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The process of health technology assessment (HTA) is a valuable tool for the pursuit of equitable and sustainable healthcare systems. Various countries have established organizations dedicated to conducting HTAs, adapting such institutions to local healthcare ecosystems. The aim of this study was to evaluate the structure, methods, and processes of organizations responsible for national-level HTAs globally.
Methods
A scoping review was conducted assessing organizations responsible for conducting HTAs for national-level decision-making in any country. Identification of eligible organizations was performed through a review of member organizations of INAHTA, EUnetHTA, RedETSA, and HTAsiaLink networks, as well as organizations evaluated in reviews with a similar scope. For each organization, the following data were searched: country, year of foundation, organizational nature, role in decision-making, funding, technologies assessed, criteria considered for decision-making (such as efficacy and safety, costs, impact on equity, among others), type of economic evaluation, and patient involvement.
Results
We identified 69 organizations, from 56 countries, mainly European (n=39; 56%). Fifty-three (77%) are government-affiliated; most (n=51; 74%) have a consultative role. Public funding is the main funding, and 12 (17%) organizations charge fees for conducting HTA. Technologies assessed include drugs (n=61; 88%), devices (n=47; 68%), and procedures (n=33; 48%). HTA is usually initiated upon request from the manufacturer (n=45; 65%). Patient involvement is not clearly described in 32 organizations (46%); in 29 organizations (42%), the role of patients is to provide information that is considered during decision-making.
Conclusions
Among the evaluated organizations, it is observed that the majority are government-affiliated, have public funding, and play a consultative role. The results of this study serve as an important reference for the development and improvement of organizations responsible for conducting HTAs.
Economic criteria have become critical for health technology assessment (HTA) due to the rising costs of health technologies. The use of explicit, predefined criteria for economic evaluations enhances the transparency, objectivity, and predictability of the process. We aimed to identify which organizations worldwide integrate explicit and predefined criteria into their health economic analyses during HTA.
Methods
We conducted a scoping review to identify organizations responsible for HTA processes at the national level in any country. The identification of eligible organizations was carried out by reviewing members of the EUnetHTA, HTAsiaLink, INAHTA, and RedETSA networks as well as organizations evaluated in reviews with a similar scope. For each eligible organization, information was extracted on the inclusion of economic factors during decision-making and the existence of predefined criteria for judging the results of economic evaluations.
Results
Sixty-nine organizations from 56 countries were identified, of which 66 (96%) considered economic factors for HTA. Fifty-two (79%) organizations conducted cost-effectiveness analyses, 42 (64%) assessed budget impact, and one focused solely on total technology costs. Thirty-four organizations (51%) declare not having criteria for economic evaluation, whereas 14 (21%) from 12 countries had explicit criteria. There were no data found for 18 organizations (27%). Among the organizations with explicit criteria, 11 (17%) applied willingness-to-pay thresholds in cost-effectiveness evaluations and five (8%) applied criteria related to budget impact for decision-making, such as a maximum percentage of budget impact.
Conclusions
Although most organizations consider economic factors for HTA, many do not have explicit, predefined criteria for decision-making. Among those that presented such criteria, willingness-to-pay thresholds for cost-effectiveness analyses were the most common. The findings of this study also help to identify complementary factors that can be considered to promote greater systematization and transparency in the decision-making process.
Health economic analyses compare the necessary investments and health outcomes for two or more technologies, assisting in resource allocation. How these analyses are conducted directly affects the results obtained. Therefore, it is essential to consider their quality during decision-making. The aim of this study was to develop a domain-based tool for the critical assessment of cost-effectiveness and cost-utility studies.
Methods
We conducted a scoping review to identify tools available for the critical assessment of health economic analyses and extracted their recommendations. Based on the tools’ items and the discussions of a working group, we identified domains related to the methodological quality of health economic analyses for inclusion in the new tool. The items extracted during the scoping review were classified according to the previously defined domains and were used to identify complementary aspects that should be included in the new tool.
Results
We identified 21 tools, all of which were checklists containing seven to 80 items. The following four quality domains were established for the new tool: (i) applicability of the research question; (ii) model structure; (iii) model parameters; and (iv) precision of the results. Assessment of each domain was guided by signaling questions. The first domain assessed the applicability of the research question to the desired setting; the second evaluated whether the model adequately represents the complexity of the clinical condition; the third assessed the quality (certainty) of the key parameters used in the model; and the fourth evaluated the certainty of the incremental cost-effectiveness or cost-utility ratio.
Conclusions
The tool was developed to integrate critical aspects that affect the methodological quality of health economic analyses, which are often missing in other tools. The quality of reporting was not included as a domain because it is already covered by existing tools. A multidisciplinary panel with different key stakeholders is being organized to review and refine the first version of the tool.
To estimate the cost of metastatic prostate cancer (mPC) treatment using the time-driven activity-based costing (TDABC) method from the perspective of a philanthropic hospital in the Brazilian public health system (PHS) and to identify determinants of costs.
Methods
We used data from patients who received docetaxel chemotherapy in the Brazilian PHS from September 2012 to May 2017. Direct medical costs were estimated with the TDABC microcosting method, taking into account the multiple departments and services the patients interacted with during their oncological treatment.
Results
The median overall survival of the forty-three patient sample was 1.8 years (95% CI 1.45–2.30), and the total cost of the sample was BRL 917.005 (USD 250,878). The median monthly cost per patient was BRL 20.201 (USD 5,526). The end-of-life cost per patient using the TDABC method was BRL 5.151 (USD 1,409). Patients who had received previous treatment at the center registered the lowest cost for hospitalizations and exams, suggesting an opportunity to better manage healthcare resources.
Conclusions
This is the first study on the economic burden of mPC in the Brazilian PHS using the TDABC costing evaluation method. Accurate cost information obtained with the TDABC can be helpful in guiding disease management to guarantee better use of ever-scarcer resources.
Healthcare organizations have invested efforts on hospital-based health technology assessment (HB-HTA) and enterprise risk management (ERM) processes for novel systems to obtain more accurate data on which to base strategic decisions. This study proposes to analyze how HB-HTA and ERM processes can share personal resources and skills to achieve principles with value-oriented results.
Methods
Literature on ERM and HB-HTA and data from interviews with healthcare managers compose the research data sources, which were submitted to a qualitative data analysis. It was oriented to identify the association between ERM and HB-HTA application in hospitals and the common principles between both processes, in addition to proposing the capability to share personal resources between both teams in a matrix.
Results
The common principles and personal background suggested for HB-HTA and ERM teams allowed the build of a matrix identifying how both teams can work in an integrated manner being more effective and value-oriented. The shared resource matrix reports how each professional (with a specific background) may interact with each activity associated to HB-HTA or ERM implementation guidelines.
Conclusions
The identification of common principles and capabilities between ERM and HB-HTA suggested advances with the literature from both research areas. The opportunity to share personal resources also contributes to the implementation of those processes in hospitals with less financial resources, approaching its own management to be more efficient with the care chain.
In Brazil, cardiovascular disease accounted for twenty-eight percent of deaths in 2013 with an estimated prevalence of five to eight in adults over forty years of age. Health care costs have quadrupled in the last decade, reaching USD 125 billion in 2013, of which forty-four percent were paid by the public system. The objective of this study was to estimate the direct costs associated with inpatient stay for myocardial infarction in a public teaching hospital from the perspective of the service provider.
Methods:
We used a bottom up microcosting methodology for collecting data from computerized hospital records and patients' hospital bills. The costs included salaries of health professionals, medications, consumables, laboratory and diagnostic tests performed during hospitalization and maintenance expenses. Mean, standard-deviation, median and total costs were calculated. The costs were presented as mean and median values in Brazilian currency and converted to US dollars by the exchange rate.
Results:
A total of eighty-one patients were included in this study. The mean population age was 60 ± 10.6 years, the follow-up period were 107 ± 2.6 months; fifty-four percent were male, eighty-four percent had hypertension, thirty-six percent had diabetes, and twelve percent had previous cerebrovascular accident. During follow-up, there were 101 hospitalizations for myocardial infarction, of which fifty-seven with intensive care unit (ICU) days. The total cost with hospitalizations was USD 177,288, of which fifty-two percent were the health professionals’ costs. The average cost for hospitalization was USD 1,755 (median USD 1,221). However, the average reimbursement paid by the public system was USD 1,188 (median USD 1,044) per hospitalization, generating a deficit of thirty-two percent for the hospital.
Conclusions:
These results may indicate the necessity of reviewing the public reimbursement policies for the service providers in Brazil. Besides that, these data may also serve as input for the economic evaluation in coronary artery disease.
Extracorporeal circulatory membrane oxygenation (ECMO) is a technology that allows recovery of adults in cardiorespiratory failure with encouraging results, but is not available in the Brazilian universal public health system (SUS) due to high implementation costs. Time-driven activity based costing (TDABC) is applied to measure processes in an economic perspective by identifying opportunities to make processes more efficient through the reduction of resources used in each activity. The literature has explored the use of TDABC to measure costs related with clinical procedures and technologies in microcosting studies, identifying opportunities to improve the process by making it more efficient. This research measures the real costs to implement ECMO in Brazil to compare with the current public reimbursement system.
Methods:
This study applied TDABC using data from 6 patients to measure costs of ECMO intervention considering the public perspective in Brazil. In sequence, standard price payed by SUS was used to estimate the current reimbursement amount received by the hospital for ECMO procedure. Cost variable analysis was conducted to understand when and how patients receiving ECMO are using hospital resources. Cost data were collected from an academic public hospital using an average of 18 months (2016–2017) for the department costs.
Results:
The real average cost was USD 128,923. Most significant resource costs was medical staff, particularly for the three survivor patients, and the ECMO equipment presented the second highest cost. ECMO activities were separated into: before implantation of ECMO, period using ECMO, intensive care post-ECMO and rehabilitation, being the period where ECMO is the most expensive, particularly in nurse and physician costs. The SUS average was USD 31,437, which shows a difference of USD 97,485 between the real ECMO cost and the public reimbursement in Brazil.
Conclusions:
A critical element of the propagation of ECMO in Brazil and its reimbursement by public health system is the high cost and out-of-date standard payments by the Ministry of Health. Effort to implement a trustworthy method to guide decisions of SUS for the adoption and financing new technologies is essential to contribute to the optimization of public health policies in a country with a universal health system and limited resources dedicated to health sectors.
Venoarterial extracorporeal life support (ECLS) is increasingly used in patients during cardiogenic shock, due to favorable results in this very high-risk scenario. However, it is a costly intervention that requires heavy financial investment and specialized human resources.
Methods:
Cost-effectiveness analysis to evaluate ECLS in the perspective of the Brazilian public health system (SUS) in the population of adult patients with cardiogenic shock. A decision tree comparing ECLS and usual care was built, using efficacy data from a systematic review of literature, and cost data from SUS reimbursement values. Impact of parameter variability and uncertainty were ascertained with deterministic and probabilistic sensitivity analysis.
Results:
Usual care resulted in thirty percent probability of survival, at an average cost of 3,000 international dollars (Int$/USD); the strategy that includes ECLS resulted in sixty-two percent survival rate, and average cost of Int$ 23,000, with incremental cost-effectiveness ratio (ICER) of Int$ 62.215 per averted in-hospital death. Results were sensitive to device cost, and survival difference between strategies. In probabilistic sensitivity analysis, ECLS was consistently more costly and more effective than usual care; based on a willingness-to-pay of three times Brazilian gross domestic product (GDP) per capita (Int$ 45,000), there was twenty-seven percent probability of ECLS being cost-effective.
Conclusions:
ECLS has the potential to increase survival for cardiogenic shock, but would significantly increase costs. In the Brazilian public health system, the cost per averted in-hospital death is 4.1 times the domestic GDP per capita.
The use of multi-criteria decision analysis (MCDA) in health technology assessment (HTA) studies has become more common due to the fact that MCDA offers a comprehensive technique for decisions that involve multiple criteria and stakeholders. How MCDA contributes to the HTA decision making process is an issue to be investigated. A systematic review was carried out in order to provide an overview of the benefits identified in MCDA applications for the strategic HTA decision making process.
Methods:
A systematic review developed by Philip Wahlster et al. (2014) was updated. The papers were analyzed in order to determine how MCDA is connected with traditional HTA, and to identify opportunities through the application of MCDA. In total 965 papers were found, and 43 articles were included in the review. The included articles detailed MCDA applications oriented to tactical and strategic decision making processes. The review was conducted by two researchers.
Results:
Of the available studies published on MCDA, 76 percent were published between 2014 and 2017, and 24 percent were published prior to 2014. Regarding the MCDA methodology defined in the included studies, 10 used the analytical hierarchy process, four used multi-attribute theory, and others refer the methodology only as “MCDA”. Seventeen studies also included health technology economic analysis, in special cost-effectiveness, safety and technological innovation. The studies suggest MCDA adds value since it allows different stakeholders to be engaged in the decision making process.
Conclusions:
The increase in studies on MCDA and healthcare point to the possibility to add different criteria, engage people with different knowledge levels, and make the decision-making process more transparent. In comparison with other technical areas, the use of MCDA in healthcare is more focused on achieving the decision about adding the new technology, and to show how to engage stakeholders than to explain how to develop the algorithms and methodologies.
Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.
METHODS:
A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.
RESULTS:
Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.
CONCLUSIONS:
Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.
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