Guidelines For Economic Evaluation Research Articles

Reliability, costs, and radiation dose of dual-energy X-ray absorptiometry in diagnosis of radiologic sarcopenia in surgically menopausal women.

The aim of this study was to evaluate and compare reliability, costs, and radiation dose of dual-energy X-ray absorptiometry (DXA) to MRI and CT in measuring muscle mass for the diagnosis of sarcopenia. Thirty-four consecutive DXA scans performed in surgically menopausal women from November 2019 until March 2020 were analyzed by two observers. Observers analyzed muscle mass of the lower limbs in every scan twice. Reliability was assessed by calculating inter- and intra-observer variability. Reliability from CT and MRI as well as radiation dose from CT and DXA were collected from literature. Costs for each type of scan were calculated according to the guidelines for economic evaluation of the Dutch National Health Care Institute. The 34 participants had a median age of 58years (IQR 53-65) and a median body mass index of 24.6 (IQR 21.7-29.7). Inter-observer variability had an intraclass correlation coefficient (ICC) of 0.997 (95% CI 0.994-0.998) with a relative variability of 0.037 ± 0.022%. Regarding intra-observer variability, observer 1 had an ICC of 0.998 (95% CI 0.996-0.999) with a relative variability of 0.019 ± 0.016% and observer 2 had an ICC of 0.997 (95% CI 0.993-0.998) with a relative variability of 0.016 ± 0.011%. DXA costs were €62, CT €77, and MRI €195. The estimated radiation dose of CT was 2.5-3.0mSv, for DXA this was 2-4 µSv. DXA has lower costs and a lower radiation dose, with low inter- and intra-observer variability, compared to CT and MRI for assessing lower limb muscle mass. Netherlands Trial Register; NL8068. DXA is a good alternative for CT and MRI in assessing lower limb muscle mass, with lower costs and lower radiation dose, while inter-observer and intra-observer variability are low. • Screening for sarcopenia should be optimized as the population ages. • DXA outperformed CT and MRI in the measured metrics. • DXA validity should be further evaluated as an alternative to CT and MRI for sarcopenia evaluation.

Guidelines for economic evaluation of post-marketing Chinese patent medicine

With the premise of drug safety and effectiveness, pharmacoeconomic evaluation can provide optimal solutions for diversified decision-making application scenarios from different research perspectives while maximizing the rational utilization of existing healthcare resources. Chinese patent medicine is an essential component of pharmaceutical utilization in China and a significant part of healthcare expenditure in China. However, the economic evaluation of post-marketing Chinese patent medicine is lacking. These evaluations often lack standardization, exhibit varying quality, and are unable to effectively support healthcare decisions, indicating a need for improvement in overall quality. Given this situation, this project has gathered leading experts from China and has strictly adhered to the requirements of the group standards set by the China Association of Traditional Chinese Medicine in developing Guidelines for economic evaluation of post-marketing Chinese patent medicine, aiming to provide methodological guidance for the post-market pharmacoeconomic evaluation of Chinese patent medicine, enhancing the standardization of pharmacoeconomic evaluations of Chinese patent medicine and the scientific validity of research results, and thereby elevating the overall quality of pharmacoeconomic evaluations for post-marketing Chinese patent medicine. The guidelines adhere to the framework provided by relevant laws and regulations in China and technical guidance documents. It is based on guidance from traditional Chinese medicine(TCM) theories, focusing on the unique characteristics of TCM. It covers various aspects of pharmacoeconomic evaluation, including fundamental principles, research topic selection, research question definition, study design type selection, cost identification and measurement, health outcomes, and evaluation methods. The guidelines offer methodological recommendations and decision guidance to address common issues and challenges in the pharmacoeconomic evaluation of post-marketing Chinese patent medicine.

Developing the Lebanese health economic evaluation guideline

ABSTRACT Objective To report on the process of developing the Lebanese Economic Evaluation Guidelines (LEEG), and to provide relevant material that could assist guideline developers in the future. Methods The development of the LEEG closely followed the process proposed by the World Health Organization, i.e. to set up a Guideline Development Group (composed of three Lebanese experts), to establish the rationale for developing the guideline in Lebanon, to identify its scope, to search and retrieve evidence through two systematic reviews, to assess and present the evidence, to translate the evidence into guidelines and recommendations through a deliberative process, and to consult international experts. The deliberative process included a survey, an in-person interview, and a consensus workshop with sixteen Lebanese key stakeholders. Data was collected and quantitative analysis was conducted using SPSS software. International experts from The Netherlands were consulted for issuing the LEEG. Supported by the Lebanese Ministry of Public Health (MoPH), the LEEG will be available for public consultation on the MoPH’s webpage, and a final version will be made available thereafter. Conclusion Clear and transparent reporting of the guideline development process should support international organizations as well as other developers in establishing their guidelines within their national context.

HTA198 Comparisons of Economic Evaluation Guidelines Between Japan and Six Countries (England, France, Germany, Sweden, Canada and Australia)

HTA198 Comparisons of Economic Evaluation Guidelines Between Japan and Six Countries (England, France, Germany, Sweden, Canada and Australia)

Healthcare costs of different treatment options for condylar fractures

ObjectiveAs treatment options for condylar fractures have comparable outcomes, getting insight into associated costs is a first step towards implementing value-based healthcare (VBH). Therefore, we described the actual costs of the different treatment options (surgical, conservative, and expectative treatment) for condylar fractures. We expected surgical treatment to be the most expensive treatment. Study designThis is a cost-of-illness study, based on estimates from the literature. Firstly, care pathways of all treatment options were described. Secondly, the costs per step were calculated based on the literature and Dutch guidelines for economic evaluations in health care. ResultsThe direct treatment costs of surgical treatment (€3721 to €4040) are three to five times higher than conservative treatment (€730 to €1332). When lost productivity costs during the recovery period are included, costs of surgical treatment remain 1.5 times higher (€9511 to €9830 for surgical treatment and €6224 to €6826 for conservative treatment). The costs of expectative treatment (€5436) are lower than both other treatments. ConclusionThe costs for surgical treatment are considerably higher than those for conservative or expectative treatment, mainly related to direct treatment cost. Future research should focus on the patients’ perspective, to support implementation of VBH in treating condylar fractures.

Costs and cost-effectiveness of Shamiri, a brief, layperson-delivered intervention for Kenyan adolescents: a randomized controlled trial

BackgroundLow- and middle-income countries (LMICs) have the highest socio-economic burden of mental health disorders, yet the fewest resources for treatment. Recently, many intervention strategies, including the use of brief, scalable interventions, have emerged as ways of reducing the mental health treatment gap in LMICs. But how do decision makers prioritize and optimize the allocation of limited resources? One approach is through the evaluation of delivery costs alongside intervention effectiveness of various types of interventions. Here, we evaluate the cost-effectiveness of Shamiri, a group– and school–based intervention for adolescent depression and anxiety that is delivered by lay providers and that teaches growth mindset, gratitude, and value affirmation.MethodsWe estimated the cost-effectiveness of Shamiri using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines for economic evaluations. Changes in depression and anxiety were estimated using the Patient Health Questionnaire (PHQ-8) and Generalized Anxiety Disorder questionnaire (GAD-7) at treatment termination and 7-month follow-up using two definitions of treatment benefit. Cost-effectiveness metrics included effectiveness-cost ratios and cost per number needed to treat.ResultsBase case cost assumptions estimated that delivering Shamiri cost $15.17 (in 2021 U.S. dollars) per student. A sensitivity analysis, which varied cost and clinical change definitions, estimated it cost between $48.28 and $172.72 to help 1 student in Shamiri, relative to the control, achieve reliable and clinically significant change in depression and anxiety by 7-month follow-up.ConclusionsShamiri appears to be a low-cost intervention that can produce clinically meaningful reductions in depression and anxiety. Lay providers can deliver effective treatment for a fraction of the training time that is required to become a licensed mental health provider (10 days vs. multiple years), which is a strength from an economic perspective. Additionally, Shamiri produced reliable and clinically significant reductions in depression and anxiety after only four weekly sessions instead of the traditional 12–16 weekly sessions necessary for gold-standard cognitive behavioral therapy. The school setting, group format, and economic context of a LMIC influenced the cost per student; however, broader conclusions about the cost-effectiveness of Shamiri have yet to be determined due to limited economic evaluations of mental health programs in LMICs.Trial registrationThis study was registered prior to participant enrollment in the Pan-African Clinical Trials Registry (PACTR201906525818462), registered 20 Jun 2019, https://pactr.samrc.ac.za/Search.aspx.

Economic analyses of behavioral health intervention implementation: Perspective on stakeholder engagement.

To provide full potential benefits to patients, behavioral health interventions often require comprehensive and systematic implementation efforts. The costs of these efforts should therefore be included when organizations decide to fund or adopt a new intervention. However, existing guidelines for conducting economic analyses like cost-effectiveness analyses and budget impact analyses are not well-suited to the complexity of the behavioral healthcare pathway and its many stakeholders. Stakeholder engagement, when used effectively with recent innovations in economic analysis, advance more equitable access to interventions for individuals living with behavioral health conditions. But early and ongoing stakeholder engagement has not yet been incorporated into best-practice guidelines for economic evaluation. We discuss our perspective, as researchers and clinicians in a large integrated health system, on how the integration of stakeholder engagement with existing economic analysis methods could improve decision-making about implementation of behavioral health interventions.

HTA29 Digital Health Interventions: A Review of Economic Evaluation Guidelines From Health Technology Assessment Agencies

HTA29 Digital Health Interventions: A Review of Economic Evaluation Guidelines From Health Technology Assessment Agencies

Cost-Effectiveness of Low-Dose Compared to Standard-Dose Alteplase for Acute Ischemic Stroke in China: A Within-Trial Economic Evaluation of the ENCHANTED Study

Introduction: The Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) showed that a low-dose alteplase was safe but not clearly non-inferior to standard-dose alteplase in acute ischemic stroke (AIS). Given the significant cost of this medicine, we undertook a cost-effectiveness analysis to determine the probability that low-dose is cost-effective relative to standard-dose alteplase in China. Methods: For ENCHANTED participants in China with available health cost data, cost-effectiveness and cost-utility analyses were undertaken in which death or disability (modified Rankin scale scores 2–6) at 90 days and quality-adjusted life-years (QALYs) were used as outcome measures, respectively. There was adherence to standard guidelines for health economic evaluations alongside non-inferiority trials and according to a health-care payer’s perspective. The equivalence margin for cost and effectiveness was set at USD 691 and −0.025 QALYs, respectively, for the base-case analysis. Probabilistic sensitivity analyses were used to evaluate the probability of low-dose alteplase being non-inferior. Results: While the mean cost of alteplase was lower in the low-dose group (USD 1,569 vs. USD 2,154 in the standard-dose group), the total cost was USD 56 (95% confidence interval [CI]: −1,000–1,113) higher compared to the standard-dose group due to higher hospitalization costs in the low-dose group. There were 462 (95% CI: 415–509) and 410 (95% CI: 363–457) patients with death or disability per 1,000 patients in the low-dose and standard-dose groups, respectively. The low-dose group had marginally lower (0.008, 95% CI: −0.016–0.001) QALYs compared to their standard-dose counterparts. The low-dose group was found to have an 88% probability of being non-inferior based on cost-effectiveness versus the standard-dose group. Conclusions: This health economic evaluation alongside the ENCHANTED indicates that the use of low-dose alteplase does not save overall healthcare costs nor lead to a gain in QALYs in the management of Chinese patients with AIS compared to the use of standard dose. There is little justification on economic grounds to shift from standard-of-care thrombolysis in AIS.

Home Telemonitoring and a Diagnostic Algorithm in the Management of Heart Failure in the Netherlands: Cost-effectiveness Analysis.

BackgroundHeart failure is a major health concern associated with significant morbidity, mortality, and reduced quality of life in patients. Home telemonitoring (HTM) facilitates frequent or continuous assessment of disease signs and symptoms, and it has shown to improve compliance by involving patients in their own care and prevent emergency admissions by facilitating early detection of clinically significant changes. Diagnostic algorithms (DAs) are predictive mathematical relationships that make use of a wide range of collected data for calculating the likelihood of a particular event and use this output for prioritizing patients with regard to their treatment.ObjectiveThis study aims to assess the cost-effectiveness of HTM and a DA in the management of heart failure in the Netherlands. Three interventions were analyzed: usual care, HTM, and HTM plus a DA.MethodsA previously published discrete event simulation model was used. The base-case analysis was performed according to the Dutch guidelines for economic evaluation. Sensitivity, scenario, and value of information analyses were performed. Particular attention was given to the cost-effectiveness of the DA at various levels of diagnostic accuracy of event prediction and to different patient subgroups.ResultsHTM plus the DA extendedly dominates HTM alone, and it has a deterministic incremental cost-effectiveness ratio compared with usual care of €27,712 (currency conversion rate in purchasing power parity at the time of study: €1=US $1.29; further conversions are not applicable in cost-effectiveness terms) per quality-adjusted life year. The model showed robustness in the sensitivity and scenario analyses. HTM plus the DA had a 96.0% probability of being cost-effective at the appropriate €80,000 per quality-adjusted life year threshold. An optimal point for the threshold value for the alarm of the DA in terms of its cost-effectiveness was estimated. New York Heart Association class IV patients were the subgroup with the worst cost-effectiveness results versus usual care, while HTM plus the DA was found to be the most cost-effective for patients aged <65 years and for patients in New York Heart Association class I.ConclusionsAlthough the increased costs of adopting HTM plus the DA in the management of heart failure may seemingly be an additional strain on scarce health care resources, the results of this study demonstrate that, by increasing patient life expectancy by 1.28 years and reducing their hospitalization rate by 23% when compared with usual care, the use of this technology may be seen as an investment, as HTM plus the DA in its current form extendedly dominates HTM alone and is cost-effective compared with usual care at normally accepted thresholds in the Netherlands.

I2S-LWR Top-Down Differential Economics Evaluation Approach

The Integral Inherently Safe Light Water Reactor (I2S–LWR) is a design concept of a large (~1000 MWe) light water reactor with integral primary circuit configuration. One of the key design features promoting inherent safety is implementation of an integral primary circuit configuration, which in turn requires a compact design of the core and primary circuit components. Assessments of the cost of I2S-LWR is an important aspect of the overall evaluation of the new reactor concept. There are several approaches to cost estimation and economics evaluation of the new nuclear power technologies. Frequently used guidelines rely on the Code of Accounts, originally developed in the U.S. Department of Energy (DOE) Energy Economics Data Base (EEDB) Program Code of Accounts, proposed as evaluation tool by C.R. Hudson, and further popularized in the guidelines for economic evaluation of bids, by The International Atomic Energy Agency (IAEA). The code of accounts allows to break down main costs (Total Capital Investment Cost, Fuel Cycle Cost, Operation and Maintenance) to individual systems and items. This work aims to implement and apply a top-down differential economics evaluation approach to the Code of Accounts based guidelines, to assess the costs of the I2S -LWR relative to a representative “standard” PWR. In this methodology, a representative PWR design was taken as a reference and the differential cost was estimated for each individual account based on the design difference (or similarity). Cost estimating techniques were applied to the accounts representing systems that differ from the ones of the reference PWR. In this manner, the cost of the common components cancels out, and the uncertainty in the estimate is reduced. While this preliminary evaluation yet needs to be completed, the indications so far are that the I2S-LWR LCOE will be economically competitive with a standard PWR.

The development process of economic evaluation guidelines in low- and middle-income countries: a systematic review

To review the development of economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs), with the goal of assisting those developing EEGs in LMICs. We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature until March 2021. We extracted data on the methods used in the EEG development process, the responsible party engaged, and the development team's composition. We conducted a quality assessment, using the Appraisal of Guidelines for Research and Evaluation-Health Systems tool, and then carried out a relative comparison. Fourteen EEGs and nine studies were identified. In ten countries, the Ministry of Health was responsible for handling the development process. The majority of LMICs who developed EEGs did not explicitly report the discipline of those involved in the process. The developers of EEGs followed four main steps: conducting a review on national guidelines, organizing workshops, and getting support from international experts or from organizations. One-third of the identified EEGs failed to engage multisectoral or multidisciplinary developers, and approximately 14 percent did not follow or report any recommended step. This study identified a scarcity of published information related to the development process and the suboptimal quality of included studies. It provides relevant material to support international organizations and developers of guidelines in LMICs in developing EEGs that fit their national context. In addition, this paper recommends a transparent approach to the design of guidelines and to reporting on the methods for developing them.

Economic evaluation guidelines in low- and middle-income countries: a systematic review.

To systematically identify the latest versions of official economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs) and explore similarities and differences in their content. We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature. Using a predefined checklist, we extracted the key features of economic evaluation and the general characteristics of EEGs. We conducted a comparative analysis, including a summary of similarities and differences across EEGs. Thirteen EEGs were identified, three pertaining to lower-middle-income countries (Bhutan, Egypt, and Indonesia), nine to upper-middle-income countries (Brazil, China, Colombia, Cuba, Malaysia, Mexico, Russian Federation, South Africa, and Thailand), in addition to Mercosur, and none to low-income countries. The majority (n = 12) considered cost-utility analysis and health-related quality-of-life outcome. Half of the EEGs recommended the societal perspective, whereas the other half recommended the healthcare perspective. Equity considerations were required in ten EEGs. Most EEGs (n = 11) required the incremental cost-effectiveness ratio and recommended sensitivity analysis, as well as the presentation of a budget impact analysis (n = 10). Seven of the identified EEGs were mandatory for pharmacoeconomics submission. Methodological gaps, contradictions, and heterogeneity in terminologies used were identified within the guidelines. As the importance of health technology assessment is increasing in LMICs, this systematic review could help researchers explore key aspects of existing EEGs in LMICs and explore differences among them. It could also support international organizations in guiding LMICs to develop their own EEGs and improve the methodological framework of existing ones.

Costing methodologies in European economic evaluation guidelines: commonalities and divergences.

From both the methodological point of view and standardization of methodology, little attention has been paid to the estimation of direct costs in evaluation of healthcare technologies. The objective is to revise the recommendations on direct costs provided in European economic evaluation guidelines and to identify the commonalities and divergences among them. To achieve this, a comprehensive search through several online databases was performed resulting in 41 documents from 26 European countries, be they economic evaluation guidelines or costing guidelines. The results show a large disparity in methodologies used in estimation of direct costs to be included in economic evaluations of health technologies recommended by European countries. A lack of standardization of cost estimation methodologies influences arbitrariness in selecting costs of resources included in economic evaluations of medicinal products or any other technologies and, therefore, in decision making process necessary to introduce new technology. In addition, this heterogeneity poses a major challenge for identifying factors that could affect the variability of unit costs across countries.

Future Offspring Costs in Economic Evaluation.

Economic evaluation guidelines increasingly prescribe inclusion of all future costs. We point at an important dimension of future costs that is systematically neglected. Healthcare can affect future offspring, either through affecting the patient's fertility or through determining future offspring's health. As we show, the future costs associated with these changes can be substantial and will vary across interventions and demographic groups. However, systematic inclusion of these future offspring costs would raise many problems on its own. Based on the population ethics concept of necessitarianism, we suggest that only those future costs that spring from 'necessary' future lives should be included in future cost calculations, while all costs associated with 'potential' future lives can be ignored. This approach allows excluding most future offspring costs and avoids skewed cost-effectiveness outcomes of interventions with fertility effects, while taking into account the economic implications of preventing disease in future generations that will exist by necessity. Overall, future generations expose a substantial gap in today's Health Technology Assessment (HTA) methodology and further discussion of the issues they raise is needed.

The Potential Impact of Digital Biomarkers in Multiple Sclerosis in The Netherlands: An Early Health Technology Assessment of MS Sherpa.

(1) Background: Monitoring of Multiple Sclerosis (MS) with eHealth interventions or digital biomarkers provides added value to the current care path. Evidence in the literature is currently scarce. MS sherpa is an eHealth intervention with digital biomarkers, aimed at monitoring symptom progression and disease activity. To show the added value of digital biomarker–based eHealth interventions to the MS care path, an early Health Technology Assessment (eHTA) was performed, with MS sherpa as an example, to assess the potential impact on treatment switches. (2) Methods: The eHTA was performed according to the Dutch guidelines for health economic evaluations. A decision analytic MS model was used to estimate the costs and benefits of MS standard care with and without use of MS sherpa, expressed in incremental cost-effectiveness ratios (ICERs) from both societal and health care perspectives. The efficacy of MS sherpa on early detection of active disease and the initiation of a treatment switch were modeled for a range of assumed efficacy (5%, 10%, 15%, 20%). (3) Results: From a societal perspective, for the efficacy of 15% or 20%, MS sherpa became dominant, which means cost-saving compared to the standard of care. MS sherpa is cost-effective in the 5% and 10% scenarios (ICERs EUR 14,535 and EUR 4069, respectively). From the health care perspective, all scenarios were cost-effective. Sensitivity analysis showed that increasing the efficacy of MS sherpa in detecting active disease early leading to treatment switches be the most impactful factor in the MS model. (4) Conclusions: The results indicate the potential of eHealth interventions to be cost-effective or even cost-saving in the MS care path. As such, digital biomarker–based eHealth interventions, like MS sherpa, are promising cost-effective solutions in optimizing MS disease management for people with MS, by detecting active disease early and helping neurologists in decisions on treatment switch.

Accounting for country- and time-specific values in the economic evaluation of health-related projects relevant to low- and middle-income countries.

Economic evaluation of health-related projects requires principles and methods to address the various trade-offs that need to be made between costs and benefits, across sectors and social objectives, and over time. Existing guidelines for economic evaluation in low- and middle-income countries embed implicit assumptions about expected changes in the marginal cost per unit of health produced by the healthcare sector, the consumption value of health and the appropriate discount rates for health and consumption. Separating these evaluation parameters out requires estimates for each country over time, which have hitherto been unavailable. We present a conceptual economic evaluation framework that aims to clarify the distinct roles of these different evaluation parameters in evaluating a health-related project. Estimates for each are obtained for each country and in each time period, based on available empirical evidence. Where existing estimates are not available, for future values of the marginal cost per unit of health produced by the healthcare sector, new estimates are obtained following a practical method for obtaining projected values. The framework is applied to a simple, hypothetical, illustrative example, and the results from our preferred approach are compared against those obtained from other approaches informed by the assumptions implicit within existing guidelines. This exposes the consequences of applying such assumptions, which are not supported by available evidence, in terms of potentially sub-optimal decisions. In general, we find that applying existing guidelines as done in conventional practice likely underestimates the value of health-related projects on account of not allowing for expected growth in the marginal cost per unit of health produced by the healthcare sector.

National Healthcare Economic Evaluation Guidelines: A Cross-Country Comparison.

Background and ObjectivesGlobally, a number of countries have developed guidelines that describe the design and conduct of economic evaluations as part of health technology assessment (HTA) or pharmacoeconomic analysis for decision making. The current scoping review was undertaken with an objective to summarize the recommendations made on methods of economic evaluation by the national healthcare economic evaluation (HEE) guidelines.MethodologyA comprehensive search was undertaken in the website repositories of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) and Guide to Economic Analysis and Research (GEAR), and websites of national HTA agencies and ministries of health of individual countries. All guidelines in the English language were included in this review. Data were extracted with respect to general and methodological characteristics, and a descriptive analysis of recommendations made across the countries was undertaken.ResultsOverall, our review included 31 national HEE guidelines, published between 1997 and August 2020. Nearly half (45%) of the guidelines targeted the evaluation of pharmaceuticals. The nature of the guidelines was either mandatory (31%), recommendatory (42%), or voluntary (16%). There was a substantial consensus among the guidelines on several key principles, including type of economic evaluation (cost-utility analysis), time horizon of the analysis (long enough), health outcome measure (quality-adjusted life-years) and use of sensitivity analyses. The recommendations on study perspective, comparator, discount rate and type of costs to be included (particularly the inclusion of indirect costs) varied widely.ConclusionDespite similarity in the overall processes, variation in several recommendations given by various national HEE guidelines was observed. This is perhaps unsurprising given the differences in the health systems and financing mechanisms, capacity of local researchers, and data availability. This review offers important lessons and a starting point for countries that are planning to develop their own HEE guidelines.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-020-00250-7.

Multidisciplinary treatment for patients with chronic kidney disease in pre-dialysis minimizes costs: a four-year retrospective cohort analysis.

Introduction:Chronic kidney disease (CKD) can progress to end-stage renal disease (ESRD), and clinical studies show that this progression can be slowed. The objective of this study was to estimate the costs to Brazil’s public health system (SUS) throughout the course of CKD in the pre-dialysis stage compared to the costs to the SUS of dialysis treatment (DT). Methods:A retrospective cohort study was conducted to analyze clinical and laboratory variables; the outcome analyzed was need for DT. To assess cost, a microcosting survey was conducted according to the Methodological Guidelines for Economic Evaluations in Healthcare and the National Program for Cost Management, both recommended by the Brazilian Ministry of Health for economic studies. Results:A total of 5,689 patients were followed between 2011 and 2014, and 537 met the inclusion criteria. Average costs increased substantially as the disease progressed. The average cost incurred in stage G1 in Brazilian reals was R$ 7,110.78, (US$1,832.06) and in stage G5, it was R$ 26,814.08 (US$6,908.53), accumulated over the four years. Conclusion:A pre-dialysis care program may reduce by R$ 33,023.12 ± 1,676.80 (US$ 8,508.26 ± 432.02) the average cost for each year of DT avoided, which is sufficient to cover the program’s operation, minimizing cost. These results signal to public health policy makers the real possibility of achieving significant cost reduction in the medium term for CKD care (4 years), to a program that disbursed R$ 24 billion (US$ 6.8 billion) for DT in Brazil between 2009 and 2018.

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries.

To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure-for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.