International Journal of Technology Assessment in Health Care最新文献

Aims: 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.

Objectives: To analyze and validate the essential domains and attributes for conducting HTA studies focused on the reimbursement of MDs in the SUS.

Methods: A baseline systematic review was performed, which was followed by two additional stages: a survey with 115 participants and a Delphi panel with 33 experts. Likert scales were used to assess the importance of the domains and attributes, along with open questions to collect suggestions and comments.

Results: The domains "clinical benefits," "evidence ecosystem," and "budget impact" were considered fundamental. "Social participation" showed high variability in response, indicating the need for greater engagement and clarity in participation mechanisms. The inclusion of the "public policy" domain emphasizes the importance of aligning government policies with population needs.

Conclusions: This study reinforced the relevance of a multidisciplinary and participatory approach in HTA for MDs, with a focus on clinical outcomes, real-world evidence, and continuous monitoring. Overcoming the identified challenges, such as information gaps and the need for robust methods, is crucial for improving the reimbursement of MDs in the SUS.

Background: 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.

Objectives: To explore Dutch stakeholders' perspectives on integrating environmental impacts into HTA and assess preferred methods and challenges.

Methods: A qualitative study using a focus group with members from ZIN (n = 7) and individual interviews (n = 7) with experts in HTA, market access, and reimbursement. Interviews were transcribed and analyzed thematically.

Results: Stakeholders highlighted the importance of addressing environmental impacts such as pharmaceutical pollution, greenhouse gas emissions, and waste. Integrated and parallel evaluations were preferred, but barriers such as data gaps, methodological complexity, and lack of guidelines were noted.

Conclusion: Incorporating environmental impacts into HTA is crucial but requires clear guidelines, better data, and stakeholder collaboration to support sustainable healthcare practices.

Objectives: 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.

Methods: We conducted a scoping review of English-language sources published between 2018 and 2023, including 66 peer-reviewed articles and 264 gray literature sources describing stakeholder involvement in HTA processes relating to medicines.

Results: Industry is commonly permitted to provide a submission for funding, though the modes and time points of industry engagement are many. Clinician and patient engagement are regarded as especially important with increased intervention complexity and innovation. Stakeholder engagement is perhaps mostly conducted to enhance the collation and interpretation of evidence, not necessarily to increase the legitimacy of the HTA process or give stakeholders influence over a decision that affects them. Patients are mostly engaged through broader public consultation. Sometimes they work directly with other stakeholders. Problems with patient engagement include challenges with recruitment, time, and resource constraints. Stakeholder groups can also differ in how they view and prioritize public and patient engagement. Public engagement is often limited to a matter of transparency and public accountability, but the reasons to undertake public engagement are numerous and varied. They include gaining input on affordability or prioritization issues.

Conclusions: HTA decision-making committees should commit to publicly communicating how they considered and made use of various stakeholder inputs. This could build trust and confidence in the committees and guide the public and patients on the information that committees find helpful.

Objectives: The healthcare system accounts for 4 percent of United Kingdom (UK) greenhouse gas (GHG) emissions annually. In response to climate change, the National Health Service (NHS) is calling for less carbon-intensive care practices through prevention. Respiratory Syncytial Virus (RSV), a leading cause of infant hospitalization, currently has no widespread immunization program in the UK. This study estimates the impact on GHG emissions generated within the care pathway from an immunization against RSV in all infants in the UK with nirsevimab, a new monoclonal antibody used in prophylaxis.

Methods: A novel approach was applied, mapping care pathway emissions from immunization and avoiding RSV-related primary and secondary care burden. Avoided healthcare resources were estimated using a published health economic model for nirsevimab versus standard of care (SoC), which is characterized as receiving palivizumab or having no immunization intervention, assuming different universal immunization scenarios. NHS England GHG emission factors were applied to each health outcome to measure the GHG emissions associated with a nirsevimab versus SoC strategy.

Results: Compared with SoC, a universal immunization program using nirsevimab leads to avoided GHG emissions, amounting to ~22 kilotons of CO₂ equivalents per year, with immunizing all UK infants at birth leading to the greatest reduction. About 40 percent of avoided emissions were from reductions in inpatient hospitalizations.

Conclusions: This study shows how prevention can deliver benefits to people, NHS system capacity, and the environment. However, avoided patient care pathway emissions must be considered alongside drug lifecycle emissions, which are not included here.

Introduction: 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.

Methods: A multistakeholder online workshop was held with 32 participants in May 2024 to define the critical issues to be considered. The resulting report underwent consultation among the ESHTA members and in a broader group of 90 additional worldwide stakeholder representatives.

Results: The workshop participants recognized defining frameworks, mechanisms, and tools for embedding environmental sustainability into HTA as an opportunity to support sustainable development and quality improvement in healthcare. Achieving this requires (1) consensus on what environmental sustainability in healthcare means, (2) reconcilement with other healthcare and environmental policies, and (3) methods that are useful and applicable within HTA frameworks.

Conclusion: This novel collaboration aims to align the global HTA community on the role of environmental sustainability in HTA. The report provides a path for the way forward for incorporating environmental sustainability into HTA based on broad perspectives from global multistakeholders.

Health technology assessment (HTA) can occur at different stages of a technology's lifecycle. In the accompanying paper, Grutters and colleagues present a consensus definition of "early HTA" as a health technology assessment conducted to inform decisions about subsequent development, research, and/or investment by explicitly evaluating the potential value of a conceptual or actual health technology. Early HTA is particularly relevant to non-medicine technologies, which are often developed more iteratively than medicines. This article explores some of the ways in which early HTA is already being conducted on non-medicine technologies in the United Kingdom, as well as future perspectives and possible challenges in using early HTA.

Introduction: Real-world evidence (RWE) is increasingly used to assess and make regulatory decisions on health technologies. However, its application in healthcare payer decision-making is less well-known.

Objectives: The objectives of this study were to (i) review the recent literature on how RWE has been used by healthcare payers, (ii) highlight barriers that limit the use of RWE in payer decision making, and (iii) explore how RWE has been used in various funding arrangements between payers and manufacturers. The benefits of utilizing RWE are also discussed.

Methods: A scoping review was conducted on articles published between 2014 and 2025 in PubMed (Medline), OVID EMBASE, Cochrane Library, and ProQuest Dissertations and Theses Global. Eligible articles were those written in English that discussed the use of real-world evidence among healthcare payers/decision-makers for health technology reimbursement decisions.

Results: Nineteen articles were selected for full-text review based on the inclusion criteria. The review highlighted payers' interest in incorporating RWE into funding and reimbursement decisions to address uncertainty in the performance of new health technologies. However, a lack of standards for collecting, analyzing, and reporting RWE limits its use. Little is known about how RWE is used in reimbursement decisions since contractual arrangements between payers and manufacturers are confidential.

Conclusions: Although payers are interested in using RWE to inform funding and reimbursement decisions, there are concerns regarding the scientific rigor used to generate such evidence. Having more insight into the contractual arrangements between payers and manufacturers would help to better understand how RWE informs these agreements.

Objectives: The National Institute for Health and Care Excellence (NICE) in England introduced early value assessments (EVAs) as an evidence-based method of accelerating access to promising health technologies that could address unmet needs and contribute to the National Health Service's Long Term Plan. However, there are currently no published works considering differences and commonalities in methods used between Assessment Reports for EVAs.

Methods: This rapid scoping review included all completed EVAs published on the NICE website up to 23 July 2024. One reviewer screened potentially relevant records for eligibility, checked by a second reviewer. Pairs of independent reviewers extracted information on the methods used in included EVAs using a prepiloted form; these were checked for accuracy. Data were described in graphical or tabular format with an accompanying narrative summary.

Results: In total, seventeen EVA Reports of sixteen EVAs were included in this scoping review. Five Reports did not specify how many reviewers undertook screening, whereas five did not report data extraction methods. Five EVAs planned to conduct meta-analyses, nine planned narrative syntheses, and seven planned narrative summaries. Eleven conceptual decision models were presented, with available evidence used to construct cost-utility analyses (N = 5); cost-effectiveness analyses (CEAs; N = 4); a mix of CEAs and cost-consequence analyses (CCA; N = 2); one CCA; and one cost-comparison.

Conclusion: Future EVA Reports should enhance the transparency of the methods used. Furthermore, EVAs could provide opportunities for the adoption of innovative methodological approaches and more flexible communication between EVA authors and key stakeholders, including patients and clinicians, companies, and NICE.