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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.
The health of migrants with type 2 diabetes has become a public health concern. Minority populations, including migrants, are often considered ‘hard-to-reach groups’ in clinical research, as researchers face challenges in engaging, accessing and retaining participants. Previous reviews have focused on either recruitment or retention, highlighting the need to gather experiences to obtain a more comprehensive picture for improving participation in research.
Aim:
To share lessons learned about the challenges of recruiting and implementing an intervention study including migrants with type 2 diabetes.
Methods:
This was a descriptive study, where researchers recorded experiences in reflective diaries and held discussions with the multi-professional teams involved. Data were analysed using Pawson’s conceptual framework, evaluating four dimensions of context: individual, interpersonal, institutional and infrastructural.
Findings:
The individual context concerns the time-consuming recruitment process since about half of the prospective participants did not want to participate, often due to illness, lack of time, the need to work, or having travelled abroad. In the interpersonal context, the main challenge was involving several professional groups; the greater the involvement, the less flexibility there was to meet expectations. The priorities in the institutional context were to provide care, with efficiency and productivity taking precedence over research. The infrastructural context was crucial due to a lack of staff available to support recruitment, the healthcare system’s burden caused by the pandemic, and the impact of laws and regulations in healthcare.
Conclusions:
Recruiting and implementing clinical research studies among migrant populations is complex. Factors across all contextual levels play a role, but the main challenges are within the institutional and infrastructural contexts. Changes in infrastructure influence institutional priorities, particularly with an already strained staff situation in primary healthcare. While political and social changes are difficult to alter, fostering positive attitudes towards research at the individual and interpersonal levels is important.
The aim of this study is to investigate family physicians’ approaches to hoarseness (dysphonia), clinical decision-making, patients’ perceptions, and structural barriers in the healthcare system using qualitative methods.
Methods:
Qualitative design was used. Research was reported in line with COREQ (32 items) and EQUATOR (SRQR) guidelines. Semi-structured telephone/internet interviews were conducted with 17 family physicians working primary care in Türkiye. Participants purposively sampled interviews were audio-recorded, transcribed, coded using thematic analysis, and developed themes.
Results:
The analysis revealed four main themes: clinical assessment and differential diagnosis, referral criteria and specialist referrals, patient perception and knowledge level, health system and structural barriers. Demographic analysis determined that veteran doctors were more sensitive to malignancy, junior doctors highlighted systemic deficits, female doctors highlighted patient behavior, while doctors who practiced in rural areas highlighted structural issues.
Conclusion:
Family physicians’ handling of hoarseness is not only dependent on clinical data but also on patient opinion and the health system’s conditions. For productive primary care management of hoarseness, it is recommended to (i) design guidelines and training for family physicians, (ii) increase patient education on voice hygiene and voice health, and (iii) establish health policies enhancing specialist accessibility.
The Dutch Children’s Food Literacy Questionnaire (DCFLQ) was developed and validated to assess food literacy among children aged 8 to 12 years. The DCFLQ is structured around farm-to-fork principles, including questions on food production, distribution, consumption, waste, and sustainability.
Design
After initial item pool creation, the DCFLQ was developed in collaboration with experts and children. The validation process included assessments of reliability and construct validity, as well as a test–retest evaluation in a subgroup of children.
Setting
The expert panel consisted of domain-related researchers, a pedagogue, a paediatrician, dietitians, and a primary school teacher. Children were recruited via primary schools and a sports club.
Participants
A total of 11 experts and 27 children participated in the development process; 608 children participated in the validation process.
Results
The final questionnaire comprised 29 questions and demonstrated good internal consistency (Cronbach’s α = 0.80) and test-retest reliability (ICC = 0.81). DCFLQ scores positively correlated with age, indicating that food literacy is higher in older children.
Conclusions
The DCFLQ is a valuable tool for assessing the effectiveness of nutrition intervention programs and monitoring Dutch children’s food literacy over time. International expert consensus on developing food literacy instruments is needed, as diversity in assessment tools impedes cross-cultural comparisons.
Autism Spectrum Disorder (ASD) has been frequently associated with an increased risk of obesity and metabolic disorders, including dyslipidaemia. However, research on lipid profiles and dietary intake in this population remains scarce. This cross-sectional study aimed to evaluate dietary patterns and their association with serum lipid profile in children and adolescents diagnosed with ASD. The study included 233 individuals from 2 to under 19 years assisted by the public health system in Pelotas, Brazil. Fasting blood samples were collected and analysed for serum concentrations of total cholesterol (TC), HDL-C, LDL-C, and triglycerides (TG). Dietary intake was assessed using three non-consecutive 24-hour food recalls (two weekdays and one weekend day). Dietary patterns were derived through reduced rank regression, using food group intakes as predictors and fibre density, energy density, carbohydrate, and saturated fat intakes as response variables. Standardised pattern scores were calculated to assess individual adherence, and linear regression models, adjusted for potential confounders, were applied to examine the association between the dietary pattern scores and lipid profiles. Elevated TG concentrations were observed in 48.9% of the participants. Four dietary patterns were identified: Healthy, Sugar and Starches, Mixed and Dairy and Biscuits. After adjustment, no significant associations were observed between dietary pattern scores and lipid profile. These findings underscore the complex nature of lipid metabolism in individuals with ASD, and suggest that dietary patterns alone may not fully explain variations in lipid profiles. This reinforces the need for further research and development of appropriate nutritional interventions for this population.
Since 2016, the emergence of continuous glucose monitors and closed-loop systems has significantly changed the way diabetes is managed. They have reduced the number of finger pricks and optimized insulin therapy by automatically adjusting insulin doses. In this evolving context, the Haute Autorité de santé (HAS) reassessed the national coverage conditions of three categories of medical devices for self-monitoring and automated insulin therapy management.
Methods
The assessment method was based on analysis of data from: (i) a systematic review of the scientific literature; (ii) proposals from concerned stakeholders (patient associations, professional organizations, manufacturers, service providers, public health institutions); and (iii) information from international health technology assessment agencies. The HAS assessment report and the new proposed reimbursement nomenclature were validated in July 2024 by the HAS committee, which appraises medical devices with respect to their reimbursement by the French health insurance scheme.
Results
The main changes to the coverage conditions included harmonized and extended indications for each category of device, which involved removing the previous requirement of six months of insulin pump use and the metabolic criterion (hemoglobin A1c level). The prescribing conditions were also updated, allowing prescriptions from public or private hospital or non-hospital based centers. Concerning relative clinical effectiveness, HAS concluded that there was no clinical added benefit between the devices in each category. The evaluation of specific clinical data for each device carried out by HAS remains necessary before considering coverage in France, and post-registration studies are still required for closed-loop systems.
Conclusions
The new HAS coverage recommendations for the three categories of connected medical devices for managing diabetes offer greater clarity and improve patient care. More patients will benefit from these systems due to the extended indications. Moreover, the post-registration studies required by HAS for each closed-loop system will allow the long-term evaluation of these systems in France.
Obesity is increasing at an alarming rate in Brazil. Beyond its strong association with chronic diseases, obesity imposes a substantial burden on the Brazilian Unified Health System (SUS). The incorporation of new treatments, including interventions for weight management, requires rigorous assessment of efficacy, safety, and cost effectiveness by the National Committee for Health Technology Incorporation (CONITEC).
Methods
This study aimed to review decisions regarding the incorporation of health technologies for obesity treatment into the SUS. A review of CONITEC recommendations was performed, utilizing reports publicly accessible on its official website. The analysis focused on the evaluation of pharmacological and procedural technologies for obesity treatment in Brazil, examining technical and economic impact assessment reports.
Results
Between 2012 and 2022, four technologies were evaluated for obesity treatment: sibutramine, orlistat, bariatric surgery via video laparoscopy (all requested by the Ministry of Health and medical societies), and liraglutide 3 mg (requested by a pharmaceutical company). Among these, only bariatric surgery was incorporated into the SUS in 2017. Sibutramine and orlistat were rejected due to limited efficacy and unfavorable safety profiles. The evaluation of liraglutide, aimed at patients with a body mass index above 35 kg/m² and cardiovascular risk, demonstrated efficacy, but was declined due to its high cost and significant economic impact on the SUS.
Conclusions
The rejection of technologies by the SUS highlighted safety, efficacy, and cost concerns. These decisions aligned with the SUS priority to remain economically sustainable while promoting multidisciplinary approaches to obesity management, which are actively offered within the SUS. Given the importance of the condition for public health, it is considered that the topic has been under-prioritized in the incorporation process within the SUS.
RSV is a leading cause of lower respiratory tract illness (LRTI) among infants in Chile. Nirsevimab was recommended for infants in 2023 to address the burden of RSV-LRTI. The cost effectiveness of maternal RSVpreF with complementary nirsevimab for infants, versus nirsevimab alone, for prevention of RSV-LRTI among infants in Chile was evaluated.
Methods
A cohort model to depict clinical and economic outcomes associated with RSV-LRTI for infants from birth to one year of age and lifetime consequences of RSV-related death. Results were based on disease and case-fatality rates, effectiveness, utility and disease-related disutility, and direct and indirect costs. The price of nirsevimab was USD260.00. The RSVpreF price was based on the economically justifiable value (EJV) of RSVpreF versus no intervention at a willingness-to-pay of one times the gross domestic product per capita. Uptake was set at 90 percent. In the complementary strategy, nirsevimab was limited to infants born to unvaccinated mothers. The healthcare system and societal perspectives were used, with costs in USD for 2023 and an annual discount rate of 3 percent.
Results
With no intervention, 10,457 patients with RSV were hospitalized (RSV-H) and 39,460 attended the emergency department (RSV-ED) in the model, with corresponding total direct and indirect costs of USD21.0 million. Nirsevimab alone would prevent 52 percent (n=5,418) of RSV-H cases and 39 percent (n=15,317) of RSV-ED cases, at a total cost of USD58.8 million. Maternal RSVpreF with complementary nirsevimab would prevent 54 percent (n=5,635) of RSV-H and 34 percent (n=13,423) of RSV-ED cases. Using an EJV of USD94.34 per dose of RSVpreF, total costs of the complementary approach were lower by USD24.1 million, with an additional nine quality-adjusted life years gained. RSVpreF with complementary nirsevimab was cost saving, compared with nirsevimab alone.
Conclusions
Use of RSVpreF with complementary nirsevimab would achieve a similar public health impact as nirsevimab alone and would yield substantial cost savings in Chile.