changed to eliminate ST use. CONCLUSIONS: Policy interventions aimed at decreasing the uptake of ST and increasing quitting success have the potential to substantially decrease the economic and health burden of ST. IMPLICATIONS: This study provides the most comprehensive estimates of the lifetime health and economic burden of ST by 5-year age and sex cohorts. This is also the first study that highlights the scale of health and economic burden of ST in Bangladesh, India, and Pakistan if there were no changes in the current ST policies. Policymakers and practitioners can use the reported data to justify their decisions to improve current ST policies and practices in their country. Researchers can use the ASTRAMOD methodology to estimate the impact of future ST policy changes.

Cost-effectiveness of offering an area-level financial incentive on breast feeding: a within-cluster randomised controlled trial analysis.

OBJECTIVE: To provide the first estimate of the cost-effectiveness of financial incentive for breastfeeding intervention compared with usual care. DESIGN: Within-cluster ('ward'-level) randomised controlled trial cost-effectiveness analysis (trial registration number ISRCTN44898617). SETTING: Five local authority districts in the North of England. PARTICIPANTS: 5398 mother-infant dyads (intervention arm), 4612 mother-infant dyads (control arm). INTERVENTIONS: Offering a financial incentive (over a 6-month period) on breast feeding to women living in areas with low breastfeeding prevalence (<40% at 6-8 weeks). MAIN OUTCOME MEASURES: Babies breast fed (receiving breastmilk) at 6-8 weeks, and cost per additional baby breast fed. METHODS: Costs were compared with differences in area-level data on babies' breast fed in order to estimate a cost per additional baby breast fed and the quality-adjusted life year (QALY) gains required over the lifetime of babies to justify intervention cost. RESULTS: In the trial, the total cost of providing the intervention in 46 wards was £462 600, with an average cost per ward of £9989 and per baby of £91. At follow-up, area-level breastfeeding prevalence at 6-8 weeks was 31.7% (95% CI 29.4 to 34.0) in control areas and 37.9% (95% CI 35.0 to 40.8) in intervention areas. The adjusted difference between intervention and control was 5.7 percentage points (95% CI 2.7 to 8.6; p<0.001), resulting in 10 (95% CI 6 to 14) more additional babies breast fed in the intervention wards (39 vs 29). The cost per additional baby breast fed at 6-8 weeks was £974. At a cost per QALY threshold of £20 000 (recommended in England), an additional breastfed baby would need to show a QALY gain of 0.05 over their lifetime to justify the intervention cost. If decision makers are willing to pay £974 (or more) per additional baby breast fed at a QALY gain of 0.05, then this intervention could be cost-effective. Results were robust to sensitivity analyses. CONCLUSION: This study provides information to help inform public health guidance on breast feeding. To make the economic case unequivocal, evidence on the varied and long-term health benefits of breast feeding to both the baby and mother and the effectiveness of financial incentives for breastfeeding beyond 6-8 weeks is required.

Estimates of costs for modelling return on investment from smoking cessation interventions.

BACKGROUND AND AIMS: Modelling return on investment (ROI) from smoking cessation interventions requires estimates of their costs and benefits. This paper describes a standardized method developed to source both economic costs of tobacco smoking and costs of implementing cessation interventions for a Europe-wide ROI model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)]. DESIGN: Focused search of administrative and published data. A standardized checklist was developed in order to ensure consistency in methods of data collection. SETTING AND PARTICIPANTS: Adult population (15+ years) in Hungary, Netherlands, Germany, Spain and England. For passive smoking-related costs, child population (0-15 years) was also included. MEASUREMENTS: Costs of treating smoking-attributable diseases; productivity losses due to smoking-attributable absenteeism; and costs of implementing smoking cessation interventions. FINDINGS: Annual costs (per case) of treating smoking attributable lung cancer were between €5074 (Hungary) and €52 106 (Germany); coronary heart disease between €1521 (Spain) and €3955 (Netherlands); chronic obstructive pulmonary disease between €1280 (England) and €4199 (Spain); stroke between €1829 (Hungary) and €14 880 (Netherlands). Costs (per recipient) of smoking cessation medications were estimated to be: for standard duration of varenicline between €225 (England) and €465 (Hungary); for bupropion between €25 (Hungary) and €220 (Germany). Costs (per recipient) of providing behavioural support were also wide-ranging: one-to-one behavioural support between €34 (Hungary) and €474 (Netherlands); and group-based behavioural support between €12 (Hungary) and €257 (Germany). The costs (per recipient) of delivering brief physician advice were: €24 (England); €9 (Germany); €4 (Hungary); €33 (Netherlands); and €27 (Spain). CONCLUSIONS: Costs of treating smoking-attributable diseases as well as the costs of implementing smoking cessation interventions vary substantially across Hungary, Netherlands, Germany, Spain and England. Estimates for the costs of these diseases and interventions can contribute to return on investment estimates in support of national or regional policy decisions.

Cost-effectiveness of alternative smoking cessation scenarios in Spain: results from the EQUIPTMOD.

AIMS: To assess the cost-effectiveness of alternative smoking cessation scenarios from the perspective of the Spanish National Health Service (NHS). DESIGN: We used the European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD), a Markov-based state transition economic model, to estimate the return on investment (ROI) of: (a) the current provision of smoking cessation services (brief physician advice and printed self-helped material + smoking ban and tobacco duty at current levels); and (b) four alternative scenarios to complement the current provision: coverage of proactive telephone calls; nicotine replacement therapy (mono and combo) [prescription nicotine replacement therapy (Rx NRT)]; varenicline (standard duration); or bupropion. A rate of 3% was used to discount life-time costs and benefits. SETTING: Spain. PARTICIPANTS: Adult smoking population (16+ years). MEASUREMENTS: Health-care costs associated with treatment of smoking attributable diseases (lung cancer, coronary heart disease, chronic obstructive pulmonary infection and stroke); intervention costs; quality-adjusted life years (QALYs). Costs and outcomes were summarized using various ROI estimates. FINDINGS: The cost of implementing the current provision of smoking cessation services is approximately €61 million in the current year. This translates to 18 quitters per 1000 smokers and a life-time benefit-cost ratio of 5, compared with no such provision. All alternative scenarios were dominant (cost-saving: less expensive to run and generated more QALYs) from the life-time perspective, compared with the current provision. The life-time benefit-cost ratios were: 1.87 (proactive telephone calls); 1.17 (Rx NRT); 2.40 (varenicline-standard duration); and bupropion (2.18). The results remained robust in the sensitivity analysis. CONCLUSIONS: According to the EQUIPTMOD modelling tool it would be cost-effective for the Spanish authorities to expand the reach of existing GP brief interventions for smoking cessation, provide pro-active telephone support, and reimburse smoking cessation medication to smokers trying to stop. Such policies would more than pay for themselves in the long run.

Assessment of cost-effective changes to the current and potential provision of smoking cessation services: an analysis based on the EQUIPTMOD.

BACKGROUND AND AIMS: Increasing the reach of smoking cessation services and/or including new but effective medications to the current provision may provide significant health and economic benefits; the scale of such benefits is currently unknown. The aim of this study was to estimate the cost-effectiveness from a health-care perspective of viable national level changes in smoking cessation provision in the Netherlands and England. METHODS: A Markov-based state transition model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)] was used to estimate costs and benefits [expressed in quality-adjusted life years (QALY)] of changing the current provision of smoking cessation programmes in the Netherlands and England. The changes included: (a) increasing the reach of top-level services to increase potential quitters (e.g. brief physician advice); (b) increasing the reach of behavioural support (group-based therapy and SMS text-messaging support) to increase the success rates; (c) including a new but effective medication (cytisine); and (d) all changes implemented together (combined change). The costs and QALYs generated by those changes over 2, 5, 10 years and a life-time were compared with that of the current practice in each country. Results were expressed as incremental net benefit (INB) and incremental cost-effectiveness ratio (ICER). A sequential analysis from a life-time perspective was conducted to identify the optimal change. RESULTS: The combined change was dominant (cost-saving) over all alternative changes and over the current practice, in both countries. The combined change would generate an incremental net benefit of €11.47 (2 years) to €56.16 (life-time) per smoker in the Netherlands and €9.96 (2 years) to €60.72 (life-time) per smoker in England. The current practice was dominated by all alternative changes. CONCLUSION: Current provision of smoking cessation services in the Netherlands and England can benefit economically from the inclusion of cytisine and increasing the reach of brief physician advice, text-messaging support and group-based therapy.

A utility of model input uncertainty analysis in transferring tobacco control-related economic evidence to countries with scarce resources: results from the EQUIPT study.

AIMS: To inform the transferability of tobacco control-related economic evidence to resource-poor countries. METHODS: We ran a univariate sensitivity analysis on a return on investment (ROI) model, the European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD), to identify key input values to which the ROI estimates were sensitive. The EQUIPTMOD used a Markov-based state transition model to estimate the ROI of several tobacco control interventions in five European countries (England, Germany, Spain, Hungary and the Netherlands). Base case ROI estimates were obtained through average values of model inputs (throughout the five countries), which were then replaced one at a time with country-specific values. Tornado diagrams were used to evaluate the significance of sensitivity, defined as a ≥ 10% difference in ROI estimates from the base case estimates. RESULTS: The ROI estimates were sensitive to 18 (of 46) input values. Examples of model inputs to which ROI estimates were sensitive included: smoking rate, costs of smoking-related diseases (e.g. lung cancer) and general population attributes. CONCLUSION: Countries that have limited research time and other resources can adapt EQUIPTMOD to their own settings by choosing to collect data on a small number of model inputs. EQUIPTMOD can therefore facilitate transfer of tobacco control related economic evidence to new jurisdictions.

Cost-effectiveness of possible future smoking cessation strategies in Hungary: results from the EQUIPTMOD.

AIMS: To evaluate potential health and economic returns from implementing smoking cessation interventions in Hungary. METHODS: The EQUIPTMOD, a Markov-based economic model, was used to assess the cost-effectiveness of three implementation scenarios: (a) introducing a social marketing campaign; (b) doubling the reach of existing group-based behavioural support therapies and proactive telephone support; and (c) a combination of the two scenarios. All three scenarios were compared with current practice. The scenarios were chosen as feasible options available for Hungary based on the outcome of interviews with local stakeholders. Life-time costs and quality-adjusted life years (QALYs) were calculated from a health-care perspective. The analyses used various return on investment (ROI) estimates, including incremental cost-effectiveness ratios (ICERs), to compare the scenarios. Probabilistic sensitivity analyses assessed the extent to which the estimated mean ICERs were sensitive to the model input values. RESULTS: Introducing a social marketing campaign resulted in an increase of 0.3014 additional quitters per 1 000 smokers, translating to health-care cost-savings of €0.6495 per smoker compared with current practice. When the value of QALY gains was considered, cost-savings increased to €14.1598 per smoker. Doubling the reach of existing group-based behavioural support therapies and proactive telephone support resulted in health-care savings of €0.2539 per smoker (€3.9620 with the value of QALY gains), compared with current practice. The respective figures for the combined scenario were €0.8960 and €18.0062. Results were sensitive to model input values. CONCLUSIONS: According to the EQUIPTMOD modelling tool, it would be cost-effective for the Hungarian authorities introduce a social marketing campaign and double the reach of existing group-based behavioural support therapies and proactive telephone support. Such policies would more than pay for themselves in the long term.

Development and application of an economic model (EQUIPTMOD) to assess the impact of smoking cessation.

BACKGROUND AND AIMS: Although clear benefits are associated with reducing smoking, there is increasing pressure on public health providers to justify investment in tobacco control measures. Decision-makers need tools to assess the Return on Investment (ROI)/cost-effectiveness of programmes. The EQUIPT project adapted an ROI tool for England to four European countries (Germany, the Netherlands, Spain and Hungary). EQUIPTMOD, the economic model at the core of the ROI tool, is designed to assess the efficiency of packages of smoking cessation interventions. The objective of this paper is to describe the methods for EQUIPTMOD and identify key outcomes associated with continued and cessation of smoking. METHODS: EQUIPTMOD uses a Markov model to estimate life-time costs, quality-adjusted life years (QALYs) and life years associated with a current and former smoker. It uses population data on smoking prevalence, disease prevalence, mortality and the impact of smoking combined with associated costs and utility effects of disease. To illustrate the tool's potential, costs, QALYs and life expectancy were estimated for the average current smoker for five countries based on the assumptions that they continue and that they cease smoking over the next 12 months. Costs and effects were discounted at country-specific rates. RESULTS: For illustration, over a life-time horizon, not quitting smoking within the next 12 months in England will reduce life expectancy by 0.66, reduce QALYs by 1.09 and result in £4961 higher disease-related health care costs than if the smoker ceased smoking in the next 12 months. For all age-sex categories, costs were lower and QALYs higher for those who quit smoking in the 12 months than those who continued. CONCLUSIONS: EQUIPTMOD facilitates assessment of the cost effectiveness of smoking cessation strategies. The demonstrated results indicate large potential benefits from smoking cessation at both an individual and population level.

Estimates of effectiveness and reach for 'return on investment' modelling of smoking cessation interventions using data from England.

BACKGROUND AND AIMS: Estimating 'return on investment' (ROI) from smoking cessation interventions requires reach and effectiveness parameters for interventions for use in economic models such as the EQUIPT ROI tool (http://roi.equipt.eu). This paper describes the derivation of these parameter estimates for England that can be adapted to create ROI models for use by other countries. METHODS: Estimates were derived for interventions in terms of their reach and effectiveness in: (1) promoting quit attempts and (2) improving the success of quit attempts (abstinence for at least 12 months). The sources were systematic reviews of efficacy supplemented by individual effectiveness evaluations and national surveys. FINDINGS: Quit attempt rates were estimated to be increased by the following percentages (with reach in parentheses): 20% by tax increases raising the cost of smoking 5% above the cost of living index (100%); 10% by enforced comprehensive indoor public smoking bans (100%); 3% by mass media campaigns achieving 400 gross rating points (100%); 40% by brief opportunistic physician advice (21%); and 110% by use of a licensed nicotine product to reduce cigarette consumption (12%). Quit success rates were estimated to be increased by the following ratios: 60% by single-form nicotine replacement therapy (NRT) (5%); 114% by NRT patch plus a faster-acting NRT (2%);124% by prescribed varenicline (5%); 60% by bupropion (1%); 100% by nortriptyline (0%), 10) 298% by cytisine (0%); 40% by individual face-to-face behavioural support (2%); 37% by telephone support (0.5%); 88% by group behavioural support (1%); 63% by text messaging (0.5%); and 19% by printed self-help materials (1%). There was insufficient evidence to obtain reliable, country-specific estimates for interventions such as websites, smartphone applications and e-cigarettes. CONCLUSIONS: Tax increases, indoor smoking bans, brief opportunistic physician advice and use of nicotine replacement therapy (NRT) for smoking reduction can all increase population quit attempt rates. Quit success rates can be increased by provision of NRT, varenicline, bupropion, nortriptyline, cytisine and behavioural support delivered through a variety of modalities. Parameter estimates for the effectiveness and reach of these interventions can contribute to return on investment estimates in support of national or regional policy decisions.

Cost-effectiveness of increasing the reach of smoking cessation interventions in Germany: results from the EQUIPTMOD.

AIMS: To evaluate costs, effects and cost-effectiveness of increased reach of specific smoking cessation interventions in Germany. DESIGN: A Markov-based state transition return on investment model (EQUIPTMOD) was used to evaluate current smoking cessation interventions as well as two prospective investment scenarios. A health-care perspective (extended to include out-of-pocket payments) with life-time horizon was considered. A probabilistic analysis was used to assess uncertainty concerning predicted estimates. SETTING: Germany. PARTICIPANTS: Cohort of current smoking population (18+ years) in Germany. INTERVENTIONS: Interventions included group-based behavioural support, financial incentive programmes and varenicline. For prospective scenario 1 the reach of group-based behavioral support, financial incentive programme and varenicline was increased by 1% of yearly quit attempts (= 57 915 quit attempts), while prospective scenario 2 represented a higher reach, mirroring the levels observed in England. MEASUREMENTS: EQUIPTMOD considered reach, intervention cost, number of quitters, quality-of-life years (QALYs) gained, cost-effectiveness and return on investment. FINDINGS: The highest returns through reduction in smoking-related health-care costs were seen for the financial incentive programme (€2.71 per €1 invested), followed by that of group-based behavioural support (€1.63 per €1 invested), compared with no interventions. Varenicline had lower returns (€1.02 per €1 invested) than the other two interventions. At the population level, prospective scenario 1 led to 15 034 QALYs gained and €27 million cost-savings, compared with current investment. Intervention effects and reach contributed most to the uncertainty around the return-on-investment estimates. At a hypothetical willingness-to-pay threshold of only €5000, the probability of being cost-effective is approximately 75% for prospective scenario 1. CONCLUSIONS: Increasing the reach of group-based behavioural support, financial incentives and varenicline for smoking cessation by just 1% of current annual quit attempts provides a strategy to German policymakers that improves the population's health outcomes and that may be considered cost-effective.

Is it cost-effective to provide internet-based interventions to complement the current provision of smoking cessation services in the Netherlands? An analysis based on the EQUIPTMOD.

BACKGROUND AND AIM: The cost-effectiveness of internet-based smoking cessation interventions is difficult to determine when they are provided as a complement to current smoking cessation services. The aim of this study was to evaluate the cost-effectiveness of such an alternate package compared with existing smoking cessation services alone (current package). METHODS: A literature search was conducted to identify internet-based smoking cessation interventions in the Netherlands. A meta-analysis was then performed to determine the pooled effectiveness of a (web-based) computer-tailored intervention. The mean cost of implementing internet based interventions was calculated using available information, while intervention reach was sourced from an English study. We used EQUIPTMOD, a Markov-based state-transition model, to calculate the incremental cost-effectiveness ratios [expressed as cost per quality-adjusted life years (QALYs) gained] for different time horizons to assess the value of providing internet-based interventions to complement the current package.). Deterministic sensitivity analyses tested the uncertainty around intervention costs per smoker, relative risks, and the intervention reach. RESULTS: Internet-based interventions had an estimated pooled relative risk of 1.40; average costs per smoker of €2.71; and a reach of 0.41% of all smokers. The alternate package (i.e. provision of internet-based intervention to the current package) was dominant (cost-saving) compared with the current package alone (0.14 QALY gained per 1000 smokers; reduced health-care costs of €602.91 per 1000 smokers for the life-time horizon). The alternate package remained dominant in all sensitivity analyses. CONCLUSION: Providing internet-based smoking cessation interventions to complement the current provision of smoking cessation services could be a cost-saving policy option in the Netherlands.

Cost-Effectiveness Analysis of Systemic Therapies in Advanced Pancreatic Cancer in the Canadian Health Care System.

OBJECTIVES: To assess the cost-effectiveness of gemcitabine (G), G + 5-fluorouracil, G + capecitabine, G + cisplatin, G + oxaliplatin, G + erlotinib, G + nab-paclitaxel (GnP), and FOLFIRINOX in the treatment of advanced pancreatic cancer from a Canadian public health payer's perspective, using data from a recently published Bayesian network meta-analysis. METHODS: Analysis was conducted through a three-state Markov model and used data on the progression of disease with treatment from the gemcitabine arms of randomized controlled trials combined with estimates from the network meta-analysis for the newer regimens. Estimates of health care costs were obtained from local providers, and utilities were derived from the literature. The model estimates the effect of treatment regimens on costs and quality-adjusted life-years (QALYs) discounted at 5% per annum. RESULTS: At a willingness-to-pay (WTP) threshold of greater than $30,666 per QALY, FOLFIRINOX would be the most optimal regimen. For a WTP threshold of $50,000 per QALY, the probability that FOLFIRINOX would be optimal was 57.8%. There was no price reduction for nab-paclitaxel when GnP was optimal. CONCLUSIONS: From a Canadian public health payer's perspective at the present time and drug prices, FOLFIRINOX is the optimal regimen on the basis of the cost-effectiveness criterion. GnP is not cost-effective regardless of the WTP threshold.

Cost effectiveness of the addition of a comprehensive CT scan to the abdomen and pelvis for the detection of cancer after unprovoked venous thromboembolism.

IMPORTANCE: Unprovoked venous thromboembolism (VTE) can be the first manifestation of cancer. It is unclear if extensive screening for occult cancer including a comprehensive computed tomography (CT) scan of the abdomen/pelvis is cost-effective in this patient population. OBJECTIVE: To assess the health care related costs, number of missed cancer cases and health related utility values of a limited screening strategy with and without the addition of a comprehensive CT scan of the abdomen/pelvis and to identify to what extent testing should be done in these circumstances to allow early detection of occult cancers. PARTICIPANTS AND SETTING: Cost effectiveness analysis using data that was collected alongside the SOME randomized controlled trial which compared an extensive occult cancer screening including a CT of the abdomen/pelvis to a more limited screening strategy in patients with a first unprovoked VTE, was used for the current analyses. MAIN OUTCOMES AND MEASURES: Analyses were conducted with a one-year time horizon from a Canadian health care perspective. Primary analysis was based on complete cases, with sensitivity analysis using appropriate multiple imputation methods to account for missing data. RESULTS: Data from a total of 854 patients with a first unprovoked VTE were included in these analyses. The addition of a comprehensive CT scan was associated with higher costs ($551 CDN) with no improvement in utility values or number of missed cancers. Results were consistent when adopting multiple imputation methods. CONCLUSIONS AND RELEVANCE: The addition of a comprehensive CT scan of the abdomen/pelvis for the screening of occult cancer in patients with unprovoked VTE is not cost effective, as it is both more costly and not more effective in detecting occult cancer.

Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis.

BACKGROUND: Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery. OBJECTIVE: The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery. DATA SOURCES: We searched articles in MEDLINE, Embase, and the Cochrane Library published from 1994 to February 2014 for evidence of effectiveness and harms; for economic literature we also searched NHS EED and Tufts CEA registry. Grey literature was also searched. REVIEW METHODS: Primary studies were sought from existing systematic reviews that had employed reliable search and screening methods. Newer studies were sought by searching the period subsequent to the last search date of the review. Two reviewers screened records and assessed study validity. We used the Cochrane risk of bias tool for randomized, generic assessment for non-randomized studies, and the Phillips checklist for economic studies. RESULTS: Ten studies including 1 randomized trial were included. The majority of the direct comparative evidence compared the mitral valve clip repair with surgery in patients not particularly at prohibitive surgical risk. Irrespective of degenerative or functional chronic mitral regurgitation etiology, evidence of effectiveness and harms is inconclusive and of very low quality. Very-low-quality evidence indicates that percutaneous mitral valve clip repair may provide a survival advantage, at least during the first 1 to 2 years, particularly in medically managed chronic functional mitral regurgitation. Because of limitations in the design of studies, the cost-effectiveness of mitral valve clips in patients at prohibitive risk for surgery also could not be established. LIMITATIONS: Because of serious concerns of risk of bias, indirectness, and imprecision, evidence is of very low quality. CONCLUSIONS: No meaningful conclusions can be drawn about the comparative effectiveness, harms, and cost-effectiveness of mitral valve clips in the population with chronic mitral regurgitation who are at prohibitive risk for surgery.

EQUIPT: protocol of a comparative effectiveness research study evaluating cross-context transferability of economic evidence on tobacco control.

INTRODUCTION: Tobacco smoking claims 700,000 lives every year in Europe and the cost of tobacco smoking in the EU is estimated between €98 and €130 billion annually; direct medical care costs and indirect costs such as workday losses each represent half of this amount. Policymakers all across Europe are in need of bespoke information on the economic and wider returns of investing in evidence-based tobacco control, including smoking cessation agendas. EQUIPT is designed to test the transferability of one such economic evidence base-the English Tobacco Return on Investment (ROI) tool-to other EU member states. METHODS AND ANALYSIS: EQUIPT is a multicentre, interdisciplinary comparative effectiveness research study in public health. The Tobacco ROI tool already developed in England by the National Institute for Health and Care Excellence (NICE) will be adapted to meet the needs of European decision-makers, following transferability criteria. Stakeholders' needs and intention to use ROI tools in sample countries (Germany, Hungary, Spain and the Netherlands) will be analysed through interviews and surveys and complemented by secondary analysis of the contextual and other factors. Informed by this contextual analysis, the next phase will develop country-specific ROI tools in sample countries using a mix of economic modelling and Visual Basic programming. The results from the country-specific ROI models will then be compared to derive policy proposals that are transferable to other EU states, from which a centralised web tool will be developed. This will then be made available to stakeholders to cater for different decision-making contexts across Europe. ETHICS AND DISSEMINATION: The Brunel University Ethics Committee and relevant authorities in each of the participating countries approved the protocol. EQUIPT has a dedicated work package on dissemination, focusing on stakeholders' communication needs. Results will be disseminated via peer-reviewed publications, e-learning resources and policy briefs.

Cost effectiveness of a survivorship care plan for breast cancer survivors.

PURPOSE: Survivorship care plans (SCPs) are recommended for patients who have completed primary treatment and are transitioning to routine follow-up care. However, SCPs may be costly, and their effectiveness is unproven. The study objective was to assess the cost effectiveness of an SCP for breast cancer survivors transitioning to routine follow-up care with their own primary care physician (PCP) using data from a recent randomized controlled trial (RCT). METHODS: Resource use and utility data for 408 patients with breast cancer enrolled in the RCT comparing an SCP with standard care (no SCP) were used. The intervention group received a 30-minute educational session with a nurse and their SCP, and their PCPs received the SCP plus a full guideline on follow-up. Analysis assessed the societal costs and quality-adjusted life years (QALYs) for the intervention group and the control group over the 2-year follow-up of the RCT. Uncertainty concerning cost effectiveness was assessed through nonparametric bootstrapping and deterministic sensitivity analysis. RESULTS: The no-SCP group had better outcomes than the SCP group: total costs per patient were lower for standard care (Canadian $698 v $765), and total QALYs were almost equivalent (1.42 for standard care v 1.41 for the SCP). The probability that the SCP was cost effective was 0.26 at a threshold value of a QALY of $50,000. A variety of sensitivity analyses did not change the conclusions of the analysis. CONCLUSION: This SCP would be costly to introduce and would not be a cost effective use of scarce health care resources.