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Importance: Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years.Objective: To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers.Design: In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process.Findings: The concept of a "reference case" and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an "impact inventory," which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses.Conclusions and Relevance: The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences. [ABSTRACT FROM AUTHOR]

The article discusses the cost-effectiveness analysis in the public health care system in the U.S. It mentions that the cost-effectiveness analysis in public healthcare concerns the measurement and the propeer communication of the value of the new drugs and other medical interventions. It adds that the cost-effective analyses is primarily concerned with the trade-offs related on the choice of alternative medical interventions.

Background: Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. Purpose: To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. Data Sources: MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. Study Selection: Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. Data Extraction: Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. Data Synthesis: 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n = 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n = 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n = 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. Limitations: Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. Conclusion: Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. Primary Funding Source: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Background: The optimal treatment for latent multiple-drug resistant tuberculosis infection remains unclear. In anticipation of future clinical trials, we modeled the expected performance of six potential regimens for treatment of latent multipledrug resistant tuberculosis. Methods: A computerized Markov model to analyze the total cost of treatment for six different regimens: Pyrazinamide/ ethambutol, moxifloxacin monotherapy, moxifloxacin/pyrazinamide, moxifloxacin/ethambutol, moxifloxacin/ethionamide, and moxifloxacin/PA-824. Efficacy estimates were extrapolated from mouse models and examined over a wide range of assumptions. Results: In the base-case, moxifloxacin monotherapy was the lowest cost strategy, but moxifloxacin/ethambutol was costeffective at an incremental cost-effectiveness ratio of $21,252 per quality-adjusted life-year. Both pyrazinamide-containing regimens were dominated due to their toxicity. A hypothetical regimen of low toxicity and even modest efficacy was costeffective compared to ''no treatment.'' Conclusion: In our model, moxifloxacin/ethambutol was the preferred treatment strategy under a wide range of assumptions; pyrazinamide-containing regimens fared poorly because of high rates of toxicity. Although more data are needed on efficacy of treatments for latent MDR-TB infection, data on toxicity and treatment discontinuation, which are easier to obtain, could have a substantial impact on public health practice. [ABSTRACT FROM AUTHOR]

Rationale: Rifapentine-based regimens for treating latent tuberculosis infection (LTBI) are being considered for future clinical trials, but even if they prove effective, high drug costs may limit their economic viability. Objectives: To inform clinical trial design by estimating the potential costs and effectiveness of rifapentine-based regimens for treatment of latent tuberculosis infection (LTBI). Methods: We used a Markov model to estimate cost and societal benefits for three regimens for treating LTBI: Isoniazid/ rifapentine daily for one month, isoniazid/rifapentine weekly for three months (self-administered and directly-observed), and isoniazid daily for nine months; a strategy of ''no treatment'' used for comparison. Costs, quality-adjusted life-years gained, and instances of active tuberculosis averted were calculated for all arms. Results: Both daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months were less expensive and more effective than other strategies under a wide variety of clinically plausibly parameter estimates. Daily isoniazid/rifapentine for one month was the least expensive and most effective regimen. Conclusions: Daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months should be studied in a large-scale clinical trial for efficacy. Because both regimens performed well even if their efficacy is somewhat reduced, study designers should consider relaxing non-inferiority boundaries. [ABSTRACT FROM AUTHOR]

Background: The CDC recommends routine voluntary HIV testing of all patients 13-64 years of age. Despite this recommendation, HIV testing rates are low even among those at identifiable risk, and many patients do not return to receive their results.Objective: To examine the costs and benefits of strategies to improve HIV testing and receipt of results.Design: Cost-effectiveness analysis based on a Markov model. Acceptance of testing, return rates, and related costs were derived from a randomized trial of 251 patients; long-term costs and health outcomes were derived from the literature. SETTING/TARGET POPULATION: Primary-care patients with unknown HIV status.Interventions: Comparison of three intervention models for HIV counseling and testing: Model A = traditional HIV counseling and testing; Model B = nurse-initiated routine screening with traditional HIV testing and counseling; Model C = nurse-initiated routine screening with rapid HIV testing and streamlined counseling.Main Measures: Life-years, quality-adjusted life-years (QALYs), costs and incremental cost-effectiveness.Key Results: Without consideration of the benefit from reduced HIV transmission, Model A resulted in per-patient lifetime discounted costs of $48,650 and benefits of 16.271 QALYs. Model B increased lifetime costs by $53 and benefits by 0.0013 QALYs (corresponding to 0.48 quality-adjusted life days). Model C cost $66 more than Model A with an increase of 0.0018 QALYs (0.66 quality-adjusted life days) and an incremental cost-effectiveness of $36,390/QALY. When we included the benefit from reduced HIV transmission, Model C cost $10,660/QALY relative to Model A. The cost-effectiveness of Model C was robust in sensitivity analyses.Conclusions: In a primary-care population, nurse-initiated routine screening with rapid HIV testing and streamlined counseling increased rates of testing and receipt of test results and was cost-effective compared with traditional HIV testing strategies. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Ovarian cancer is a leading cause of cancer-related deaths among women. Given the low prevalence of this disease, the effectiveness of screening strategies has not been established. We wished to estimate the clinical impact and cost-effectiveness of potential screening strategies for ovarian cancer using population-specific data. Methods: A Markov state transition model to simulate the natural history of ovarian cancer in a cohort of women age 20 to 100. Age-specific incidence and mortality rates were obtained from SEER. Base-case characteristics of a potential screening test were sensitivity 85%, specificity 95%, and cost $50. Outcome measures were mortality reduction, lifetime number of false positive screening tests, positive predictive value, years of life saved (YLS), lifetime costs in US dollars, and incremental cost-effectiveness ratios (ICER, in cost/YLS). Results: Model-predicted lifetime risk of ovarian cancer (1.38%), lifetime risk of death from ovarian cancer (0.95%), and stage distribution (stage I-19%; stage II-7%; stage III, IV, or unstaged — 74%) closely approximated SEER data. Annual screening resulted in 43% reduction in ovarian cancer mortality, with ICER of $73,469/YLS (base case) and $36,025/YLS (high-risk population) compared to no screening. In the base case, the average lifetime number of false positive tests is 1.06. Cost-effectiveness of screening is most sensitive to test frequency, specificity and cost. Conclusions: Annual screening for ovarian cancer has the potential to be cost effective, particularly in high-risk populations. Clinically acceptable positive predictive values are achieved if specificity exceeds 99%. Mortality reduction above 50% may not be achievable without screening intervals less than 12 months. [Copyright &y& Elsevier]

The article focuses on guideline-driven therapies intended on stopping sudden cardiac death (SCD). It states that one therapy to prevent SCD is the implantable cardioverter defrillator (ICD). It mentions that while ICD is cost effective and beneficial, most patients at risk of SCD are not receiving ICD. It examines results of a think tank by the Duke Center for the Prevention of SCD at Duke Clinical Research Institute in Durham, North Carolina.

The article presents an analysis of the cost effectiveness of human immunodeficiency virus (HIV) monitoring strategies. Among the strategies studied are the symptom-based strategies, CD4-based strategies and CD4 counts. Viral load strategies for highly active antiretroviral therapy (HAART) are also included in the study. The analysis and assumptions were made using clinical and cost data from Southern Africa. According to the authors, CD4 monitoring and initiation of HAART are effective in reducing health care expenditures in South Africa.

The article presents a study concerning the effectiveness of thrombolysis in treating patients with submassive pulmonary embolism. A cost effective analysis was performed to compare the health effects and treatment costs of alteplase with heparin sodium against heparin alone in thermodynamically stable patients with pulmonary embolism and right ventricular dysfunction. It was concluded in the study that thrombolysis may be cost-effective in selected subgroups of hemodynamically stable patients.

Purpose: Among patients with deep vein thrombosis, hypercoagulable conditions impart a substantial risk of recurrent thrombosis. We sought to determine the cost-effectiveness of testing for these disorders, as well as which tests should be selected and how results should be used.Methods: Using a Markov state-transition model, strategies of testing or not testing for a hypercoagulable state followed by anticoagulation for 6 to 36 months were compared in a hypothetical cohort of patients with apparently idiopathic deep vein thrombosis who were followed for life. Strategies were compared based on lifetime costs, quality-adjusted life-years (QALYs), and marginal cost-effectiveness.Results: In the base case, testing followed by 24 months of anticoagulation in patients with a hypercoagulable condition was more cost-effective ($54,820; 23.76 QALYs) than usual care, which comprised 6 months of anticoagulation without testing ($55,260; 23.72 QALYs). All hypercoagulable conditions tested were common enough and associated with a sufficient risk of recurrence to justify inclusion in a test panel. Twenty-four months of initial anticoagulation was preferred (<$50,000/QALY) for most conditions, whereas lifetime anticoagulation was preferred for patients with antiphospholipid antibody syndrome ($2928/QALY) or homozygous factor V Leiden mutation ($3804/QALY). Models using newer evidence on recurrence suggested 18 to 36 months of anticoagulation without testing as the preferred approach.CONCLUSION: Testing for hypercoagulable disorders in patients with idiopathic deep vein thrombosis followed by 2 years of anticoagulation in affected patients is cost-effective. A simpler approach of treating all patients with prolonged anticoagulation without testing is justified if data confirm the persistent risk of recurrent thrombosis. [Copyright &y& Elsevier]

Coccidioidomycosis, a systemic fungal infection, affects Americans living in the Southwest. We evaluated the cost-effectiveness of a potential vaccine against Coccidioides immitis. Using a decision model we developed, we estimate that among children, vaccination would save 1.9 quality-adjusted life days (QALD) and $33 per person. Among adults, screening followed by vaccination would save 0.5 QALD per person and cost $62,000 per quality adjusted life year gained over no vaccination. If the birth cohort in highly endemic counties of California and Arizona were immunized in 2001, 11 deaths would be averted and $3 million would be saved (in net present value) over the lifetime of these infants. Vaccination of adults to prevent disseminated coccidioidomycosis would provide a modest health benefit similar in magnitude to other vaccines but would increase net expenditures. Vaccination of children in highly endemic regions would provide a larger health benefit and would reduce total health care expenditures. [ABSTRACT FROM AUTHOR]

This JAMA Guide to Statistics and Methods reviews the use of cost-effectiveness analysis to quantify the tradeoffs in costs, harms, and benefits of new health care interventions compared with existing interventions. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the letters in the issue regarding the authors' article "Recommendations for Conduct, Methodological Practices, and Reporting of Cost-Effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine" in volume 316 issue 10 of the journal.

Background: Eight randomized trials have evaluated whether the prophylactic use of an implantable cardioverter–defibrillator (ICD) improves survival among patients who are at risk for sudden death due to left ventricular systolic dysfunction but who have not had a life-threatening ventricular arrhythmia. We assessed the cost-effectiveness of the ICD in the populations represented in these primary-prevention trials. Methods: We developed a Markov model of the cost, quality of life, survival, and incremental cost-effectiveness of the prophylactic implantation of an ICD, as compared with control therapy, among patients with survival and mortality rates similar to those in each of the clinical trials. We modeled the efficacy of the ICD as a reduction in the relative risk of death on the basis of the hazard ratios reported in the individual clinical trials. Results: Use of the ICD increased lifetime costs in every trial. Two trials — the Coronary Artery Bypass Graft (CABG) Patch Trial and the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) — found that the prophylactic implantation of an ICD did not reduce the risk of death and thus was both more expensive and less effective than control therapy. For the other six trials — the Multicenter Automatic Defibrillator Implantation Trial (MADIT) I, MADIT II, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) — the use of an ICD was projected to add between 1.01 and 2.99 quality-adjusted life-years (QALY) and between $68,300 and $101,500 in cost. Using base-case assumptions, we found that the cost-effectiveness of the ICD as compared with control therapy in these six populations ranged from $34,000 to $70,200 per QALY gained. Sensitivity analyses showed that this cost-effectiveness ratio would remain below $100,000 per QALY as long as the ICD reduced mortality for seven or more years. Conclusions: Prophylactic implantation of an ICD has a cost-effectiveness ratio below $100,000 per QALY gained in populations in which a significant device-related reduction in mortality has been demonstrated. N Engl J Med 2005;353:1471-80. [ABSTRACT FROM AUTHOR]

Background: The costs, benefits, and cost-effectiveness of screening for human immunodeficiency virus (HIV) in health care settings during the era of highly active antiretroviral therapy (HAART) have not been determined. Methods: We developed a Markov model of costs, quality of life, and survival associated with an HIV-screening program as compared with current practice. In both strategies, symptomatic patients were identified through symptom-based case finding. Identified patients started treatment when their CD4 count dropped to 350 cells per cubic millimeter. Disease progression was defined on the basis of CD4 levels and viral load. The likelihood of sexual transmission was based on viral load, knowledge of HIV status, and efficacy of counseling. Results: Given a 1 percent prevalence of unidentified HIV infection, screening increased life expectancy by 5.48 days, or 4.70 quality-adjusted days, at an estimated cost of $194 per screened patient, for a cost-effectiveness ratio of $15,078 per quality-adjusted life-year. Screening cost less than $50,000 per quality-adjusted life-year if the prevalence of unidentified HIV infection exceeded 0.05 percent. Excluding HIV transmission, the cost-effectiveness of screening was $41,736 per quality-adjusted life-year. Screening every five years, as compared with a one-time screening program, cost $57,138 per quality-adjusted life-year, but was more attractive in settings with a high incidence of infection. Our results were sensitive to the efficacy of behavior modification, the benefit of early identification and therapy, and the prevalence and incidence of HIV infection. Conclusions: The cost-effectiveness of routine HIV screening in health care settings, even in relatively low-prevalence populations, is similar to that of commonly accepted interventions, and such programs should be expanded. N Engl J Med 2005;352:570-85. [ABSTRACT FROM AUTHOR]