146-OR: A New Type 2 Diabetes Microsimulation Model to Estimate Long-Term Health Outcomes, Costs, and Cost-Effectiveness

BackgroundComprehensive control of multiple cardiovascular risk factors reduces cardiovascular risk but is difficult to achieve.DesignA multinational, cross-sectional, observational study.MethodsThe International ChoLesterol management Practice Study (ICLPS) investigated achievement of European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guideline low-density lipoprotein cholesterol (LDL-C) targets in patients receiving lipid-modifying therapy in countries outside Western Europe. We examined the rate of, and association between, control of multiple risk factors in ICLPS participants with dyslipidaemia, diabetes and hypertension (N = 2377).ResultsMean (standard deviation) age of patients was 61.4 (10.4) years; 51.3% were male. Type 2 diabetes was the most common form of diabetes (prevalence, 96.9%). The prevalence of metabolic syndrome was 67.8%, obesity 40.4%, atherosclerotic disease 39.6% and coronary artery disease 33.5%. All patients were at high (38.2%) or very high (61.8%) cardiovascular risk according to ESC/EAS guidelines. Body mass index (BMI) was <25 kg/m2 in 20.3% of patients, 62.8% had never smoked and 25.2% were former smokers. Overall, 12.2% achieved simultaneous control of LDL-C, diabetes and blood pressure. Risk factor control was similar across all participating countries. The proportion of patients achieving individual guideline-specified treatment targets was 43.9% for LDL-C, 55.5% for blood pressure and 39.3% for diabetes. Multiple correspondence analysis indicated that control of LDL-C, control of blood pressure, control of diabetes, BMI and smoking were associated.ConclusionComprehensive control of multiple cardiovascular risk factors in high-risk patients is suboptimal worldwide. Failure to control one risk factor is associated with poor control of other risk factors.

Preventable Coronary Heart Disease Events from Control of Cardiovascular Risk Factors in US Adults With Diabetes (Projections from Utilizing the UKPDS Risk Engine)

BackgroundEconomic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia.Methods/designThis economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018.DiscussionWe hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings.Trial registrationClinicalTrials.gov: NCT01212328.

To assess the cost-effectiveness of a multicomponent strategy versus usual care in people with type 2 diabetes in South Asia. Economic evaluation from healthcare system and societal perspectives. Ten diverse urban clinics in India and Pakistan. 1146 people with type 2 diabetes (575 in the intervention group and 571 in the usual care group) with mean age of 54.2 years, median diabetes duration: 7 years and mean HbA1c: 9.9% (85 mmol/mol) at baseline. Multicomponent strategy comprising decision-supported electronic health records and non-physician care coordinator. Control group received usual care. Incremental cost-effectiveness ratios (ICERs) per unit achievement in multiple risk factor control (HbA1c <7% (53 mmol/mol) and SBP <130/80 mmHg or LDLc <2.58 mmol/L (100 mg/dL)), ICERs per unit reduction in HbA1c, 5-mmHg unit reductions in systolic BP, 10-unit reductions in LDLc (mg/dl) (considered as clinically relevant) and ICER per quality-adjusted life years (QALYs) gained. ICERs were reported in 2020 purchasing power parity-adjusted international dollars (INT$). The probability of ICERs being cost-effective was considered depending on the willingness to pay (WTP) values as a share of GDP per capita for India (Int$ 7041.4) and Pakistan (Int$ 4847.6). Compared to usual care, the annual incremental costs per person for intervention group were Int$ 1061.9 from a health system perspective and Int$ 1093.6 from a societal perspective. The ICER was Int$ 10,874.6 per increase in multiple risk factor control, $2588.1 per one percentage point reduction in the HbA1c, and $1744.6 per 5 unit reduction in SBP (mmHg), and $1271 per 10 unit reduction in LDLc (mg/dl). The ICER per QALY gained was $33,399.6 from a societal perspective. In a trial setting in South Asia, a multicomponent strategy for diabetes care resulted in better multiple risk factor control at higher costs and may be cost-effective depending on the willingness to pay threshold with substantial uncertainty around cost-effectiveness for QALYs gained in the short term (2.5 years). Future research needs to confirm the long-term cost-effectiveness of intensive multifactorial intervention for diabetes care in diverse healthcare settings in LMICs.

Background: Lisbon has about 500,000 inhabitants and it’s the capital and the main economic hub of Portugal. Studies have demonstrated that exposure to Particulate Matter with an aerodynamic diameter<2.5 μm (PM2.5) have strong association with health effects. Researchers continue to identify new harmful air pollutants effects in our health even in low levels. Objectives: This study evaluates air pollution scenarios considering a Health Impact Assessment approach in Lisbon, Portugal. Methods: We have studied abatement scenarios of PM2.5 concentrations and the health effects in the period from 2015 to 2017 using the APHEKOM tool and the associated health costs were assessed by Value of Life Year. Results: The mean concentration of PM2.5 in Lisbon was 23 μg/m3 ± 10 μg/m3 (±Standard Deviation). If we consider that World Health Organization (WHO) standards of PM2.5 (10 μg/m3) were reached, Lisbon would avoid more than 423 premature deaths (equivalent to 9,172 life years’ gain) and save more than US$45 million annually. If Lisbon city could even diminish the mean of PM2.5 by 5 μg/m3, nearly 165 deaths would be avoided, resulting in a gain of US$17 million annually. Conclusion: According to our findings, if considered the worst pollution scenario, levels of PM2.5 could improve the life’s quality and save a significant amount of economic resources. Implications: The manuscript addresses the health effects and costs of air pollution and constitutes an important target for improving public policies on air pollutants in Portugal. Although Portugal has low levels of air pollution, there are significant health and economic effects that, for the most part, are underreported. The health impact assessment approach associated with costs had not yet been addressed in Portugal, which makes this study more relevant in the analysis of policies aimed to drive stricter control on pollutants’ emissions. Health costs are a fundamental element to support decision-making process and to orientate the trade-offs in investments for improving public policies so that to diminish health effects, which can impact the management of the local health services and the population’s quality of life, especially after the pandemic period when resources are scarce.

Although control of multiple risk factors is essential to prevent FD with and without DM, longitudinal studies are scarce that directly and quantitatively compare effects of such control. Thus, we assessed whether reaching multifactorial targets for HbA1c, blood pressure, non-HDLC, and lifestyle risks such as smoking and no physical activity are associated with FD in those with and without DM. Enrolled were 9652 Japanese aged 39-98 y. FD was defined based on the Japanese long-term care insurance system, and targets were based on ADA and Japanese guidelines. Of 8,861 non-DM persons, 6.3, 25.2 and 49.1% were on target for 0-2, 3 and 4 factors, respectively. Of 791 persons with DM, 12.4, 68.0 and 19.3% were on target for 0-2, 3-4 and 5 factors, respectively. Multivariate Cox analysis showed increased FD with decreased targets reached regardless of DM (Table, upper). Compared with people with non-DM who achieved 4 targets, non-DM persons who achieved 0 to 2 targets and DM persons who achieved 3 to 4 targets had nearly twice the incidence of FD (Table, lower). Moreover, people with DM who achieved only 0 to 2 targets had an approximately 4 times higher incidence of FD (Table, lower). Control of modifiable risk factors was effective regardless of DM. Achievement of all 5 targets among people with DM may reduce FD to the same level as in non-DM persons who achieved all 4 targets. Disclosure H. Shiozaki: None. K. Fujihara: None. K. Tsuruoka: None. I. Ikeda: None. M. Kitazawa: None. Y. Matsubayashi: None. M. Yamamoto: None. T. Yamada: None. S. Kodama: None. H. Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Eisai Inc., Sumitomo Dainippon Pharma Co., Ltd. Funding the Japan Society for the Promotion of Science (21K11569); Daiwa Securities Health Foundation

Although control of multiple risk factors is essential to prevent CAD in persons with and without DM, longitudinal studies are scarce that directly and quantitatively compared effects of such control in DM and non-DM. Thus, we investigated effects on subsequent CAD of the number of controlled risk factors among blood pressure, LDL cholesterol and HbA1c using a nationwide claim-based database (median follow-up 4.8 y) in Japan. Targets were based on ADA and Japanese guidelines. Of 207,029 non-DM persons, 42.8% and 37.9% were at target for 1 and 2 factors, respectively. Of 13,471 persons with DM, 39.5%, 32.1%, and 10.0% were at target for 1, 2, and 3 factors, respectively. Multivariate Cox analysis showed reduced CAD risk with increased numbers of risk factor targets reached in DM compared to non-DM (Table, upper). However, in DM, although fulfillment of the target for only 1 risk factor significantly elevated the hazard ratio (HR) (i.e., 1.98 (1.28-3.07)) to non-significance (i.e., 1.03 (0.68-1.66)), no further significant HR reduction below reference (i.e., non-DM with no target achieved) was found (Table, lower). These findings show that composite control of modifiable risk factors has a larger effect in DM compared to non-DM, but the effect was not sufficient to bring CAD risk in DM below that for non-DM persons with none of 3 risk factors being at target based on current target levels. Disclosure K. Fujihara: None. Y. Matsubayashi: None. M. Kitazawa: None. M. Yamamoto: None. T. Osawa: None. M. Kaneko: None. N. Yamanaka: None. H. Seida: None. K. Kato: None. S. Kodama: None. H. Sone: Research Support; Self; Novo Nordisk Inc., Eli Lilly and Company, MSD K.K., Chugai Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Daiichi Sankyo Company, Limited, Ono Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Sanofi, Kowa Pharmaceuticals America, Inc., Eisai Inc..

Longitudinal ethnic differences in multiple cardiovascular risk factor control in a cohort of US adults with diabetes

AB1204 COST-EFFECTIVENESS OF ABATACEPT IN SPAIN IN SEROPOSITIVE BIOLOGIC-NAÏVE EARLY RHEUMATOID ARTHRITIS PATIENTS WITH SHARED EPITOPE

ObjectivesThis study aimed to evaluate the effectiveness of multiple risk factor control (MRFC) at reducing mortality and cardiovascular events in diabetes and chronic kidney disease (CKD) in clinical practice.DesignPopulation-based cohort...

AimsA Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban, dabigatran and apixaban. Each of these non-vitamin K antagonist oral anticoagulants was compared with vitamin K antagonist for stroke prevention in patients with non-valvular atrial fibrillation in Spain.MethodsAll inputs were derived from real-world studies: baseline patient characteristics, clinical event rates, as well as persistence rates for the vitamin K antagonist treatment option. A meta-analysis of real-world studies provided treatment effect and persistence data for rivaroxaban, dabigatran and apixaban, each compared with vitamin K antagonist therapy. The model considered 3-month cycles over a lifetime horizon. The model outcomes included different costs, quality-adjusted life years and life-years gained. Sensitivity analyses were performed to test the robustness of the model.ResultsWhen compared with vitamin K antagonist, rivaroxaban incurred incremental costs of €77 and resulted in incremental quality-adjusted life years of 0.08. The incremental cost per quality-adjusted life year was €952. For the same comparison, the incremental cost per quality-adjusted life year for dabigatran was €4,612. Finally, compared with vitamin K antagonist, the incremental cost per quality-adjusted life year for apixaban was €32,015. The sensitivity analyses confirmed the robustness of the base case results. The probabilities to be cost-effective versus vitamin K antagonist were 94%, 86% and 35%, respectively, for rivaroxaban, dabigatran and apixaban, considering a willingness-to-pay threshold of €22,000 per quality-adjusted life year gained, based on a cost-effectiveness study of the Spanish National Health System.ConclusionThese results suggest that rivaroxaban and dabigatran are cost-effective versus vitamin K antagonist for stroke prevention in non-valvular atrial fibrillation, from the Spanish National Health System perspective.

Making her MTM vision reality

Undetected Hypertension and Prehypertension in Children with Diabetes Need Attention

Background The burden of CV disease is a health and economic challenge to societies that is expected to grow in future years due to an increased prevalence in CV risk factors. Adequate management and appropriate therapy positively modify risk factors and, consequently, improve outcomes and cost-effectiveness of care. The CNIC-polypill has demonstrated in real-life, clinical effectiveness studies, its superiority over monocomponents in improving the lipidic parameters and in reduction of blood pressure in secondary CV prevention patients. Purpose To assess the cost-effectiveness of the CNIC-polypill (acetylsalicylic acid 100mg, atorvastatin 20/40mg, ramipril 2.5/5/10mg) compared to usual care with individual monocomponents for the secondary prevention of CV events in patients with a history of coronary heart disease (CHD) based on control of CV risk factors. Methods A Markov cost-effectiveness model (1-year cycles; 4 health states: stable disease, subsequent CHD, subsequent stroke, death; payer perspective; direct medical costs; lifetime horizon; 4% discount rate) based on changes in TC (10,1% reduction), HDL-c (7.4% increment) and SBP (2.6% reduction) obtained from the NEPTUNO* – a real-life, clinical effectiveness study conducted in Spain – was set for Portugal (base case). The probability of transition between health states was based on the SMART risk equation (S0, t=10= 0.8107). Cost-effectiveness was calculated for a hypothetical population (n=1,000) that replicated the characteristics of the population in the proACS registry, comprised of Portuguese patients with previous CHD. Systematic reviews identified epidemiological, costs, utility and mortality data. Outcomes were costs (€, 2020), life years (LY) and quality adjusted LY (QALY) gained. Results In patients with a history of CHD, the incremental cost of the CNIC-polypill strategy reaches €365,527, while preventing 35 recurrent CHD events and 17 subsequent strokes. In women and men with previous CHD, the incremental cost reaches €392,529 and €354,444 respectively while preventing recurrent 47 and 30 CHD events and 19 and 16 subsequent strokes respectively. The ICER is €5,130/LY gained for the overall population, €5,768/LY gained for women and €4,884/LY gained for men. The ICUR is €5,332/QALY gained in total, €5,817/QALY gained for women and €5,137/QALY gained for men. Assuming a willingness-to-pay (WTP) threshold of €30,000/QALY gained, there is 76.1% chances in total, 75.8% in women and 76.9% in men for the CNIC-polypill to be cost-effective and 27.8% chances overall, 27.7% in women and 25.5% in men of it being cost saving compared to usual care. Conclusion The CNIC-polypill seems to be a cost-effective strategy in men and women compared to usual care with monocomponents for the secondary prevention of CV disease based on improved control of risk factors. A larger reduction in the number of recurrent events is seen in women compared to men at a slightly higher cost. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Ferrer International S.A. Base case resultsProbabilistic sensitivity analysis

Community-Based Strategies for Blood Pressure Control in Low-Income Countries