The Causal-Benefit Model to Prevent Cardiovascular Events.

Selecting individuals for preventive lipid-lowering therapy is presently governed by the 10-year risk model. Once a prespecified level of cardiovascular disease risk is equaled or exceeded, individuals become eligible for preventive lipid-lowering therapy. A key limitation of this model is that only a small minority of individuals below the age of 65 years are eligible for therapy. However, just under one-half of all cardiovascular disease events occur below this age. Additionally, in many, the disease that caused their events after 65 years of age developed and progressed before 65 years of age. The causal-benefit model of prevention identifies individuals based both on their risk and the estimated benefit from lowering atherogenic apoB lipoprotein levels. Adopting the causal-benefit model would increase the number of younger subjects eligible for preventive treatment, would increase the total number of cardiovascular disease events prevented at virtually the same number to treat, and would be cost-effective.

A cost-effectiveness analysis of a South African pregnancy support grant.

Poverty among expectant mothers often results in sub-optimal maternal nutrition and inadequate antenatal care, with negative consequences on child health outcomes. South Africa has a child support grant that is available from birth to those in need. This study aims to determine whether a pregnancy support grant, administered through the extension of the child support grant, would be cost-effective compared to the existing child support grant alone. A cost-utility analysis was performed using a decision-tree model to predict the incremental costs (ZAR) and disability-adjusted life years (DALYs) averted by the pregnancy support grant over a 2-year time horizon. An ingredients-based approach to costing was completed from a governmental perspective. The primary outcome was the incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses were performed. The intervention resulted in a cost saving of R13.8 billion ($930 million, 95% CI: ZAR3.91 billion - ZAR23.2 billion/ $1.57 billion - $264 million) and averted 59,000 DALYs (95% CI: -6,400-110,000), indicating that the intervention is highly cost-effective. The primary cost driver was low birthweight requiring neonatal intensive care, with a disaggregated incremental cost of R31,800 ($2,149) per pregnancy. Mortality contributed most significantly to the DALYs accrued in the comparator (0.68 DALYs). The intervention remained the dominant strategy in the sensitivity analyses. The pregnancy support grant is a highly cost-effective solution for supporting expecting mothers and ensuring healthy pregnancies. With its positive impact on child health outcomes, there is a clear imperative for government to implement this grant. By investing in this program, cost savings could be leveraged. The implementation of this grant should be given high priority in public health and social policies.

Extended cost-effectiveness analysis of interventions to improve uptake of diabetes services in South Africa.

The rising prevalence of diabetes in South Africa (SA), coupled with significant levels of unmet need for diagnosis and treatment, results in high rates of diabetes-associated complications. Income status is a determinant of utilization of diagnosis and treatment services, with transport costs and loss of wages being key barriers to care. A conditional cash transfer (CCT) programme, targeted to compensate for such costs, may improve service utilization. We applied extended cost-effectiveness analysis (ECEA) methods and used a Markov model to compare the costs, health benefits and financial risk protection (FRP) attributes of a CCT programme. A population was simulated, drawing from SA-specific data, which transitioned yearly through various health states, based on specific probabilities obtained from local data, over a 45-year time horizon. Costs and disability-adjusted life years (DALYs) were applied to each health state. Three CCT programme strategies were simulated and compared to a 'no programme' scenario: (1) covering diagnosis services only; (2) covering treatment services only; (3) covering both diagnosis and treatment services. Cost-effectiveness was reported as incremental net monetary benefit (INMB) using a cost-effectiveness threshold of USD3015 per DALY for SA, while FRP outcomes were reported as catastrophic health expenditure (CHE) cases averted. Distributions of the outcomes were reported by income quintile and sex. Covering both diagnosis and treatment services for the bottom two quintiles resulted in the greatest INMB (USD22 per person) and the greatest CHE cases averted. There were greater FRP benefits for women compared to men. A CCT programme covering diabetes diagnosis and treatment services was found to be cost-effective, when provided to the poorest 40% of the SA population. ECEA provides a useful platform for including equity considerations to inform priority setting and implementation policies in SA.

Cost-Effectiveness of Masked Hypertension Screening and Treatment in US Adults With Suspected Masked Hypertension: A Simulation Study.

BACKGROUND: Recent US blood pressure (BP) guidelines recommend using ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) to screen adults for masked hypertension. However, limited evidence exists of the expected long-term effects of screening for and treating masked hypertension. METHODS: We estimated the lifetime health and economic outcomes of screening for and treating masked hypertension using the Cardiovascular Disease (CVD) Policy Model, a validated microsimulation model. We simulated a cohort of 100,000 US adults aged ≥20 years with suspected masked hypertension (i.e., office BP 120-129/<80 mm Hg, not taking antihypertensive medications, without CVD history). We compared usual care only (i.e., no screening), usual care plus ABPM, and usual care plus HBPM. We projected total direct healthcare costs (2021 USD), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Future costs and QALYs were discounted 3% annually. Secondary outcomes included CVD events and serious adverse events. RESULTS: Relative to usual care, adding masked hypertension screening and treatment with ABPM and HBPM was projected to prevent 14.3 and 20.5 CVD events per 100,000 person-years, increase the proportion experiencing any treatment-related serious adverse events by 2.7 and 5.1 percentage points, and increase mean total costs by $1,076 and $1,046, respectively. Compared with usual care, adding ABPM was estimated to cost $85,164/QALY gained. HBPM resulted in lower QALYs than usual care due to increased treatment-related adverse events and pill-taking disutility. CONCLUSIONS: The results from our simulation study suggest screening with ABPM and treating masked hypertension is cost-effective in US adults with suspected masked hypertension.

Estimating the healthcare cost of overweight and obesity in South Africa.

BACKGROUND: Overweight and obesity are major risk factors for noncommunicable diseases. This presents a major burden to health systems and to society in South Africa. Collectively, these conditions are overwhelming public healthcare. This is happening when the country has embarked on a journey to universal health coverage, hence the need to estimate the cost of overweight and obesity. OBJECTIVE: Our objective was to estimate the healthcare cost associated with treatment of weight-related conditions from the perspective of the South African public sector payer. METHODS: Using a bottom-up gross costing approach, this study draws data from multiple sources to estimate the direct healthcare cost of overweight and obesity in South Africa. Population Attributable Fractions (PAF) were calculated and multiplied by each disease's total treatment cost to apportion costs to overweight and obesity. Annual costs were estimated for 2020. RESULTS: The total cost of overweight and obesity is estimated to be ZAR33,194 million in 2020. This represents 15.38% of government health expenditure and is equivalent to 0.67% of GDP. Annual per person cost of overweight and obesity is ZAR2,769. The overweight and obesity cost is disaggregated as follows: cancers (ZAR352 million), cardiovascular diseases (ZAR8,874 million), diabetes (ZAR19,861 million), musculoskeletal disorders (ZAR3,353 million), respiratory diseases (ZAR360 million) and digestive diseases (ZAR395 million). Sensitivity analyses show that the total overweight and obesity cost is between ZAR30,369 million and ZAR36,207 million. CONCLUSION: This analysis has demonstrated that overweight and obesity impose a huge financial burden on the public health care system in South Africa. It suggests an urgent need for preventive, population-level interventions to reduce overweight and obesity rates. The reduction will lower the incidence, prevalence, and healthcare spending on noncommunicable diseases.

Costs of seasonal influenza vaccination in South Africa.

BACKGROUND: Influenza accounts for a substantial number of deaths and hospitalisations annually in South Africa. To address this disease burden, the South African National Department of Health introduced a trivalent inactivated influenza vaccination programme in 2010. METHODS: We adapted and populated the WHO Seasonal Influenza Immunization Costing Tool (WHO SIICT) with country-specific data to estimate the cost of the influenza vaccination programme in South Africa. Data were obtained through key-informant interviews at different levels of the health system and through a review of existing secondary data sources. Costs were estimated from a public provider perspective and expressed in 2018 prices. We conducted scenario analyses to assess the impact of different levels of programme expansion and the use of quadrivalent vaccines on total programme costs. RESULTS: Total financial and economic costs were estimated at approximately USD 2.93 million and USD 7.91 million, respectively, while financial and economic cost per person immunised was estimated at USD 3.29 and USD 8.88, respectively. Expanding the programme by 5% and 10% increased economic cost per person immunised to USD 9.36 and USD 9.52 in the two scenarios, respectively. Finally, replacing trivalent inactivated influenza vaccine (TIV) with quadrivalent vaccine increased financial and economic costs to USD 4.89 and USD 10.48 per person immunised, respectively. CONCLUSION: We adapted the WHO SIICT and provide estimates of the total costs of the seasonal influenza vaccination programme in South Africa. These estimates provide a basis for planning future programme expansion and may serve as inputs for cost-effectiveness analyses of seasonal influenza vaccination programmes.

Beyond 10-Year Risk: A Cost-Effectiveness Analysis of Statins for the Primary Prevention of Cardiovascular Disease.

BACKGROUND: Cholesterol guidelines typically prioritize primary prevention statin therapy on the basis of 10-year risk of cardiovascular disease. The advent of generic pricing may justify expansion of statin eligibility. Moreover, 10-year risk may not be the optimal approach for statin prioritization. We estimated the cost-effectiveness of expanding preventive statin eligibility and evaluated novel approaches to prioritization from a Scottish health sector perspective. METHODS: A computer simulation model predicted long-term health and cost outcomes in Scottish adults ≥40 years of age. Epidemiologic analysis was completed using the Scottish Heart Health Extended Cohort, Scottish Morbidity Records, and National Records of Scotland. A simulation cohort was constructed with data from the Scottish Health Survey 2011 and contemporary population estimates. Treatment and cost inputs were derived from published literature and health service cost data. The main outcome measure was the lifetime incremental cost-effectiveness ratio, evaluated as cost (2020 GBP) per quality-adjusted life-year (QALY) gained. Three approaches to statin prioritization were analyzed: 10-year risk scoring using the ASSIGN score, age-stratified risk thresholds to increase treatment rates in younger individuals, and absolute risk reduction (ARR)-guided therapy to increase treatment rates in individuals with elevated cholesterol levels. For each approach, 2 policies were considered: treating the same number of individuals as those with an ASSIGN score ≥20% (age-stratified risk threshold 20, ARR 20) and treating the same number of individuals as those with an ASSIGN score ≥10% (age-stratified risk threshold 10, ARR 10). RESULTS: Compared with an ASSIGN score ≥20%, reducing the risk threshold for statin initiation to 10% expanded eligibility from 804 000 (32% of adults ≥40 years of age without CVD) to 1 445 500 individuals (58%). This policy would be cost-effective (incremental cost-effectiveness ratio, £12 300/QALY [95% CI, £7690/QALY-£26 500/QALY]). Incremental to an ASSIGN score ≥20%, ARR 20 produced ≈8800 QALYs and was cost-effective (£7050/QALY [95% CI, £4560/QALY-£10 700/QALY]). Incremental to an ASSIGN score ≥10%, ARR 10 produced ≈7950 QALYs and was cost-effective (£11 700/QALY [95% CI, £9250/QALY-£16 900/QALY]). Both age-stratified risk threshold strategies were dominated (ie, more expensive and less effective than alternative treatment strategies). CONCLUSIONS: Generic pricing has rendered preventive statin therapy cost-effective for many adults. ARR-guided therapy is more effective than 10-year risk scoring and is cost-effective.

Hypertension in the South African public healthcare system: a cost-of-illness and burden of disease study.

OBJECTIVES: To quantify the health and economic burden of hypertension in the South African public healthcare system. SETTING: All inpatient, outpatient and rehabilitative care received in the national public healthcare system. PARTICIPANTS: Adults, aged ≥20 years, who receive care in the public healthcare system. OUTCOMES: Worksheet-based models synthesised data from multiple sources to estimate the burden of disease, direct healthcare costs, and societal costs associated with hypertension. Results were disaggregated by sex. RESULTS: Approximately 8.22 million (30.8%, 95% CI 29.5% to 32.1%) South African adults with no private health insurance have hypertension. Hypertension was estimated to cause 14 000 (95% CI 11 100 to 17 200) ischaemic heart disease events, 13 300 (95% CI 10 600 to 16 300) strokes and 6100 (95% CI 4970 to 7460) cases of chronic kidney disease annually. Rates of hypertension, hypertension-related stroke and hypertension-related chronic kidney disease were greater for women compared with men.The direct healthcare costs associated with hypertension were estimated to be ZAR 10.1 billion (95% CI 8.98 to 11.3 billion) or US$0.711 billion (95% CI 0.633 to 0.793 billion). Societal costs were estimated to be ZAR 29.4 billion (95% CI 26.0 to 33.2 billion) or US$2.08 billion (95% CI 1.83 to 2.34 billion). Direct healthcare costs were greater for women (ZAR 6.11 billion or US$0.431 billion) compared with men (ZAR 3.97 billion or US$0.280 billion). Conversely, societal costs were lower for women (ZAR 10.5 billion or US$0.743 billion) compared with men (ZAR 18.9 billion or US$1.33 billion). CONCLUSION: Hypertension exerts a heavy health and economic burden on South Africa. Establishing cost-effective best practice guidelines for hypertension treatment requires further research. Such research will be essential if South Africa is to make progress in its efforts to implement universal healthcare.

Trial-Based Economic Evaluations of Supported Employment for Adults with Severe Mental Illness: A Systematic Review.

To identify, appraise, and summarize outcomes reported in trial-based economic evaluations of Individual Placement and Support programs for adults with severe mental illness. Six databases were searched, including Medline, PsycINFO, CINAHL, Cochrane, Scopus, and EconLit. Inclusion criteria were trial-based, full economic evaluations comparing Individual Placement and Support programs to traditional vocational rehabilitation programs for adults 18 years and older with severe mental illness. Study quality was appraised using the Consolidated Health Economic Evaluation Reporting Standards statement. Of the 476 articles identified in the database search, seven were included in the review. Studies conducted across Europe (n = 4) and Japan (n = 1) suggested that Individual Placement and Support may be a cost-effective alternative to traditional vocational rehabilitation programs. Two studies conducted in the United States demonstrated that Individual Placement and Support led to better vocational outcomes, but at neutral or higher costs than traditional vocational rehabilitation, depending on the benefit measure used. Trial-based economic evaluations of supported employment for adults with severe mental illness are limited and heterogeneous. The interpretation of economic outcomes warrants consideration of factors that may impact cost-effectiveness, such as geographical location. Future studies should evaluate whether the benefits of IPS outweigh additional costs for patients and other stakeholders.

From Spreadsheets to Script: Experiences From Converting a Scottish Cardiovascular Disease Policy Model into R.

Given the advantages in transparency, reproducibility, adaptability and computational efficiency in R, there is a growing interest in converting existing spreadsheet-based models into an R script for model re-use and upskilling training among health economic modellers. The objective of this exercise was to convert the Scottish Cardiovascular Disease (CVD) Policy Model from Excel to R and discuss the lessons learnt throughout this process. The CVD model is a competing risk state transition cohort model. Four health economists, with varied experience of R, attempted to replicate an identical model structure in R based on the model in Excel and reproduce the intermediate and final results. Replications varied in their use of specialist health economics packages in addition to standard data management packages. Two versions of the CVD model were created in R along with a Shiny app. Version 1 was developed without health economics specialist packages and produced identical results to the Excel version. Version 2 used the heemod package and did not achieve the same results, possibly due to the non-standard elements of the model and limited time to adapt the functions. The R model requires less than half the computational time than the Excel model. Conversion of the spreadsheet models to script models is feasible for health economists. A step-by-step guide for the conversion process is provided and modellers' experience is discussed. Coding without specialist packages allows full flexibility, while specialist packages may add convenience if the model structure is suitable. Whichever approach is taken, transparency and replicability remain the key criteria in model programming. Model conversions must maintain standards in these areas regardless of the choice of software.

Cost-Effectiveness of Lipid-Lowering Treatments in Young Adults.

BACKGROUND: Raised low-density lipoprotein cholesterol (LDL-C) in young adulthood (aged 18-39 years) is associated with atherosclerotic cardiovascular disease (ASCVD) later in life. Most young adults with elevated LDL-C do not currently receive lipid-lowering treatment. OBJECTIVES: This study aimed to estimate the prevalence of elevated LDL-C in ASCVD-free U.S. young adults and the cost-effectiveness of lipid-lowering strategies for raised LDL-C in young adulthood compared with standard care. METHODS: The prevalence of raised LDL-C was examined in the U.S. National Health and Nutrition Examination Survey. The CVD Policy Model projected lifetime quality-adjusted life years (QALYs), health care costs, and incremental cost-effectiveness ratios (ICERs) for lipid-lowering strategies. Standard care was statin treatment for adults aged ≥40 years based on LDL-C, ASCVD risk, or diabetes plus young adults with LDL-C ≥190 mg/dL. Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL. RESULTS: Approximately 27% of ASCVD-free young adults have LDL-C of ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL. The model projected that young adult lipid lowering with statins or lifestyle interventions would prevent lifetime ASCVD events and increase QALYs compared with standard care. ICERs were US$31,000/QALY for statins in young adult men with LDL-C of ≥130 mg/dL and US$106,000/QALY for statins in young adult women with LDL-C of ≥130 mg/dL. Intensive lifestyle intervention was more costly and less effective than statin therapy. CONCLUSIONS: Statin treatment for LDL-C of ≥130 mg/dL is highly cost-effective in young adult men and intermediately cost-effective in young adult women.

A cost-effectiveness analysis of South Africa's seasonal influenza vaccination programme.

BACKGROUND: Seasonal influenza imposes a significant health and economic burden in South Africa, particularly in populations vulnerable to severe consequences of influenza. This study assesses the cost-effectiveness of South Africa's seasonal influenza vaccination strategy, which involves vaccinating vulnerable populations with trivalent inactivated influenza vaccine (TIV) during routine facility visits. Vulnerable populations included in our analysis are persons aged ≥ 65 years; pregnant women; persons living with HIV/AIDS (PLWHA), persons of any age with underlying medical conditions (UMC) and children aged 6-59 months. METHOD: We employed the World Health Organisation's (WHO) Cost Effectiveness Tool for Seasonal Influenza Vaccination (CETSIV), a decision tree model, to evaluate the 2018 seasonal influenza vaccination campaign from a public healthcare provider and societal perspective. CETSIV was populated with existing country-specific demographic, epidemiologic and coverage data to estimate incremental cost-effectiveness ratios (ICERs) by comparing costs and benefits of the influenza vaccination programme to no vaccination. RESULTS: The highest number of clinical events (influenza cases, outpatient visits, hospitalisation and deaths) were averted in PLWHA and persons with other UMCs. Using a cost-effectiveness threshold of US$ 3400 per quality-adjusted life year (QALY), our findings suggest that the vaccination programme is cost-effective for all vulnerable populations except for children aged 6-59 months. ICERs ranged from ~US$ 1 750 /QALY in PLWHA to ~US$ 7500/QALY in children. In probabilistic sensitivity analyses, the vaccination programme was cost-effective in pregnant women, PLWHA, persons with UMCs and persons aged ≥65 years in >80% of simulations. These findings were robust to changes in many model inputs but were most sensitive to uncertainty in estimates of influenza-associated illness burden. CONCLUSION: South Africa's seasonal influenza vaccination strategy of opportunistically targeting vulnerable populations during routine visits is cost-effective. A budget impact analysis will be useful for supporting future expansions of the programme.

The clinical utility of apoB versus LDL-C/non-HDL-C.

BACKGROUND: The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB. OBJECTIVE: To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician. METHODS AND RESULTS: We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs. CONCLUSION: We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.

Cost-effectiveness of Low-density Lipoprotein Cholesterol Level-Guided Statin Treatment in Patients With Borderline Cardiovascular Risk.

Importance: American College of Cardiology/American Heart Association cholesterol guidelines prioritize primary prevention statin therapy based on 10-year absolute risk (AR10) of atherosclerotic cardiovascular disease (ASCVD). However, given the same AR10, patients with higher levels of low-density lipoprotein cholesterol (LDL-C) experience greater absolute risk reduction from statin therapy. Objectives: To estimate the cost-effectiveness of expanding preventive statin treatment eligibility from standard care to patients at borderline risk (AR10, 5.0%-7.4%) for ASCVD and with high levels of LDL-C and to estimate cost-effectiveness of statin treatment across ranges of age, sex, AR10, and LDL-C levels. Design, Setting, and Participants: This study evaluated 100 simulated cohorts, each including 1 million ASCVD-free survey respondents (50% men and 50% women) aged 40 years at baseline. Cohorts were created by probabilistic sampling of the 1999-2014 US National Health and Nutrition Examination Surveys from the perspective of the US health care sector. The CVD Policy Model microsimulation version projected lifetime health and cost outcomes. Probability of first-ever coronary heart disease or stroke event was estimated by analysis of 6 pooled US cohort studies and recalibrated to match contemporary event rates. Other model variables were derived from national surveys, meta-analyses, and published literature. Data were analyzed from May 15, 2018, through June 10, 2019. Exposures: Four statin treatment strategies were compared: (1) treat all patients with AR10 of at least 7.5%, diabetes, or LDL-C of at least 190 mg/dL (standard care); (2) add treatment for borderline risk and LDL-C levels of 160 to 189 mg/dL; (3) add treatment for borderline risk and LDL-C levels of 130 to 159 mg/dL; and (4) add treatment for remainder of patients with AR10 of at least 5.0%. Statin treatment was also compared with no statin treatment in age, sex, AR10, and LDL-C strata. Main Outcomes and Measures: Lifetime quality-adjusted life-years (QALYs) and costs (2019 US dollars) were projected and discounted 3.0% annually. The primary outcome was the incremental cost-effectiveness ratio. Results: In these 100 simulated cohorts, each with 1 million patients aged 40 years at baseline (50% women and 50% men), adding preventive statins to individuals with borderline AR10 and LDL-C levels of 160 to 189 mg/dL would be cost-saving; further treating borderline AR10 and LDL-C levels of 130 to 159 mg/dL would also be cost-saving; and treating all individuals with AR10 of at least 5.0% would be highly cost-effective ($33 558/QALY) and would prevent the most ASCVD events. Within age, AR10, and sex categories, individuals with higher baseline LDL-C levels gained more QALYs from statin therapy. Cost-effectiveness increased with LDL-C level and AR10. Conclusions and Relevance: In this study, lifetime statin treatment of patients in a hypothetical cohort with borderline ASCVD risk and LDL-C levels of 160 to 189 mg/dL was found to be cost-saving. Results suggest that treating all patients at borderline risk regardless of LDL-C level would likely be highly cost-effective.

Long-term weight loss trajectories following participation in a randomised controlled trial of a weight management programme for men delivered through professional football clubs: a longitudinal cohort study and economic evaluation.

BACKGROUND: Obesity is a major public health concern requiring innovative interventions that support people to lose weight and keep it off long term. However, weight loss maintenance remains a challenge and is under-researched, particularly in men. The Football Fans in Training (FFIT) programme engages men in weight management through their interest in football, and encourages them to incorporate small, incremental physical activity and dietary changes into daily life to support long-term weight loss maintenance. In 2011/12, a randomised controlled trial (RCT) of FFIT demonstrated effectiveness and cost-effectiveness at 12 months. The current study aimed to investigate long-term maintenance of weight loss, behavioural outcomes and lifetime cost-effectiveness following FFIT. METHODS: A longitudinal cohort study comprised 3.5-year follow-up of the 747 FFIT RCT participants. Men aged 35-65 years, BMI ≥ 28 kg/m2 at RCT baseline who consented to long-term follow-up (n = 665) were invited to participate: those in the FFIT Follow Up Intervention group (FFIT-FU-I) undertook FFIT in 2011 during the RCT; the FFIT Follow Up Comparison group (FFIT-FU-C) undertook FFIT in 2012 under routine (non-research) conditions. The primary outcome was objectively-measured weight loss (from baseline) at 3.5 years. Secondary outcomes included changes in self-reported physical activity and diet at 3.5 years. Cost-effectiveness was estimated at 3.5 years and over participants' lifetime. RESULTS: Of 665 men invited, 488 (73%; 65% of the 747 RCT participants) attended 3.5-year measurements. The FFIT-FU-I group sustained a mean weight loss of 2.90 kg (95% CI 1.78, 4.02; p < 0.001) 3.5 years after starting FFIT; 32.2% (75/233) weighed ≥5% less than baseline. The FFIT-FU-C group had lost 2.71 kg (1.65, 3.77; p < 0.001) at the 3.5-year measurements (2.5 years after starting FFIT); 31.8% (81/255) weighed ≥5% less than baseline. There were significant sustained improvements in self-reported physical activity and diet in both groups. The estimated incremental cost-effectiveness of FFIT was £10,700-£15,300 per QALY gained at 3.5 years, and £1790-£2200 over participants' lifetime. CONCLUSIONS: Participation in FFIT under research and routine conditions leads to long-term weight loss and improvements in physical activity and diet. Investment in FFIT is likely to be cost-effective as part of obesity management strategies in countries where football is popular. TRIAL REGISTRATION: ISRCTN32677491 , 20 October 2011.

Comparative Cost-Effectiveness of Conservative or Intensive Blood Pressure Treatment Guidelines in Adults Aged 35-74 Years: The Cardiovascular Disease Policy Model.

The population health effect and cost-effectiveness of implementing intensive blood pressure goals in high-cardiovascular disease (CVD) risk adults have not been described. Using the CVD Policy Model, CVD events, treatment costs, quality-adjusted life years, and drug and monitoring costs were simulated over 2016 to 2026 for hypertensive patients aged 35 to 74 years. We projected the effectiveness and costs of hypertension treatment according to the 2003 Joint National Committee (JNC)-7 or 2014 JNC8 guidelines, and then for adults aged ≥50 years, we assessed the cost-effectiveness of adding an intensive goal of systolic blood pressure <120 mm Hg for patients with CVD, chronic kidney disease, or 10-year CVD risk ≥15%. Incremental cost-effectiveness ratios <$50 000 per quality-adjusted life years gained were considered cost-effective. JNC7 strategies treat more patients and are more costly to implement compared with JNC8 strategies. Adding intensive systolic blood pressure goals for high-risk patients prevents an estimated 43 000 and 35 000 annual CVD events incremental to JNC8 and JNC7, respectively. Intensive strategies save costs in men and are cost-effective in women compared with JNC8 alone. At a willingness-to-pay threshold of $50 000 per quality-adjusted life years gained, JNC8+intensive had the highest probability of cost-effectiveness in women (82%) and JNC7+intensive the highest probability of cost-effectiveness in men (100%). Assuming higher drug and monitoring costs, adding intensive goals for high-risk patients remained consistently cost-effective in men, but not always in women. Among patients aged 35 to 74 years, adding intensive blood pressure goals for high-risk groups to current national hypertension treatment guidelines prevents additional CVD deaths while saving costs provided that medication costs are controlled.