Horizon scanning (HS) identifies future trends and weak signals, aiding timely healthcare decisions, but lacks a formal framework. The Innovation Observatory’s MedTech Horizon Scanning Techniques (MIST) framework integrates evidence synthesis, HS methods, and foresight approaches. MIST aligns scanning techniques with foresight stages and the technology development pipeline, offering a structured approach to detect emerging science and technology trends for healthcare advancements.

The MIST framework was developed iteratively, combining HS expertise with regulatory knowledge of medical devices. First, a MedTech development pathway was established with international HS agencies, providing a foundation. Second, the pathway was mapped against the regulatory milestones involved in medical technology development from ideation to post-marketing according to recent European legislation. Last, we overlaid the foresight “Three Horizons Model” with the development stages to produce a framework that combines different innovation stages with their regulatory requirements and maps sources of weak signal detection to the horizons where those sources are most likely to be relevant.

Our MIST framework presents three horizons: emerging, transitional, and imminent. Each horizon maps to different technology readiness levels, life cycle stages, time periods, and regulatory milestones. Each horizon includes guidance on the best-fit HS, information retrieval, and analysis methods. Furthermore, each horizon recommends relevant sources of weak signal detection maximizing the sensitivity of the searches, avoiding unnecessary noise, and achieving efficiencies. The use of the MIST framework is recommended in combination with transparent reporting of the methods and sources used. We have also developed a checklist of reporting items that is available for download in the Open Science Framework (https://osf.io/m39vw/).

The MIST framework represents a stride forward in the direction of HS methods standardization and fulfills a known methodological gap. Our framework aims to underpin robust and systematic HS methods that will add value to the outputs supporting unbiased decision-making. Next steps include its publication and dissemination to facilitate adoption and use by other HS agencies.

Atrial fibrillation (AF) is the most common sustained arrhythmia. Thermal catheter ablation (radiofrequency or cryoablation) is a standard treatment but risks complications like pulmonary vein stenosis. Pulsed field ablation (PFA), a non-thermal alternative, offers selective myocardial targeting through irreversible electroporation. This literature review evaluated PFA’s safety and efficacy compared to thermal ablation to support its incorporation into the Brazilian Supplementary Health sector.

Electronic databases (MEDLINE via PubMed, the Cochrane Library, LILACS, and Embase) were systematically searched through to March 2024, identifying 421 titles after excluding duplicates. Following two screening stages, six articles were fully read. Data were integrated, and duplicates were removed using Rayyan artificial intelligence tool. Eligible studies included systematic literature reviews (SLRs) and randomized controlled trials (RCTs) comparing PFA with both thermal ablation methods (radiofrequency and cryoablation). Observational studies were included as additional evidence. Evidence quality was assessed using the GRADE tool by outcome. The risk of bias was evaluated with the revised Cochrane risk-of-bias tool for RCTs and AMSTAR-2 for SLRs.

One SLR with meta-analysis (moderate quality) showed that PFA had shorter procedure times without significant differences in rates of periprocedural complications or recurrent atrial fibrillation. In another study by the same authors (low quality), significantly fewer periprocedural complications were found in the PFA group versus thermal ablation (p=0.001). Another SLR with meta-analysis (high quality) reported higher durability percentages for pulmonary vein isolation with PFA. The ADVENT trial (no critical bias concerns, moderate certainty of evidence) showed PFA’s non-inferior efficacy and safety relative to thermal ablation, with less pulmonary vein narrowing. Observational studies highlighted PFA’s favorable learning curve.

PFA had a favorable safety profile and non-inferior efficacy compared with thermal ablation. It resulted in fewer periprocedural complications and greater durability in pulmonary vein isolation. Its favorable learning curve suggests PFA can be efficiently integrated into clinical practice with minimal procedural challenges. These findings support PFA as a promising alternative for treating paroxysmal AF in Brazil.

Health technology assessment (HTA) of rare diseases and cancer face significant challenges in illustrating value. This is compounded by small patient populations, limited data, and undefined endpoints. We tackled these barriers by engaging patients directly, defining a pragmatic data strategy, combining site-based and decentralized models focusing on patient-first data collection, and incorporating patient preferences to generate high quality real-world evidence (RWE) to inform HTA decisions.

A relevant use case supporting pricing reimbursement for a uveal melanoma treatment required ambispective data that illustrated an unmet need. Integrated data, including patient-reported outcomes and clinical registries can help shape better therapeutic practices and inform regulatory approval pathways. This can then support data capture and inform patient-centric endpoints for regulatory approval, aligning clinical trials with real-world needs.

The data collected in a RWE platform and used in conjunction with early access program data resulted in pricing reimbursement in multiple regions. Substantiating unmet need requires robust, long-term data collected in a standardized data format in the Pulse registry platform to demonstrate disease progression in untreated patients. A similar strategy was used in lung cancer to support a pricing dossier and subsequent approval. The design of studies relevant for HTA requires a data driven approach with relevant and pragmatic study design that focuses on expected patient benefits. These examples were conducted on historical cohorts but should include contemporaneous data and patient input through preferences and outcomes in future analyses.

The road to accessing therapies is not a straight line. Our work demonstrated how RWE bridged gaps between clinical trials and real-world applications. By aligning patient needs with regulatory priorities, RWE facilitates informed, patient-centered decisions, improving access to lifesaving therapies for patients with rare diseases or cancer worldwide.

Health technology assessment (HTA), conducted by the National Committee for Health Technology Incorporation (CONITEC), guides the incorporation of technologies into the Unified Health System (SUS). This process is challenging because it requires diverse evidence and applying appropriate economic methods to the national context. This study analyzed the types of evidence and economic models used in medical device assessment reports, identifying gaps and opportunities for improvement.

Twenty-one reports published on the CONITEC Recommendations Panel between 2012 and 2021 were analyzed using the filters “Technology Type – Product” and “Ministry of Health Decision – Incorporate.” We reviewed the reports to identify: (i) types of evidence used, including public consultations, patient perspectives, and technology horizon monitoring (THM); (ii) applied economic models; and (iii) described limitations. The extracted data were categorized and analyzed to assess patterns, frequencies, and methodological gaps.

Of the reports analyzed, 85.7 percent included systematic reviews and meta-analyses, and 52.4 percent cited observational studies or randomized clinical trials. Most reports conducted public consultations, while fewer than 20 percent considered patient perspectives. THM appeared in 14.3 percent of the reports. There was no use of real-world evidence or evaluation of wearable devices. In economic models, 71.4 percent applied cost-effectiveness analysis, while 42.9 percent of reports lacked detailed economic analysis. Common gaps included reliance on international data and a need for more local information, impacting the accuracy of evaluations.

Brazil can improve HTA by including more real-world evidence, using THM more substantially, and considering patient perspectives more broadly. Enhancing the systematization of evidence searches and prioritizing local data would reduce uncertainties, aligning CONITEC’s practices with global next-generation evidence trends, leading to more effective and contextually relevant decisions.

Patient-reported outcome measures (PROMs) are used to quantify health-related quality of life and generate utility data for economic evaluations. Accurate translation and adaptation of PROMs into non-European languages, such as Swahili, is essential for ensuring the intended health information is captured. A case study evaluated the appropriateness of current Swahili PROMs translations and determined whether these captured a person’s health.

Swahili translations of the common PROMs tool EQ-5D were obtained from EuroQol for all dialects. Native Swahili-speaking experts in health and linguistics reviewed the translations for inconsistencies in key concepts such as “usual activities,” “anxiety/depression,” and “mobility.” The review assessed the adequacy of cultural adaptations, whether translation processes were documented, and the perspective and qualifications of the translators. Qualitative insights were gathered through expert interviews to understand challenges and propose recommendations for achieving cultural and linguistic equivalence in PROMs. The analysis also explored whether the translations addressed sociocultural nuances and aligned with the lived experiences of Swahili-speaking populations.

In total, three versions of the EQ-5D Swahili translation were obtained from EuroQol. The analysis revealed significant inconsistencies in translating concepts like “usual activities,” “anxiety/depression” and “mobility” across Swahili versions. Translation methods were undocumented, and translator qualifications and perspective were not reported. Cultural nuances, such as the sociological and anthropological understanding of anxiety and mobility, were inadequately addressed. For instance, “anxiety/depression” was translated differently across all three translations. Qualitative feedback emphasized the importance of tailoring translations to cultural contexts. The findings informed recommendations for improving translation methods, focusing on transparency, cultural sensitivity, and linguistic accuracy.

There is a need for culturally informed and transparent PROMs translations to ensure accurate health assessments. Engaging local linguistic and medical experts and addressing sociocultural nuances are crucial for improving PROMs validity and reliability. This is particularly important when translating to non-European languages spoken in low-resource settings. When translated correctly, aggregated PROMs data support equitable healthcare decision-making and resource allocation.

Hospital-based health technology assessment is relevant for optimal decision-making, particularly in a low-middle income country like Colombia. As a vital tool for application at the regional level, we present the manual for studies in the hospital context of the Institute for Health Technology Assessment, through the applied case of the financial analysis of a hospital procurement process.

A technology assessment was carried out from a hospital perspective to analyze the purchase of 12 medical devices in some hospitals in Colombia. The perspective was from the hospital and the data used were obtained from a review of the effectiveness and safety literature, from the hospital’s own information, and from consultation with the supplier. A financial analysis was carried out considering the main variables of relevance in relation to the costs of infrastructure, human capital, adaptation of the institution, and maintenance of the device. Likewise, a technical feasibility analysis of the implementation of the technology was carried out.

Through analysis, it was possible to recommend the feasibility of and the most efficient purchase options for the analyzed medical devices: three types of X-ray machines, two types of computed tomography scanners, an anesthesia machine, a bronchoscope, a bronchoscopy tower, an echocardiograph, a cardiac stress test, an ultrasound machine, and a vascular Doppler device. It was concluded that, in some cases, the technical analysis of implementation feasibility offers relevant information for the selection of investment in a health technology, and that this is additional to the financial analysis and the analysis of effectiveness and safety.

We constructed a manual for evaluating hospital technologies in Colombia as well as an analysis of the acquisition of seven medical devices for some hospitals. This study provided the main guidelines for carrying out this type of analysis for the country and provided the tools for decision-makers to choose the most efficient investment.

We live in an increasingly long-lived society with rising rates of multimorbidity, which requires the formulation of multiple medications to treat chronic conditions. This can result in polypharmacy (the use of more than five medications in the same month) with consumption maintained over time, making it necessary for health policies and professionals to jointly resolve this issue to reduce the associated health risks.

We conducted a before-and-after intervention study in 661 patients over 74 years of age with persistent excessive polypharmacy (≥10 medications for more than six months). The intervention was carried out by the Healthcare Provider Institution primary care team led by a family doctor, accompanied by the pharmacoepidemiology area of the Cafam pharmaceutical manager. After six and 12 months of intervention (a time established to notice the effects of the adjustment), the patients’ medications were evaluated through the pharmacy manager’s dispensing history to identify changes in the pharmacotherapy of prioritized patients.

Some type of adjustment was made to pharmacotherapy for 36 percent of the patients seen in consultation; for 35 percent of the cohort, it was not necessary to modify any aspect of their pharmacological therapy; and for 29 percent, it was not possible to carry out an intervention (users belonged to other cohorts or there was not enough information to define an intervention). Having achieved a 20 percent decrease in use of the group of agents for the treatment of stomach acid disorders during the study period implies progress in terms of reducing future clinical complications and improving pharmacological efficiency.

The intervention of the comprehensive care program led to an improvement in the pharmacotherapy among selected users by reducing the number of prescribed drugs and promoting the rational use of health technologies. In addition, a net reduction of COP67,387,362 million (USD16,846) was achieved in the first year of monitoring the program.

The ongoing CINDERELLA trial evaluates an innovative artificial intelligence (AI)-based tool designed to enhance the shared decision-making process in breast cancer treatment. The trial aimed to assess the effectiveness of the CINDERELLA app in improving patient satisfaction with locoregional treatment aesthetic outcomes and evaluate its influence on overall quality of life and psychological well-being, as well as its economic, organizational, and environmental impacts.

An international, multicenter randomized controlled, open-label trial is currently recruiting patients with primary early stage breast cancer to follow either a comprehensive AI-powered approach with photographs of aesthetic outcomes of various surgical techniques or standard of care. A trial-based economic evaluation from a societal perspective is planned together with a budget impact analysis. The implementability of the CINDERELLA approach was assessed with respect to its usability, acceptability, organizational impact, and overall feasibility. The environmental impact was quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data were gathered from questionnaires, interviews, focus groups, and app data.

The clinical trial has recruited 1,000 patients across seven study sites in five countries. So far, the average duration of app use was 19.25 minutes (median four logins/user). There were no statistically significant differences in median app usage time based on age group (p=0.136) or estimated type of surgery (p=0.721). The focus groups with healthcare professionals and managers across different sites highlighted comparative similarities and differences across organizational models that will aid interpretation of trial results and adaptation of the intervention to different settings.

Initial data indicated good engagement with the CINDERELLA app. The presence of only minor differences in usage patterns across countries, age groups, and treatment types suggested it can fill information gaps for patients with breast cancer. A multidimensional evaluation of the CINDERELLA app can foster its successful translation into real-world settings, hopefully benefiting patients and clinical practice.

Accidents involving scorpions of the Tityus genus are common in Brazil. While there is no consensus on the ideal dose of anti-scorpionic serum, its use is not recommended for mild cases, whereas two to four vials are suggested for moderate cases and four to six vials for severe cases. Our objective was to synthesize the available literature on serum dosage in Brazil.

A scoping review was conducted of Brazilian studies on patients with suspected or confirmed scorpion envenomation that described serum dosages used for treatment (protocol registered on Open Science Framework DOI 10.17605/OSF.IO/8F7ZB). The study followed the PRISMA Extension for Scoping Reviews guidelines. The ROBINS-I tool was used for risk of bias assessment, with a traffic light plot generated using the Robvis app. Data collection and analysis were performed by two independent reviewers, with a third reviewer consulted when necessary.

After screening 410 records, five studies were included. One study reported using 7.5 (standard deviation [SD] 3.5) vials for mild cases, 4.0 (SD 1.7) for moderate, and 6.5 (SD 2.1) for severe cases. Another study described one to 10 vials for mild cases, one to 15 for moderate, and one to 20 for severe cases. Other studies report using one to six vials, four vials, or that most patients received no more than four vials, although none of these studies provided the risk classification. All studies presented a high risk of bias, mainly due to lack of control for confounding variables.

Available data on anti-scorpionic serum use in Brazil revealed significant variability in clinical management, with the volumes administered often exceeding the Ministry of Health’s recommendations. This highlights a lack of standardization, which increases the likelihood of resource waste in the health care system and safety concerns. Strategies such as educational initiatives and clinical audits are recommended to promote rational serum use.

To promote robust prevention strategies and reflect broader economic impacts, we developed the productivity-adjusted life years (PALYs) metric, which captures a more comprehensive view of health’s societal value. This systematic review explores the use of PALYs across various disease contexts, illustrating its application as a novel outcome measure in health economic evaluations.

We conducted a comprehensive review of studies utilizing PALYs to identify effective methods for decision-making and to illustrate their applications. Using a snowball search, we selected studies that applied PALYs to quantify societal health burdens in specific diseases or contexts. Extracted data included health conditions, country setting, time frame, model type, outcomes, data type (incidence or prevalence), discounting, time horizon, prevention strategies, working-age population, productivity index components, PALY economic value, gross domestic product (GDP), and sensitivity analysis details. Income-level classifications were based on World Bank standards, and findings were summarized through narrative synthesis.

We reviewed 34 studies published from 2018 to 2024, covering conditions like cardiovascular and kidney disease, and environmental factors such as PM2.5 exposure. Most were conducted in high-income countries (n=20). Life table models (n=23) and dynamic models (n=8) were predominant, with other methods including mathematical projections, questionnaires, and cross-sectional designs. Studies focused more on prevention (n=18) than on chronic disease management (n=14). Diabetes, hypertension, sleep apnea, and non-optimal temperatures had the greatest societal impact, while epilepsy led to significant losses in life years and PALYs. Productivity indices varied, with losses ranging from USD1,137 to USD217,983 per full-time worker.

The diversity of health conditions and economic contexts covered in these studies highlighted a broad interest in the determinants of health as measured by the PALY. This diversity is essential, as it provides a comprehensive understanding of the economic impacts and health challenges. Moreover, the emphasis on prevention over chronic disease management suggests a strategic shift toward averting disease onset.

The climate crisis is a health crisis. The health technology assessment (HTA) community is lacking appropriate support and resources to adequately support the evaluation of health technology environmental sustainability. There is a need for reporting guidance to help authors, journal editors, and peer reviewers in their identification and interpretation of sustainability outcomes within HTA. The goal of the Sustainability in HTA (SUSHTA) checklist is to promote key collaboration that aids sustainable healthcare development.

The key aims of the SUSHTA checklist were to validate an environmental model created by industry and provide recommendations to support appropriate framing and reporting of the environmental data. International methodological guideline sources, HTA principles including reproducibility and transparency, and best practice health economics model validity frameworks were used with an interdisciplinary, multidimensional approach. The framework supports pertinent, high quality evidence that extends beyond conventional sources. The checklist has been used as a tool to facilitate collaboration with industry in reporting an information conduit to further aid data sharing and reduce data paucity among HTA agencies and to support healthcare decision-making.

The SUSHTA checklist is holistic and comprehensive through its interpretation of environmental models, including validity checks of terminology, labeling and referencing, model justification, data collection and calculation techniques, assumptions, sensitivity and scenario analysis, and uncertainty modeling. The framework also supports applying the same principles to environmental impacts other than greenhouse gas emissions. Therefore, this framework can be applied to assess a wider range of environmental outcomes (data) for human health impact (disability-adjusted life years), resource use (e.g., water or fossil fuel use), and biodiversity loss (number of species lost per year). The checklist is generalizable and integrates well with healthcare system frameworks.

The SUSHTA checklist is primarily intended for researchers to recommend the minimum amount of information required for reporting environmental data. However, familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for HTA agencies seeking guidance on reporting, as there is an increasing emphasis on transparency and reproducibility in more sustainable decision-making processes.

Neurodivergent children and young people (CYP) experience delays in accessing diagnostic services (two years and three months in the UK). This may harm their development and create missed opportunities for support. Telehealth offers alternative solutions to streamline services and improve the identification of neurodivergence. An early economic analysis was developed to estimate telehealth’s likely costs and consequences in delivering care to CYP.

A conceptual care pathway involving assessment using a telehealth platform—vCreate Neuro—compared to an assessment without vCreate Neuro, was derived from expert consultation and published UK clinical guidelines. A cost-consequence analysis was conducted from a societal perspective in Glasgow, Scotland using data from ongoing pilot studies in National Health Service (NHS) and published literature. Surveys and expert consultations with clinicians assessed trade-offs between costs and consequences associated with the delivery of care in the care pathway. Cost data included direct and overhead expenses related to service delivery.

Costs incurred in the vCreate Neuro pathway were estimated to be GBP1,141.50 (USD1,569.50) and GBP1,220.00 (USD1,677.45) (per patient) without vCreate Neuro, which resulted in GBP78.50 (USD107.90) savings. The clinician survey results indicated possible improvements in time to diagnosis by several weeks to months, with an average decrease of up to four unnecessary appointments. Clinician-to-patient relationships and quality of care may also improve, with 90 minutes of medical time liberated per patient. Additionally, clinicians reported potential improvements in the quality of relationships with parents. Results from the expert consultation highlighted a likely increase in administrative burden for clinicians using the telehealth platform.

The possible administrative burden of using the vCreate Neuro care pathway was rewarded by resource use savings and reduced time to diagnosis. Further evaluation of the system’s costs, benefits, and acceptability by parents or carers is required. This study is relevant for health systems with limited resources, complex services requiring multidisciplinary teams, and the need to overcome barriers to care.

Prematurity accounts for 75 percent of neonatal morbidity, imposing a substantial burden on healthcare services that extends beyond the neonatal period and leads to considerable healthcare costs. This study aimed to investigate factors associated with inpatient healthcare costs for preterm born infants in the first year of life in Brazil.

A population-based cohort study was conducted from the perspective of the Brazilian public health system. We linked infants from the National Live Birth Information and Hospital Information Systems using deterministic record linkage. Infants born prematurely between January 2017 and December 2022 who were admitted to hospitals in the first year of life were included. Data on gestational age (GA), five-minute Apgar score (Apgar5), type of delivery, and inpatient healthcare costs were extracted from the databases. Generalized linear regression was used to analyze the association between GA, Apgar5, type of delivery, and the dependent variable of inpatient care costs.

A total of 196,375 preterm born infants were linked. Each additional week of GA was associated with a reduction in inpatient healthcare costs of BRL1,543.87 (USD285.90) (95% confidence interval [CI]: −BRL1568.85 [−USD290.52], −BRL1518.89 [−USD281.27]) and each additional point increase in Apgar5 score with a reduction of BRL722.67 (USD133.82) (95% CI: −BRL765.83 [−USD141.82], −BRL679.51 [−USD125.83]). Vaginal delivery was associated with a decrease of BRL1,350.26 (USD250.04) (95% CI: −BRL1429.51 [−USD264.72], −BRL1271.01 [−USD235.37]), compared with Cesarean section.

Vaginal delivery and higher GA and Apgar5 score were associated with a significant reduction in inpatient care costs. Public policies aimed at reducing the rate of preterm births and promoting vaginal births in Brazil are essential for reducing hospital costs in the country.

Current Australian and global cardiovascular disease (CVD) prevention guidelines utilize a five-year risk assessment, potentially overlooking individuals with low short-term but high long-term CVD risk. This study evaluated the cost effectiveness of initiating intervention for risk factor control at age 40 years, regardless of calculated risk, compared with the conventional strategy recommended by guidelines, thereby advancing HTA to meet broader global health demands.

We employed a novel causal-microsimulation model containing 108 varied risk factor profiles from the UK Biobank, each replicated 10,000 times, to project outcomes from age 40 to 85 years. The model evaluated the effects of early low-density lipoprotein cholesterol and blood pressure management versus beginning treatment at the conventional five-year CVD risk threshold of 10 percent. The main side effect in the model was an increased type 2 diabetes risk due to statin use. This trade-off was quantified in quality-adjusted life years (QALYs). Incremental cost-effectiveness ratios (ICERs) were compared to Australia’s AUD28,000 (EUR15,631) per QALY willingness-to-pay threshold, with financial outcomes adjusted annually at a three percent discount rate.

Early intervention was effective in preventing CVD across almost all risk profiles, resulting in increased QALYs and life expectancy for a significant portion of the population (37/54 females and 44/54 males in QALYs; 46/54 females and 47/54 males in life expectancy). Moreover, it was cost effective in various cases (5/54 females and 17/54 males). Notably, immediate intervention showed a favorable ICER in individuals who exhibit moderate long-term risk that may not be captured by short-term assessments.

This study highlighted the urgency of reevaluating CVD prevention strategies within HTA, demonstrating that broader, more inclusive preventive interventions are not only effective but cost-effective as well. It signals the need for a significant shift to prioritize CVD, the top cause of global morbidity and mortality.

Advances in digital technologies are changing how users interact with health care. While technologies such as telehealth can be trialed in a randomized controlled trial (RCT), evidence may come predominantly from real-world data. Synthesizing this type of data is challenging, particularly for complex interventions. We present the case study of an evidence synthesis of teledermatology for triaging referrals from primary care.

A systematic review was undertaken of the clinical efficacy, effectiveness, impact on service utilization, and safety of teledermatology-supported triage of primary care referrals, compared with traditional face-to-face dermatology consultations. Searching (through to June 2024), screening and extraction were undertaken as outlined in our protocol (CRD42024608084). All comparative study designs were considered, including chart reviews and single-center experiences. Risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials and the ROBINS-I tool for all other designs. Meta-analysis was undertaken, where appropriate, and an evidence and gap map developed.

Ninety-one studies were identified: 10 RCTs, two quasi-RCTs, 56 prospective non-RCTs, and 23 retrospective non-RCTs. Study samples ranged between 15 and 106,500 participants, with most completed in a single center. There was significant heterogeneity in study populations, indications, interventions, and outcome definitions and measurement. Tables, graphs, and plots (including forest plots) were used to produce a coherent narrative, assisting the decision-maker in understanding the complex evidence base. Overall findings and strength of evidence were summarized using an evidence and gap map, enabling the decision-maker to consider the balance of outcomes for teledermatology-supported triage, including clinical non-inferiority, and efficiency in management.

As policymakers must make decisions based on the best evidence available at a point in time, it is important to capture all relevant information, including real-world data. This case study shows that real-world data can be used to inform assessments of complex interventions. Traditional evidence-synthesis presentation methods can be adapted to facilitate the inclusion of these data.

Mounting evidence shows that gene expression signatures in early breast cancer enable more precise chemotherapy recommendations, targeting those most likely to benefit and safely avoiding it for others. International guidelines highlight their role in optimizing adjuvant chemotherapy decisions. This study examined chemotherapy recommendation patterns in Brazil, providing decision-makers with locally specific data to support evidence-based and patient-centered care.

We conducted an online survey with 10 independent clinical oncology experts, blinded to each other’s responses, to evaluate average chemotherapy recommendations considering age, menopausal status, and clinical risk assessment using the MINDACT study criteria with and without the Oncotype DX Breast Recurrence Score test. For node-negative patients, we analyzed recommendations by clinical risk level (high versus low), age category (over or under 50 years), and recurrence score (RS) ranges (<11; 11 to 25; >25). For node-positive patients, menopausal status and RS ranges (<14; 14 to 25; >25) were evaluated. The results were summarized as the arithmetic means of observed responses.

Chemotherapy recommendations were as follows.

• • For node-negative patients under 50 years by clinical risk (low/high risk): Without Oncotype DX: 36 percent/89 percent; with Oncotype DX and RS less than 11: zero percent/eight percent; RS 11 to 25: 41 percent/70 percent; RS greater than 25: 88 percent/98 percent.

• • For patients older than 50 years without Oncotype DX (low/high risk): 17 percent/77 percent; with Oncotype DX and RS less than 11: zero percent/six percent; RS 11 to 25: one percent/30 percent; RS greater than 25: 88 percent/98 percent.

• • For node-positive patients: Premenopausal women had high chemotherapy rates (82 to 100%) regardless of RS, while in postmenopausal women rates ranged from three percent (RS<11) to 94 percent (RS>25), compared with 81 percent without testing.

Oncotype DX Breast Recurrence Score reduced chemotherapy use in node-negative and postmenopausal node-positive patients, improving treatment targeting. This study revealed differences in chemotherapy recommendations between local Brazilian data and prior Oncotype DX models. Next-generation HTA should prioritize local realities to avoid misrepresentations that could misguide policymakers and to support sustainable and personalized healthcare frameworks in Brazil.

The rapid evolution of health technologies presents opportunities and challenges for the integration of new procedures and treatments within health systems. In Brazil, the National Supplementary Health Agency (ANS) plays a key role in ensuring the continuous updating of their catalog of drugs, devices, and procedures, which defines the coverage of health services in the supplementary sector. This study detailed an initiative designed to provide ANS with evidence-based technical support.

The Hospital Sírio-Libanês, in collaboration with the ANS and the Ministry of Health, has supported health technology assessment strategies that facilitate updating the catalog of drugs, devices, and procedures of the ANS in the “Supporting the Brazilian regulatory agency for supplementary healthcare through health technology assessment actions” project. Initiated in 2019, the project is now entering its third three-year phase (2024 to 2026).

From 2019 to 2024, the project developed 97 technical-scientific health technology assessment reports or workshops, with 93 analyses of social participation and workshops. A total of 43 tutoring sessions on clinical and methodological topics were held for the ANS team involved in the catalog update, which were delivered through synchronous and asynchronous formats. The project developed five methodological templates and conducted three educational initiatives that trained approximately 100 professionals from ANS and the Ministry of Health in health technology assessment through remote synchronous courses. Furthermore, 17 scientific dissemination strategies were executed, including articles and presentations at events, which helped broaden knowledge and foster informed discussions on priority issues that can affect society.

By encouraging evidence-based methods, this project has enhanced the ANS team’s decision-making capacity regarding coverage of the catalog of drugs, devices, and procedures of the ANS. This has supported the updating process, guaranteeing that decisions on technology incorporation are informed by the best scientific evidence available and consider effects on Unified Health System resources, benefiting health plan users and public health policies.