The increase in Cesarean section (C-section) rates is a global phenomenon, but it is mainly observed in Latin America and the Caribbean, which from the 1990s through to 2014 saw the average rate of C-sections increase from 22.8 to 42.2 percent. Recommendations from international organizations on the need to reduce rates of C-sections, as well as initiatives in several countries, can be highlighted in this scenario.

This study involved an overview of systematic reviews to evaluate interventions aimed at reducing rates of C-sections. The methodological quality of the reviews was assessed using the AMSTAR tool. Comprehensive searches were performed in indexed databases, including PubMed, the Cochrane Library, the Virtual Health Library Regional Portal, Epistemonikos, and Health Systems Evidence. Identified interventions were classified using the Effective Practice and Organization of Care (EPOC) taxonomy from the Cochrane Collaboration, ensuring a structured evaluation of effective practices and care organization.

Out of 969 identified studies, twelve were duplicates. Following the screening of titles and abstracts, nine studies were selected for full-text analysis, ultimately resulting in six studies included in the review. According to the EPOC taxonomy, the most prevalent intervention types were financing and mixed interventions. Notably, mixed interventions, which combined implementation strategies and governance, demonstrated the most significant effectiveness in reducing C-section rates.

The effectiveness of interventions to reduce rates of C-sections varied based on context and evidence certainty. Public policies must account for the existing healthcare system and cultural norms, ensuring that they adapt to local contexts to effectively address resistance. Tailoring strategies to align with community values is essential for successful implementation and for achieving desired outcomes in reducing C-section rates.

Health technology assessment (HTA) has gained increased attention and investment in low- and middle-income countries (LMICs). HTAi Interest Groups provide critical platforms for networking, information exchange, and collaborative research. To understand the challenges and advances in HTA across LMICs, the Developing Countries Interest Group (DCIG) conducted a comprehensive survey in 2024.

The survey targeted LMICs, focusing on the following dimensions of HTA: operational frameworks (geographical distribution, focus areas, patient engagement, rare disease processes) and a SWOT analysis assessing: (i) strengths—things that the country does particularly well or that distinguishes it from others; (ii) weaknesses—features, resources, systems, and procedures, including what could improve and the sort of practices should be avoided; (iii) opportunities—openings or chances for something positive to happen; and (iv) threats—any issue that can negatively affect the development. Additionally, respondents identified key challenges in implementing HTA and proposed ways the HTAi DCIG could address these barriers.

The survey received 33 responses, with 50 percent being HTAi members, 36.3 percent from Latin America, 27.2 percent from Africa, and others from Asia. Of the respondents, 57.6 percent reported having an HTA department in their ministry of health, 48.5 percent had a national policy, and 84.4 percent used HTA for assessing medicines and devices. However, 54.5 percent lacked patient engagement processes. Genuine interest in building local capacity for HTA, but weaknesses included knowledge gaps, with limited funding and awareness among stakeholders as significant threats. Opportunities arose from growing interest among health professionals. Respondents suggested the DCIG support HTA institutionalization and provide foundational training.

The findings underscored active HTAi member engagement, especially in Latin America, Asia and Africa. While many countries have established HTA departments and policies, gaps persist in patient engagement and knowledge dissemination. Key strengths included interest in capacity building, while weaknesses included knowledge gaps. Opportunities for growth exist, but limited funding poses a threat. Respondents recommended that the DCIG provide support in institutionalizing HTA and training.

Congenital cytomegalovirus (CMVc) is a major cause of neonatal morbidity, with long-term effects such as hearing loss and neurodevelopmental impairments. Screening strategies, including systematic and targeted approaches, aim to improve early detection and management. This study evaluated the cost utility of these strategies to inform decision-making in Spain’s healthcare system.

A cost-utility analysis was performed using a decision tree and Markov model over an 18-year horizon. Incremental cost-effectiveness ratios (ICERs) were calculated based on quality-adjusted life years (QALYs). The analysis compared systematic screening using a saliva polymerase chain reaction test, targeted screening linked to universal newborn hearing screening (UNHS), and symptom-based detection. Sensitivity analyses explored the robustness of results, focusing on key cost and effectiveness variables.

Systematic screening detected 1,547 CMVc cases at birth, compared with 112 cases for targeted screening and 49 cases for symptom-based detection. At 18 years, systematic screening had the lowest number of patients with hearing loss and neurodevelopmental impairments. The ICER for systematic screening was EUR33,225 per QALY, compared with symptom-based detection and EUR37,254 per QALY compared with targeted screening. Targeted screening demonstrated an ICER of EUR6,912 per QALY compared with symptom-based detection.

Targeted screening linked to UNHS is a cost-effective strategy for detecting CMVc in Spain. Systematic screening, while identifying more cases, exceeded cost-effectiveness thresholds and may not be economically viable under current conditions. Optimizing the cost of systematic screening could improve feasibility and should be a focus of future research.

The United States Food and Drug administration (FDA) Accelerated Approval (AA) pathway facilitates early access to therapies for severe conditions based on surrogate endpoints, requiring confirmatory trials to validate benefits. This study compared FDA AA outcomes with Brazilian regulatory decisions, highlighting alignment and discrepancies, and their implications for patient safety and healthcare systems, focusing on post-market surveillance and evidence-based decision-making.

Data on drugs on the FDA AA pathway were retrieved from the FDA’s publicly available repository as of 7 November 2024. Each drug was categorized by approval status: ongoing, verified clinical benefit, withdrawn, and other. Drugs were further analyzed for approval, coverage, and reimbursement decisions in Brazil using data from the Brazilian Health Regulatory Agency (ANVISA), the National Committee for Health Technology Incorporation (CONITEC), and the National Supplementary Health Agency (ANS). The analysis focused on discrepancies between FDA and ANVISA decisions and the implications for Brazilian healthcare systems.

A total of 336 drugs were analyzed: 53 percent achieved confirmed clinical benefit, 12.8 percent were withdrawn due to safety or efficacy concerns, and 30.7 percent are still undergoing confirmatory trials. The average time from AA to withdrawal was 7.35 years, highlighting extended patient exposure to unverified therapies. Of the 43 drugs withdrawn by the FDA, 12 retained active label indications by ANVISA. This regulatory lag impacts the Brazilian National and Supplementary Health Systems through potential inefficiencies in resource allocation.

Discrepancies between FDA and ANVISA decisions underscore the need for stronger international collaboration on post-market surveillance and harmonized criteria for drug approvals. For Brazil, addressing these gaps could enhance patient safety, optimize healthcare resources, and align regulatory practices to ensure timely, evidence-based decision-making.

Public consultations (PCs) are widely used by health technology assessment (HTA) agencies, but there is no consensus on methodological procedures for analyzing PCs. We propose a method for analyzing and synthesizing PCs, offering an agile approach, systematic and transparent steps, reproducible aspects, and reliable analyses. The aim of this study was to validate the method.

The Delphi technique was used to validate the proposed method in terms of face (applicability and relevance) and content validity (analysis results). The setting included the HTA processes conducted by the National Committee for Health Technology Incorporation (CONITEC). A group of 20 Brazilian experts was invited to participate, each of whom had experience in at least one of the following areas: HTA, social participation, IRaMuTeQ software, or qualitative research. Consensus was defined as at least 70 percent with “agree” or “strongly agree” responses or an interquartile range of one or less. Comments were summarized and categorized thematically. A pilot study was also conducted.

Fifteen experts participated in the face validity assessment and 14 in the content validity assessment. Both validations achieved over 80 percent consensus in the first round. In face validity, five methodological steps were validated, including corpus analysis, corpus preparation and organization, data mining using IRaMuTeQ software, systematization and interpretation, and synthesis of findings. In content validity, the results were deemed adequate, providing sufficient information to understand PCs. Although this method was used in the Brazilian HTA setting, it can be adapted by different countries. The method provides a way to organize data already collected in HTA PCs, contributing to processes already in use.

This study validated a method for analyzing and systematizing HTA PCs—the first strategy of this kind. The method proposes a systematic and transparent approach to organizing data collected for HTA agencies. This initial strategy for systematizing PC analyses can support more participatory, agile, and transparent processes that include public perspectives, which can be a challenge in HTA.

Over the past decade, there has been an increase in the development of innovative cancer treatments that have positively impacted upon mortality rates. However, the approval process at the local level remains lengthy. This study estimated the clinical and economic impact of the availability of innovative therapies for treating advanced lung cancer in men in five Latin American countries.

Using public data, we analyzed the relationship between available innovative therapies and age-specific mortality rates for Argentina, Brazil, Chile, Colombia, and Mexico through a regression model. By comparing the number of therapies approved by the United States Food and Drug Administration (FDA) with those approved by each local regulatory agency, we estimated the avoidable deaths (ADs) that could have been averted if innovations had been available. We calculated years of life lost (YLLs) based on life expectancy, median age of death, and ADs. Productivity loss was estimated using each country’s retirement age and the annual gross domestic product (GDP) per capita in 2022.

Between 2006 and 2021, the FDA approved 24 innovative treatments for 30 indications. By 2021, only 60 to 77 percent of these therapies were available locally. Total ADs, YLLs, and PL were USD8,694, USD114,477, and USD439,179,876, respectively. The most significant productivity losses were found in Brazil and Argentina due to the large Brazilian population and Argentina’s high GDP per capita. Despite its low population, Chile’s high GDP per capita resulted in considerable productivity loss. Colombia and Mexico showed a notable clinical impact, suggesting the advantages of early approval. Although the availability of FDA-approved therapies has increased, local time lags have recently increased.

Our results highlight the potential of improving regulatory processes to increase the availability of innovative therapies in five Latin American countries. Accelerating the introduction of these therapies for advanced lung cancer presents a major opportunity to enhance survival rates, instilling a sense of hope and optimism while avoiding substantial productivity losses.

Venous thromboembolism (VTE) prevention for women with additional risk factors during pregnancy is centered on anticoagulant therapy, with enoxaparin as the anticoagulant of fchoice. This study evaluated the efficacy, safety, and costs of enoxaparin for thromboprophylaxis in pregnant or postpartum women at risk for VTE, aiming to expand access to the Brazilian national Clinical Protocols and Therapeutic Guidelines (PCDT).

A search was performed in the MEDLINE, LILACS, and Embase databases (January 2024) using a strategy that combined target population, enoxaparin, and low molecular weight heparin; filters for systematic review (SR) with or without meta-analysis; and publications up to five years, without language restriction. Duplicate exclusion and study eligibility were performed using Rayyan. Only eight studies met the pre-established criteria. For budget impact, enoxaparin values and doses, local hospital consumption, and epidemiological data were used. The daily, average, and annual costs of hospitalization of pregnant women (n=259) with VTE in the State of Bahia were calculated.

Results showed a reduction of thromboembolic events; a reduction of VTE in pregnant women at high perinatal risk as well as postpartum women who did not use anticoagulation in the antepartum period; an increased risk of hemorrhagic events in pregnant women, worsening during in vitro fertilization; a reduction in the risk of miscarriage and an increase in the rate of live births; and a significant increase in allergic reactions. Only one SR converged with the national guideline. The annual avoidable hospitalization cost was USD239,725.80, while the budget impact was USD163,207.47 in the first year. A group of experts was established to develop the state protocol with the expanded use of enoxaparin.

The economic analysis showed a high average cost of prolonged hospitalization in pregnant women receiving enoxaparin. Thus, considering the High-Risk Pregnancy Manual after the PCDT, vulnerability, prevention of maternal morbidity and mortality, turnover of obstetric beds, reduction of hospitalization costs, and qualification of care, it was decided to develop a state protocol with expansion of anticoagulation indications.

Decisions to not reimburse or discontinue reimbursement of health technologies from public funding are considered increasingly necessary. However, such decisions remain politically sensitive and often provoke public opposition. Such opposition may be considerable and puts pressure on decision-makers to revoke or revise a decision; however, the specifics of this opposition remain largely unclear. Our aim was to obtain insight into these specifics by mapping the scientific literature on this topic.

We performed a systematic review following PRISMA guidelines. The electronic search was performed in Embase and using the Google Scholar, Google, and Startpage search engines and supplemented with a hand search in 2021. Both the electronic searches and the hand search were updated in 2022 and 2024.

Based on 81 articles, we developed a framework of 27 categories grouped under the ‘who, what, when, where, and why’ of public opposition to negative reimbursement decisions. Our findings indicated that patient representatives, physicians, and citizens are the primary actors opposing such decisions—often influenced by industry and politicians. These actors typically challenge the outcomes and arguments underlying decisions, driven by unrealistically high expectations of technology effectiveness and the assumption that decision-makers prioritize cost containment above all else. Additionally, our findings indicate increasing distrust among these actors toward decision-makers and evidence-based processes, leaving them vulnerable to commercial exploitation and misinformation.

Understanding the dynamics between actors is crucial for understanding public opposition to negative reimbursement decisions in health care. Aligning decision-making processes with public values, addressing misconceptions, and countering misinformation may enhance the legitimacy of reimbursement decisions. Further research should explore strategies to mitigate distrust and foster evidence-based engagement among actors to ensure more informed and equitable healthcare decision-making.

For the technology incorporating process, indirect comparisons (IC) may be presented as alternatives when head-to-head studies are unavailable. However, health technology assessment (HTA) reports often fail to address the methodological fragilities of network meta-analysis. This interim analysis examined the frequency of IC methods in technology assessments for incorporation into the Brazilian supplementary health system and inclusion in the National Agency of Supplementary Health (ANS) catalog.

This meta-research study was conducted at the Center of HTA, Hospital Sírio-Libanês, São Paulo, Brazil. A search on the ANS website identified critical analysis reports of technologies incorporated by ANS in 2023 and 2024. Eligible reports were analyzed to identify the frequency of IC in plaintiff’s submissions and in ANS analyses. The incremental budget impact of incorporating technologies with IC in HTA reports was also evaluated.

A total of 47 reports were evaluated. Of these, 36.2 percent of the submissions and 25.5 percent of the ANS analyses included IC, mostly using network meta-analysis. Among 32 favorable recommendations, IC appeared in 31.3 percent of submissions and 25 percent of ANS analyses. From 2023 to 2024, the use of IC increased by 12.7 percent in submissions and by 21.8 percent in ANS analyses. Within incorporated technologies containing IC, the incremental budget impact analysis predicted savings of BRL61,385,084.02 to BRL174,217,905.44 for savings scenarios, and increased spending of BRL179,524,075.54 to BRL488,084,349.61 for increased investment scenarios.

IC methods were present in approximately 25 to 30 percent of all technology assessments for incorporation into the Brazilian supplementary health system, with an increased number observed from 2023 to 2024. Within technology assessments employing IC, projected financial outcomes indicated savings in some scenarios, while others suggested substantial increases in budget expenditure.

Adults with intellectual disability (ID) experience marked mental health inequities, yet population-wide estimates that capture both primary- and specialist-care diagnoses remain scarce.

Using nationwide Swedish registries, including primary care, specialist, inpatient, prescription drug, criminal, and suspicion registers, we included all individuals born in Sweden between 1958 and 1997 (N = 3,970,600), including 38,818 individuals with ID diagnoses (0.98%; 49.1% mild, 13.3% moderate, and 9.6% severe/profound). Hazard ratios (HR) were calculated using Cox proportional hazards regression to estimate the relative risk of lifetime diagnoses of major depression, anxiety disorders (ANX), obsessive-compulsive disorder (OCD), bipolar disorder (BD), attention-deficit/hyperactivity disorder (ADHD), drug use disorder, alcohol use disorder, schizophrenia, and other nonaffective psychosis. Additionally, cohort effects on psychiatric diagnosis risks in adults with intellectual disabilities versus the general population were evaluated.

People with ID were at higher risk for all psychiatric and substance use disorders, with HRs ranging from 1.7–2.0 for major depression and anxiety, drug and alcohol use disorders, 3.5–5.8 for BD, OCD and ADHD, and 10.9–12.7 for schizophrenia and other nonaffective psychosis. Higher prevalence was consistently seen among those with mild versus moderate or severe/profound intellectual disability. Relative risks narrowed modestly in successive birth cohorts, although absolute differences remained substantial.

Across six decades of follow-up, adults with ID faced markedly higher psychiatric and substance-use morbidity – most pronounced for psychotic disorders – than the general population. Whole-system mental-health screening and tailored interventions are required to address this persistent disparity.

Understanding health technology assessment (HTA) is essential for effective public participation in Brazil’s Unified Health System (SUS). The Participa SUS/ATS project simplifies the concepts of HTA to foster training and knowledge dissemination. Through scientific marketing on social media, it provides interactive posts, making HTA accessible and empowering lay audiences to actively engage in decision-making processes.

The project leveraged social media platforms (LinkedIn, YouTube, and Instagram) to disseminate knowledge on HTA and train lay audiences of the SUS. Educational videos, including versions with Brazilian Sign Language, illustrations for inclusivity, whiteboards, and live sessions carried out by the project team and guests addressing topics of social participation, were shared on YouTube. A logo was created as part of its visual identity. Instagram featured weekly polls, stories, and personalized posts using accessible and engaging language. LinkedIn promoted broad professional dialogue. This multiplatform approach combined multiple formats to increase reach and understanding, and to promote public interaction and empowerment in HTA processes.

By 2024, the initiative garnered 518 Instagram followers, 218 YouTube subscribers, and 1,202 LinkedIn followers. LinkedIn promoted conversations among healthcare professionals, Instagram’s engaging weekly posts connected with audiences, and the most-watched YouTube video garnered 323 views. Real-time interaction was encouraged with three live sessions. A specialized logo improved brand recognition and connection with the intended audience. Carousel postings were a user-friendly format, particularly on mobile devices. Users praised the content’s clarity and emphasized how well it demystified HTA contents. Posting schedule optimization raised exposure and interaction. Feedback highlighted improved understanding, empowering users to contribute more effectively to decision-making processes.

The Participa SUS/ATS project showcases an innovative use of social media to demystify HTA for diverse audiences, fostering inclusivity and active public engagement in health decisions. Its scalable, multiplatform approach offers a replicable model for enhancing citizen participation and equity in healthcare systems worldwide, making it highly relevant for global public health initiatives.

Anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is a rare disease with high morbidity and mortality rates, posing challenges for incorporating treatments due to limited high-quality evidence. Brazil recently developed a Clinical Protocol and Therapeutic Guideline (PCDT) after incorporating rituximab into the public healthcare system. This study explored the development of a Technical Scientific Report (TSR) addressing rituximab’s effectiveness and costs as well as stakeholder participation in shaping equitable, evidence-based recommendations.

A TSR was initially developed that included an evaluation of evidence, an economic model, and a budget impact analysis. Cyclophosphamide, which is already available in the public health system, was used as the comparator. Based on this analysis, the National Committee for Health Technology Incorporation (CONITEC) issued a preliminary recommendation against incorporating rituximab for ANCA-associated vasculitis. This TSR was submitted for public consultation (6 to 25 April 2023), during which community contributions were received. All submissions were thematically analyzed, and relevant contributions were re-evaluated. The updated findings were then presented to CONITEC for a final decision, incorporating new perspectives and refined results.

During the public consultation, 169 contributions were received: 56 from patients and caregivers unanimously supporting rituximab’s incorporation and 113 technical submissions highlighting cyclophosphamide’s toxicity and lack of response in 25 percent of patients, and rituximab’s economic benefits. Revised economic analyses found a reduced incremental cost-effectiveness ratio when comparing rituximab with intravenous cyclophosphamide and clarified the five-year budget impact. These updates, along with strong patient participation, influenced the reversal of CONITEC’s initial recommendation, leading to rituximab’s approval in June 2023 and the development of the PCDT.

The incorporation of rituximab into Brazil’s public health system and the creation of the PCDT for ANCA-associated vasculitis represents a significant advancement in treating rare diseases and may help promote remission, reduce relapses, and improve patient quality of life. By integrating patient perspectives and evidence-based practices, the PCDT strengthens equity and access, fostering comprehensive care for rare diseases in Brazil.

In Singapore, patient involvement has been an integral component of health technology assessment (HTA) since 2022. Processes co-designed with local patient organizations have encouraged meaningful collaboration, reflection, and learning. This presentation discusses the impact of tailored training resources implemented by the Agency for Care Effectiveness (ACE) to build capacity and empower patients and caregivers to contribute to healthcare decision-making.

Surveys were electronically distributed to 27 local patient organizations in 2023 to identify knowledge gaps and the information needs of their members. A comprehensive review of patient resources from overseas HTA agencies and patient groups was undertaken to identify best practices for enhancing capacity building. The insights gathered informed the co-development of two interactive training workshops and a series of self-directed learning modules on HTA. Feedback was gathered from participants at the end of each workshop, and post-training surveys were conducted to assess changes in participants’ understanding of HTA, skill development, attitudes towards patient involvement, and expectations for future training resources.

Thirty-seven patient leaders attended the workshops, which introduced HTA in plain language and role-playing as decision-makers to explore factors considered for funding recommendations. Learning modules were published online and disseminated to all local patient organizations. Survey results showed that the training resources led to marked increases in patients’ self-reported confidence to participate in future HTAs, and in their knowledge of HTA concepts. The resources were viewed as a positive step toward improving the quality of patient input in HTAs, and overcoming local perceptions of tokenistic involvement, by strengthening the value of experiential knowledge over traditional scientific evidence.

Workshops and learning modules tailored specifically to the information needs of patients play an important role in building confidence and skills in HTA. ACE will continue to expand its resources to equip patients and caregivers with the skills required to meaningfully participate in healthcare decision-making. Impact evaluation of training initiatives will drive continuous improvement and ensure they remain relevant to patients’ needs.

Patients with difficult biliary stones often require repeated conventional ERCP procedures or others surgical interventions, leading to complications and unnecessary expenses for the healthcare system. ERCP with cholangioscopy allows direct visualization and use of laser or electrohydraulic lithotripsy, which are not possible without cholangioscopy. This study aimed to evaluate the cost effectiveness of ERCP with cholangioscopy for treating difficult biliary stones.

A decision tree model was developed to estimate the cost effectiveness of ERCP with cholangioscopy for direct visualization. Patients started the model with difficult biliary stones after an initial failed ERCP procedure. In the base scenario, patients underwent a second conventional ERCP procedure. In the proposed scenario, cholangioscopy was used in the same procedure immediately after the first failed ERCP. In the case of technical success with complete removal of the stones, patients exited the model, otherwise surgery was performed. Estimates of success rate, resources used, and costs were obtained from the literature or expert opinion and estimated from the supplementary health sector’s perspective.

ERCP with cholangioscopy used immediately after a failed conventional ERCP in the same procedure was cost-effective and dominant alternative. It increased success rates for removing difficult biliary stones and reduced resource use and complication rates, benefiting the Brazilian supplementary health sector. This approach offered significant advantages over repeated conventional ERCP procedures or surgical interventions.

Reducing the number of repeated attempts at endoscopic extraction of complex gallstones prevented several adverse patient outcomes and reduced healthcare resource utilization, medical costs, safety implications, and delays to more effective treatment.