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.

Like many Latin American countries, Colombia and the Dominican Republic grapple with the financial burden of covering high-cost medicines (HCMs). While some of these drugs are highly effective, others have reduced clinical effectiveness. Each of these drugs carries an opportunity cost in terms of the health gains lost by allocating these resources elsewhere. We quantified the health opportunity cost of funding HCMs in Colombia and the Dominican Republic.

An identification strategy for HCMs was employed in both countries, based on their significant budgetary impact or high cost per case. This resulted in a shortlist of 10 molecules for Colombia and another 10 for the Dominican Republic. The health opportunity costs were estimated using the standard methodology of net health benefit, with the country-specific cost-effectiveness threshold employed as a proxy for average health production per dollar invested in the health systems of the two cases under study.

The selected HCMs included drugs for cancer, rare diseases, diabetes, and multiple sclerosis. The incremental health gains provided by these drugs were less than two life years in perfect health. In Colombia, funding the analyzed HCMs instead of the best available therapeutic alternatives implied an additional cost of USD642 million for the treatment of 22,155 covered patients. If these resources were allocated to expand services available within the system, the net gain would be 122,507 quality-adjusted life years (QALYs). In the Dominican Republic, the additional cost was estimated to be USD154 million (14,577 patients), with an estimated opportunity cost of 35,221 QALYs.

The significant health opportunity costs for two countries with gaps in essential health services highlight the need for policies prioritizing efficient spending. Redirecting resources from the analyzed HCMs to cost-effective essential services could enhance health gains, addressing coverage gaps and advancing progress toward universal health coverage.

Existential distress is a debilitating condition in end-of-life cancer patients. The Psycho-existential Symptom Assessment Scale (PeSAS) was developed to screen psycho-existential symptoms in palliative care, but limited research has examined its use. This study aimed to implement the Italian version of the PeSAS in palliative care services and to evaluate changes in healthcare providers’ (HCPs) competence after experiential training. It also aimed to estimate the frequency of psycho-existential symptoms and explore the scale structure using network analysis.

Two-hour experiential workshops were conducted in 5 Italian palliative care services by a clinical psychologist specialized in psycho-oncology and palliative care. Training covered psycho-existential distress, role-play, and feedback. Pre- and post-workshop questionnaires assessed clinicians’ self-efficacy in evaluating physical, psycho-existential, and suicidal symptoms, managing distress, and providing psychosocial support. Patient cross-sectional data were analyzed with descriptive statistics, t-tests, chi-square tests, and exploratory graph analysis.

One hundred one clinicians from 3 services participated. Significant results were found in HCPs’ self-efficacy, with the largest effect in assessing suicidal symptoms (Cohen’s d = 0.54), followed by managing distress (d = 0.47) and evaluating psycho-existential symptoms (d = 0.40). Of 210 patients screened, 194 were included. PeSAS scores were strongly associated with Hopelessness (strength = 1.30) and depression (1.18), while being trapped by illness (−1.64) and wishing to die (−1.12) had weaker associations.

The Italian PeSAS is feasible for integration into palliative care. Strong associations highlight targets for interventions, while weaker associations suggest the need for additional approaches. PeSAS enhances HCPs’ ability to address the psycho-existential needs in end-of-life care.

The Health Information and Quality Authority (HIQA) Health Technology Assessment (HTA) Directorate, established in 2007, has rapidly expanded to more than 50 personnel working across seven teams. This expansion requires significant support for HTA activities, particularly in light of ongoing work to support implementation of the European Union Regulation on HTA. This abstract describes the impact of a recently established support function within the Directorate.

The Strategy, Support, and Research (SSR) team was established in May 2023 to support HTA Directorate project delivery. The SSR team currently includes a Senior Management Team Lead, a Senior HTA Program Manager, a Librarian, and a Program Administrator. Specifically, the SSR team provides program management, administration, librarian support, corporate reporting, placement coordination, and risk management services, and supports research, learning and development, and quality improvement initiatives.

In 2024, the SSR team facilitated HTA activities by coordinating administration, project management, and librarian support for 16 projects, including 15 meetings with expert advisory groups comprising 285 key stakeholders. Twelve literature searches were conducted and 17 reports were published. Two Impact assessment reports were produced, which have 83 downloads and 3,217 social media impressions. The SSR team supported competitive grant funding applications securing more than EUR2.56 million in research funding, successfully applied for tenders with European HTA partners, and supported HIQA to successfully attain ISO 9001:2015 accreditation. This work supports outputs which inform health policy and decision-making in the healthcare ecosystem.

With the increasing demand on HTA agencies, it is imperative that there is an effective support system in place to ensure that high quality outputs are delivered and stakeholders’ needs are met. The establishment of the SSR team in the HIQA HTA Directorate provides an example of how a dedicated team can provide support and impact for an expanding HTA agency.

Adapting health technology assessment (HTA) reports developed by other institutions is efficient to avoid duplication of effort, foster collaboration and knowledge exchange internationally, and improve efficiency. Similar challenges can be faced by institutions who can benefit from experience sharing. A tool for adapting HTA reports in the Americas region was proposed by the Health Technology Assessment Network of the Americas (RedETSA).

The RedETSA adaptation tool was developed by the RedETSA Working Group on Adaptation of HTA Reports with the participation of 14 people from different countries in the region. To develop this tool, the EUnetHTA tool—translated to Spanish and adapted by the Working Group of the Rapid Reporting Guide for HTA of the Spanish Network of Agencies for HTA and Services of the National Health System (RedETS)—was used as a basis. An iterative process of review, design, and decision was conducted by the entire RedETSA Working Group to develop and finalize the RedETSA tool.

The proposed procedure for adapting reports includes two stages: (i) identification of HTA reports to adapt using different search engines; and (ii) evaluation of the HTA report for adaptation. The proposed tool for evaluating the report to adapt includes a set of questions organized around three modules: module one is a rapid screening on initial operational aspects of the report; module two questions the quality of the report, including the use of technology in the context of the report, efficacy, effectiveness, and safety domains; and module three reviews the feasibility of its application to the local context.

Adapting HTA reports promotes inter-country cooperation, strengthens technical capacities, and avoids duplication of effort. A variety of aspects determines whether a report is suitable or not for adaptation. This proposed tool should be considered as a support guide, subject to local criteria in decision-making, and not a quantitative tool with prescriptive cut-off points.

Horizon scanning is a methodology used to identify signals and insights that serve as early awareness indicators. We present a free web application that houses the National Institute for Health and Care Research (NIHR) Innovation Observatory’s data dictionary, allowing users to generate a data extraction template and provide search source suggestions. This resource aims to build capacity in horizon scanning by promoting knowledge exchange and improving productivity.

We identified core data extraction points from four years of horizon scans (n=20). These were divided into 11 categories and linked to scan type, time horizon, and potential search sources. We used Microsoft Access to create a relational database, later converted to SQLite. Python and Streamlit were used to develop a front-end web application. The tool enables users to select parameters relevant to their horizon scan needs and generates customized data extraction templates and search source suggestions. Eight data points specific to the NIHR Innovation Observatory were included in the data dictionary but excluded from the template generator.

The web application incorporates 148 data points linked to nine types of horizon scans, three scan categories, three time horizons, and 183 search sources. Users can generate tailored data extraction templates based on selected criteria, facilitating a structured approach to horizon scanning. The tool’s features include an intuitive interface, customizable templates, and comprehensive search source recommendations. While formal evaluation is planned, initial internal feedback indicated the tool effectively reduces time on tasks and improves productivity. Future updates will focus on incorporating user feedback and enhancing functionality.

This free-to-access resource provides a starting point for anyone wanting to conduct a horizon scan. It offers a comprehensive data dictionary, promotes knowledge exchange and transparency, and allows users to generate robust and reproducible data extraction templates. Plans are underway to formally evaluate the tool’s effectiveness and gather user feedback to inform future updates.

Since 2012, all drugs dispensed in the Brazilian Unified Health System (SUS) must be incorporated by the National Committee for Health Technology Incorporation (CONITEC). However, the characteristics of budget impact analyses (BIA) of incorporated drugs for chronic degenerative and rare diseases are unclear. Thus, our aim was to identify the profile of BIA of these drugs in the SUS between 2012 and 2024.

Based on the 2012 to 2024 public reports of the CONITEC, data were collected on proposals for the incorporation of drugs for chronic degenerative and rare diseases into the SUS. The proposals were categorized by the type of incorporation proponent (public or private) and disease (rare or other chronic), by the presence of BIA, and by adoption of measured demand and active comparator. In addition, the median values of the eligible population and market share (first and fifth years) were calculated.

Among the 153 incorporated drugs, 53.6 percent (n=82) were proposed by private institutions, 36.6 percent (n=56) were for rare diseases, and 69.3 percent (n=106) presented a budget impact analysis. Among all BIA, 68.7 percent (n=79) adopted measured demand, frequently in other chronic diseases (76.1% [n=51] versus 58.3% [n=28]), and 25.0% (n=29) had no active comparator, more often in rare diseases (41.7% [n=20] versus 13.2% [n=9]). The median of the estimated population was higher for the other chronic diseases (27,237 versus 1,550). The median market share values were higher for rare diseases in both the first and fifth years (41.3% and 70.0% versus 20.0% and 50.0%).

Most of the proposals presented BIA. The BIA for rare diseases used measured demand less frequently, had fewer active comparators, and smaller population medians, which may justify the higher market share rates. Since drugs for chronic degenerative and rare diseases are often high cost, knowing the profile of BIA is essential to improve CONITEC’s decision-making and to ensure the sustainability of the SUS.

Health technology assessment (HTA) is essential for informed, transparent, and efficient resource allocation in Mexico’s health system. Despite efforts by institutions like the General Health Council and the National Center for Health Technology Excellence (CENETEC), formal prioritization methods are lacking. This study aimed to develop a prioritization framework, based on the EVIDEM model, via a Delphi panel, integrating clinical, economic, ethical, and social criteria to enhance decision-making.

Conducted between May and December 2024, this project was initiated by the Interinstitutional HTA Working Group to develop a preliminary multi-criteria decision analysis (MCDA) framework for prioritizing health technologies in Mexico. Phases included a systematic literature review, the formation of a multidisciplinary expert panel, and consensus rounds to select key criteria based on the EVIDEM model, ensuring non-redundancy and independence. The process and results were documented in a manuscript for publication in 2025, aiming to strengthen decision-making in Mexico’s health system.

In the first phase, 10 key studies were identified through a comprehensive search protocol, 60 percent of which utilized MCDA for prioritization. These studies averaged 19 relevant criteria, many of which were aligned with the EVIDEM framework, negating the need for new criteria. In the second phase, a multidisciplinary panel of 20 experts from key Mexican public health institutions was formed. Through two consensus rounds in the third phase, 10 of 25 fundamental criteria were selected, including disease severity, comparative effectiveness, costs, and evidence quality. Notably, 80 percent of the selected criteria aligned with the core EVIDEM model.

The proposed MCDA framework marks an initial step toward a structured tool for prioritizing health technologies in Mexico. While validation is needed to confirm its applicability, implementation of the framework has the potential to optimize equitable, criteria-based decision-making, benefiting both the health system and the population.

Influenza is an acute infectious disease that is highly transmissible and affects the respiratory system. It impacts the health system and society by reducing a patient’s productivity and quality of life. The population group most susceptible to complications and death is adults older than 65 years and children younger than five years.

The analysis was performed from the perspective of the Unified Health System (SUS) as the funder. The eligible population was estimated based on epidemiological data from population projections by the Brazilian Institute of Geography and Statistics for a five-year time horizon. The assumption of 90 percent vaccination coverage was adopted as market share. Analyses were performed by scenarios that varied market share and added costs with clinical benefits. Costs were estimated on a national basis, considering the price of the technology, inputs, and waste. Hospitalization costs and their confidence intervals were obtained from the SUS Hospitalization Authorization database.

The cost of vaccination with the high-dose trivalent influenza vaccine was estimated at USD119,637,999.04 in the first year and USD657,405,529.68 over a five-year time horizon. The increase in the budget was USD104,034,983.12 in the first year and USD571,747,563.22 over five years. The alternative scenario one was estimated considering vaccination coverage in 2023 of 63.3 percent, obtaining an incremental impact of USD72,824,488.19 in the first year and USD400,167,351.63 in five years. Alternative scenario two considered the reduction in hospitalizations and found an incremental impact of USD103,908,194.74 in the first year and USD570,970,948.59 in five years.

The budgetary impact was estimated at over USD571 million in five years. In absolute numbers, the reduction in hospitalizations due to influenza (0.4%) and pneumonia (0.3%) was not very significant, which generated a reduction in the incremental budgetary impact, in relation to the main scenario of the analysis, of 0.02 percent in the first year and 0.13 percent in five years.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, affecting one to 1.5 new individuals per million annually worldwide. In Brazil, there are three registered treatments: eculizumab, pegcetacoplan, and ravulizumab, while crovalimab is currently under evaluation by ANVISA, the Brazilian Health Regulatory Agency. This study examined the impact of these PNH treatments on the logistics and time required by healthcare professionals and patients for administration.

Quantitative and descriptive analysis was conducted based on information from the package leaflets of eculizumab, ravulizumab, pegcetacoplan, and crovalimab regarding the number of vials, volume, and administration time for each medication for a patient with PNH weighing between 60 and 100 kg over a period of 52 weeks.

The number of vials required for treatment over 52 weeks was 78 for eculizumab, 102 for pegcetacoplan, 70 for ravulizumab, and 26 for crovalimab. The volume to be transported would be 4,680 mL for eculizumab, 2,080 mL for pegcetacoplan, 231 mL for ravulizumab, and 52 mL for crovalimab. Regarding the time required for each infusion per year (52 weeks), it would take 14.6 hours for eculizumab, 4.7 hours for ravulizumab, 78 hours for pegcetacoplan, and 1.1 hours for crovalimab.

This study demonstrated that crovalimab can reduce the number of vials needed by 169 percent, transportation and storage volume by 344 percent, and infusion time by 331 percent. These efficiencies, applicable to both healthcare professionals and patients, highlight crovalimab’s potential to significantly enhance the sustainability of Brazilian public healthcare system and improve quality of life for patients.

The primary objective of the Handbook of EBPP is to empower professionals, researchers, students, and the public with the skills needed to read and critically interpret biomedical literature relevant to psychology. By fostering a deeper understanding of evidence-based approaches, the Handbook aims to enhance the quality and effectiveness of mental health services, ultimately improving care outcomes.

The Handbook is systematically organized into three main sections.

• • Foundations: This section explores the conceptual and historical development of EBPP, establishing its relevance and importance within psychological practice.

• • Methodology: Detailed guidance is provided on essential methodological tools, such as framing research questions with the PICO (population, intervention, comparator, outcome) model, navigating electronic databases effectively, and critically analyzing scientific literature. Emphasis is placed on the role of experimental designs, systematic reviews, and meta-analyses in evidence-based practice.

• • Interventions: The third section focuses on the efficacy, effectiveness, and safety of psychosocial interventions, highlighting their critical role in the prevention and treatment of mental health disorders.

Although quantitative assessments of the Handbook’s impact are not included in this abstract, its comprehensive approach addresses a crucial gap in the Portuguese-speaking mental health community. By presenting accessible, scientifically validated practices, it establishes itself as a cornerstone for evidence-based psychological education and care.

The Handbook of EBPP meets an urgent demand for Portuguese-language educational materials on evidence-based psychology. Adhering to the principles of the Cochrane Collaboration, it ensures that clinical guidelines are transparent, rigorously evaluated, and regularly updated. This resource is a significant step forward for the professionalization of psychological practice in Brazil, advancing ethical, evidence-based care and improving individual mental health outcomes.

Breast cancer (BC) confers a high burden on the Brazilian population. Moreover, the possible overuse of adjuvant chemotherapy in patients with a low risk of tumor recurrence may subject these individuals to harmful side effects, without offering substantial therapeutic advantages. The implementation of genomic testing for risk stratification represents a promising strategy to optimize patient care.

We assessed the economic implications of integrating the Oncotype DX Breast Recurrence Score Test® for stratifying BC patients according to their recurrence score (RS). A decision tree and Markov model estimated the long-term costs and outcomes linked to transitions between the health states of recurrence-free, distant recurrence, acute myeloid leukemia, and death. Patient distributions and probabilities of distant recurrence were obtained from the TAILORx (N0) and RxPONDER (N1) clinical trials. Local evidence on utility and overall survival was also considered. The analysis was carried out from the perspective of the Brazilian private healthcare system. Deterministic and sensitivity analyses were conducted.

Compared with clinical and pathological risk alone, adding the Oncotype DX test for all BC patients (N0 or N1) generated more quality-adjusted life years (QALYs) at lower costs (0.15 QALYs and −USD41,251.80). The three most efficient indications included: restricted to N1 (0.28 QALYs and −USD6,032.65); N0 restricted to high risk and N1 restricted to post-menopause (0.22 QALYs and −USD6,276.73); and N0 restricted to high risk (0.20 QALYs and −USD6.335,99). The main impact drivers were chemotherapy costs, chemotherapy prescription probabilities, and acute myeloid leukemia incidence rate. The sensitivity analysis indicated a high probability of the test being cost effective.

The Oncotype DX test has a high likelihood of being a cost-effective strategy from the Brazilian private healthcare perspective. Alternative scenarios and test indications did not alter these conclusions.

Rituximab is a monoclonal antibody used to treat non-Hodgkin’s lymphoma. Since the expiration of the reference rituximab’s patent, several biosimilars have been marketed. As biosimilar products are not identical to reference medicines, synthesis of evidence comparing them is needed to understand their effects and harms.

We performed a Cochrane systematic review and searched main bibliographic (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trials databases up to February 2024. We included head-to-head randomized controlled trials conducted in adults with lymphoma treated with rituximab biosimilar or reference. When possible, we pooled the results of the following outcomes using random-effects meta-analyses: progression-free survival, duration of response, overall survival, serious adverse events, objective response rate, and health-related quality of life. We used the revised Cochrane risk-of-bias tool to assess the risk of bias and GRADE to evaluate the certainty of evidence of critical and important outcomes.

We included 16 studies (n=4,342 participants). The overall risk of bias was low. Rituximab biosimilar was likely similar to reference in progression-free survival, duration of response, and overall survival (moderate certainty evidence; data not pooled as survival estimates were adjusted for different factors or reported as rates); serious adverse events (risk ratio [RR] 1.03, 95% confidence interval [CI]: 0.94, 1.14]; 15 studies, n=4,197; moderate certainty evidence); objective response (RR 1.01, 95% CI: 0.98, 1.04; 15 studies, n=3,852; moderate certainty evidence); and mortality (RR 0.97, 95% CI: 0.70, 1.35; 8 studies, n=2,557; high certainty evidence). Imprecision was the main reason for downgrading certainty in the findings.

Treatment with rituximab biosimilars was likely similar to the reference in survival outcomes and rates of adverse events. The overall certainty of evidence was moderate.

Diabetes insipidus (DI) is a rare disease characterized by water balance disorders and is often associated with high morbidity. Incorporating new technologies into Brazil’s Unified Health System (SUS) requires technical rigor and public participation to ensure equitable health system. This study explored how public participation in developing a Clinical Protocol and Therapeutic Guideline (PCDT) could enhance equity and transparency in health policies.

To analyze the demographic characteristics and opinions of patients and stakeholders involved in the public consultation and to describe the transparency in handling these contributions. Contributions were collected during a 90-day open public consultation and analyzed in three stages: (i) reading all submissions; (ii) categorizing key ideas; and (iii) discussing implications. This methodology provided insights into public engagement and its influence on fairness and transparency in decision-making processes, highlighting the importance of inclusive approaches to health governance.

A total of 15 contributions were received, with 86 percent originating from individuals, predominantly white women from southern Brazil aged 25 to 39 years. Participants rated the preliminary recommendations as very good (53%), good (40%), and average (7%). Although no suggestions were incorporated, all contributions were analyzed and responded to, with positive feedback on the protocol’s clarity. The contributions underscored the importance of a PCDT in the SUS for improving rare disease management and for fostering community engagement. The findings highlighted the need for broader knowledge dissemination to stimulate public participation and enhance diversity and inclusion across the country.

The public consultation for the PCDT on DI emphasized the importance of transparency and community engagement in health policies. While contributions praised the protocol’s clarity, findings revealed the need to expand outreach for greater inclusivity and regional diversity. Strengthening participation processes can enhance equity, improve rare disease management, and foster more responsive and inclusive health governance in Brazil.