Cost-effectiveness Considerations Research Articles

SHOULD CHRONIC HEPATITIS B BE TREATED AS EARLY AS POSSIBLE?

We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B. Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis. We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years. Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

Incorporating Considerations of Cost-Effectiveness, Affordability, and Resource Implications in Guideline Development

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are based on the best available research evidence. This is the sixth of a series of 14 articles prepared to advise guideline developers for respiratory and other diseases on how to achieve this goal. In this article, we focused on integrating cost and resource information in guideline development and formulating recommendations focusing on four key questions. We addressed the following specific questions. (1) When is it important to incorporate costs, and/or resource implications, and/or cost-effectiveness, and/or affordability considerations in guidelines? (2) Which costs and which resource use should be considered in guidelines? (3)What sources of evidence should be used to estimate costs, resource use, and cost-effectiveness? (4) How can cost-effectiveness, resource implications, and affordability be taken into account explicitly? Our work was based on a prior review on this topic and our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions. Many authorities suggest that there is a need to include explicit consideration of costs, resource use, and affordability during guideline development. Where drug use is at issue, "explicit consideration" may need to involve only noting whether the price (easily determined and usually the main component of "acquisition cost") of a drug is high or low. Complex interventions such as rehabilitation services are to a greater degree setting- and system-dependent. Resources used, and the costs of those resources, will vary among systems, and formal identification by a guideline group of the resource requirements of a complex intervention is essential. A clinical guideline usually contains multiple recommendations, and in some cases there are hundreds. Defining costs and resource use for all of them-especially for multiple settings-is unlikely to be feasible. At present, disaggregated resource utilization accompanied by some cost information seems to be the most promising approach. The method for assigning values to costs, including external or indirect cost (such as time off work), can have a significant impact on the outcome of any economic evaluation. The perspective that the guideline assumes should be made explicit. Standards for evidence for clinical data are usually good-quality trials reporting a relevant endpoint that should be summarized in a systematic review. Like others, we are therefore proposing that the ideal sources of evidence for cost and resource utilization data for guideline development are systematic reviews of randomized controlled trials that report resource utilization, with direct comparisons between the interventions of interest.

The Results of Cultural Management of the Croatian Archaeological Heritage with Special Consideration for Cost Effectiveness: The Case of Roman Iovia (Ludbreg)

During the four seasons of excavations of the Roman town of Iovia-Botivo (present-day Ludbreg, Croatia), a smaller bath and sizeable (presumably public) building were discovered. An optimal plan for presentation was made with all due consideration for the site’s specific situation. The plan encompassed scholarly and professional requirements concerning conservation in situ combined with the needs of successful cultural management, thus resulting in alignment between the latter two factors as well as cost effectiveness. By applying the aforementioned principles (which served more as guidelines rather than rigid edicts) and facilitating successful, interdisciplinary cooperation between the national government, the municipal authorities, and researchers, it was possible to provide a sound, legally secure future for this site.

Cost, Coverage, and Comparative Effectiveness Research: The Critical Issues for Oncology

A new national initiative in comparative effectiveness research (CER) is part of a broad and long-term evolution toward greater reliance on scientific evidence in clinical practice and medical policy. But CER has been controversial because of its high profile in the health care reform effort, its instantiation in a prominent new national research institute, and lingering concerns that the ultimate goal of CER is to empower the government and private insurers to reduce health care costs by restricting access to expensive new medical tests and treatments. This article presents an analysis of the policy development behind CER and focuses on its potential impact on insurance coverage and payment for oncology services. By itself, CER will not solve the tension that exists between the goal of innovative, personalized care and the eroding affordability of cancer treatment in the United States. But CER does offer an important opportunity for progress. Oncologists have taken important first steps in acknowledging their responsibility for addressing cost issues; as a professional society, they should now move forward to assume leadership in the effort to integrate clinical evidence with considerations of cost effectiveness to guide clinical practice and insurer policies.

Cost-utility assessment of amifostine as first-line therapy for ovarian cancer

Bennett CL, Golub R, Calhoun E, Weinstein J; Fishman D, Lurain J, Roland P, Medio F, Bukowski RM. Cost-utility assessment of amifostine as first-line therapy for ovarian cancer. Int J Gynecol Cancer 1998; 8: 64-72. Nearly 27,000 female patients were diagnosed with ovarian cancer in the United States in 1997. While chemotherapeutic agents are effective in prolonging the time to progression of disease, concerns exist over treatment- related toxicities. In addition to considerations related to effectiveness, the decision to prescribe new cytoprotective agents requires consideration of costs and cost-effectiveness. The objective of this study was to describe cost-utility estimates of a new supportive care agent, amifostine, and to illustrate these issues for patients with ovarian cancer. The phase III Food and Drug Administration (FDA) licensing trial found that pretreatment with amifostine prior to each cycle of chemotherapy resulted in reduction of cumulative toxicities with cyclophosphamide and cisplatinum. While amifostine use is approximately $3,146 more per patient, after adjustment for direct medical costs and potential health status changes from reductions in hematologic toxicity, neurotoxicity, and nephrotoxicity, its use was estimated to cost $36,161 in direct medical costs per quality-adjusted life year saved. Sensitivity analyses indicated that cost-effectiveness estimates of amifostine therapy ranged front $25,474 to $78,574. Based on the phase III FDA licensing trial, amifostine use is associated with a favorable cost-utility profile that is in the range associated with widely used cancer therapeutic and supportive care agents. The decision to use (or not use) amifostine in conjunction with cisplatin and cyclophosphamide for women with ovarian cancer should be based on clinical, not economic, considerations.

A framework for production of systematic review based briefings to support evidence-informed decision-making.

BackgroundWe have developed a framework for translating existing sources of synthesized and quality-assessed evidence, primarily systematic reviews, into actionable messages in the form of short accessible briefings. The service aims to address real-life problems in response to requests from decision-makers.Development of the framework was based on a scoping review of existing resources and our initial experience with two briefing topics, including models of service provision for young people with eating disorders. We also drew on previous experience in dissemination research and practice. Where appropriate, we made use of the SUPporting POlicy relevant Reviews and Trials (SUPPORT) tools for evidence-informed policymaking.FindingsTo produce a product that it is fit for this purpose it has been necessary to go beyond a traditional summary of the available evidence relating to effectiveness. Briefings have, therefore, included consideration of cost effectiveness, local applicability, implications relating to local service delivery, budgets, implementation and equity. Our first evidence briefings produced under this framework cover diagnostic endoscopy by specialist nurses and integrated care pathways in mental healthcare settings.ConclusionsThe framework will enable researchers to present and contextualize evidence from systematic reviews and other sources of synthesized and quality-assessed evidence. The approach is designed to address the wide range of questions of interest to decision-makers, especially those commissioning services or managing service delivery and organization in primary or secondary care. Evaluation of the use and usefulness of the evidence briefings we produce is an integral part of the framework and will help to fill a gap in the literature.

Perspectives from the Common Ground

Perspectives from the Common Ground

Barriers to translating EU and US CVD guidelines into practice in China

With the increasing globalization of clinical research and evidence, clinical-practice guidelines (CPGs) developed by the European Union (EU) and the USA are also becoming increasingly international. However, these CPGs can encounter barriers to their practical application. In this Perspectives article, we analyze the main obstacles to the application of EU and US CPGs for cardiovascular diseases from the unique perspective of China, and highlight some potential problems in the globalization of CPGs. Currently, China and other countries with limited independent evidence for CPG development must localize or adapt the CPGs developed by the EU, the USA, or international medical organizations, with systematic consideration of cost-effectiveness and alternative strategies on the basis of the available evidence from the native populations. At the same time, comprehensive capabilities to collect and review clinical evidence to produce population-specific CPGs should be developed.

Theoretical analysis and experimental validation of a novel multilevel inverter topology for renewable energy interfacing applications

This paper presents a new topological structure for symmetrical cascaded multilevel inverters. The proposed circuit consists of cross-connected separate symmetrical DC sources which can generate number of levels equal to that of a cascaded H-bridge topology with reduced number of power switches. It is especially suitable for utility interfacing of renewable energy sources. It also offers the possibility of a transformer less and filter less operation. The working principle of the proposed topology is explained with the help of a single-phase five level inverter. Simulation results are obtained in matlab/simulink environment and are verified experimentally on a laboratory prototype. An exhaustive comparison of the proposed topology is made with the classical cascaded H-bridge topology, especially with the considerations of conduction losses and cost-effectiveness. The proposed topology results in the reduction of number of power switches, losses, installation area, and converter cost and thus can be implemented as an effective and efficient power electronic interface for renewable sources of energy with the utility grid.

Innovation in Health Care: Time for a Gut Check

O the past several decades, advances in science and technology have yielded great strides in our ability to reat major medical conditions such as heart disease and cancer. he genesis of many of these technologies has been innovative iopharmaceutical, medical device, and diagnostic start-up ompanies often formed by physicians and researchers within cademic medical institutions and hospitals. These start-up companies often have taken on venture captal funding to complete product development and clinical rials. As a reward for successful clinical trials, these companies ere historically able to raise additional capital through muliple investment rounds and sometimes through an initial pubic offering of their stock to public investors. Indeed, there are several very successful examples of new herapies that followed this playbook in the area of gastroenerology including treatments for morbid obesity, hepatic enephalopathy, hepatitis C, reflux disease, and Barrett’s esophaus, all developed by small companies that effectively developed nd launched these products with the backing of high-risk nvestment capital and in concert with thought-leading physiians and inventors. Over the past 30 years, this ecosystem of physician, acaemia, start-up, and venture capital fostered a very successful ilieu for the advancement of innovation in health care and as yielded many new drugs and devices in use today by phyicians. Indeed, it has been shown previously that contrary to opular belief, venture capital returns from health care start-up nvestments actually have exceeded the returns from informaion technology and Internet investments since 2000 by a very ide margin.1 Today, however, we are at serious risk of dismantling this medical innovation ecosystem. There are 3 major reasons for this looming crisis in financing innovation in health care.

The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy

Bevacizumab is a biologically and clinically active antineoplastic agent in the management of epithelial ovarian cancer. While phase III trial data have revealed the favorable impact on progression-free survival associated with combining the agent with cytotoxic chemotherapy, at the current time a strong argument can be made (based on both efficacy and cost-effectiveness considerations) that a more rational approach to utilizing bevacizumab in ovarian cancer would be to administer the drug as a single agent in the platinum-resistant setting.

Assessing the Scale-Up of a Weight Loss Program: Narrowing the Gap Between Research and Practice

Assessing the Scale-Up of a Weight Loss Program: Narrowing the Gap Between Research and Practice

Evaluating Treatment Strategies in Patients with Early Rheumatoid Arthritis: Merging Modeling Theory with Clinical Practice

It is impossible to ignore: costs and budget considerations increasingly influence the way rheumatologists can treat and care for their patients in clinical practice. This is especially the case for biologics in the treatment of patients with inflammatory rheumatologic diseases. Until 15 years ago, drug reimbursement decisions in rheumatology were mainly influenced by data on effectiveness and safety. Costs and pricing were a minor issue. This changed somewhat when cyclooxygenase II selective nonsteroidal antiinflammatory drugs were marketed. However, with the introduction of the biologic disease-modifying antirheumatic drugs (DMARD) in rheumatology, the balance between clinical effectiveness and economic aspects of decision options, assessed using cost-effectiveness analyses, played an essential role in reimbursement decisions. This resulted in mounting debates among rheumatologists, and many became involved in negotiations with their hospitals or health insurance companies on how to afford treatments with these drugs within existing budgets. Cost and cost-effectiveness considerations are nowadays also taken into account in treatment recommendations. In the American College of Rheumatology (ACR) recommendations of 2008 on the use of biologic and nonbiologic DMARD in rheumatoid arthritis (RA), the “role of costs for treatment with biologic DMARD” was one of the 5 domains of the literature search that addressed the scientific evidence1. Along the same lines, the role of biologics in the European League Against Rheumatism (EULAR) recommendations for the management of RA with synthetic and biological DMARD2 is supported by a literature over view on cost-effectiveness of biologics, published separately3. While the clinical position of biologic DMARD in early DMARD-naive patients in terms of effectiveness, safety, and preferences remains an issue for further studies, the above mentioned EULAR overview3, as well as a more recent systematic review on cost-effectiveness of biologic DMARD in RA4, conclude that it is unlikely that … Address correspondence to Dr. Boonen; E-mail: a.boonen{at}mumc.nl

National Clinical Guideline Centre Cost-Effectiveness Assessment for the National Institute for Health and Clinical Excellence

The National Clinical Guideline Centre (NCGC) develops evidence-based clinical guidelines on behalf of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. The U.K. Department of Health has commissioned NICE to make recommendations on the basis of both clinical effectiveness and cost-effectiveness. This article describes how cost-effectiveness is evaluated and accounted for in NCGC guidelines. Six recent case studies are presented, in which consideration of cost-effectiveness has informed recommendations in various ways for clinical guidelines on alcohol use disorders, chronic obstructive pulmonary disease, glaucoma, lower urinary tract symptoms, non-ST-segment elevation myocardial infarction and unstable angina, and venous thromboembolism prophylaxis. Some of the challenges faced in trying to account for cost-effectiveness in clinical guidelines are outlined, as well as some of the difficulties in adapting cost-effectiveness guidelines for other settings.

Bipolar units and programmes: are they really needed?

In the era of managed care and cost-effectiveness considerations, some see specialized units and programmes as expensive, sophisticated and elitistic organizations which might not be needed at all in the field of psychiatry, where technology is still a little part of what we do. But what lays behind those considerations is the concept that expertise is not needed in psychiatry, and that everybody can provide psychiatric care because, at the end of the day, what is basically needed is some empathy, compassion, and a minimal knowledge on how to provide some “sedation” to the mentally ill. The reality is that psychiatry is probably the most difficult and clinically sophisticated medical speciality, and that, precisely because of the limited role of technology, expertise is crucial for clinical success. Are specialized units the future of psychiatry? I believe so. Of course, they will have to coexist with generalists, who have the challenging task to know a little of everything, and to deal with the majority of those who seek psychiatric help; but, as it happened with internal medicine or even more recently with neurology, we need superspecialists to deal with the most complex cases, generate high-quality research, and provide education on specific conditions. The patients who do not do well on standard treatment want to find experts in their condition, and this is the spot for specialized clinics and programmes. Specialized units should not be exclusive of the Western world. Their sophistication does not mean that they are necessarily expensive. The main ingredients are striving for excellence, meritocracy, team work, competitive funding, and some intangible joy of living with the privilege to help and learn from our patients. As far as the ingredients are there, this can be done anywhere. I had the privilege to start what is now considered by many not only one of the first specialized health care and research psychiatry programmes in Europe, but also what I like to see as a school of psychiatry, where young doctors, fellows, residents, and medical students receive a sophisticated training in psychopathology, psychopharmacology, and psychotherapy. We used to call this center “the Bipolar Unit”, especially when it started and had only one staff member (a literal “Unit”). With time and a little luck, some Spanish government funding came up, and I was able to hire a psychologist to lead what I wanted to be our first research project, a clinical trial testing the efficacy of psychoeducation for bipolar disorder 1. Subsequently, we got further funding, with special mention of that coming from the Stanley Medical Institute in Bethesda, and we started doing drug clinical trials 2 and research in emerging areas of interest, such as neuropsychology 3, functional outcome 4, and epidemiological studies 5. Right from the beginning, the center had one aim: to generate, teach, and apply knowledge on how to best treat patients with bipolar disorder. It was clear to me then, and still is today, that there is a huge gap between the available scientific evidence and the questions that come up from everyday clinical practice and from the daily contact with patients with bipolar disorder and their caregivers. The center aims to fill that gap as much as possible. Over 700 patients with bipolar disorder attend the programme (mostly as outpatients), and we count on 26 beds for inpatients, which we share with the schizophrenia and depression programmes. About 60% of outpatients come from our designated catchment area, while 40% are sent to us as a reference center for difficult-to-treat cases, including patients with severe rapid cycling, somatic and psychiatric comorbidities, and treatment refractoriness. One unique feature of our department is that programmes take preeminence, and therefore the patients are followed up regardless of the facility which they attend (inpatient unit, outpatient clinic, emergency room). This ensures quality and continuity of care and is particularly helpful for teaching and research. Other features of our programme are the team approach and the open-door policy 6. I believe that specialized programmes such as the Barcelona Bipolar Disorders Programme are truly needed. It is time for evidence-based, but personalized medicine, and for coordinating the efforts of all those who participate in the healing process, from the generalist to the top specialist.

La evaluación de tecnologías sanitarias en intervenciones de salud pública: ¿más vale prevenir que curar?

Medical activities are increasingly performed with preventive purposes, as part of community programs for secondary prevention but also as part of many clinical activities. However, there are few evaluations of preventive and health promotion activities and, in general, these evaluations only assess aspects of efficacy/effectiveness with little consideration of cost and cost-effectiveness and even less of the ethical, legal, social or organizational consequences. Given the growing interest in evaluation of these interventions from different perspectives, health technology assessment (HTA) has emerged as a multidisciplinary analysis strategy with distinct methodological approaches that may be useful to health administrations and policy-makers for decision making at different levels (micro, meso and macro). This manuscript discusses the characteristics and differential aspects related to assessment of preventive and health promotion activities. This type of evaluation poses constraints, limitations and challenges that should be considered during the process of HTA. In the case of public health there are additional challenges, because the evidence must satisfy a diverse audience, including public health professionals, clinicians, politicians, managers, economists and consumers. The challenge is even greater when evaluating complex, integrated community interventions in which local and contextual aspects are of tremendous importance. In addition, assessment of ethical issues is of the utmost importance since these issues comprise the origin of health services and the target populations are usually healthy.

Neuromodulation for intractable OAB

To review the current status of sacral neuromodulation (SNM) in the treatment of intractable overactive bladder symptoms, the PubMed English-language literature was used to address efficacy, technical issues, alternative techniques, the mechanism of action, adverse events, the cost-effectiveness, and current considerations on the use of SNM as second-line treatment in OAB. Several studies attest to the short- and long-term efficacy of SNM in reducing urgency incontinence and the remaining OAB symptoms. Few, medium-sized sample, randomized controlled trials exist. Little is known about long-term patient satisfaction from SNM and prognostic factors have not been identified. Technical advances have significantly improved patient selection and outcomes, as well as complication rates, but revision rates still remain high. The mechanism of action remains largely unknown, but appears to be associated with reorganization of spinal reflexes and regulation of cortical activity. Reports on cost-effectiveness are conflicting. Less invasive forms of SNM may offer a viable alternative to central SNM. In conclusion, current evidence supports the short- and long-term efficacy of SNM in treating intractable OAB, but further research is needed to improve patient selection, identify prognostic factors, clarify the mechanism of action and reduce complications and revision rates.

Development of a 64 channel ultrasonic high frequency linear array imaging system

In order to improve the lateral resolution and extend the field of view of a previously reported 48 element 30 MHz ultrasound linear array and 16-channel digital imaging system, the development of a 256 element 30 MHz linear array and an ultrasound imaging system with increased channel count has been undertaken. This paper reports the design and testing of a 64 channel digital imaging system which consists of an analog front-end pulser/receiver, 64 channels of Time-Gain Compensation (TGC), 64 channels of high-speed digitizer as well as a beamformer. A Personal Computer (PC) is used as the user interface to display real-time images. This system is designed as a platform for the purpose of testing the performance of high frequency linear arrays that have been developed in house. Therefore conventional approaches were taken it its implementation. Flexibility and ease of use are of primary concern whereas consideration of cost-effectiveness and novelty in design are only secondary. Even so, there are many issues at higher frequencies but do not exist at lower frequencies need to be solved. The system provides 64 channels of excitation pulsers while receiving simultaneously at a 20–120 MHz sampling rate to 12-bits. The digitized data from all channels are first fed through Field Programmable Gate Arrays (FPGAs), and then stored in memories. These raw data are accessed by the beamforming processor to re-build the image or to be downloaded to the PC for further processing. The beamformer that applies delays to the echoes of each channel is implemented with the strategy that combines coarse (8.3 ns) and fine delays (2 ns). The coarse delays are integer multiples of the sampling clock rate and are achieved by controlling the write enable pin of the First-In-First-Out (FIFO) memory to obtain valid beamforming data. The fine delays are accomplished with interpolation filters. This system is capable of achieving a maximum frame rate of 50 frames per second. Wire phantom images acquired with this system show a spatial resolution of 146 μm (lateral) and 54 μm (axial). Images with excised rabbit and pig eyeball as well as mouse embryo were also acquired to demonstrate its imaging capability.

CE3 COST-EFFECTIVENESS ANALYSIS AND BUDGET IMPACT ASSESSMENT: A GRAPHICAL WAY TO COMBINE THE TWO FOR THE AID OF DECISION-MAKERS

Cost-effectiveness analysis (CEA) has traditionally been seen as a means of satisfying a specific and explicit social objective subject to a fixed budget constraint. As a result, existing CEA methods largely ignore budget impact considerations in health systems where budgets are not fixed. In particular, none of the traditional methods of presenting results (such as the cost-effectiveness plane, ICER tables and CEAC graphs) can be used to summarize the results of a CEA and budget impact assessment simultaneously. Our objective was to develop such a method in a manner which is meaningful to decision makers. We present a novel way of combining cost-effectiveness and budget impact considerations into a single graph. To do this, we disaggregate the incremental costs of the new technology into those which fall on the health budget and displace other technologies (resulting in forgone health) and those which lead to an expansion of the health budget (resulting in a net budget impact). The incremental health benefit of the technology and any forgone health are combined to give the net health benefit of the technology, which is plotted against the net budget impact. Our method clearly reveals the trade-off between the cost-effectiveness and budget impact of the technology in question. This trade-off is simultaneously revealed across a range of plausible values of the cost-effectiveness threshold. Decision makers who are concerned with both the cost-effectiveness and budget impact of new technologies have tended to consider each of these separately, with the inherent trade-off between the two blurred in the process. Our proposed method makes this trade-off explicit and does so across a range of threshold values, enabling analysts to provide meaningful information to decision makers while respecting decision makers' authority in determining the appropriate threshold to use.

Service failures identification: The involvement of the interrelation effect in service practices

The emergence of new information technologies (IT) changed the way organizations carried out their day-to-day operations. In view of the significant capital investments and expenditures with the IT service, organizations were concerned about what the impact of investment will be on the performance. Thus, drawing up a service failure recovery program with the consideration of cost-effectiveness was the primary concern in order to maintain a sustainable competition. In response, the purpose of this study was to develop a new decision-making model by integrating the Importance-Performance-Gap model and DEMATEL approach to understand the customers’/managers’ perceptions and clarify the interrelationship on service practices to help identify the critical service failures. The study validated the model by using data collected from an online tax declaration service in Taiwan. The results indicated that considering interrelationship effects of service practices based on the managers’ perceptions was beneficial for extracting more critical service failures. Some practical implications from the empirical case were also discussed. Key words: Service failures, Customer’s/Manager’s perception, interrelationship effect, DEMATEL, Importance-performance-gap analysis, IT/IS service.