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The preferred regimen for initiating HIV/AIDS treatment, according to the Clinical Protocol and Therapeutic Guidelines (PCDT), is tenofovir, lamivudine, and dolutegravir (TDF/3TC/DTG). Fiocruz, through a productive development partnership (PDP), produces these antiretrovirals, strengthening the national industry. The National Committee for Health Technology Incorporation (CONITEC) evaluated the budgetary impact of incorporating bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) combination therapy and its effect on the sustainability of the PDP.
Methods
The analysis used data from the 2022 HIV Clinical Monitoring Report to identify the eligible population. The unit cost of the current regimen (TDF/3TC/DTG) was obtained from the Health Price Database, while the cost of the new regimen (BIC/FTC/TAF) was extracted from CONITEC Recommendation Report No. 675/2021. Using a market share analysis, a moderate 10 percent annual increase in uptake of BIC/FTC/TAF was projected, reaching 50 percent by the fifth year.
Results
For the budget impact calculation, a total of 245,923 people aged 50 years or older who were living with HIV and/or AIDS and undergoing antiretroviral therapy were considered. The costs with and without the incorporation of the BIC/FTC/TAF regimen were analyzed. The incorporation of the new technology resulted in an estimated budget impact of BRL15,463,638.24 (USD2,693,122.18) over the analyzed period.
Conclusions
The BIC/FTC/TAF regimen is an effective, safe treatment approved by international agencies. It is administered in a daily dose, which simplifies treatment. However, its patent restricts national production, and its use in place of the current regimen could impact PDPs, harming the national industry and the sustainability of the health system. Therefore, incorporations require balancing clinical benefits with innovation and financial impacts.
Neonatal disorders are a significant contributor to years lost to premature mortality and years lived with disability worldwide. Healthcare cost estimates for neonatal inpatient health care and the health conditions that most affect newborns in Brazil remain unknown at the national level. We estimated the inpatient healthcare costs in Brazil and identified the most burdensome health conditions.
Methods
This population-based descriptive study was conducted from the perspective of the Brazilian public health system. We used secondary nationwide data from the Hospital Information System. Inpatient healthcare records between 2011 and 2022 for newborns from zero to 27 days of life were included. Inpatient healthcare costs consisted of reimbursements for hospital procedures and daily hospital stays, including neonatal intensive care unit (NICU) admissions. Costs were adjusted for the 2023 inflation rate and presented in USD considering the parity index of 2023. The main health conditions are presented as International Classification of Diseases, 10th Revision categories.
Results
A total of 3,835,128 neonatal hospital admissions accounted for approximately USD6 billion, of which 26.7 percent were for NICU admissions. The ten costliest health condition categories accounted for 75.6 percent of total inpatient healthcare costs. Although the most prevalent neonatal health condition was neonatal jaundice (n=652,314), the category of disorders related to prematurity accounted for most inpatient neonatal care costs at USD1.7 billion (USD1.1 billion for NICU), followed by neonatal respiratory distress syndrome at USD1.6 billion (USD1.2 billion for NICU), and the category of other respiratory disorders at USD316.1 million (USD238.3 million for NICU).
Conclusions
This study revealed the economic burden of neonatal inpatient healthcare in Brazil, driven predominantly by NICU admissions for prematurity and respiratory conditions. The findings highlight the importance of targeted health interventions and policies to improve neonatal outcomes and optimize resource allocation.
Clinical trial registries provide relevant information to address publication bias in systematic reviews. However, monitoring these registries is a complex process. Results are rarely posted in registries, and finding publications in journals requires a laborious search across multiple resources. We aimed to monitor registries of randomized clinical trials, results posted on platforms, and articles published in journals in the context of a rapid review to inform decision-makers.
Methods
We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform from April 2020 to November 2024 as part of a systematic search on the use of vitamin D in COVID-19, including the MEDLINE, Embase, Web of Science, and the Cochrane Library databases. We collected data such as the study start date, sample size, principal trial characteristics, population, intervention, control, and main outcome. We reviewed new register monitoring results published in databases or platforms and assessed each report’s update frequency until November 2024.
Results
We found 54 unique register numbers with this different status information: 29 trials were completed, two terminated, four active (one recruiting and three not yet recruiting), two were ongoing, one had recruitment and regulatory approvals pending, 11 had unknown status, one was prematurely ended, and two were withdrawn. Two clinical trials were matched with one study published. In total, 26 trials had results published in journals. However, only two trials posted results on the platform. In the last review, 25 trials remained without results, and related publications were not found.
Conclusions
Searching clinical trial registries as part of a systematic review strategy is a necessary source for addressing publication bias. Monitoring clinical trial registries provides relevant information on the development and length of trials, identifying gaps and failures to assist research. Lack of updated information on registries, and finding accurate and worthy information about trials, can result in a time consuming and sometimes unsuccessful process.
Argentina’s healthcare system is fragmented, comprising public, private, and social security sectors. The guidance for incorporating a new health technology into the healthcare system suggests a single threshold value (0.016% of total health expenditure). This study analyzed the influence of cost heterogeneity on budget impact using the reimbursement of talazoparib for the treatment of metastatic prostate cancer as an example.
Methods
A budget impact analysis (BIA) was adapted for the National Institute of Social Services for Retirees and Pensioners and SURGE (union social security sector) perspectives. To be able to estimate the impact of medical costs, other parameters such as population and market share were fixed. Drug costs were estimated using reimbursement values, while the costs of healthcare resources and management of adverse events were obtained from the 3Eff SA cost database (3val), which is based on tariffs of institutions within the subsectors of the Argentine healthcare system.
Results
For direct medical resources (medication, medical consultations, laboratory tests, etc.) associated with metastatic prostate cancer treatment, cost heterogeneity across health sectors was 79 percent. The lowest variability was observed in laboratory tests (18%), while the highest was in medical consultations (310%). The cost of managing adverse events varied by 38 percent across sectors, with the highest variability in managing fatigue (118%) and the lowest in thrombocytopenia (2.4%). As a result, the average annual budget impact varied across sectors by just over 15 percent.
Conclusions
Our results showed a significant heterogeneity in costs among Argentina’s healthcare subsectors. This heterogeneity might lead to different reimbursement decisions based on the BIA results. Variability in costs underscores the need for sector-specific guidelines or thresholds for reimbursement decisions to ensure equitable and efficient resource allocation.
Emerging regions require equitable training processes to implement health technology assessment (HTA) effectively. This work presents the initial adaptive curriculum designed for a professional master’s degree in HTA, tailored to the regional context in Brazil, particularly for areas with evolving infrastructure. The objective was to foster HTA expertise by enhancing methodological skills, technical knowledge, and collaborative abilities among students.
Methods
The curricular adaptation was developed through collaboration between students and course coordinators, utilizing a cooperative methodology grounded in the first four stages of the Cooperation Pedagogy framework.
Results
The class consisted of 20 students: 75 percent were women, 60 percent from the Central-West region, 30 percent from the Northeast, and 10 percent from the North. Ten students worked in HTA units in hospitals and two worked in legal units. Students’ topics of interest included vaccination in remote areas, judicialization, post-incorporation assessments, and budget impact analyses. The results of the four stages were: (i) a coexistence contract developed based on students’ expectations; (ii) a “World Café” dynamic that facilitated the creation of “hot questions”; (iii) the curricular adaptation integrating all relevant subjects; and (iv) the affective environment fostering mutual learning and collaboration.
Conclusions
The next steps involve co-creating solutions to the students’ hot questions, which were: (i) Does decision-making overturn an HTA report?; (ii) Is the HTA language understandable to stakeholders?; (iii) How to raise awareness among judges?; (iv) How to stimulate the creation of HTA units in emerging regions?; and (v) What is the future of HTA?
Including drugs in the National Essential Medicines List is a complex process that considers population, budget, and socioeconomic factors. In Ecuador, these decisions rely on efficacy and safety data from existing studies without estimating the real impact and clinical benefit of the drugs. This study proposed a multicriteria model using minimal clinically important difference (MCID) values to evaluate oncologic drugs for inclusion.
Methods
Safety and efficacy were assessed using MCID values for primary outcomes, incorporating measures such as overall survival (OS), disease-free survival (DFS), and complete remission, following the Magnitude of Clinical Benefit Scale (v1.1) of the European Society for Medical Oncology. Epidemiological and demographic data were obtained from the National Institute of Statistics and quality of life was evaluated using EuroQol-5D scores. Information on oncologic drugs and regulatory considerations was sourced from authoritative organizations. All parameters were systematically organized and weighted, ensuring the total criteria groups accounted for 100 percent.
Results
Seven criteria groups were established, each containing parameters evaluated on a scale from zero to five, designed to reward or penalize based on assessment goals. The groups were weighted from five to 30 percent to reflect their relative importance or impact on decision-making. The criteria and weights were as follows: (i) disease burden (30%); (ii) efficacy (30%); (iii) safety (15%); (iv) quality of life impact (5%); (v) availability and accessibility (5%); (vi) therapeutic alternatives and international recommendations (10%); and (vii) other important criteria (5%). Consequently, scores were weighted differently across groups.
Conclusions
Accurately estimating the impact of oncologic drugs is critically important for public health. Implementing this multicriteria model will provide a more efficient, objective, and systematic framework for evaluating the inclusion, modification, or exclusion of oncologic drugs with respect to the National Essential Medicines List. This approach enhances decision-making processes and ensures the optimal selection of anti-cancer therapies, ultimately improving patient outcomes and resource allocation in Ecuador.
In Brazil’s Unified Health System (SUS), initial treatment for follicular lymphoma (FL) is generally effective, but many patients relapse and continue treatment with rituximab plus chemotherapy. Lenalidomide plus rituximab (LR) has been shown to improve overall survival (OS) and progression-free survival (PFS) in patients with FL. We assessed the cost utility and budget impact of LR for previously treated patients with FL from the SUS perspective.
Methods
A three-state partitioned survival model was built using rituximab OS and PFS curves from the AUGMENT clinical trial, which were extrapolated over a 40-year horizon using parametric distributions and adjusted with hazard ratios (HRs) from the comparison with LR (OS: HR 0.45, 95% confidence interval [CI]: 0.22, 0.92; PFS: HR 0.40, 95% CI: 0.29, 0.56). Curve selection was based on the Akaike and Bayesian information criterion and visual inspection. Utility values were obtained from international literature. Direct medical costs, including the cost of drugs, monitoring, and pre- and post-progression were considered. For the budget impact analysis, eligible patients were estimated based on measured demand, and two different market shares were compared with the reference scenario (without LR).
Results
LR showed an incremental benefit (3.10 quality-adjusted life years [QALYs]) and incremental costs (USD76,718 [BRL187,192]). The incremental cost-effectiveness ratio (ICER) suggested that LR was cost effective (USD24,712 [BRL60,298]/QALY), considering the Brazilian threshold of USD49,180 (BRL120,000) per QALY. In sensitivity analyses, LR remained cost effective in most scenarios except when the OS HR was adjusted to the upper limit of the 95 percent CI. Budget impact analysis showed that listing LR in the SUS would increase the budget by USD12,523,280 (BRL30,557,046) in five years if market share reached 50 percent by the fifth year (approximately 648 to 737 eligible patients per year).
Conclusions
Standard treatment options for relapsed FL are limited. Previously treated individuals with FL may benefit more from LR than from standard treatment with rituximab and chemotherapy. The ICER showed that lenalidomide could be cost effective for the Brazilian health system.
The reallocation of resources to efficacious and safe health technologies (HT) using disinvestment strategies to identify technologies considered to have low health value is relevant to ensure efficient use of resources. The objective of this work was to identify HT disinvestment strategies in Latin American countries and to describe the procedures used.
Methods
Participants in the 15th meeting of the Health Technology Assessment Network of the Americas (RedETSA), held in November 2024, were interviewed. Representatives of agencies from 10 Latin American countries (Argentina, Chile, Colombia, Cuba, Dominican Republic, Ecuador, El Salvador, Mexico, Peru, Uruguay) answered the following open questions: (i) Is disinvestment performed in your country?; (ii) Do you have established procedures for disinvestment?; (iii) How do you select HT to be disinvested?; and (iv) What type of HT are remove from the coverage of benefits?
Results
Argentina and Colombia have established procedures and have used them to implement HT disinvestment. Mexico also has procedures, but they have been used rarely. El Salvador does not have explicit procedures, but mechanisms for disinvestment have been used following requests from different stakeholders. The rest of the countries do not have established procedures but have excluded HT due to obsolescence or occurrence of adverse events that were previously unknown. Health technology assessment has been used to remove coverage for obsolete technologies and indications not previously assessed. Most technologies disinvested using health technology assessment were high-priced oncological medications.
Conclusions
In Latin America, very few countries have explicit procedures to identify and disinvest inefficient HT. Since the reallocation of resources is a well-known tool to improve the efficiency of health systems, it is necessary to establish well defined procedures to identify potential technologies for disinvestment and to remove their funding in the different health systems.
Intensive care unit (ICU) hospitalization costs are relevant due to their high impact on the healthcare system. ICU admissions financed by the Brazilian government through the Unified Health System totaled USD2.260 billion in 2023. Given the magnitude of these expenditures, economic evaluations of innovations in ICU care are critical. Because of the limitations of conventional sources of cost data, this study aimed to develop a cost estimation tool for health technology assessments.
Methods
Data were extracted from the IMPACTO-MR Project, a collaborative research platform coordinated by Brazilian hospitals, including Hospital Israelita Albert Einstein, partnering with the Ministry of Health and the National Health Surveillance Agency (ANVISA). Patient-level data were collected from 15 Brazilian ICUs from October 2019 to October 2024. Costs were categorized into fixed costs (doctors, nurses, physiotherapists, nursing assistants, administrative assistants, other workers, depreciation, electricity, water, telephone, internet, indirect costs, office supplies) and variable costs (drugs, materials, hemodialysis, blood transfusions, laboratory and imaging tests, medical gases). ICU costs were estimated by identifying consumption patterns using machine learning and considering clinical variables. Costs were adjusted for purchasing power parity and inflation.
Results
ICU costs per patient showed substantial variability. Fixed costs were more related to the structure of the ICU, management practices, and local and regional characteristics, did not vary in the short term, and had a strong correlation with length of stay. Variable costs were more related to the patient characteristics, reflected direct consumption, and varied in the short term. Estimating costs for health technology comparisons was possible with this calculator. Machine learning can be used to identify consumption patterns in ICUs and help estimate costs while taking into account clinical variables.
Conclusions
The IMPACTO-MR Project is conducting several health technology assessments in ICUs in Brazil. With this calculator, it is possible to perform cost-effectiveness analyses in ICUs when cost data are not available.
Economic restrictions can affect breast cancer healthcare attention; therefore, it is essential to identify the main economic factors that impact the health system’s budget. This study identified and quantified monetarily the events generating direct costs associated with the care of HER2+ breast cancer according to stage of the disease in a Colombian healthcare institution.
Methods
This retrospective observational study included women over 18 years of age with a diagnosis of HER2+ breast cancer identified through International Classification of Diseases, 10th Revision codes present in medical records between January 2018 and December 2022. Resources were organized into the categories of laboratory tests, medical consultations, procedures, diagnostic imaging, supplies, radiotherapy, and medications. The monetary valuation was carried out using the UPC Sufficiency, RIPS, SOAT, and SISMED prices databases for 2023. A micro-costing technique and a third-payer perspective were employed. The average and total care costs by baseline stage were evaluated.
Results
During the study period, 289 patients with HER2+ breast cancer were identified (age 53 years, standard deviation 11.7) with the following disease stages: in situ (n=2 patients), early (n=68), locally advanced (n=165), metastatic (n=41), and not reported (n=13). The total cost for managing the cohort was USD13,012,354, with the cost for the in situ stage being USD11,953 versus USD7,465,033 for locally advanced. Compared with treating patients in the situ stage, the average treatment cost was 4.8 times higher for early cancer, 7.6 times higher for locally advanced cancer, and 13.8 times for metastatic disease. The costs associated with medications represented 83 percent of the total, followed by procedures with eight percent.
Conclusions
The comprehensive care of patients with HER2+ breast cancer reflects a significant economic burden for the healthcare system, showing an increase in average costs in the advanced stages of the disease. These results highlight the importance of early diagnosis from an economic perspective on resources used for patients with HER2+ breast cancer to guide decision-making and achieve efficient resource allocation.
The rising costs of rare disease therapies pose significant challenges for health technology assessment (HTA) decision-makers and payers, particularly given the limited clinical evidence available at the time of appraisal. This has created a growing need for outcome-based managed entry agreements (OBMEAs) that link post-launch evidence generation to appropriate payment models. This study examined the implementation of OBMEAs in Belgium and offers best practices to optimize their use globally.
Methods
A document analysis was conducted of managed entry agreements (MEAs) for all rare disease therapies reimbursed between January 2012 and August 2024. Through a standardized template, OBMEAs were identified and classified based on type of uncertainties included and outcomes to be collected. HTA reports were analyzed to assess the impact of clinical and real-world evidence (RWE) on the reassessment of these therapies at the end of the OBMEA.
Results
The Belgian payer implemented outcome-based managed entry agreements (OBMEAs) for 57 orphan drugs, including five advanced therapy medicinal products. All OBMEAs followed a coverage with evidence development scheme, primarily addressing budget impact (32%) and efficacy (27%). The median duration was 24 months, with some agreements extended or renewed up to five times. Only eight percent of OBMEAs resulted in a definitive listing. RWE was frequently rejected during reassessment due to concerns about validity and incomplete registries. Key recommendations include establishing clearer data collection protocols and improving transparency at multiple levels to enhance the effectiveness of these agreements.
Conclusions
The findings highlight the challenges of implementing outcome-based MEAs in a manner that truly addresses long-term uncertainties. Adopting the best practices outlined in this study could support OBMEAs to fulfill their promise of balancing sustainability with timely patient access to innovative therapies.
Constraints on surgical capacity due to budgetary and workforce shortages necessitate prioritization. Lessons learned from the COVID-19 pandemic emphasize the societal debate around these decisions and stress the need to align decisions with societal preferences. This study examined societal preferences for prioritizing patients with three different conditions—breast cancer, deafness, or knee arthrosis—for scarce surgical capacity.
Methods
We conducted a labeled discrete choice experiment among 1,046 members of the Dutch public. Respondents completed 14 choice tasks in which they prioritized patients for surgery, based on condition, age, health-related quality of life (HRQoL) before and after surgery, and waiting time until surgery.
Results
Respondents were more likely to prioritize patients suffering from breast cancer over patients suffering from knee arthrosis or deafness. Respondents were also more likely to prioritize patients with lower levels of HRQoL before surgery, larger surgery-related increases in HRQoL, and longer waiting times until surgery. They were less likely to prioritize patients who were relatively older, although the opposite held true for patients suffering from deafness. Observed preference heterogeneity largely resulted from differences in preference strength, rather than preference direction.
Conclusions
Our results provided insight into societal preferences for prioritizing patients with different conditions for surgery. This insight aids in understanding public outcry that may follow decisions deviating from societal preferences. Aligning prioritization decisions with societal preferences may increase their legitimacy. Further research may examine the relevance of these preferences for physicians and their willingness to be guided by this.
Atrial fibrillation (AF) has a high economic burden for the healthcare system. Due to the emboligenic profile of AF, stroke prevention with oral anticoagulants (OAC) is usually recommended. For patients with AF at risk of bleeding who are contraindicated for OAC, non-pharmacological thromboembolism prevention therapies such as left atrial appendage closure (LAAC) is recommended. We aimed to incorporate the LAAC procedure into the Brazilian Supplementary Health Sector (SHS).
Methods
A scientific technical opinion (STO) including a literature review and economic and budget impact analysis was submitted to the National Supplementary Health Agency (ANS). The STO was technically evaluated and a health technology assessment based ANS decision rite was followed. The rite was composed of an applicant defense meeting, publication of an ANS critical report, a preliminary decision, public consultation, a public hearing, presentation of the public consultation results, and a final decision. Applicants could participate in the defense meeting and all stages of public participation.
Results
Arguing insufficient randomized controlled trials specifically addressing the OAC-contraindicated AF population and some concerns regarding the economic modeling, ANS preliminary decision was unfavorable to the incorporation. The ANS full critical report was published and received extensive responses from the applicants in the public consultation, which received 919 contributions. The main points addressed during public debates, including the public hearing were the ethical implications of allocating OAC-contraindicated patients to an OAC treatment arm; the lack of treatment available for this population in the Brazilian SHS; the importance of real-world evidence; the impact of stroke on patients, families, and society; and clarifications on the economic model. After considering all the contributions, the ANS reversed its verdict.
Conclusions
The LAAC procedure has been available in the Brazilian SHS since 1 July 2024. The ANS’ final favorable decision was only possible thanks to the broad space for public debate made available during the ANS decision rite, added to extensive popular engagement throughout the process.
Severe scoliosis affects three percent of the population, with 0.3 percent requiring surgery that often results in significant blood loss. The cell saver technique collects and reinfuses lost blood, potentially reducing the need for transfusions. This study evaluated its clinical outcomes and feasibility in scoliosis surgeries performed between January 2022 and March 2024 in a Brazilian Health Maintenance Organization.
Methods
A non-concurrent cohort study analyzed the use of cell savers in scoliosis surgeries performed between January 2022 and March 2024 within a non-profit health assistance organization in Brazil. Patients were divided into two groups: those who underwent intraoperative use of the cell saver technique and those who did not. Data on patient demographics, procedural details, and clinical outcomes were collected from institutional databases. Primary outcomes included the length of hospital stay, the need for blood transfusion, and rates of major complications. Statistical comparisons were performed using chi-square tests and t-tests (statistical significance set at p<0.05).
Results
Among 311 patients, nine received the cell saver technique. The mean age was 14.8 years, with 66 percent being younger than 19 years. In the non-cell saver group (302 patients), 36 percent required blood transfusions (average two units/patient) and the mean hospital stay was 7.52 days. In the cell saver group, 44 percent required transfusions (average 1.25 units/patient), and the mean hospital stay was 6.89 days. The results suggested trends toward reduced transfusion needs, use of fewer blood units, and shorter hospital stays in the cell saver group, although the sample size was limited.
Conclusions
This study identified potential benefits of intraoperative cell saver use in scoliosis surgeries, including reduced transfusion needs, use of fewer blood units, and shorter hospital stays. However, the findings require validation in larger, more diverse samples to establish clinical significance and cost effectiveness in routine practice.
Structured expert elicitation (SEE) is a method of formally collecting expert opinions and beliefs using a statistical framework that can be used to generate qualitative data for health technology assessment (HTA). SEE is a particularly useful strategy for rare diseases and innovative technologies, where clinical trial data can be subject to additional uncertainty.
Methods
To investigate how SEE evidence has been used in HTA submissions for rare diseases, a targeted literature search was conducted to identify relevant submissions to the National Institute for Health and Care Excellence (NICE) in the UK via the highly specialized technology (HST) pathway. HST reports were screened to ensure that the company submission documents were publicly available and that details of any SEE studies were included. Fields of extraction included the methods used by SEE, the value drivers that SEE data justified, and the consideration of such evidence by the NICE decision-making committee in the final appraisal document (FAD).
Results
All 27 submissions included in the final analysis leveraged SEE; eight submissions used two SEE methods, and 11 submissions used three methods. The most popular method was semi-structured interviews (81%), followed by surveys (59%), advisory boards (33%), and Delphi panels (26%). The majority of SEE evidence supported core value elements such as quality-adjusted life years (81%). However, SEE evidence was also used to support innovative value elements including family spillover (59%) and productivity (29%). Expert evidence was assessed in the majority of FADs but was accepted mostly when supporting core value elements.
Conclusions
Commonalities in submissions that successfully leveraged SEE to support holistic value elements included providing clear justification for why the data could not be sourced elsewhere, conducting multiple formats of expert engagement, recruiting large samples of experts, and including a detailed overview of the SEE study design. Manufacturers should consider these critical success factors when including SEE in evidence generation strategies.
Glaucoma is a leading cause of blindness. Ocular hypertension (OHT) is a key risk factor modifiable by regular monitoring and treatment. Population aging leads to rapid rise of OHT patients, and thus overburdens the UK healthcare system, but innovative technology may provide a solution. We assessed the cost effectiveness of making treatment decisions based on a validated risk prediction (RP) tool.
Methods
A discrete event simulation model was constructed to compare the cost effectiveness of an alternative care pathway in which the treatment decision was guided by a validated RP tool in secondary care against decision-making based on standard care (SC). Individual patient sampling was used. Patients diagnosed with OHT and with an intraocular pressure of at least 24 mmHg entered the model with a set of predefined individual characteristics related to their risk of conversion to glaucoma. These characteristics were retrieved from electronic medical records (n=5,740). Different stages of glaucoma were modeled following conversion to glaucoma.
Results
Almost all (99%) patients were treated using the RP strategy, and less than half (47%) of the patients were treated using the SC strategy. The RP strategy produced higher cost but also higher quality-adjusted life years (QALYs) than the SC strategy. The RP strategy was cost effective compared with the SC strategy in the base case analysis, with an incremental cost-effectiveness ratio value of GBP11,522 (USD15,843). The RP strategy had a 96 percent probability of being cost effective under a GBP20,000 (USD27,500) per QALY threshold.
Conclusions
The use of an RP tool for the management of patients with OHT is likely to be cost effective. However, the generalizability of the result might be limited due to the high risk nature of this cohort and the specific RP threshold used in the study.
How the role of health technology assessment (HTA) agencies in relation to medical technologies (MedTech) is framed in the literature reflects and influences governance, shaping perceptions and guiding decisions. We identify different academic discourses to advance MedTech policy debates, in light of several factors potentially influencing this role. This is the first time that discourse on the role of HTA agencies in relation to MedTech has been reviewed. We conducted a comprehensive search, screened for eligibility, and synthesised findings using discourse analysis. 119 articles were included, from which 5 discourses were constructed. The first discourse describes the HTA agency as an independent evaluator of appropriate evidence for all health technologies. The second discourse explicitly categorises MedTech as separate from pharmaceuticals and expands the role of evaluator to include encouraging evidence generation for MedTech. The third discourse moves away from the role of independent evaluator and describes the HTA agency as a convenor of all stakeholder perspectives, using an experimental approach. The fourth and fifth discourses critically reflect on the role of HTA agencies, the fourth on their level of normative reflection and the fifth on their level of nuanced, clinical expertise. We conclude with recommendations for policy and research.
Quality of life is crucial for assessing the impact of health and social care interventions, particularly in economically vulnerable contexts. The Dara Institute, a Brazilian non-governmental organization, uses an integrated approach to combat poverty. This study applied the EQ-HWB-S instrument to evaluate the quality of life of families served by the Institute by analyzing its relationship with income before and after intervention.
Methods
Using a hybrid study design, including cross-sectional and cohort analyses, the EQ-HWB-S instrument was applied to 100 families served by the Dara Institute in Brazil before and after the intervention, enabling an analysis of wellbeing and quality of life data based on income. Microsoft Excel and Python were used for data tabulation and statistical analysis, respectively.
Results
A total of 100 individuals, each representing their family served by the Institute, were included. According to the Brazil Criteria (socioeconomic status measurement score), 41 were classified as category C and 58 as D/E. In EQ-5D-3L, category C scored 0.787 (interquartile range [IQR] 0.692–0.801) and D/E scored 0.787 (IQR 0.695–0.801). In EQ-5D-5L, category C scored 0.762 (IQR 0.687–0.817) and D/E scored 0.754 (IQR 0.733–0.817). In EQ-HWB-S, category C scored 0.605 (IQR 0.457–0.865) and D/E scored 0.594 (IQR 0.449–0.743).
Conclusions
Although income differences influenced EQ-5D-3L, EQ-5D-5L, and EQ-HWB scores, interquartile ranges suggested a moderate impact on quality of life outcomes measured by EQ-HWB-S. Lower-income individuals (D/E) had slightly lower EQ-HWB-S scores than those in category C, reflecting additional challenges despite intervention. The EQ-HWB-S demonstrated potential for evaluating quality of life and wellbeing in at-risk populations.
Judicialization processes are a tool used by the population to access benefits not included in health coverage. New technologies present challenges in terms of financing health systems. Uruguay has suffered a substantial increase in the last decade in writs of protection and health costs associated with them. Different actions have been taken in order to reduce judicialization throughout these years.
Methods
We performed a descriptive study of the evolution of the number of writs of protection in Uruguay in the period 2012 to 2023. The data were obtained by analyzing requests for access to public information available on the web, requested by different stakeholders. Types of technologies and their frequency were analyzed. The costs per year were obtained from the national government’s accounts. The strategies implemented in each period were obtained from regulations available on the website of the Ministry of Health (MoH).
Results
Writs of protection have substantially increased, with a total of 124 in 2012 and increasing to 1,750 in 2023. The MoH’s spending on writs of protection rose from two percent in 2012 to 59 percent of its overall spending in 2023. Different measures taken by the MoH in the period 2014 to 2017 were introduced with the intention of reducing judicialization; examples include advice to lawyers from experts in health technology assessment, abbreviated administrative processes, and interinstitutional committees for price negotiation. Also, coverage of the most demanded technologies was a strategy used in most recent years.
Conclusions
In Uruguay, writs of protection continue to increase constantly. The different strategies implemented have not achieved a real impact in terms of quantity and costs associated with writs of protection. The recent creation of the Health Technology Agency may contribute to reducing the impact of judicialization on the health system.
Equity-informed economic evaluations require the baseline distribution of health across equity subgroups upon which the equity impact of interventions is evaluated. The distribution of health status, measured as quality-adjusted life expectancy (QALE), by socioeconomic status (SES) is unknown for Australia. We aimed to estimate QALE across SES groups, stratified by sex and year of age, for the Australian population.
Methods
SES was measured with the Socio-Economic Indexes for Areas Index of Relative Socio-Economic Disadvantage, from quintile one (Q1) most socioeconomically disadvantaged, to quintile five (Q5) least disadvantaged, and remoteness categories from the Australian Statistical Geography Standard: major cities, inner regional, and outer regional to very remote. Life expectancy (LE) was estimated from 2022 Australian Bureau of Statistics mortality data. Mean short form (SF-6D) utility by age, sex, and SES was estimated from the Household, Income and Labour Dynamics in Australia Survey (2022) using linear regression. Person-years were multiplied by utility to determine the QALE for each sex-SES group.
Results
At birth, LE for all individuals in Q1 was 78.7 years, compared with 86.3 years for those in Q5. Incorporating health-related quality of life amplified disparities, with those in Q1 experiencing a QALE of 43.9 (95% confidence interval [CI]: 42.6, 45.2) years, compared with 55.6 (95% CI: 54.1, 57.1) years for Q5, a 27 percent relative difference. There were modest disparities by remoteness. Individuals in major cities had a LE of 83.1 years and a QALE of 50.8 (95% CI: 49.8, 51.7) years, while those in outer regional to remote areas had a LE of 80.5 years and a QALE of 47.0 (95% CI: 44.2, 49.7) years.
Conclusions
There is clear disparity in QALE by SES in Australia, whereby both the quantity and quality of life decrease with increasing socioeconomic disadvantage and geographical remoteness. These findings highlight the need for targeted interventions to address health inequalities. These detailed QALE estimates can be applied to future equity-informed economic evaluations.