Horizon scanning (HS) initiatives in Brazil began in 2008. Since then, the implementation of a national HS system has shown great evolution and expansion, especially after the creation of the National Committee for Health Technology Incorporation (CONITEC), which absorbed it in 2011. This work aimed to present Brazil’s National Horizon Scanning System, conducted by CONITEC, and its most recent results.

We developed an experience report, using mixed methods, with a descriptive analysis of HS activities conducted nationally and quantification of documents produced between December 2023 and November 2024 by CONITEC.

HS reports developed by CONITEC currently support the decision-making processes regarding the: (i) incorporation of technologies into the public health system (90 reports); (ii) granting of new or emerging technologies by court order (five alerts); (iii) prioritization of topics for the elaboration or update of national clinical practice guides (28 topics); (iv) national preparation in case of public health emergencies (e.g., COVID-19 and mpox) (two documents); (v) innovation and national development (five brief syntheses); and (vi) financing of research with health technologies (one document).

The implementation of a national HS system in Brazil has evolved significantly and today it represents an important source of evidence that supports strategic decisions for Brazil’s public health system. From December 2023 to November 2024, CONITEC produced 131 HS studies to support decision-making in six different processes within the public health system.

HIV/AIDS continues to pose a significant public health challenge in Chile, despite advances in prevention and treatment. The Explicit Health Guarantees (GES) framework provides comprehensive access to antiretroviral therapy (ART) for eligible patients. This study assessed the budget impact of including bictegravir/emtricitabine/tenofovir alafenamide (BET) in first-line ART regimens for treatment-naïve adults under the Ministry of Health methodology for the GES program, evaluating its clinical benefits and financial viability.

A budget impact model was developed from the perspective of the GES system, utilizing updated public data on ART costs, therapy utilization, and demographic projections for 2025 to 2027. The analysis incorporated updated ART prices, therapy utilization frequencies, and clinical efficacy evidence. BET was evaluated as an alternative to abacavir/dolutegravir/lamivudine (ADL) using comparative evidence from clinical studies. Three scenarios were modeled: current prices, adjusted usage frequencies, and inclusion of BET in the treatment framework.

The inclusion of BET had no significant budget impact, primarily due to cost-saving efficiencies from centralized procurement by the National Health Supply Center. Updated ART prices for 2023 indicated a 34.7 percent reduction compared with the 2022 Verification of Costs Study. Projected costs for GES HIV/AIDS management, including BET, were USD259 million (2025), USD284 million (2026), and USD312 million (2027). Therapy uptake and procurement efficiencies were the primary cost drivers. The addition of BET enhanced therapeutic options without imposing additional financial burden.

The integration of BET into first-line ART regimens aligns with the GES goals of financial sustainability and clinical efficacy, offering an effective alternative for HIV management. These findings underscore the importance of evidence-based policymaking and optimized resource allocation to improve healthcare outcomes in Chile.

For the first time, worldwide digital health applications (DiGA) have been reimbursed by the German Statutory Health Insurance. For full reimbursement, the manufacturers must provide scientific evidence based on efficacy studies. This study aimed to assess the methodological quality of efficacy studies for permanently listed and reimbursed DiGA in the categories of ‘nervous system’ and ‘psyche’ within the DiGA register.

DiGA in the categories of “nervous system” and “psyche” were selected from the governmental DIGA platform. The methodological quality of the studies was assessed using the revised Cochrane risk-of-bias tool for randomized trials. The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis.

Six DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all six DiGA that showed a high risk of bias, which was mainly due to a lack of blinding in the studies. In addition, dropouts were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA, no published study protocol was available in advance, so an analysis of potential selective choice of the evaluation methodology was not possible.

The results revealed the low quality of supporting evidence for DiGA recently introduced in Germany, mainly due to methodological flaws, that is, a high potential for bias. Studies of DiGA should be blinded by comparing DiGA with a sham application to reduce the risk of bias. It should be emphasized that manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGA investigated.

Access to gender reassignment surgery (GRS) as an isolated process would not imply achieving clinical and satisfaction results in transgender people. Public subsystems face a shortage of trained professionals, a lack of protocols, fragmented care, and economic and geographic barriers. This review sought evidence on integrated and equitable care models for access to GRS.

A systematic review (SR) was conducted on the effectiveness and safety of GRS prevalent in Argentina (vulvovaginoplasty [VVP] and mastectomy [MRP]) in transgender people older than 16 years. The SR also considered final perceptions from an integrated and comprehensive management approach. The Web of Science and MEDLINE databases were consulted, prioritizing clinical trials, SRs, health technology assessments, and relevant individual studies from 1988 to 2024, using a rapid umbrella review methodology. The results of the evidence were ordered by relevant outcomes (aesthetic, satisfaction, complications, mental health) within the framework of integrated models applicable to inclusive and equitable health policies.

For MRP, six SRs (two specific, four general) and six cohort studies (three specific, three general) were included. For VVP, 16 SRs (nine specific, seven general) and 38 cohort studies (35 specific, three general) were included. Techniques for each surgery were described, citing results about complications (71%), quality of life (48%), mental health (16%), aesthetic aspects (58%), and satisfaction (73%), but only 0.2 percent considered them within frameworks of integrated models. With a lack of quality evidence, challenges persist in unifying classifications of outcomes over time and generalizing findings to different health systems.

The recommendations of scientific societies and current legal frameworks suggest access to GRS as an advanced step within comprehensive care processes for transgender people. The evidence showed a divergence between this approach and the findings, with data on complications and satisfaction predominating, less information on associated quality of life and mental health, and few references to integrated models.

Equity is a pivotal element in health technology assessment (HTA) to ensure fair and proportional access to healthcare needs and to mitigate health disparities. The incorporation of equity-oriented prioritization criteria into the development of clinical practice guidelines (CPGs) promotes social justice in health. This study systematically mapped equity-related criteria used to prioritize topics for CPGs.

A comprehensive scoping review was conducted in accordance with the Joanna Briggs Institute’ Manual for Evidence Synthesis and the PRISMA Extension for Scoping Reviews. The review protocol was pre-registered on the Open Science Framework. The review encompassed both peer-reviewed publications and gray literature published from 2000 onwards, without language limitations, that addressed topic prioritization criteria for CPG development. From an initial list of 22,675 records, 25 studies met the inclusion criteria. The extracted prioritization criteria were categorized into six domains and further refined into 20 distinct criterion.

Of the included studies, 48 percent mentioned the criterion “equity relevance”, within the domain of “factors related to the health condition”, and/or “impact on equity/access” within the domain of “potential impact of the intervention”. These criteria were variably characterized, encompassing aspects such as “frequency of inequality-related issues in specific population groups (e.g., children under five years old)”, “inequities in access and specific needs of vulnerable groups”, “potential of the recommendation to reduce or increase health disparities”, “impact on patient autonomy and independence,” and “user perceptions of the CPG.”

Evaluating equity considerations related to a disease or health condition and the potential of a CPG to mitigate disparities are imperative in the topic prioritization process. Incorporating this approach can optimize resource allocation, enhance care for marginalized groups, promote social justice, reduce health disparities, and foster social cohesion, thereby contributing to public health and societal well-being.

Assessing health-related quality of life (HRQoL), quality of life (QoL), and well-being (WB) are essential for measuring health outcomes. This study provided a conceptual mapping of these measures, proposed evidence-based frameworks, and linked them to widely used generic patient-reported outcome measures.

A systematic literature review was conducted that included articles from databases and gray literature through to December 2023. Studies describing HRQoL, QoL, and WB concepts with their dimensions or domains were included, focusing on general population studies without design restrictions. Domains, subdomains, and facets were extracted and analyzed based on frequency and qualitative methods. These frameworks were then mapped to commonly used generic patient-reported outcome measures.

From 14,114 papers, 35 studies and 36 frameworks were included (HRQol=15, Qol=5, WB=16). A total of 168 first, 225 second, and 79 third-level domains were retrieved and curated into 118 unique entities: HRQoL had 82 dimensions, QoL had 49, and WB had 69. Overlap analysis revealed 26 shared dimensions, with 26 unique to WB, 29 to HRQoL, and seven to QoL. Final models included 18 HRQoL, 22 QoL (18 from HRQoL plus 4), and 10 WB dimensions. Mapping of patient-reported outcome measures showed coverage for HRQoL of 59.4 percent, QoL of 65.9 percent, and WB of 34 percent. The EuroQol Health and Wellbeing instrument had the broadest coverage for HRQoL (17/18) and WB (5/10).

Significant inconsistencies and overlaps exist among definitions and domains for HRQoL, QoL, and WB. The lack of clear conceptual and operational definitions hinders the validity of measurement tools. This study underscored the need for clearer definitions and provided an initial step toward better understanding and measurement of these essential health and policy concepts.

National healthcare systems face challenges, including rising costs, aging populations, and increasing rates of chronic diseases, especially in rural and underserved areas. Decentralized care (DC) offers healthcare services in less complex settings, reducing travel, optimizing resource use, and enhancing patient centricity. This study explored DC initiatives, implementation strategies, challenges, and outcomes in four countries to establish a scalable framework.

Four countries with strong policies and initiatives supporting decentralized care were selected (Belgium, the Netherlands, Singapore, the UK) to understand how governments can enhance clinical outcomes, optimize costs, and improve patient satisfaction through DC models. Data collection involved a review of government documents and reports, complemented by interviews with senior stakeholders from hospital systems and government bodies. The analysis focused on understanding the principles and practice of DC in these countries.

Significant progress was observed in these countries. The UK’s integrated care providers achieved a 12 percent reduction in hospital admissions, while Singapore’s MIC@Home saved 7,000 bed days and increased telemedicine usage by 40 percent. The Netherlands’ Better@Home saved EUR2 million annually and increased remote care by 20 percent. Belgium’s model reduced heart failure readmissions by 15 percent and improved rural access and appointment satisfaction by seven percent. A common framework emerged, structured around four central pillars: robust policies and regulations, advanced technology and data integration, development of infrastructure and community care, and comprehensive training for healthcare professionals.

DC is a pivotal and transformative approach that can enhance patient care and ensure sustainability of health systems, despite implementation complexities. Success hinges on robust policies, technological infrastructure, data integration, and adaptive training mechanisms. These benchmarks underscore the importance of collaboration among multiple stakeholders to implement DC, in order to sustainably meet the evolving demands and provide patient-centered care.

Initial symptoms of benign prostatic hyperplasia (BPH) include difficulty urinating and low urinary flow. Worsening of BPH can lead to acute urinary retention and renal failure. Although it is fully treatable in urban centers, indigenous and remote area people are severely impacted. The experience presented herein shows how minimally invasive treatments can promote access to health care even in remote areas.

In October 2024, after 48 hours of travel—two flights and more than six hours by boat—a team of six people in association with a specialized non-governmental organization arrived at the community of Assunção do Içana, in the middle of the Brazilian Amazon rainforest. Screening of the community population with BPH was initiated a year earlier and eligibility was double-checked with the lower urinary tract symptoms visual score and ultrasound. Patient interest in undergoing the procedure was a criterion. A mobile surgical center was set up in the community. Waterproof and thermally insulating materials were used to create a controlled environment, with adequate temperature and sterile conditions.

A general practitioner specialized in indigenous health initially screened 180 patients, and 14 procedures were performed by a urologist. The mean room time (from patient entry to discharge) and time from anesthesia to the placement of the catheter were 55 minutes and 29 minutes, respectively. The mean urologist’s field time was 20 minutes, while mean time for use of the Rezūm water vapor therapy disposable delivery device was four minutes. Challenges faced during the expedition were power outages, lack of full leg braces (making patient positioning more difficult), and an error in oxygen delivery. All issues were quickly resolved and did not affect patient care.

In areas where it can take days to reach the nearest hospital, minimally invasive therapy that does not require hospitalization may be the only option. The Rezūm device has proven to be an effective and adaptable solution. Simplicity of the procedure and minimal need for resources were key to treatment success. This expedition highlighted the transformative potential of innovative technologies.

Patients with a life-threatening illness and their family caregivers are often affected by biopsychosocial factors that contribute to suffering and burden-sharing and affect quality-of-life.

To compare anxiety and depression levels between patients with incurable cancer and caregivers, investigate the association between perceived burdensomeness and psychological outcomes over time, and evaluate factors associated with perceived burden.

Secondary analysis of a larger prospective, longitudinal study. Patients with incurable cancer and their family caregivers were interviewed every 3 months, from study enrollment to 12 months, to assess psychological factors. Anxiety and depression were measured with Hospital Anxiety and Depression Scale (HADS) and perceived of burden was assessed using distinct questions directed to patients and caregivers about feeling or perceiving caregiving as a burden. For the data analysis, generalized estimating equations were applied to assess the impact of patient and family caregiver related variables on HADS over time, considering anxiety and depression scores as binary variables.

A total of 190 patient-family caregiver dyads were included. Anxiety was more frequent among family caregivers than patients across all follow-up moments. No significant difference was found in mean depression scores. Feeling like a burden to their family (32.6%) was significantly associated with higher anxiety [odds ratio (OR) = 4.45] and depression scores (OR = 2.73). Poor health perception increased the likelihood of anxiety and depression for patients (OR = 11.00; OR = 38.81) and FC (OR = 2.73; OR = 4.30). Family caregivers demonstrated higher psychological distress, with active employment reducing anxiety (OR = 0.54) and depression (OR = 0.43).

The perceived burden experienced by patients with advanced cancer and their family caregivers over time were factors relevant in the disease process. The feeling of being a burden and poor health perception were key factors contributing to psychological distress, underlining the need for specific interventions in palliative care.

Anhedonia is a multidimensional concept, and it is not known which aspects of it are linked to the heterogeneity of treatment responses in major depressive disorder (MDD). We examine the role of anhedonia dimensions in predicting response to antidepressant medication and adjunctive pharmacotherapy.

In CAN-BIND-1, 187 adults with MDD completed the Dimensional Anhedonia Rating Scale (DARS) and the Snaith–Hamilton Pleasure Scale (SHAPS) before undergoing 8 weeks of treatment with escitalopram. At week 8, 90 nonresponders received adjunctive treatment with aripiprazole for an additional 8 weeks. Mixed-effects models tested the hobbies, food, social, and sensory subscales and items of DARS and SHAPS as predictors of change in the Montgomery-Åsberg Depression Rating Scale (MADRS).

Of the four DARS subscales, sensory anhedonia predicted a worse treatment outcome with escitalopram (b = 1.14, 95%CI 0.08 to 2.20, p = 0.034) as did a three-item SHAPS sensory anhedonia subscale (b = 1.50, 95%CI 0.43 to 2.57, p = 0.006). A combined DARS–SHAPS sensory anhedonia subscale complemented the previously reported interest–activity symptom dimension to improve treatment outcome prediction. In contrast, food and social anhedonia dimensions predicted worse outcomes with adjunctive aripiprazole (b = 2.52, 95%CI 1.25 to 3.80, p < 0.001; b = 2.56, 95%CI 1.16 to 3.96, p < 0.001). Corresponding SHAPS items showed similar results.

The inability to enjoy sensory experiences and the lack of interest in food and social activities distinctly predict outcomes with serotonergic versus dopaminergic pharmacotherapy. These findings require replication and extension to other treatments.

Effects of sodium-glucose transport protein 2 inhibitor (SGLT2i) on diabetes, cardiovascular, and renal outcomes have been shown in the evidence, partially disaggregating results according to glomerular filtration rate (GFR) subgroups, which limits the ability to identify relevant benefits. In addition, when specific renal outcomes were analyzed, no thresholds were established to define clinical relevance. A review of evidence by specific GFR levels for critical outcomes was proposed, as defined by clinical benefit thresholds.

We conducted a systematic review using the PRISMA checklist, searching relevant databases for double-blind controlled trials of 1,000 or more patients with a duration longer than six months, SGLT2i use, and results disaggregated by GFR levels. Based on utilities, thresholds were expressed as minimum important detectable (MID) events of absolute effect reduction (AER) per 1,000 individuals for death (MID=10), GFR deterioration (MID=22), and composite renal outcome (MID=16). The Credibility of Effect Modification Analyses (ICEMAN) tool was used to assess effect modification credibility.

Thirteen studies were selected (90,403 patients, 75% diabetic, mean initial estimated GFR of 61 mL/minute per 1.73 m2).

• • Mortality: GFR (<60): 22,816 patients, relative risk (RR) 0.91 (95% CI: 0.82, 1.01), AER 0.3 percent, null effect, high certainty; GFR (>60): 55,037 patients, RR 0.89 (95% CI: 0.83, 0.96), AER 1.5 percent, probable reduction, moderate certainty.

• • GFR deterioration: GFR (30 to 45): 9,335 patients, RR 0.76 (95% Ci: 0.61, 0.95), AER 3.4 percent, slight reduction, moderate certainty; GFR (45 to 60): 9,245 patients, RR 0.54 (95% CI: 0.45, 0.66), AER 1.9 percent, small or null effect, high certainty; GFR (>60): 43,635 patients, RR 0.61 (95% CI: 0.48, 0.78), AER 0.8 percent, null effect, high certainty.

• • Composite renal outcome: GFR (<60): 27,114 patients, RR 0.83 (95% CI: 0.63, 1.08), AER 1.5 percent, slight reduction, low certainty; GFR (>60): 60,422 patients, RR 0.70 (95% CI: 0.58, 0.86), AER 0.9 percent, minimal reduction, moderate certainty.

SGLT2i may have relevant effects in patients with a GFR less than 60, with slight reductions in mortality rate and improvements in clinically important composite renal outcomes. When the GFR is greater than 60, the benefits are uncertain or not clinically relevant, underlining the importance of individually tailored treatments considering renal function for each patient.

In Brazil, the health sector is a relevant contributor to the gross domestic product (GDP). On the other hand, the public health system can cause redistributive effects on household income. The objective of this study was to present an estimate of the multiplier effect of public health spending on GDP and household income.

This analytical study was based on the national accounts for the year 2021. A social accounting matrix (SAM) was structured using values of transactions between economic sectors. This matrix was transformed into a mathematical model to capture the impact of an impulse in one sector on the others. The model consisted of complementary matrices of endogenous and exogenous accounts. The multiplier factor of the impulse was calculated, expressed as the percentage change in GDP or household income obtained by generating a 1 percent impulse in spending.

Based on the SAM 2021 constructed, it was possible to estimate that an additional one percent of resources applied to health by the government generated an additional 1.61 percent to the GDP. When estimated with the average multiplier effect of government consumption, a factor of 1.35 was found. Data suggested that 0.90 of this could be attributable to the additional workforce, possibly related to the demand for workers to respond to increased health services. The multiplier effect on household income demonstrated that every USD1.00 invested by the government in health generated USD1.23 in additional income for households.

The impact of social expenditure in health on GDP and household income is positive, which is a positive contribution to the debate on increasing the allocation of resources to health. Regional differences and other social determinants are very relevant in Brazil and may be analyzed to evaluate the impact of health spending on different household settings.

Scalp seborrheic dermatitis (SSD) is a chronic inflammatory condition with various treatment options, including antifungal shampoos, corticosteroids, calcineurin inhibitors, and phototherapy. This study aimed to evaluate the efficacy, safety, and evidence certainty of topical and oral treatments for SSD, highlighting the importance of this research for health technology assessment (HTA) to guide healthcare decisions and optimize resource utilization.

A systematic review (PROSPERO CRD42024537759) was conducted by searching PubMed, the Cochrane Library, and Embase databases through to 18 April 2024, using descriptors and terms related to SSD and study design. Systematic reviews evaluating evidence certainty (GRADE or Oxford Centre for Evidence-Based Medicine) for efficacy and safety outcomes of SSD treatments were included. Data selection and extraction were independently performed by two reviewers, and the risk of bias was assessed using the AMSTAR tool. A qualitative synthesis of the results was conducted.

Eight systematic reviews (80 studies on SSD) were included. Evidence quality supporting topical and oral treatments for SSD varied significantly. Ketoconazole shampoo (2 to 7%; 30 studies) and ciclopirox gel (0.77 to 1.0%; 16 studies) were the most frequently studied treatments and had moderate certainty of evidence for symptom reduction, as they were assessed in better designed studies. In contrast, other treatments commonly used in daily clinical practice were graded as having low-quality evidence (e.g., bifonazole shampoo, selenium sulfide shampoo, coal tar-ciclopirox olamine combination, gluconate ointment, succinate ointment) or very low-quality evidence according to GRADE (e.g., clobetasol propionate shampoo, zinc pyrithione shampoo, hydrocortisone).

The review highlighted significant variability in evidence quality for SSD treatments. While ketoconazole shampoo and ciclopirox gel showed moderate evidence for symptom reduction, many commonly used treatments were supported by low or very low quality evidence. These findings underscore the importance of rigorous studies to inform HTA and support evidence-based decision-making in health care.

Oral squamous cell carcinoma (OSCC) is a public health issue due to late diagnosis, often caused by its initial silent manifestation and economic barriers. This leads to higher rates of metastasis and recurrence. Diagnosis is made through biopsy, followed by staging using imaging techniques such as neck or chest computed tomography (CT), neck magnetic resonance imaging (MRI), and positron emission tomography-computed tomography (PET-CT) for metastasis detection.

A cost-effectiveness analysis was conducted using a decision tree model with a one-year time horizon and no discount rate applied. The model included estimates of direct costs related to OSCC management and used correct diagnosis as the main outcome. The approach was based on a comparative evaluation of costs and clinical outcomes, considering the resources available in the healthcare system. Data were extracted from reliable sources, ensuring the robustness of the results and their applicability to public health practices related to the management of patients with this neoplasm.

PET-CT had an incremental cost of USD362.54, an incremental effectiveness of 0.17, and an incremental cost-effectiveness ratio (ICER) of USD2,122.33 for each correct diagnosis. PET-CT was classified as a non-dominated strategy, meaning it is economically viable for improving case identification. In contrast, neck MRI combined with chest CT had an ICER of −USD1,969.85 per correct diagnosis, indicating that it is a dominated strategy—less efficient and with an unfavorable cost-benefit when compared with other diagnostic alternatives.

PET-CT for detecting cervical and distant metastases in patients with OSCC had higher effectiveness but incurred greater costs than clinical strategies such as neck and chest CT or neck MRI combined with chest CT. While more precise, PET-CT is less favorable economically, presenting a trade-off between accuracy and cost.

Although several studies have explored the prevalence of low back pain (LBP) in Brazilian individuals, no meta-analysis has yet been carried out to comprehensively estimate epidemiological aspects, such as the point, period, and lifetime prevalence of LBP in this population. The aim of this systematic review and meta-analysis was to investigate the one-off, annual, and lifetime prevalence of LBP in the Brazilian population.

Systematic searches were carried out in the following databases, with no restriction on publication date: MEDLINE (Ovid), Embase, Web of Science, Scientific Electronic Library Online, and LILACS. Google Scholar was also checked. The reference lists of included studies were also screened for potentially relevant studies. Prevalence rates per period were combined and calculated.

Sixty-seven studies were included in the review. Eight of these studies (11.8%) were of higher methodological quality. The pooled prevalence of LBP was 23 percent (95% confidence interval: 11, 43) based on a random-effects model. Heterogeneity was extremely high (I²=99.5%; p<0.0001), indicating significant variability between studies. Each study contributed equally to the analysis (approximately 12.5% weight).

LBP prevalence in Brazil exceeds global averages, affecting a significant portion of the population. This study highlighted the need for policies focused on LBP prevention and management, to improve health outcomes for Brazilians and potentially benefit a large global population.

Horizon scanning is an advanced health technology assessment (HTA) tool integrated into the decision-making process to proactively inform stakeholders about new health technologies. The objective of this pilot was to conduct horizon scanning for new health technologies for HIV/AIDS that could be appropriate for Ukraine’s health system, and to assess prospects for using the horizon scanning tool in Ukraine.

The pilot project was conducted at the State Expert Centre of the Ministry of Health in Ukraine. The pilot project tested the basic horizon scanning methodology as well as the PRITECTOOLS prioritization tool using a dataset compiled from international and local databases of clinical trials, patents, academic publications, international horizon scanning and early assessment databases, media resources (including online resources), and websites of public and charitable organizations.

The team identified the following new medicines that may be relevant for Ukraine: cabotegravir (long-acting injectable integrase strand transfer inhibitor—an alternative to tablet-based regimens for daily pre-exposure prophylaxis to increase patient adherence); ibalizumab. an injectable CD4 receptor inhibitor that, in combination with other antiretroviral therapy, is indicated for treatment of HIV-1 in adults with multidrug-resistant HIV (more than five lines of therapy) to expand access and coverage of HIV treatment services; and dapivirine vaginal ring, a vaginal ring used to reduce the risk of HIV-1 infection in women during sexual intercourse to increase adherence to pre-exposure prophylaxis.

The pilot showed that the horizon scanning tool can be used to inform the Ukrainian healthcare system about new medicines for prevention, diagnosis, and treatment of HIV/AIDS. The tool can also be one of the stages in the HTA process in Ukraine for healthcare decision-makers to proactively anticipate and plan for HTA for priority health conditions.

Brazil’s Unified Health System (SUS) ensures universal and free healthcare access. However, when technologies are unavailable in this system, users can appeal to the courts. To support such decisions, the National Council of Justice established technical support centers that provide technical-scientific reports (TRs) to evaluate health technologies. This study aimed to analyze these TRs and rank the most judicialized health conditions.

This descriptive cross-sectional study was conducted at the Center of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo-SP, Brazil, using the TRs available in the e-NATJus system (https://www.pje.jus.br/e-natjus/pesquisaPublica.php). The sample was limited to TRs published between 3 December 2018 and 12 November 2024. Quantitative analyses were summarized as percentages.

Over 235,000 TRs were analyzed, with requests rising from 1,004 in 2019 to 71,120 in 2024. Medications represented 56.1 percent of TR demands, and 56.5 percent of the requested technologies were available in SUS. Favorable rulings occurred in 50.5 percent of cases. The most judicialized conditions were autism spectrum disorder (ASD), insulin-dependent diabetes, non-insulin-dependent diabetes, prostate cancer, and diabetic retinopathy. The main requests for ASD were aripiprazole, cannabis derivates, and applied behavior analysis therapy. Insulin glargine was the most requested drug for insulin-dependent diabetes, dapagliflozin for non-insulin-dependent diabetes, abiraterone acetate for prostate cancer, and ranibizumab for diabetic retinopathy.

The surge in TRs highlights growing demand for innovative treatments, many of which are unavailable in the SUS or lack robust evidence. Access challenges persist even for included therapies, emphasizing the need for equitable access and reliable evidence to guide decisions.

The Health Technology Assessment Network of the Americas (RedETSA) working groups gather members aiming to develop projects and research jointly. The Real-World Evidence (RWE) Working Group seeks to identify methodologies and approaches allowing RWE integration into health technology assessment (HTA) in the region. This collaborative initiative is crucial to enhancing evidence-based decision-making processes in the Americas, shaping regional health policies.

A survey was conducted among RedETSA members to identify RWE use in the context of HTA within the network. The survey included responses from 22 members, reflecting diverse perspectives from across the Americas. A search of official documents issued by various regulatory and HTA agencies was carried out to perform a detailed analysis of the RWE frameworks accessible online. Relevant documents published between 2013 and 2024 were selected, reviewing both the official portals of each agency and publicly accessible academic databases. Documents in English, Spanish, Portuguese, and French were searched.

RWE documents from various HTA or regulatory agencies from different countries or regions were identified. The following domains were analyzed from each document: institution type, RWE definition, objective or purpose of RWE use, data quality and tools to assess RWE, data sources used, proposals for analytical methodologies, approved regulatory uses, and specific initiatives or tools. The RWE Working Group document was developed in Spanish. The document provides practical guidelines and checklists for implementing RWE, making it accessible for both specialists and general stakeholders within RedETSA.

The document was a helpful tool aimed at RedETSA members integrating RWE into HTA. Additional tools will include a procedure to meet regulatory and HTA expectations; and a decision tool to support a particular study design adoption. By leveraging these tools, decision-makers in the region can justify their choice of study design and align with regulatory requirements more effectively.