Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study

OBJECTIVETo assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study.RESEARCH DESIGN AND METHODSData were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars.RESULTSOver the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT.CONCLUSIONSWhether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.     

Cost-Effectiveness of a Diabetes Self-Management Education and Support Intervention Led by Community Health Workers and Peer Leaders: Projections From the Racial and Ethnic Approaches to Community Health Detroit Trial

OBJECTIVETo simulate the long-term cost-effectiveness of a peer leader (PL)–led diabetes self-management support (DSMS) program following a structured community health worker (CHW)–led diabetes self-management education (DSME) program in reducing risks of complications in people with type 2 diabetes (T2D).RESEARCH DESIGN AND METHODSThe trial randomized 222 Latino adults with T2D to 1) enhanced usual care (EUC); 2) a CHW-led, 6-month DSME program and 6 months of CHW-delivered monthly telephone outreach (CHW only); or 3) a CHW-led, 6-month DSME program and 12 months of PL-delivered weekly group sessions with telephone outreach to those unable to attend (CHW + PL). Empirical data from the trial and the validated Michigan Model for Diabetes were used to estimate cost and health outcomes over a 20-year time horizon from a health care sector perspective, discounting both costs and benefits at 3% annually. The primary outcome measure was the incremental cost-effectiveness ratio (ICER).RESULTSOver 20 years, the CHW + PL intervention had an ICER of $28,800 and $5,900 per quality-adjusted life-year (QALY) gained compared with the EUC and CHW-only interventions, respectively. The CHW-only intervention had an ICER of $430,600 per QALY gained compared with the EUC intervention. In sensitivity analyses, the results comparing the CHW + PL with EUC and CHW-only interventions were robust to changes in intervention effects and costs.CONCLUSIONSThe CHW + PL–led DSME/DSMS intervention improved health and provided good value compared with the EUC intervention. The 6-month CHW-led DSME intervention without further postintervention CHW support was not cost effective in Latino adults with T2D.     

Assessing the Cost-effectiveness of a Hypothetical Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic Alzheimer Disease

PurposeClinical trials have produced promising results for disease-modifying therapies (DMTs) for Alzheimer’s disease (AD); however, the evidence on their potential cost-effectiveness is limited. This study assesses the cost-effectiveness of a hypothetical DMT with a limited treatment duration in AD.MethodsWe developed a Markov state–transition model to estimate the cost-effectiveness of a hypothetical DMT plus best supportive care (BSC) versus BSC alone among Americans living with mild cognitive impairment (MCI) due to AD or mild AD. AD states included MCI due to AD, mild AD, moderate AD, severe AD, and death. A hypothetical DMT was assumed to confer a 30% reduction in progression from MCI and mild AD. The base case annual drug acquisition cost was assumed to be $56,000. Other medical and indirect costs were obtained from published literature or list prices. Utilities for patients and caregivers were obtained from the published literature and varied by AD state and care setting (community care or long-term care). We considered 3 DMT treatment strategies: (1) treatment administered until patients reached severe AD (continuous strategy), (2) treatment administered for a maximum duration of 18 months or when patients reached severe AD (fixed-duration strategy), and (3) 40% of patients discontinuing treatment at 6 months because of amyloid plaque clearance and the remaining patients continuing treatment until 18 months or until they reached severe AD (test-and-discontinue strategy). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost per quality-adjusted life-year (QALY) gained.FindingsFrom the health care sector perspective, continuous treatment with a hypothetical DMT versus BSC resulted in an ICER of $612,354 per QALY gained. The ICER decreased to $157,288 per QALY gained in the fixed-duration strategy, driven by large reductions in treatment costs. With 40% of patients discontinuing treatment at 6 months (test-and-discontinue strategy), the ICER was $125,631 per QALY gained. In sensitivity and scenario analyses, the ICER was the most sensitive to changes in treatment efficacy, treatment cost, and the initial population AD state distribution. From the modified societal perspective, ICERs were 6.3%, 20.4%, and 25.1% lower than those from the health care sector perspective for the continuous, fixed-duration, and test-and-discontinue strategies, respectively.ImplicationsUnder a set of assumptions for annual treatment costs and the magnitude and duration of treatment efficacy, DMTs used for a limited duration may deliver value consistent with accepted US cost-effectiveness thresholds.     

CB7-05: Incremental Cost-effectiveness of Preventing Depression in At-risk Adolescents

Background/Aims Adolescent depression is common and leads to many negative personal, social, and economic consequences for youth and their families; unfortunately, most youth who experience major depression do not receive any treatment. Depression prevention programs can reduce these negative consequences, but they must be affordable to be widely disseminated and useful for health care systems. Decision-makers need to weigh relative costs and benefits of providing efficacious prevention programs to depressed adolescents, but little cost-effectiveness analysis exists. The Prevention of Depression trial (POD) was a brief prevention program that compared a group cognitive- behavioral preventive (CBP) intervention to usual care (UC) to reduce depression risk in at-risk youth; the intervention decreased the number of days with depression. We present an incremental cost- effectiveness analysis of the group CBP program relative to UC, from the societal perspective, for 9 months following the intervention. Methods POD was conducted in four U.S. academic and community clinics. Participants were 316 youth aged 13-17 with a past history of depression and/or current elevated, but sub-diagnostic, depressive symptoms. They were randomly assigned to the CBP group consisting of 8 weekly, 90- minute group sessions followed by 6 monthly continuation sessions or to UC alone. The main clinical outcome measures were depression-free days (DFD) and quality-adjusted life-years based on DFD (DFD-QALYs). Costs of intervention, non-protocol services, and families were included. Results CBP achieved 13 additional DFD (p=.008), 0.022 more DFD-QALYs (p=.008). CBP cost $591 (SD=286) on average. Cost per DFD was $59 (ICER = $59; 95% CI: 11-263), $35,434 per DFD-QALY (ICER=$35,434; 95% CI: 6,350 - 157,594). Cost-effectiveness acceptability curve analyses suggest a 69% probability that CBP is more cost-effective at a willingness to pay of $50,000 per QALY. CBP had a higher net benefit for youth whose parent's depression was in remission at baseline. Discussion The societal cost-effectiveness of POD is comparable to or better than that of many health care services currently covered under most insurance programs. The program is particularly cost effective for the sub-group of youth whose parent's depression was in remission at baseline.     

Economic evaluation of aquatic exercise for persons with osteoarthritis

OBJECTIVES: To estimate cost and outcomes of the Arthritis Foundation aquatic exercise classes from the societal perspective. DESIGN: Randomized trial of 20-week aquatic classes. Cost per quality-adjusted life year (QALY) gained was estimated using trial data. Sample size was based on 80% power to reject the null hypothesis that the cost/QALY gained would not exceed $50,000. SUBJECTS AND METHODS: Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis to participate in aquatic classes. The Quality of Well-Being Scale (QWB) and Current Health Desirability Rating (CHDR) were used for economic evaluation, supplemented by the arthritis-specific Health Assessment Questionnaire (HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), and Perceived Quality of Life Scale (PQOL) collected at baseline and postclass. Outcome results applied to life expectancy tables were used to estimate QALYs. Use of health care facilities was assessed from diaries/questionnaires and Medicare reimbursement rates used to estimate costs. Nonparametric bootstrap sampling of costs/QALY ratios established the 95% CI around the estimates. RESULTS: Aquatic exercisers reported equal (QWB) or better (CHDR, HAQ, PQOL) health-related quality of life compared with controls. Outcomes improved with regular class attendance. Costs/QALY gained discounted at 3% were $205,186 using the QWB and $32,643 using the CHRD. CONCLUSION: Aquatic exercise exceeded $50,000 per QALY gained using the community-weighted outcome but fell below this arbitrary budget constraint when using the participant-weighted measure. Confidence intervals around these ratios suggested wide variability of cost effectiveness of aquatic exercise.     

An evaluation of cost sharing to finance a diet and physical activity intervention to prevent diabetes

OBJECTIVE: The Diabetes Prevention Program (DPP) lifestyle intervention is a cost-effective strategy to prevent type 2 diabetes, but it is unclear how this intervention could be financed. We explored whether this intervention could be offered in a way that allows return on investment for private health insurers while remaining attractive for consumers, employers, and Medicare. RESEARCH DESIGN AND METHODS: We used the DPP and other published reports to build a Markov simulation model to estimate the lifetime progression of disease, costs, and quality of life for adults with impaired glucose tolerance. The model assumed a health-payer perspective and compared DPP lifestyle and placebo interventions. Primary outcomes included cumulative incidence of diabetes, direct medical costs, quality-adjusted life-years (QALYs), and cost per QALY gained. RESULTS: Compared with placebo, providing the lifestyle intervention at age 50 years could prevent 37% of new cases of diabetes before age 65, at a cost of $1,288 per QALY gained. A private payer could reimburse $655 (24%) of the $2,715 in total discounted intervention costs during the first 3 intervention years and still recover all of these costs in the form of medical costs avoided. If Medicare paid up to $2,136 in intervention costs over the 15-year period before participants reached age 65, it could recover those costs in the form of future medical costs avoided beginning at age 65. CONCLUSIONS: Cost-sharing strategies to offer the DPP lifestyle intervention for eligible people between ages 50 and 64 could provide financial return on investment for private payers and long-term benefits for Medicare.     

Cost-effectiveness of outpatient geriatric assessment with an intervention to increase adherence

BACKGROUND: Comprehensive geriatric assessment (CGA) can be effective in inpatient units, but such inpatient settings are prohibitively expensive. If similar benefits could be obtained in outpatient settings, CGA might be a more attractive option. OBJECTIVES: To assess the cost-effectiveness (CE) of an outpatient geriatric assessment with an intervention to increase adherence. SUBJECTS: Three hundred fifty-one community-dwelling, elderly subjects with at least one of four geriatric conditions. MEASURES: In addition to the measures of functioning, we collected data on the costs of the intervention itself and on the use of medical services in the 64 weeks after the intervention. RESULTS: The intervention, which prevented functional decline, cost $273 per participant. The intervention group averaged three more visits than the control group in the first 32 weeks after the intervention, but only 1.2 extra visits in the next 32 weeks. We estimate that the costs of these additional medical services would be $473 for the 5 years after the intervention, leading to a total cost per Quality Adjusted Life Year (QALY) of $10,600. CONCLUSIONS: The CE of this program compares favorably with many common medical interventions. Whether investments should be made in health care resources on treatments that lead to modest improvements in the functioning of community-dwelling elderly people remains a societal decision.     

Structured headache services as the solution to the ill-health burden of headache. 3. Modelling effectiveness and cost-effectiveness of implementation in Europe: findings and conclusions

BackgroundThere have been several calls for estimations of costs and consequences of headache interventions to inform European public-health policies. In a previous paper, in the absence of universally accepted methodology, we developed headache-type-specific analytical models to be applied to implementation of structured headache services in Europe as the health-care solution to headache. Here we apply this methodology and present the findings.MethodsData sources were published evidence and expert opinions, including those from an earlier economic evaluation framework using the WHO-CHOICE model. We used three headache-type-specific analytical models, for migraine, tension-type-headache (TTH) and medication-overuse-headache (MOH). We considered three European Region case studies, from Luxembourg, Russia and Spain to include a range of health-care systems, comparing current (suboptimal) care versus target care (structured services implemented, with provider-training and consumer-education). We made annual and 5-year cost estimates from health-care provider and societal perspectives (2020 figures, euros). We expressed effectiveness as healthy life years (HLYs) gained, and cost-effectiveness as incremental cost-effectiveness-ratios (ICERs; cost to be invested/HLY gained). We applied WHO thresholds for cost-effectiveness.ResultsThe models demonstrated increased effectiveness, and cost-effectiveness (migraine) or cost saving (TTH, MOH) from the provider perspective over one and 5 years and consistently across the health-care systems and settings. From the societal perspective, we found structured headache services would be economically successful, not only delivering increased effectiveness but also cost saving across headache types and over time. The predicted magnitude of cost saving correlated positively with country wage levels. Lost productivity had a major impact on these estimates, but sensitivity analyses showed the intervention remained cost-effective across all models when we assumed that remedying disability would recover only 20% of lost productivity.ConclusionsThis is the first study to propose a health-care solution for headache, in the form of structured headache services, and evaluate it economically in multiple settings. Despite numerous challenges, we demonstrated that economic evaluation of headache services, in terms of outcomes and costs, is feasible as well as necessary. Furthermore, it is strongly supportive of the proposed intervention, while its framework is general enough to be easily adapted and implemented across Europe.Supplementary InformationThe online version contains supplementary material available at 10.1186/s10194-021-01305-8.     

What does the value of modern medicine say about the $50,000 per quality-adjusted life-year decision rule?

BACKGROUND: In the United States, $50,000 per Quality-Adjusted Life-Year (QALY) is a decision rule that is often used to guide interpretation of cost-effectiveness analyses. However, many investigators have questioned the scientific basis of this rule, and it has not been updated. METHODS: We used 2 separate approaches to investigate whether the $50,000 per QALY rule is consistent with current resource allocation decisions. To infer a lower bound for the decision rule, we estimated the incremental cost-effectiveness of recent (2003) versus pre-"modern era" (1950) medical care in the United States. To infer an upper bound for the decision rule, we estimated the incremental cost-effectiveness of unsubsidized health insurance versus self-pay for nonelderly adults (ages 21-64) without health insurance. We discounted both costs and benefits, following recommendations of the Panel on Cost-Effectiveness in Health and Medicine. RESULTS: Our base case analyses suggest that plausible lower and upper bounds for a cost-effectiveness decision rule are $183,000 per life-year and $264,000 per life-year, respectively. Our sensitivity analyses widen the plausible range (between $95,000 per life-year saved and $264,000 per life-year saved when we considered only health care's impact on quantity of life, and between $109,000 per QALY saved and $297,000 per QALY saved when we considered health care's impact on quality as well as quantity of life) but it remained substantially higher than $50,000 per QALY. CONCLUSIONS: It is very unlikely that $50,000 per QALY is consistent with societal preferences in the United States.     

Cost Effectiveness of an Electrocardiographic Deep Learning Algorithm to Detect Asymptomatic Left Ventricular Dysfunction

ObjectiveTo evaluate the cost-effectiveness of an artificial intelligence electrocardiogram (AI-ECG) algorithm under various clinical and cost scenarios when used for universal screening at age 65.Patients and MethodsWe used decision analytic modeling to perform a cost-effectiveness analysis of the use of AI-ECG to screen for asymptomatic left ventricular dysfunction (ALVD) once at age 65 compared with no screening. This screening consisted of an initial screening decision tree and subsequent construction of a Markov model. One-way sensitivity analysis on various disease and cost parameters to evaluate cost-effectiveness at both $50,000 per quality-adjusted life year (QALY) and $100,000 per QALY willingness-to-pay threshold.ResultsWe found that for universal screening at age 65, the novel AI-ECG algorithm would cost $43,351 per QALY gained, test performance, disease characteristics, and testing cost parameters significantly affect cost-effectiveness, and screening at ages 55 and 75 would cost $48,649 and $52,072 per QALY gained, respectively. Overall, under most of the clinical scenarios modeled, coupled with its robust test performance in both testing and validation cohorts, screening with the novel AI-ECG algorithm appears to be cost-effective at a willingness-to-pay threshold of $50,000.ConclusionUniversal screening for ALVD with the novel AI-ECG appears to be cost-effective under most clinical scenarios with a cost of <$50,000 per QALY. Cost-effectiveness is particularly sensitive to both the probability of disease progression and the cost of screening and downstream testing. To improve cost-effectiveness modeling, further study of the natural progression and treatment of ALVD and external validation of AI-ECG should be undertaken.     

Cost-effectiveness of epoetin and autologous blood donationin reducing allogeneic blood transfusions incoronary artery bypass graft surgery

BACKGROUND: Coronary artery bypass graft (CABG) surgery accounts for a substantial portion of all allogeneic units of blood transfused. Drugs and autologous blood donation (ABD) are alternative or adjunctive methods for reducing complications and costs induced by allogeneic blood transfusions. Recombinant human erythropoietin (epoetin) has the potential to decrease perioperative need for allogeneic blood during CABG, but its high cost calls for a careful economic evaluation before it can be recommended for widespread use. STUDY DESIGN AND METHODS: A decision tree was used to compare a hypothetical strategy of no epoetin with one in which epoetin was utilized to control blood transfusion needs in CABG; each strategy was tested with and without ABD. The impact of these strategies on both the quality-adjusted life years (QALYs) and costs ($US) was calculated. RESULTS: Using epoetin alone and with ABD, respectively, avoided the transfusion of 0.61 and 1.35 units of allogeneic blood per patient and saved 0.000086 and 0.000146 QALYs per patient. This made cost-effectiveness (CE) higher than $7 million and $5 million for each QALY saved, respectively. ABD alone cost more than $1 million per QALY saved. If the risk of bacterial infections following allogeneic transfusions was included in the model, epoetin alone cost $6288 per QALY saved, while ABD, both alone and with epoetin, saved money. CONCLUSION: On the basis of the existing evidence, neither of the blood-saving strategies modeled was a cost-effective means of avoiding the deleterious health effects of perioperative blood transfusions in CABG. However, if allogeneic blood-related infections were to be considered, both ABD and epoetin would be acceptable interventions.     

Cost-effective diagnostic cardiovascular imaging: when does it provide good value for the money?

To summarize the results of all original cost-utility analyses (CUAs) in diagnostic cardiovascular imaging (CVI) and characterize those technologies by estimates of their cost-effectiveness. We systematically searched the literature for original CVI CUAs published between 2000 and 2008. Studies were classified according to several variables including anatomy of interest (e.g. cerebrovascular, aorta, peripheral) and imaging modality under study (e.g. angiography, ultrasound). The results of each study, expressed as cost of the intervention to number of quality-adjusted life years saved ratio (cost/QALY) were additionally classified as favorable or not using 20,000,20,000, 50,000, and $100,000 per QALY thresholds. The distribution of results was assessed with Chi Square or Fisher exact test, as indicated. Sixty-nine percent of all cardiovascular imaging CUAs were published between 2000 and 2008. Thirty-two studies reporting 82 cost/QALY ratios were included in the final sample. The most common vascular areas studied were cerebrovascular (n = 9) and cardiac (n = 8). Sixty-six percent (21/32) of studies focused on sonography, followed by conventional angiography and CT (25%, n = 8, each). Twenty-nine (35.4%), 42 (51.2%), and 53 (64.6%) ratios were favorable at WTP $100,000 per QALY thresholds. The distribution of results was assessed with Chi Square or Fisher exact test, as indicated. Sixty-nine percent of all cardiovascular imaging CUAs were published between 2000 and 2008. Thirty-two studies reporting 82 cost/QALY ratios were included in the final sample. The most common vascular areas studied were cerebrovascular (n = 9) and cardiac (n = 8). Sixty-six percent (21/32) of studies focused on sonography, followed by conventional angiography and CT (25%, n = 8, each). Twenty-nine (35.4%), 42 (51.2%), and 53 (64.6%) ratios were favorable at WTP 20,000/QALY, 50,000/QALY, and50,000/QALY, and 100,000/QALY, respectively. Thirty (36.6%) ratios compared one imaging test versus medical or surgical interventions; 26 (31.7%) ratios compared imaging to a different imaging test and another 26 (31.7%) to no intervention. Imaging interventions were more likely (P < 0.01) to be favorable when compared to observation, medical treatment or non-intervention than when compared to a different imaging test at WTP $100,000/QALY. The diagnostic cardiovascular imaging literature has growth substantially. The studies available have, in general, favorable cost-effectiveness profiles with major determinants relating to being compared against observation, medical or no intervention instead of other imaging tests.     

Cost effectiveness of aggressive care for patients with nontraumatic coma

OBJECTIVE: To estimate the cost effectiveness of aggressive care for patients with nontraumatic coma. DESIGN: Cost-effectiveness analysis. SETTING: Five academic medical centers. PATIENTS: Patients with nontraumatic coma enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). Patients with reversible metabolic causes of coma such as diabetic ketoacidosis or uremia were excluded. MEASUREMENTS: We calculated the incremental cost effectiveness of continuing aggressive care vs. withholding cardiopulmonary resuscitation and ventilatory support after day 3 of coma. We estimated life expectancy based on up to 4.6 yrs of follow-up. Utilities (quality-of-life weights) were estimated using time-tradeoff questions. Costs were based on hospital fiscal data and Medicare data. Separate analyses were conducted for two prognostic groups based on five risk factors assessed on day 3 of coma: age > or = 70 yrs, abnormal brainstem response, absent verbal response, absent withdrawal to pain, and serum creatinine > or = 132.6 micromol/L (1.5 mg/dL). RESULTS: For the 596 patients studied, the median (25th, 75th percentile) age was 67 yrs (range, 55-77), and 52% were female. By 2 months after enrollment, 69% had died, 19% were severely disabled, 7% had survived without severe disability, and 4% had survived with unknown functional status. The incremental cost effectiveness of the more aggressive care strategy was $140,000 (1998 dollars) per quality-adjusted life year (QALY) for high-risk patients (3-5 risk factors, 93% 2-month mortality) and $87,000/QALY for low-risk patients (0-2 risk factors, 49% mortality). In sensitivity analyses, the incremental cost per QALY did not fall below $50,000/QALY, even with wide variation in our baseline estimates. CONCLUSIONS: Continuing aggressive care after day 3 of nontraumatic coma is associated with a high cost per QALY gained, especially for patients at high risk for poor outcomes. Earlier decisions to withhold life-sustaining treatments for patients with very poor prognoses may yield considerable cost savings.     

Cost‐effectiveness of Acupuncture for Chronic Nonspecific Low Back Pain

Cost‐effectiveness is a major criterion underpinning decisions in mainstream health care. Acupuncture is increasingly used in patients with chronic lower back pain (LBP), but there is a lack of evidence on cost‐effectiveness. The objective of this study was to assess the cost‐effectiveness of acupuncture in alleviating chronic LBP either alone or in conjunction with standard care compared with patients receiving routine care, and/or sham. To determine effectiveness, we undertook meta‐analyses which found a significant improvement in pain in those receiving acupuncture and standard care compared with those receiving standard care alone. For acupuncture and standard care vs. standard care and sham, a weak positive effect was found for weeks 12 to 16, but this was not significant. For acupuncture alone vs. standard care alone, a significant positive effect was found at week 8, but not at weeks 26 or 52. The main outcome parameters for our cost‐effectiveness analysis were the incremental cost‐effectiveness ratio (ICER) of acupuncture treatment presented as cost (A$) per disability‐adjusted life‐year (DALY) saved. The WHO benchmark for a very highly cost‐effective intervention is one that costs less than gross domestic product per capita per quality‐adjusted life‐year (QALY) gained or DALY averted, or less than around $A52,000 in 2009 (the base year for the analysis). According to this threshold, acupuncture as a complement to standard care for relief of chronic LBP is highly cost‐effective, costing around $48,562 per DALY avoided. When comorbid depression is alleviated at the same rate as pain, cost is around $18,960 per DALY avoided. Acupuncture as a substitute for standard care was not found to be cost‐effective unless comorbid depression was included. According to the WHO cost‐effectiveness threshold values, acupuncture is a cost‐effective treatment strategy in patients with chronic LBP.     

Cost-Effectiveness of Interventions to Prevent and Control Diabetes Mellitus: A Systematic Review

OBJECTIVE

To synthesize the cost-effectiveness (CE) of interventions to prevent and control diabetes, its complications, and comorbidities.

RESEARCH DESIGN AND METHODS

We conducted a systematic review of literature on the CE of diabetes interventions recommended by the American Diabetes Association (ADA) and published between January 1985 and May 2008. We categorized the strength of evidence about the CE of an intervention as strong, supportive, or uncertain. CEs were classified as cost saving (more health benefit at a lower cost), very cost-effective (≤$25,000 per life year gained [LYG] or quality-adjusted life year [QALY]), cost-effective ($25,001 to $50,000 per LYG or QALY), marginally cost-effective ($50,001 to $100,000 per LYG or QALY), or not cost-effective (>$100,000 per LYG or QALY). The CE classification of an intervention was reported separately by country setting (U.S. or other developed countries) if CE varied by where the intervention was implemented. Costs were measured in 2007 U.S. dollars.

RESULTS

Fifty-six studies from 20 countries met the inclusion criteria. A large majority of the ADA recommended interventions are cost-effective. We found strong evidence to classify the following interventions as cost saving or very cost-effective: (I) Cost saving— 1) ACE inhibitor (ACEI) therapy for intensive hypertension control compared with standard hypertension control; 2) ACEI or angiotensin receptor blocker (ARB) therapy to prevent end-stage renal disease (ESRD) compared with no ACEI or ARB treatment; 3) early irbesartan therapy (at the microalbuminuria stage) to prevent ESRD compared with later treatment (at the macroalbuminuria stage); 4) comprehensive foot care to prevent ulcers compared with usual care; 5) multi-component interventions for diabetic risk factor control and early detection of complications compared with conventional insulin therapy for persons with type 1 diabetes; and 6) multi-component interventions for diabetic risk factor control and early detection of complications compared with standard glycemic control for persons with type 2 diabetes. (II) Very cost-effective— 1) intensive lifestyle interventions to prevent type 2 diabetes among persons with impaired glucose tolerance compared with standard lifestyle recommendations; 2) universal opportunistic screening for undiagnosed type 2 diabetes in African Americans between 45 and 54 years old; 3) intensive glycemic control as implemented in the UK Prospective Diabetes Study in persons with newly diagnosed type 2 diabetes compared with conventional glycemic control; 4) statin therapy for secondary prevention of cardiovascular disease compared with no statin therapy; 5) counseling and treatment for smoking cessation compared with no counseling and treatment; 6) annual screening for diabetic retinopathy and ensuing treatment in persons with type 1 diabetes compared with no screening; 7) annual screening for diabetic retinopathy and ensuing treatment in persons with type 2 diabetes compared with no screening; and 8) immediate vitrectomy to treat diabetic retinopathy compared with deferred vitrectomy.

CONCLUSIONS

Many interventions intended to prevent/control diabetes are cost saving or very cost-effective and supported by strong evidence. Policy makers should consider giving these interventions a higher priority.The cost of diabetes in the U.S. in 2007 was $174 billion (1). Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes prevention/control should be prioritized. We wanted to compare the effectiveness and costs of various interventions to find those that were the most effective for the least expense. Cost-effective analysis is a useful tool for this purpose. Such analyses consist of compiling incremental cost-effectiveness ratios (ICERs), which are calculated as a ratio of the difference in costs to the difference in effectiveness between the intervention being evaluated and the comparison intervention.With the same health outcome indicator, ICERs of interventions are comparable. Therefore, these ICERs can make it easier to decide how to allocate resources. Although many cost-effectiveness (CE) analyses of diabetes interventions have been published, their qualities and conclusions vary. A systematic review, which appraises individual studies and summarizes results, would aid policy makers and clinicians in prioritizing interventions to prevent or treat diabetes and its complications.Few investigators have conducted systematic reviews of the CE of diabetes interventions (2–5). The systematic review presented here, following the Cochrane Collaboration''s protocol (6), includes all English language studies available from 1985 to May 2008. The interventions included only those recommended by the 2008 American Diabetes Association (ADA) Standards of Medical Care in Diabetes (7).     

Cost-effectiveness of field trauma triage among injured children transported by emergency medical services

BackgroundA pediatric field triage strategy that meets the national policy benchmark of ≥95% sensitivity would likely improve health outcomes but increase heath care costs. Our objective was to compare the cost-effectiveness of current pediatric field triage practices to an alternative field triage strategy that meets the national policy benchmark of ≥95% sensitivity.Study designWe developed a decision-analysis Markov model to compare the outcomes and costs of the two strategies. We used a prospectively collected cohort of 3507 (probability weighted, unweighted n = 2832) injured children transported by 44 emergency medical services (EMS) agencies to 28 trauma and non-trauma centers in the Northwestern United States from 1/1/2011 to 12/31/2011 to derive the alternative field triage strategy and to populate model probability and cost inputs for both strategies. We compared the two strategies by calculating quality adjusted life years (QALYs) and health care costs over a time horizon from the time of injury until death. We set an incremental cost-effectiveness ratio threshold of less than $100,000 per QALY for the alternative field triage to be a cost-effective strategy.ResultsCurrent pediatric field triage practices had a sensitivity of 87.4% (95% confidence interval [CI] 71.9 to 95.0%) and a specificity of 82.3% (95% CI 81.0 to 83.5%) and the alternative field triage strategy had a sensitivity of 97.3% (95% CI 82.6 to 99.6%) and a specificity of 46.1% (95% CI 43.8 to 48.4%). The alternative field triage strategy would cost $476,396 per QALY gained compared to current pediatric field triage practices and thus would not be a cost-effective strategy. Sensitivity analyses demonstrated similar findings.ConclusionCurrent field triage practices do not meet national policy benchmarks for sensitivity. However, an alternative field triage strategy that meets the national policy benchmark of ≥95% sensitivity is not a cost-effective strategy.     

First-line Daratumumab in Addition to Chemotherapy for Newly Diagnosed Multiple Myeloma Patients Who are Transplant Ineligible: A Cost-Effectiveness Analysis

PurposeDaratumumab is a standard-of-care treatment for newly diagnosed multiple myeloma (NDMM). According to the ALCYONE trial, the addition of daratumumab to bortezomib, melphalan, and prednisone (D-VMP) provides significantly longer overall survival and progression-free survival than bortezomib, melphalan, and prednisone (VMP) in patients with NDMM. However, considering the high price of daratumumab, it is necessary to conduct further research on its efficacy and cost. This study evaluated the cost-effectiveness, from the US payer perspective, of D-VMP vs VMP in the first-line setting for patients with NDMM who are not eligible for autologous stem cell transplantation.MethodsA Markov model was developed to estimate the lifetime cost and effectiveness of VMP with or without daratumumab as the first-line therapy for patients with NDMM. Univariable sensitivity analysis and probabilistic sensitivity analysis were performed to address the model robustness and uncertainty. Expected value of perfect information analysis was conducted to explore the uncertainty of decision-making and future costs.FindingsD-VMP provides an additional 2.417 quality-adjusted life years (QALYs), at a cost of $30,893 per QALY. Sensitivity analysis revealed that the transition probability of progression-free survival in D-VMP strategy, the price of daratumumab, and body weight of the patient influenced the model results most strongly. Probabilistic sensitivity analysis showed that D-VMP versus VMP has a 90.8% probability of being cost-effective at the $150,000/QALY willingness-to-pay (WTP) threshold. The population expected value of perfect information was $2150 million at a WTP threshold of $50,000/QALY and $1481 million at $100,000/QALY.ImplicationsIn this study, D-VMP was estimated to be cost-effective compared with VMP for patients with NDMM at a WTP threshold of $150,000/QALY.     

Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia,Including Ventilator-associated Pneumonia,in Italy

PurposeCeftazidime/avibactam (CAZ-AVI) is a fixed-dose combination antibiotic approved in Europe and the United States for patients with hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP). The economic benefits of a new drug such as CAZ-AVI are required to be assessed against those of available comparators, from the perspective of health care providers and payers, through cost-effectiveness and cost-utility analyses. The objective of this analysis was to compare the cost-effectiveness of CAZ-AVI versus meropenem in the empirical treatment of appropriate hospitalized patients with HAP/VAP caused by gram-negative pathogens, from the perspective of publicly funded health care in Italy (third-party perspective, based on the data from the REPROVE (Ceftazidime-Avibactam Versus Meropenem In Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia) clinical study; ClinicalTrials.gov NCT01808092).MethodsA patient-level, sequential simulation model of the HAP/VAP clinical course was developed using spreadsheet software. The analysis focused on direct medical costs. The time horizon of the model selected was 5 years, with an annual discount rate of 3% on costs and quality-adjusted life-years (QALYs). Clinical inputs for treatment comparisons were mainly obtained from the REPROVE clinical study data. In addition to clinical outcomes observed in the trial, the model incorporated impact of resistance pathogens, based on data from published studies and expert opinion. Certain assumptions were made for some model parameters due to a lack of data.FindingsThe analysis demonstrated that the intervention sequence (CAZ-AVI followed by colistin + high-dose meropenem) versus the comparator sequence (meropenem followed by colistin + high-dose meropenem) provided a better clinical cure rate (+13.52%), which led to a shorter hospital stay (−0.40 days per patient), and gains in the number of life-years (+0.195) and QALYs (+0.350) per patient. The intervention sequence had an estimated net incremental total cost of €1254 ($1401) per patient, and the estimated incremental cost-effectiveness ratio was €3581 ($4000) per QALY gained, well below the willingness-to-pay threshold of €30,000 ($33,507) per QALY in Italy.ImplicationsThe model results showed that CAZ-AVI is expected to provide clinical benefits in hospitalized patients with HAP/VAP in Italy at an acceptable cost compared to meropenem.     

Cost-effectiveness of pharmaceutical care on patients undergoing maintenance hemodialysis – a multicenter randomized controlled study

Objectives: The aim of the study is to assess the cost-effectiveness of pharmaceutical care versus usual care on the treatment costs in patients undergoing maintenance hemodialysis (HD) in the outpatient HD centers of academic, government, and corporate hospitals.

Methods: An open-labeled randomized controlled study was registered under clinical trial registry of India (Ref. no. CTRI/2014/004900). The study was conducted for a period of 12-month follow-up in patients undergoing maintenance HD. The patients were randomized into Usual Care (UC) group and Pharmaceutical Care (PC) group by the block design method. The UC group received the usual care provided by the hospital staff like physicians, nurses, and technicians whereas, the PC group received the usual care along with the pharmaceutical care delivered by a qualified registered pharmacist. The patient perspective ‘out-of-pocket expenditures’ was considered for calculating the annual cost incurred for the treatment of HD patients.

Results: Out of 153 patients, academic hospital (n = 83), government hospital (n = 18), and corporate hospital (n = 52). The incremental cost-effectiveness ratio for academic, government, and corporate hospitals HD patients of PC group compared with UC group were 86,230 Indian Rupee (INR)/Quality-adjusted life year (QALY), 231,016.66 INR/QALY, and 87,430 INR/QALY, respectively. Our study results revealed that PC group was costlier and more effective compared to the UC group.

Conclusions: It depends upon the policymakers and regulators to take the decision, if they believe that the extra cost is worth the extra QALY.     

A cost-utility analysis of mitoxantrone hydrochloride and interferon beta-1b in the treatment of patients with secondary progressive or progressive relapsing multiple sclerosis

BACKGROUND: Information on the cost utility of interferon beta-1b and mitoxantrone hydrochloride, 2 disease-modifying agents approved by the US Food and Drug Administration for the treatment of secondary progressive (SP) multiple sclerosis (MS), is limited. OBJECTIVE: The aim of this study was to compare the cost utility of i.v. mitoxantrone hydrochloride administered every 3 months, s.c. interferon beta-1b administered every other day, and routine supportive care from the perspectives of both the insurer and society. METHODS: We used a Markov model with health states based on the Kurtzke Expanded Disability Status Scale (EDSS) scores from both an insurer's and a societal perspective (including direct and total costs, respectively). Theoretical patients entered the model with an EDSS score of 3; their progression was followed for 10 years. Transition probabilities were derived from clinical trial data. Cost and utility inputs were taken from the literature. Sensitivity analyses were conducted on all variables. RESULTS: From the insurer's perspective, the incremental cost-utility ratio of mitoxantrone hydrochloride therapy compared with routine supportive care was 58,272 dollars per quality-adjusted life year (QALY) gained. From a societal perspective, mitoxantrone hydrochloride was more effective and less costly than supportive care. From the perspectives of insurers and society, the cost-utility ratios of interferon beta-1b compared with routine supportive care were 338,738 dollars and 245,700 dollars per QALY gained, respectively. When compared with mitoxantrone hydrochloride, interferon beta-1b had an incremental cost-utility ratio of 741,331 dollars and 658,402 dollars per QALY from the insurer's and society's perspectives, respectively. Cost-utility ratios for mitoxantrone hydrochloride were sensitive to acquisition and administration costs of therapy and to effectiveness at slowing disease progression. Cost-utility ratios for interferon beta-1b were not sensitive to any of the variables included in the model. CONCLUSIONS: Mitoxantrone hydrochloride is likely to be a cost-effective treatment for patients with SPMS or progressive relapsing MS from an insurer' perspective and is cost saving from a societal perspective. Interferon beta-1b is not likely an efficient treatment using conventional comparisons for cost-effectiveness. This analysis has potentially important implications for policy implementation; however, decisions about which agent to use for each patient should consider the treatment's adverse-event profile, the method of administration, and the patient's preferences for these factors.