The dynamic nature of the prehospital environment poses a challenge for maintaining optimal storage conditions for medicines and other products. Failure to ensure adequate temperature control can impact drug efficacy, potentially compromising effective prehospital care. This study aims to monitor temperature variations in vehicles operated by a helicopter Emergency Medical Service (EMS) in the east of England to evaluate temperature variation and the potential exposure of therapeutic products to extreme temperatures.

This was a prospective observational study over a 12-month period (September 2022 through August 2023). ALTA Industrial Wireless temperature sensors were deployed across five Volvo XC90 rapid response vehicles (RRVs) and an AgustaWestland 169 (AW169) helicopter operated by Essex & Herts Air Ambulance (EHAAT). One RRV (RRV02) remained permanently outside for the period of observation. Sensors recorded at 30-minute intervals, triggering alerts if temperatures exceeded 25°C or dropped below 2°C. Ambient data were obtained from the Writtle Weather Station, via the Met Office Integrated Data Archive System (MIDAS). The study did not involve any patients and ethical board review was not required.

A total of 102,524 readings were recorded; temperatures ranged from −9°C to 46.8°C. The RRV02 recorded the lowest monthly mean (7.9°C) while the AW169 recorded the highest (24.9°C). Overall, daily maximum temperatures ranged from 17.7°C to 46.8°C, with the AW169 reaching 46.8°C in May. Daily minimum values ranged from −9°C to 19.6°C, with the RRV02 recording −9°C in December.

Temperatures inside the vehicles and aircraft frequently exceed recommended limits for environmental temperatures. Indoor RRV storage provides some protection from extreme temperatures, particularly mitigating against low temperatures. The AW169 aircraft demonstrated the poorest overall temperature control. These results can be used to guide effective storage protocols and climate control strategies to ensure the integrity of therapeutic products.

Countries face the challenge of advancing access to innovative health technologies. There is growing interest in managed entry agreements (MEAs) in Latin America, but very few publications. A recent cross-country comparison of Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, and Peru analyzed state-of-the-art MEAs in these settings. After collecting information from 69 relevant stakeholders through focus groups, interviews, and surveys, a series of recommendations for MEA scalability were provided.

Qualitative methods were used. A desk review of recent regulations and publications of successful MEAs in the eight countries of interest was performed, followed by eight focus groups with 63 key informants. Also, three key informants from local authorities and three representatives from the local pharmaceutical federations of Argentina, Brazil, and Chile were invited to participate in a survey. The qualitative methods used served to provide relevant information to inform a set of recommendations.

In total, 69 key informants participated in the study. The level of knowledge and understanding of the use and limitations of MEAs was moderate to high in all countries. There seemed to be positive or moderate political will and policy commitment to implementing MEAs in the region.

The most common barriers to implementing MEAs were a lack of clear rules, roles, and responsibilities; the lack of enabling legal and policy frameworks; and the scarcity of available information on successful implementation of MEAs in neighboring countries.

The Regional Database of Health Technology Assessment Reports of the Americas (BRISA) provides free access to bibliographic information on health technology assessment (HTA) prepared and published by member institutions of the HTA Network of the Americas (RedETSA) and strategic partners. BRISA is the first open regional virtual library that centralizes HTA reports which would otherwise be scattered or inaccessible to the public.

BRISA was developed in collaboration with the Latin American and Caribbean Center on Health Sciences Information (BIREME) through the Virtual Health Library. The platform and the methodology for registering, organizing, and disseminating reports were developed by BIREME, in coordination with the Pan American Health Organization. HTA reports are shared in Spanish, Portuguese, French, and English. A retrospective analysis of BRISA’s development and achievements since its launch was conducted. The analysis included the number of countries and institutions providing HTA reports, the number of HTA reports published over time, the number of users per country, and the total number of page views since its creation.

Since its launch in 2017, the number of contributors to BRISA has reached 14 countries and more than 40 institutions. BRISA is constantly growing and in 2024, it reached more than 4,000 reports. In 2024, Brazil, Mexico, and Argentina had the highest number of users (with 16,620, 12,750, and 9,338 users, respectively). The number of page views increased from 4,833 in 2018 to more than 840,000 in 2024. Since 2024, BRISA also includes HTA reports from partner networks like the Spanish Network of Agencies for HTA and Services of the National Health System (RedETS) in Spain.

BRISA is a collaborative network that facilitates learning from the experiences of other countries, helps avoid duplication of effort, and promotes the incorporation of cost-effective health technologies and their appropriate use. With the BRISA database, RedETSA seeks to promote the use of HTA to improve the decision-making process for incorporating technologies in health systems, improving access and equity.

One way of communicating the effect of interventions is by converting relative effects, such as relative risk, into absolute effects. Guidelines from the GRADE working group and the Cochrane Handbook for Systematic Reviews of Interventions recommend this conversion for summarizing and concluding evidence syntheses. However, this conversion can lead to errors, and previous research has indicated that inadequacies are frequent in Cochrane reviews that convert hazard ratios to absolute effect measures.

A descriptive study outlined the development of the abseff program, created using the ado programming language of the Stata software and R. This program was developed in the context of two projects conducted by the Center of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo-SP, Brazil in collaboration with the Ministry of Health, the National Supplementary Health Agency, and the National Council of Justice through the Support Program for Institutional Development of the Unified Health System (PROADI-SUS). Both projects involve drawing up evidence summaries, and the abseff program aims to convert relative effect into corresponding absolute effect measures.

Abseff converts data on relative effects (relative risks, odds ratios, hazard ratios) into absolute effects, including 95 percent confidence intervals (CI). Researchers input a relative effect and its confidence interval with a baseline risk for the calculation. For example, the command abseff rr 0.83 0.63 1.03 50 130 converts a relative risk of 0.83 (95% CI: 0.63, 1.03) with a baseline risk of 50/130 (38%). The result is presented in absolute anticipated effects and absolute risk difference, and calculations account for bases of 100 and 1,000. The program is freely available via Stata and R. For more details access https://rlpacheco.github.io/abseff/; https://github.com/rlpacheco/abseff_R.

Effective communication of evidence can be challenging, and translating scientific knowledge can be facilitated by presenting absolute effect measures to the decision maker. The abseff program standardizes these conversions, minimizing errors and ensuring reproducibility in analyses. Originally created as part of two projects funded by PROADI-SUS, abseff is now available for use by all health technology assessment researchers.

Life cycle health technology assessment (LC-HTA) refers to continuous methodologies used to evaluate, reassess, and de-adopt technologies. In LC-HTA, the consequences of using a technology are assessed throughout its life cycle, from development to obsolescence. This study examined the experience of the National Committee for Health Technology Incorporation (CONITEC), the Brazilian Health Technology Agency, in applying LC-HTA at various stages of the health technology life cycle.

This study analyzed CONITEC’s implementation of the LC-HTA by reviewing publicly available recommendation reports and other data published by the Committee. A systematic analysis of these documents was conducted to identify and categorize activities performed across the health technology life cycle: pre-commercialization, post-commercialization, and disinvestment. The analysis aimed to identify when each LC-HTA activity was first implemented and to understand how these processes are operationalized within the Brazilian public health system.

CONITEC has implemented LC-HTA activities across various life cycle stages, including pre-commercialization, post-commercialization, and disinvestment. Since 2014, early awareness syntheses have evaluated technologies with potential health system impacts or emerging technologies for priority diseases. Horizon scanning identifies new and emerging technologies that could compete with the technology under evaluation by CONITEC and has been included in every report since 2017. Implementation monitoring, consistently conducted since 2020, prioritizes technologies with uncertainties regarding safety, effectiveness, or economic outcomes. Disinvestment activities, initiated in 2013, target technologies no longer used in the Brazilian public healthcare system, optimizing resources and improving decision-making.

LC-HTA activities were independently implemented by CONITEC, but not all health technologies are routinely evaluated across all phases of their life cycle. LC-HTA implementation is most beneficial in specific contexts, such as during a public health crisis (e.g., a pandemic) or for technologies deemed strategically important for the country. However, each phase-specific activity has yielded valuable results, contributing to evidence-based decision-making.

The New Zealand health system provides universal health coverage to a population of 5.2 million, delivered through a range of public, private, and voluntary providers. New Zealand has extensive experience applying health technology assessment (HTA) to pharmaceuticals and vaccines. These models could potentially be adapted and applied to innovative precision health technologies that offer substantive potential health and equity benefits for patients and whānau (families), and health system financial sustainability.

The New Zealand Ministry of Health developed a Long-Term Insights Briefing on Precision Health to highlight future trends, risks, and opportunities represented by genomics and artificial intelligence-enabled technologies. The briefing was developed collaboratively with consultation with patients and the public, including deliberative consultation with Māori and Pacific peoples. Organizational input was provided from across the sector including from government agencies, clinicians, researchers, industry, and patient organizations. The briefing was structured around key themes identified through engagement.

The briefing identified multiple themes with important implications for any future design and approach to the conduct and delivery of HTA for genomic and artificial-intelligence-enabled technologies in New Zealand. Core issues raised by stakeholders included the need for sustained and coordinated investment pathways, societal-wide consideration of the impact of new technology adoption, specific incorporation of multiple dimensions of equity, and consideration of impacts on the efficiency and financial sustainability of the health system. The importance of maintaining data sovereignty was a major element of the briefing, including the conduct of research and collection and use of information.

This policymaker-led session detailed the incremental progress New Zealand has made toward realizing and managing the opportunities and risks of precision health. HTA processes and methodology are useful tools that may be adapted to ensure appropriate consideration of identified objectives and trade-offs associated with expanded investment and use of precision health technologies in New Zealand’s publicly funded health system.

Climate change is a global concern. Medical technology, from production to disposal, has diverse environmental impacts. Many healthcare systems use value frameworks to inform transparent decision-making. Our objective was to review how healthcare systems currently consider environmental sustainability in health technology assessment (HTA) value frameworks.

A scoping review was conducted to identify value frameworks focused on the assessment of any type of medical technology from 2000 to 2024. We examined main literature databases, HTA agency websites, and gray literature, with no language restrictions. Two researchers extracted dimensions from the surveyed frameworks. A wide range of value frameworks were included, and we surveyed whether environmental impact (broad term) was included within the dimensions of value. Value framework characteristics extracted included variables like origin, intended use, and the presence of evaluation or explicit weighting methods for a technology’s environmental impact.

Forty-eight value frameworks were identified. Sixteen percent (n=8) mentioned the environmental impact of the technology. Three were developed by HTA agencies (Australia, Canada, and the UK) and the rest were from other stakeholders in Europe, Latin America, the USA, and a global alliance. Except for two frameworks focused on diagnostic technologies, most were geared toward healthcare technologies more broadly. Only one framework suggested an assessment tool for environmental impact. Four frameworks provided a conceptual definition of this dimension without tools or metrics for assessing it, while the remaining three solely listed this dimension.

Despite the increasing global relevance of the effect that human activities and natural events have on the environment, only a minority of value frameworks considered the incorporation of environmental impact of the healthcare technologies they assess. This study’s key contribution is surveying current consideration of environmental impact in health systems, providing a starting point for future actions.

The study aims to understand the perceptions of deprescribing in primary care for patients with a limited life expectancy.

In the setting of limited life expectancy, medications may become inappropriate when the possible harms of use outweigh the benefits. Whilst the cessation of potentially inappropriate medications is associated with improved patient outcomes, incorporating this process into routine primary care is poorly enacted.

Qualitative interview study performed in primary care settings in the Netherlands, including primary care health professionals, patients with limited life expectancy, and their caregivers. Semi-structured interviews were conducted and analysed using inductive thematic analysis.

Three key themes emerged: (1) facilitating well-being, (2) preventing harm, and (3) dealing with uncertainty. A key goal of mediation use is to facilitate well-being, although the perceptions of this effect may not always match the reality due to changed clinical circumstances. The decision to continue or stop medication is influenced by the wish to prevent harm and to what extent participants find ways to deal with the uncertainties facing them.

Reluctance to deprescribe medications is often related to uncertainties around ceasing medications, lack of clear clinical guidance, and the evolving situation of advanced illness. Integrating these discussions into routine primary care for patients with chronic and incurable illnesses may assist patients and healthcare professionals to address issues around medication use in a proactive manner and promote advance care planning discussions.

Sex differences and gender inequalities in health are increasingly recognized in health technology assessment (HTA), but their analysis remains inconsistent. Despite advancements in addressing ethical, organizational, and social issues in HTA, neglecting sex/gender (S/G) considerations can distort its outcomes. This initiative aimed to enhance equity by exploring international experiences and identifying frameworks for S/G-sensitive HTA processes.

The first phase involved an exploratory analysis to assess the inclusion of S/G in methodological and report prioritization processes, using both Medical Subject Heading terms and free keywords. The search was then expanded to include international experiences, frameworks, and tools incorporating a S/G approach from organizations such as the World Health Organization, International Network of Agencies for Health Technology Assessment, European Network for Health Technology Assessment, Cochrane Collaboration, and other frameworks (GRADE, VALIDATE). HTA agencies and ministries of health from Latin America and high-income countries were reviewed. Data were extracted, focusing on the practical application of S/G in HTA.

No specific tools were identified, and S/G perspectives were generally absent, with “gender” mainly referring to the male/female distinction. The Cochrane Collaboration has a S/G Methods Group and a S/G in Systematic Reviews Planning Tool. Both the Cochrane Collaboration and GRADE incorporate S/G in equity frameworks (PROGRESS-Plus). Ecuador and Argentina (Instituto de Efectividad Clínica y Sanitaria) integrate gender in the Sustainable Development Goals. The National Institute for Health and Care Excellence includes S/G in qualitative study appraisals, and Canada’s Drug Agency (CDA) advocates for gender equity in health care. The Institute for Quality and Efficiency in Health Care (IQWiG) in Germany emphasizes the need to account for gender differences in health assessments as part of general HTA methods, and the French National Authority for Health (HAS) proposes integrating gender into public health policies and health technology guidance.

S/G perspectives are internationally recognized as a key axis of inequity. Several entities incorporate these perspectives into documents and frameworks (the Cochrane Collaboration, CDA’s real-world evidence guidelines, IQWiG’s general methods). HAS plans methodological frameworks, and both the Institute for Clinical Effectiveness and Health Policy and IQWiG promote non-sexist/neutral language guidelines. The next exploratory phase would be to see whether and how they are being used in HTA processes.

As a step in the process of incorporating technologies, the National Supplementary Health Agency (ANS) prepares critical assessment reports (RACs). The analysis of the RACs can help in understanding the demands in supplementary health. The aim of this work was to characterize the technologies submitted to and incorporated into the ANS with respect to type of intervention, certainty of evidence, and economic aspects.

A descriptive study was conducted in which data from the RACs of the proposals for updating the list of covered procedures, incorporated between October 2021 and December 2023, were analyzed. The extracted data included type of intervention; classification of the disease or condition; level of certainty of the evidence for the main outcome; incremental cost-effectiveness ratio (ICER); and incremental budget impact (IBI) over five years. For the ICER evaluation, the percentage of technologies where the cost exceeded three times the Brazilian gross domestic product (GDP) for 2023 (USD31,103.4557) was considered. Data were presented using descriptive statistics.

Of the 50 incorporated technologies, 96 percent were therapeutic and 4 percent were preventive or prophylactic. Most of the proposals were for oncological conditions (68%). The certainty of the evidence was moderate to high in 52 percent of the incorporations and low to very low in 48 percent. The average IBI was USD32,001,783.74. In 24 percent of the incorporations, the IBI was negative, with 75 percent of these having low to very low evidence certainty. A cost-minimization analysis was conducted for 15 proposals; for the others, the ICER was more than three times the GDP in 54.3 percent of the incorporations.

A relevant percentage of the technologies incorporated by the ANS had low to very low certainty of evidence. Costs exceeded three times the Brazilian GDP in more than half the technologies where the ICER was calculated. The results highlight the need for decisions based on robust evidence and cost effectiveness to ensure the sustainability of the supplementary health system.

Accelerated approval facilitates timely access to innovative drugs in the USA, but confirmatory trials are required for traditional approval. This study evaluated alignment between United States Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines & Healthcare Products Regulatory Agency (MHRA), and National Institute for Health and Care Excellence (NICE) recommendations regarding drugs converted by the FDA from accelerated to traditional approval. This research addresses a gap in the literature by examining drugs across all therapeutic categories converted to traditional approval after 2020.

This retrospective cohort study analyzed drug-indication pairs granted FDA accelerated approval and converted to traditional approval between January 2020 and October 2024. Data from EMA, MHRA, and NICE documents were reviewed to identify decisions regarding market authorization (EMA and MHRA) and coverage recommendation type (NICE). Drug-indication pairs were categorized by FDA therapeutic classification, including infectious diseases (vaccines and non-vaccines), cancer, hematologic, neurological, and other disorders.

From January 2020 to October 2024, 115 drug-indication pairs received FDA accelerated approval. Eight of these were later withdrawn and 78 remain with ongoing confirmatory trials, while 29 successfully verified clinical benefit and were converted to traditional approval. Among these, 25 received EMA market authorization and 21 received MHRA market access after departure from the European Union (EU), with 14 requiring additional monitoring. By October 2024, 14 pairs had not been reviewed by NICE. Eight drug-indication pairs received a “recommended” status, two were “optimized” for smaller populations, and two were recommended for the Cancer Drugs Fund. One appraisal was terminated, and two were not recommended due to insufficient clinical benefits or cost effectiveness.

This study showed that FDA decisions to convert drugs from accelerated to traditional approval do not always align with EMA, MHRA, and NICE recommendations, highlighting potential global differences in regulatory and reimbursement criteria. Next steps will focus on analyzing NICE appraisal rationales, clinical evidence, and cost-effectiveness considerations to better understand these discrepancies, particularly in the post-EU departure period.

Healthcare systems are substantial greenhouse gas emitters, responsible for five percent of emissions worldwide. Inhalers are particularly problematic, and while all inhalers have a negative impact, pressurized metered-dose inhalers (pMDIs) are the worst offenders. With carbon minimal pMDIs in development, this research evaluated the economic value that selected carbon minimal pMDIs could offer and explored how this value can be represented in economic evaluations.

The analysis employed a partial economic evaluation framework. Given the carbon minimal and current standard pMDIs are expected to be clinically equivalent, clinical outcomes and downstream resources offset each other in an incremental analysis. Thus, the evaluation centered around reduction in carbon and incremental costs. Two approaches were undertaken: parallel and integrated evaluation. Environment impact (carbon footprint) was sourced from published life cycle assessments, dosage was based on international guidelines, and costs were taken from the British National Formulary. The cost of carbon used was the UK Treasury’s carbon value of GBP269 (USD370) per ton of carbon dioxide equivalent (CO2e).

Current selected pMDIs produce 103 kg to 150 kg of CO2e per person per year depending on which product is used, whereas the carbon minimal pMDIs produce 13 kg to 18 kg of CO2e per person per year, a reduction of around 88 percent. The undiscounted additional value of the selected carbon minimal pMDIs ranges from GBP776 (USD1,068) to GBP1,134 (USD1,561) per person with asthma over their lifetime. Based on these results, at a population level, if all people currently being prescribed pMDIs moved to a low carbon pMDIs, this could save carbon emissions to the value of GBP112 to 166 million (USD154 to 229 million) annually in the UK alone.

The added value demonstrates the environmental and economic benefits available from switching from existing pMDIs to low carbon pMDIs where clinical outcomes are equivalent. This additional value can be reflected in economic evaluations as part of an HTA process, although challenges remain related to data availability and in the interpretation of environmental impact data in cases of non-dominance.