Diabetes affects over 500 million people worldwide and contributes substantially to the environmental impact of health care, including carbon emissions and plastic waste. As healthcare systems globally aim to reduce their environmental footprint, there is a need to embed environmental sustainability into decision making and foster innovation in health and life sciences.This commentary outlines the environmental sustainability challenges and opportunities across the diabetes care pathway, highlighting innovations that reduce the demand for healthcare resources and associated environmental impact. We discuss the current and potential role of health technology assessment (HTA) agencies in promoting more sustainable health systems, by incorporating environmental considerations into the value assessment of technologies. Several approaches, such as integrated and parallel evaluation, are emerging to support this aim, whereas HTA agencies increasingly consider parameters of environmental life cycle assessment (eLCA), a comprehensive framework for evaluating the environmental sustainability of technology. Although a framework is evolving, early implementation by HTA bodies, for example, in the United Kingdom, Thailand, Canada, and Italy, highlights growing momentum. Moreover, sustainability policies at government and health system levels are developing globally, signaling opportunities to incorporate environmental sustainability in HTA (ESHTA).Given the scale of health care's environmental footprint, large disease areas offer critical opportunities for sustainable action. Diabetes, with its growing global prevalence, presents a particularly suitable domain for piloting the integration of environmental sustainability into HTA.

Since 2019 the Dutch National Healthcare Institute has operated a coverage with evidence development (CED) program for specific products with insufficient evidence of their clinical benefit: orphan medicinal products (OMPs), medicines with conditional marketing authorization (CMA), and medicines with marketing authorization under exceptional circumstances (AEC). The objective of this study is to give an overview of this program and reflect on learnings, challenges, and opportunities.

This study's primary objective was to test the feasibility of using the online personal utility function (OPUF) approach and develop a preliminary utility tariff for the EQ-5D-5L based on a South African community sample.

Despite omics technologies gaining traction in clinical settings, particularly in oncology, challenges persist in their widespread adoption due to the pre-requisite robust evidence supporting efficacy and cost-effectiveness. This study aims to explore the experiences of organizations working in the health technology assessment (HTA) field in evaluating omics technologies, with a particular focus on the adoption and application of specific assessment frameworks.

The simultaneous existence of low-value health care and underutilization of high-value care are global problems. Health technology reassessment (HTR) aims to optimize the value for money of technologies already in use within health care. Identifying candidate interventions for HTR remains challenging. Therefore, we tested a novel method to identify candidate outpatient prescription drugs for HTR through practice variation.

Developing therapies for rare diseases is challenging due to limited evidence and high degrees of uncertainty regarding the value of new treatments. Clinical expert judgment can inform modeling assumptions and address areas of uncertainty in reimbursement submissions. As current protocols do not adequately address the challenges faced in rare diseases, this research aimed to generate recommendations for the collection and reporting of clinical expert judgment in rare diseases.

Health technology assessment (HTA) for medical devices (MDs) is essential for adoption decisions, but the sector's particularities studied here defy regulatory frameworks. In Brazil, the National Policy for Health Technology Management (PNGTS) provides guidelines for HTA, but the reimbursement of MDs in the Brazilian National Health System (SUS) still faces challenges. This study aimed to identify and validate relevant domains and attributes for HTA of MDs in the SUS, considering the perspectives of various stakeholders.

Under the Universal Health Care Act of the Philippines, all health technologies should undergo health technology assessment. This manuscript details the process of the development of the Philippine guidance document for the use of real-world evidence (RWE) in the clinical evaluation of health technologies.

This scoping review aims to synthesize the literature on pediatric health technology assessments (HTAs) and map out the challenges of assessing new technologies for use in children, with a particular focus on pharmaceutical interventions.

The introduction of a new healthcare technology within the technological facilities of a hospital is a complex action that must go through the mandatory decision-making process of health technology assessment (HTA). Nowadays, developing a universal HTA model poses a significant challenge within the current landscape. This paper describes the proposal of a novel supporting healthcare technology evaluation toolbox, aligned with the principles of the European Network for Health Technology Assessment (EUnetHTA) shared by the Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR).

The reimbursement of, and subsequent patient access to, high-risk medical devices (MD) and in vitro diagnostics (IVD) across Europe often vary. The Health Technology Assessment Regulation (HTAR) aims to standardize clinical evaluations through Joint Clinical Assessments. Still, national differences in reimbursement frameworks and evidence integration for MD/IVD may impede the realization of HTAR's expected benefits. This review aims to map existing reimbursement frameworks for high-risk MD/IVD, identify key oversight structures, and evaluate the use of comparative effectiveness and safety evidence in reimbursement decisions across the EU/EEA/UK.

The Dutch National Health Care Institute (ZIN) advises the Dutch Minister of Health on the basic benefit package using Health Technology Assessment (HTA), focusing on necessity, clinical effectiveness, cost-effectiveness, and feasibility. Despite the huge environmental impact of the healthcare sector, this impact is not taken into consideration. Several methodological approaches to integrate the environmental impact into HTA have been proposed, including information conduit, integrated evaluation, parallel evaluation, and environment-focused evaluation. There is significant uncertainty as to which approach is the most appropriate. Therefore, it is important to understand stakeholders' perspectives on these approaches.

The National Institute for Health and Care Excellence (NICE) early value assessment (EVA) was launched in 2022 as a process to assess new technologies that have the potential to meet an unmet need or demand. The recommendations that result from the process are best viewed as a type of managed entry agreement - that is, time-limited and conditional on further evidence being generated. This commentary, from authors in PenTAG (an external assessment group involved in assessing medical technologies for NICE, based at the University of Exeter), explores the challenges that have arisen during 3 years of performing EVAs, offers some thoughts on EVA's role in evidence generation, and their fit in NICE's wider evidence landscape. The commentary identifies areas for potential improvement in terms of timelines, scoping and protocol development, searching, reviewing, and economic modeling. Many of the suggested changes are relatively minor tweaks to the process, or requests for clearer guidance or expectation management. We conclude that, with some changes to the EVA process and its accompanying guidance, the assessments could become more efficient. In summary, the EVA represents NICE's life cycle approach in their HealthTech program, wherein evidence is collected along the life cycle to help monitor initial assumptions and recommendations made. The process is designed to continuously capture incremental innovation over the lifetime of a medical device. As such, EVAs reflect a small but important shift in how health technology assessment is practiced.

The life cycle of health technologies contribute to air pollution, ecotoxicity, and resource depletion, impacting the environment and human health. Increasing healthcare resource use globally increases emissions that accelerate climate change and negatively affect the health of current and future generations.Health Technology Assessment (HTA) should inform decision makers to prioritize the adoption of technologies demonstrating value in terms of health benefits, costs, and other relevant dimensions such as environmental sustainability.This paper reports on a multistakeholder approach to guiding an international working group for Environmental Sustainability in Health Technology Assessment (ESHTA) that has been formed by Health Technology Assessment international.

Health technology assessment (HTA) has been characterized as a complex adaptive system that centrally features stakeholder interactions. This article provides an overview of current practices in HTA stakeholder engagement concerning medicines.