Cost-effectiveness of Icosapent Ethyl for High-risk Patients With Hypertriglyceridemia Despite Statin Treatment.

Importance: The Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins. Objective: To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment. Design, Setting, and Participants: An in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021. Interventions: Patients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was $4.16 per day after rebates using SSR Health net cost (SSR cost) and $9.28 per day with wholesale acquisition cost (WAC). Main Outcomes and Measures: Main outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness. Results: A total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost ($18 786) or WAC ($24 544) than with standard care ($17 273; mean difference from SSR cost, $1513 [95% CI, $155-$2870]; mean difference from WAC, $7271 [95% CI, $5911-$8630]). Icosapent ethyl cost $22 311 per QALY gained using SSR cost and $107 218 per QALY gained using WAC. Over a lifetime, IPE was projected to be cost saving when using SSR cost ($195 276) compared with standard care ($197 064; mean difference, -$1788 [95% CI, -$9735 to $6159]) but to have higher costs when using WAC ($202 830) compared with standard care (mean difference, $5766 [95% CI, $1094-$10 438]). Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC. Conclusions and Relevance: This study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.

Association Between Poverty and Appropriate Statin Prescription for the Treatment of Hyperlipidemia in the United States: An Analysis From the ACC NCDR PINNACLE Registry.

BACKGROUND: Poverty is associated with a higher risk of myocardial infarction and cardiac death, both of which are decreased by treatment of hyperlipidemia. There may be differences in the appropriate treatment of hyperlipidemia between richer and poorer Americans. In this study, we aimed to evaluate the association between income level and appropriate lipid-lowering therapy. METHODS: We identified outpatient visits in the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence (PINNACLE) Registry and determined appropriateness of lipid-lowering therapy among patients in different income quintiles (Quintile 5 being the highest income quintile). Logistic regression at the patient level was performed to evaluate the independent association of income and the primary outcome of appropriate statin therapy. The analysis was repeated before and after November 2013 given a change in guideline definitions. RESULTS: The study included 1,655,723 patients. Overall, 68-73% of patients were treated appropriately under the ATP III Guidelines and 57-62% of patients were treated appropriately under the ACC/AHA Guidelines. Patients in the wealthiest quintile had higher odds of appropriate statin therapy under both guidelines relative to patients in the poorest quintile (OR 1.06 [1.05-1.07] for ATP III and OR 1.03 [1.01-1.04] for ACC/AHA). In the whole sample, patients with higher estimated income had a small but significant increased likelihood of appropriate statin therapy (point-biserial correlation 0.035 [p < 0.001] for ATP III and 0.026 [p < 0.001] for ACC/AHA). CONCLUSIONS: Here we describe a small association between appropriate statin use and income. Further investigation into barriers in the use of evidence-based therapies in poorer populations is needed.

Multiple chronic conditions at a major urban health system: a retrospective cross-sectional analysis of frequencies, costs and comorbidity patterns.

OBJECTIVE: To (1) examine the burden of multiple chronic conditions (MCC) in an urban health system, and (2) propose a methodology to identify subpopulations of interest based on diagnosis groups and costs. DESIGN: Retrospective cross-sectional study. SETTING: Mount Sinai Health System, set in all five boroughs of New York City, USA. PARTICIPANTS: 192 085 adult (18+) plan members of capitated Medicaid contracts between the Healthfirst managed care organisation and the Mount Sinai Health System in the years 2012 to 2014. METHODS: We classified adults as having 0, 1, 2, 3, 4 or 5+ chronic conditions from a list of 69 chronic conditions. After summarising the demographics, geography and prevalence of MCC within this population, we then described groups of patients (segments) using a novel methodology: we combinatorially defined 18 768 potential segments of patients by a pair of chronic conditions, a sex and an age group, and then ranked segments by (1) frequency, (2) cost and (3) ratios of observed to expected frequencies of co-occurring chronic conditions. We then compiled pairs of conditions that occur more frequently together than otherwise expected. RESULTS: 61.5% of the study population suffers from two or more chronic conditions. The most frequent dyad was hypertension and hyperlipidaemia (19%) and the most frequent triad was diabetes, hypertension and hyperlipidaemia (10%). Women aged 50 to 65 with hypertension and hyperlipidaemia were the leading cost segment in the study population. Costs and prevalence of MCC increase with number of conditions and age. The disease dyads associated with the largest observed/expected ratios were pulmonary disease and myocardial infarction. Inter-borough range MCC prevalence was 16%. CONCLUSIONS: In this low-income, urban population, MCC is more prevalent (61%) than nationally (42%), motivating further research and intervention in this population. By identifying potential target populations in an interpretable manner, this segmenting methodology has utility for health services analysts.

Cost effectiveness of lifelong therapy with PCSK9 inhibitors for lowering cardiovascular events in patients with stable coronary artery disease: Insights from the Ludwigshafen Risk and Cardiovascular Health cohort.

Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) reduce cardiovascular events in coronary artery disease (CAD). Their costs exceed that of established oral lipid-lowering agents. Previous cost-effectiveness assessments have been inconsistent. Markov cohort state transitions models for stable CAD patients were calculated using information from 1530 participants of the Ludwigshafen Risk and Cardiovascular Health Study (LURIC) with known causes of deaths. Non-fatal to fatal event rates, drug prices, direct treatment costs, and utility weights were from public sources. At an assumed relative risk reduction of 32.5% and an annual drug price of 8500 Euros, QALYs gained were 1.23 and 1.20, savings were 2390 and 2410 Euros, and ICERs were 112,530 and 108,660 Euros in women and men, respectively. When the annual cost of this medication was set at 1600 Euros, corresponding ICERs were 21,180 and 20,450 Euros. PCSK9i treatment is cost-effective in stable CAD at a threshold of 150,000 Euro and annual costs of 8500 Euros. As the broad use of PCSK9i therapy in CAD would have a disruptive impact on the healthcare budget, treatment should be focused on very high risk patients (≥3 comorbidities, annual risk of 10%); alternatively, and for lower risk, significant cost reductions would be needed.

Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study.

BACKGROUND: Statins are effective in helping prevent cardiovascular disease (CVD). However, studies suggest that only 20%-64% of patients taking statins achieve reasonable low-density lipoprotein cholesterol (LDL-C) thresholds. On-treatment levels of LDL-C remain a key predictor of residual CVD event risk. OBJECTIVES: To (a) determine how many patients on statins achieved the therapeutic threshold of LDL-C < 100 mg per dL (general cohort) and < 70 mg per dL (secondary prevention cohort, or subcohort, with preexisting CVD); (b) estimate the number of potentially avoidable CVD events if the threshold were reached; and (c) forecast potential cost savings. METHODS: A retrospective, longitudinal cohort study using electronic health record data from the Indiana Network for Patient Care (INPC) was conducted. The INPC provides comprehensive information about patients in Indiana across health care organizations and care settings. Patients were aged > 45 years and seen between January 1, 2012, and October 31, 2016 (ensuring study of contemporary practice), were statin-naive for 12 months before the index date of initiating statin therapy, and had an LDL-C value recorded 6-18 months after the index date. Subsequent to descriptive cohort analysis, the theoretical CVD risk reduction achievable by reaching the threshold was calculated using Framingham Risk Score and Cholesterol Treatment Trialists' Collaboration formulas. Estimated potential cost savings used published first-year costs of CVD events, adjusted for inflation and discounted to the present day. RESULTS: Of the 89,267 patients initiating statins, 30,083 (33.7%) did not achieve the LDL-C threshold (subcohort: 58.1%). In both groups, not achieving the threshold was associated with patients who were female, black, and those who had reduced medication adherence. Higher levels of preventive aspirin use and antihypertensive treatment were associated with threshold achievement. In both cohorts, approximately 64% of patients above the threshold were within 30 mg per dL of the respective threshold. Adherence to statin therapy regimen, judged by a medication possession ratio of ≥ 80%, was 57.4% in the general cohort and 56.7% in the subcohort. Of the patients who adhered to therapy, 23.7% of the general cohort and 50.5% of the subcohort had LDL-C levels that did not meet the threshold. 10-year CVD event risk in the at-or-above threshold group was 22.78% (SD = 17.24%) in the general cohort and 29.56% (SD = 18.19%) in the subcohort. By reducing LDL-C to the threshold, a potential relative risk reduction of 14.8% in the general cohort could avoid 1,173 CVD events over 10 years (subcohort: 15.7% and 454 events). Given first-year inpatient and follow-up costs of $37,300 per CVD event, this risk reduction could save about $1,455 per patient treated to reach the threshold (subcohort: $1,902; 2017 U.S. dollars) over a 10-year period. CONCLUSIONS: Across multiple health care systems in Indiana, between 34% (general cohort) and 58% (secondary prevention cohort) of patients treated with statins did not achieve therapeutic LDL-C thresholds. Based on current CVD event risk and cost projections, such patients seem to be at increased risk and may represent an important and potentially preventable burden on health care costs. DISCLOSURES: Funding support for this study was provided by Merck (Kenilworth, NJ). Chase and Boggs are employed by Merck. Simpson is a consultant to Merck and Pfizer. The other authors have nothing to disclose.

Strong Association Between Migraine and Transient Global Amnesia: A National Inpatient Sample Analysis.

The purpose of this article was to explore sex- and race-specific variables and comorbidities associated with transient global amnesia (TGA) using a nationally representative database. Data were obtained from the Nationwide Inpatient Sample using ICD-9 and procedure codes. Descriptive and survey logistic regression analyses were conducted and adjusted for influence of comorbidities, demographic characteristics, and hospitalization-related factors. Patients with migraines were 5.98 times more likely to also have a diagnosis of TGA compared with patients without migraines. Similarly, patients with TGA were more likely to have hypertension, precerebral disease, and hyperlipidemia. The odds of being diagnosed with TGA was lower among African Americans and Hispanics as well as among patients classified as Asian/Other, compared with Caucasians. TGA was associated with lower hospital charges ($14,242 versus $21,319), shorter hospital stays (mean days: 2.49 [SE=0.036] versus 4.72 [SE=0.025]), and routine hospital discharges (91.4% versus 74.5%). Patients with migraines and patients classified as Caucasian had higher odds of being diagnosed with TGA. All minority populations showed a lower rate of diagnosis that fell short of statistical significance.

The cost-effectiveness of PCSK9 inhibitors - The Australian healthcare perspective.

BACKGROUND: For patients in whom statins are not tolerated or effective as monotherapy, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a new class of lipid lowering therapies that may reduce low-density lipoprotein cholesterol (LDL-C) levels by up to 50% and lower cardiovascular events. While an important treatment option, the cost-effectiveness of PCSK9i in Australia remains unknown. This study aimed to determine the cost-effectiveness of PCSK9i compared to placebo in the prevention of atherosclerotic cardiovascular disease (CVD). METHODS AND RESULTS: A Markov cohort state-transition model was developed in Microsoft Excel. A hypothetical sample of 1000 individuals based on subjects in the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial populated the model. With each five-year cycle, model subjects could have non-fatal CVD events (myocardial infarction and/or stroke), or die from CVD or other causes. Follow-up was simulated for 25 years. CVD risk reduction, cost and utility data were gathered from published sources. At current acquisition prices (AU$8174 per person per year), the incremental cost effectiveness ratio (ICER) was AU$308,558 per quality-adjusted life year (QALY) saved. Acquisition prices would need to be reduced to approximately AU$1500 per person per annum for PCSK9i to reach the arbitrary cost-effectiveness threshold of AU$50,000 per QALY saved. CONCLUSION(S): PCSK9i are an effective alternative for those with existing CVD or at high risk of CVD in whom statin therapy alone is ineffective, but are not cost-effective to the Australian healthcare system based on current prices.

A Cost Analysis of Universal versus Targeted Cholesterol Screening in Pediatrics.

OBJECTIVE: To compare the number of children needed to screen to identify a case of childhood dyslipidemia and estimate costs under universal vs targeted screening approaches. STUDY DESIGN: We constructed a decision-analytic model comparing the health system costs of universal vs targeted screening for hyperlipidemia in US children aged 10 years over a 1-year time horizon. Targeted screening was defined by family history: dyslipidemia in a parent and/or early cardiovascular disease in a first-degree relative. Prevalence of any hyperlipidemia (low-density lipoprotein [LDL] ≥130 mg/dL) and severe hyperlipidemia (LDL ≥190 mg/dL or LDL ≥160 mg/dL with family history) were obtained from published estimates. Costs were estimated from the 2016 Maryland Medicaid fee schedule. We performed sensitivity analyses to evaluate the influence of key variables on the incremental cost per case detected. RESULTS: For universal screening, the number needed to screen to identify 1 case was 12 for any hyperlipidemia and 111 for severe hyperlipidemia. For targeted screening, the number needed to screen was 7 for any hyperlipidemia and 49 for severe hyperlipidemia. The incremental cost per case detected for universal compared with targeted screening was $1980 for any hyperlipidemia and $32 170 for severe hyperlipidemia. CONCLUSIONS: Our model suggests that universal cholesterol screening detects hyperlipidemia at a low cost per case, but may not be the most cost-efficient way to identify children with severe hyperlipidemia who are most likely to benefit from treatment.

Cost-effectiveness of Financial Incentives for Patients and Physicians to Manage Low-Density Lipoprotein Cholesterol Levels.

Importance: Financial incentives shared between physicians and patients were shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels in a randomized clinical trial, but it is not known whether these health benefits are worth the added incentive and utilization costs required to achieve them. Objective: To evaluate the long-term cost-effectiveness of financial incentives on LDL-C level control. Design, Setting, and Participants: In this economic evaluation, a previously validated microsimulation computer model was parameterized using individual-level data from the randomized clinical trial on financial incentives, National Health and Nutrition Examination Surveys for model population inputs, and other published sources. The study was conducted from April 15, 2016, to March 29, 2018. Interventions: The following interventions were used: (1) usual care, (2) trial control strategy (increased cholesterol level monitoring and use of electronic pill bottles), (3) financial incentives for physicians, (4) financial incentives for patients, and (5) incentives shared between physicians and patients. Main Outcomes and Measures: Discounted costs (2017 US dollars), lifetime cardiovascular disease risk, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Results: The model population (n = 1 000 000 [30.7% women]) had similar mean (SD) age (61.5 [11.9] years) and LDL-C level (153.9 mg/dL) as the observed trial population (n = 1503 [42.7% women]; age, 62.0 [8.7] years; and LDL-C level, 160.6 mg/dL). Using base-case assumptions (including a 10-year waning period of LDL-C level reductions), the usual-care strategy was dominated (higher costs and lower QALYs) by all other strategies. Strategies for physician- or patient-only incentives were dominated by the shared-incentives strategy, which had an ICER of $60 000/QALY compared with the trial control strategy. In a sensitivity analysis regarding the duration of LDL-C level reductions, the shared-incentives strategy remained cost-effective (ICERs <$100 000/QALY and <$150 000/QALY) for scenarios with LDL-C level reductions lasting, with linear waning, at least 7 and 5 years, respectively. In the 1-way sensitivity analysis for the time horizon of the analysis, the ICER of the shared-incentives strategy exceeded $100 000/QALY at 11 years and $150 000/QALY at 8 years. In probabilistic sensitivity analysis, the shared-incentives intervention was cost-effective in 69% to 77% of iterations using cost-effectiveness thresholds of $100 000 to $150 000/QALY. Cost-effectiveness results were also sensitive to the duration of intervention costs. Conclusions and Relevance: This study suggests that the financial incentives shared between patients and physicians for LDL-C level control meet conventional standards of cost-effectiveness, but these results appeared to be sensitive to assumptions about the durations of LDL-C level reductions and years of intervention costs included, as well as to the choice of time horizon.

Comorbidity Status and Annual Total Medical Expenditures in U.S. Hypertensive Adults.

INTRODUCTION: The purpose of this study is to investigate comorbidity status and its impact on total medical expenditures in non-institutionalized hypertensive adults in the U.S. METHODS: Data from the 2011-2014 Medical Expenditure Panel Survey were used. Patients were included if they had a diagnosis code for hypertension, were aged ≥18 years, and were not pregnant during the study period (N=26,049). The Elixhauser Comorbidity Index was modified to add hypertension-related comorbidities. The outcome variable was annual total medical expenditures, and a generalized linear model regression (gamma distribution with a log link function) was used. All costs were adjusted to 2014 U.S. dollars. RESULTS: Based on the modified Elixhauser Comorbidity Index, 14.0% of patients did not have any comorbidities, 23.0% had one, 24.4% had two, and 38.7% had three or more. The five most frequent comorbidities were hyperlipidemia, diabetes, rheumatoid arthritis, depression, and chronic pulmonary disease. Estimated mean annual total medical expenditures were $3,914 (95% CI=$3,456, $4,372) for those without any comorbidity; $5,798 (95% CI=$5,384, $6,213) for those with one comorbidity; $8,333 (95% CI=$7,821, $8,844) for those with two comorbidities; and $13,920 (95% CI=$13,166, $14,674) for those with three or more comorbidities. Of the 15 most frequent comorbidities, the condition with the largest impact on expenditures for an individual person was congestive heart failure ($7,380). Hypertensive adults with stroke, coronary heart disease, diabetes, renal diseases, and hyperlipidemia had expenditures that were $6,069, $6,046, $5,039, $4,974, and $4,851 higher, respectively, than those without these conditions. CONCLUSIONS: Comorbidities are highly prevalent among hypertensive adults, and this study shows that each comorbidity significantly increases annual total medical expenditures.

Methods for estimating costs in patients with hyperlipidemia experiencing their first cardiovascular event in the United Kingdom.

AIMS: Methods for integrating external costs into clinical databases are not well-characterized. The purpose of this research was to describe and implement methods for estimating the cost of hospitalizations, prescriptions, and general practitioner and specialist visits used to manage hyperlipidemia patients experiencing cardiovascular (CV) events in the United Kingdom (UK). METHODS: This study was a retrospective cohort study using the Clinical Practice Research Datalink and Hospital Episode Statistics data. Costs were incorporated based on reference costs from the National Health Service, and labor costs from the Personal Social Services Research Unit. The study population included patients seen by general practitioners in the UK from 2006-2012. Patients ≥18 years were selected at the time of their first CV-related hospitalization defined as myocardial infarction, ischemic stroke, heart failure, transient ischemic attack, unstable angina, or revascularization. To be included, patients must have received ≥2 lipid-lowering therapies. Outcome measures included healthcare utilization and direct medical costs for hospitalizations, medications, general practitioner visits, and specialist visits during the 6-month acute period, starting with the CV hospitalization, and during the subsequent 30-month long-term period. RESULTS: There were 24,093 patients with a CV hospitalization included in the cohort. This study identified and costed 69,240 hospitalizations, 673,069 GP visits, 32,942 specialist visits, and 2,572,792 prescriptions, representing 855 unique drug and dose combinations. The mean acute period and mean annualized long-term period costs (2014£) were £4,060 and £1,433 for hospitalizations, £377 and £518 for GP visits, £59 and £103 for specialist visits, and £98 and £209 for medications. CONCLUSIONS: Hospital costs represent the largest portion of acute and long-term costs in this population. Detailed costing using utilization data is feasible and representative of UK clinical practice, but is labor intensive. The availability of a standardized coding system in the UK drug costing data would greatly facilitate drug costing.

Impact of a value-based formulary in three chronic disease cohorts.

OBJECTIVES: Value-based insurance design has been suggested as an effective approach to ensure access to highvalue medications in health insurance markets. Premera Blue Cross, a large regional health plan, implemented a value-based formulary (VBF) for pharmaceuticals in 2010 that explicitly used cost-effectiveness analysis to inform medication co-payments. This study assesses the impact of a VBF on adherence and patient and health plan expenditures on 3 chronic disease states: diabetes, hypertension, and hyperlipidemia. STUDY DESIGN: Interrupted time series design of employer-sponsored plans from 2006 to 2013. Beneficiaries exposed to the VBF formed the intervention group, and beneficiaries in similar plans without any changes in pharmacy benefits formed the control group. METHODS: We measured medication expenditures from member, health plan, and member-plus-health plan (overall) perspectives and medication adherence as proportion of days covered. We conducted an exploratory analysis of medication utilization classifying medications according to whether co-payments moved up or down in the year following VBF implementation. RESULTS: For the diabetes cohort, there was a statistically significant reduction in member and overall expenditures of $5 per member per month (PMPM) and $9 PMPM, respectively. For the hypertension cohort, there was a statistically significant reduction in member expenditures of $4 PMPM and an increase in health plan expenditures of $3 PMPM. There were no statistically significant effects on hyperlipidemia cohort expenditures or on medication adherence in any of the 3 disease cohorts. Exploratory analyses suggest that patients in the diabetes and hyperlipidemia cohorts were switching to higher-value medications. CONCLUSIONS: A VBF can ensure access to high-value medications while maintaining affordability.

Hyperlipidemia and Medical Expenditures by Cardiovascular Disease Status in US Adults.

BACKGROUND: Hyperlipidemia is a major risk factor for cardiovascular disease (CVD), affecting 73.5 million American adults. Information about health care expenditures associated with hyperlipidemia by CVD status is needed to evaluate the economic benefit of primary and secondary prevention programs for CVD. METHODS: The study sample includes 48,050 men and nonpregnant women ≥18 from 2010 to 2012 Medical Expenditure Panel Survey. A 2-part econometric model was used to estimate annual hyperlipidemia-associated medical expenditures by CVD status. The estimation results from the 2-part model were used to calculate per-capita and national medical expenditures associated with hyperlipidemia. We adjusted the medical expenditures into 2012 dollars. RESULTS: Among those with CVD, per person hyperlipidemia-associated expenditures were $1105 [95% confidence interval (CI), $877-$1661] per year, leading to an annual national expenditure of $15.47 billion (95% CI, $5.23-$27.75 billion). Among people without CVD, per person hyperlipidemia-associated expenditures were $856 (95% CI, $596-$1211) per year, resulting in an annual national expenditure of $23.11 billion (95% CI, $16.09-$32.71 billion). Hyperlipidemia-associated expenditures were attributable mostly to the costs of prescription medication (59%-90%). Among people without CVD, medication expenditures associated with hyperlipidemia were $13.72 billion (95% CI, $10.55-$15.74 billion), higher in men than in women. CONCLUSIONS: Hyperlipidemia significantly increased medical expenditures and the increase was higher in people with CVD than without. The information on estimated expenditures could be used to evaluate and develop effective programs for CVD prevention.

A Systematic Review of Cardiovascular Outcomes-Based Cost-Effectiveness Analyses of Lipid-Lowering Therapies.

BACKGROUND: Previous reviews have evaluated economic analyses of lipid-lowering therapies using lipid levels as surrogate markers for cardiovascular disease. However, drug approval and health technology assessment agencies have stressed that surrogates should only be used in the absence of clinical endpoints. OBJECTIVE: The aim of this systematic review was to identify and summarise the methodologies, weaknesses and strengths of economic models based on atherosclerotic cardiovascular disease event rates. METHODS: Cost-effectiveness evaluations of lipid-lowering therapies using cardiovascular event rates in adults with hyperlipidaemia were sought in Medline, Embase, Medline In-Process, PubMed and NHS EED and conference proceedings. Search results were independently screened, extracted and quality checked by two reviewers. RESULTS: Searches until February 2016 retrieved 3443 records, from which 26 studies (29 publications) were selected. Twenty-two studies evaluated secondary prevention (four also assessed primary prevention), two considered only primary prevention and two included mixed primary and secondary prevention populations. Most studies (18) based treatment-effect estimates on single trials, although more recent evaluations deployed meta-analyses (5/10 over the last 10 years). Markov models (14 studies) were most commonly used and only one study employed discrete event simulation. Models varied particularly in terms of health states and treatment-effect duration. No studies used a systematic review to obtain utilities. Most studies took a healthcare perspective (21/26) and sourced resource use from key trials instead of local data. Overall, reporting quality was suboptimal. CONCLUSIONS: This review reveals methodological changes over time, but reporting weaknesses remain, particularly with respect to transparency of model reporting.

Costs for a health coaching intervention for chronic care management.

OBJECTIVES: Health coaches can help patients gain knowledge, skills, and confidence to manage their chronic conditions. Coaches may be particularly valuable in resource-poor settings, but they are not typically reimbursed by insurance, raising questions about their budgetary impact. STUDY DESIGN: The Health Coaching in Primary Care (HCPC) study was a randomized controlled trial that showed health coaches were effective at helping low-income patients improve control of their type 2 diabetes, hypertension, and/or hyperlipidemia at 12 months compared with usual care. METHODS: We estimated the cost of employing 3 health coaches and mapped these costs to participants. We tested whether the added costs of the coaches were offset by any savings in healthcare utilization within 1 year. Healthcare utilization data were obtained from 5 sources. Multivariate models assessed differences in costs at 1 year controlling for baseline characteristics. RESULTS: Coaches worked an average of 9 hours with each participant over the length of the study. On average, the health coach intervention cost $483 per participant per year. The average healthcare costs for the coaching group was $3207 compared with $3276 for the control group (P = .90). There was no evidence that the coaching intervention saved money at 1 year. CONCLUSIONS: Health coaches have been shown to improve clinical outcomes related to chronic disease management. We found that employing health coaches adds an additional cost of $483 per patient per year. The data do not suggest that health coaches pay for themselves by reducing healthcare utilization in the first year.

Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.

BACKGROUND: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China. METHODS: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China. RESULTS: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion. CONCLUSIONS: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.

Clinical and economic burden associated with cardiovascular events among patients with hyperlipidemia: a retrospective cohort study.

BACKGROUND: Annual direct costs for cardiovascular (CV) diseases in the United States are approximately $195.6 billion, with many high-risk patients remaining at risk for major cardiovascular events (CVE). This study evaluated the direct clinical and economic burden associated with new CVE up to 3 years post-event among patients with hyperlipidemia. METHODS: Hyperlipidemic patients with a primary inpatient claim for new CVE (myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, coronary artery bypass graft, percutaneous coronary intervention and heart failure) were identified using IMS LifeLink PharMetrics Plus data from January 1, 2006 through June 30, 2012. Patients were stratified by CV risk into history of CVE, modified coronary heart disease risk equivalent, moderate- and low-risk cohorts. Of the eligible patients, propensity score matched 243,640 patients with or without new CVE were included to compare healthcare resource utilization and direct costs ranging from the acute (1-month) phase through 3 years post-CVE date (follow-up period). RESULTS: Myocardial infarction was the most common CVE in all the risk cohorts. During the acute phase, among patients with new CVE, the average incremental inpatient length of stay and incremental costs ranged from 4.4-6.2 days and $25,666-$30,321, respectively. Acute-phase incremental costs accounted for 61-75% of first-year costs, but incremental costs also remained high during years 2 and 3 post-CVE. CONCLUSIONS: Among hyperlipidemic patients with new CVE, healthcare utilization and costs incurred were significantly higher than for those without CVE during the acute phase, and remained higher up to 3 years post-event, across all risk cohorts.

Healthcare costs associated with cardiovascular events in patients with hyperlipidemia or prior cardiovascular events: estimates from Swedish population-based register data.

OBJECTIVES: To estimate healthcare costs of new cardiovascular (CV) events (myocardial infarction, unstable angina, revascularization, ischemic stroke, transient ischemic attack, heart failure) in patients with hyperlipidemia or prior CV events. METHODS: A retrospective population-based cohort study was conducted using Swedish national registers and electronic medical records. Patients with hyperlipidemia or prior CV events were stratified into three cohorts based on CV risk level: history of major cardiovascular disease (CVD), coronary heart disease (CHD) risk-equivalent, and low/unknown risk. Propensity score matching was applied to compare patients with new events to patients without new events for estimation of incremental costs of any event and by event type. RESULTS: A CV event resulted in increased costs over 3 years of follow-up, with the majority of costs occurring in the 1st year following the event. The mean incremental cost of patients with a history of major CVD (n = 6881) was €8588 during the 1st year following the event. This was similar to that of CHD risk-equivalent patients (n = 3226; €6663) and patients at low/unknown risk (n = 2497; €8346). Ischemic stroke resulted in the highest 1st-year cost for patients with a history of major CVD and CHD risk-equivalent patients (€10,194 and €9823, respectively); transient ischemic attack in the lowest (€3917 and €4140). Incremental costs remained elevated in all cohorts during all three follow-up years, with costs being highest in the major CVD history cohort. CONCLUSIONS: Healthcare costs of CV events are substantial and vary considerably by event type. Incremental costs remain elevated for several years after an event.