International Journal of Technology Assessment in Health Care最新文献

Objectives: Health technology assessment (HTA) has become an integral part of Ukraine's health system since its formal introduction into national legislation in 2017. By 2020, HTA was mandated for evaluating publicly funded medicines, laying the groundwork for more evidence-based healthcare decisions. Although the creation of an independent HTA agency was initially planned for 2022, implementation was delayed due to the COVID-19 pandemic and Russia's ongoing invasion. The relevant Cabinet Resolution calls for the establishment of an autonomous agency by January 2026. This commentary outlines a strategic, evidence-informed framework to guide the agency's formation.

Methods: Drawing on the 2018 State Strategy for Access to Medicines, the 2022 Law on Medicinal Products, and international best practices, we proposed to the Government of Ukraine a two-tier structure encompassing core business functions (HTA and appraisal, guideline development, pricing, and listing) and support business functions (data and analytics, finance and strategy, IT, human resources, legal, and communications). Each department is tasked with clear mandates and supported by performance indicators to promote transparency, accountability, and operational efficiency.

Results: A phased roadmap for 2025-2027 details the legal, institutional, and financial steps required for successful implementation. Key opportunities - including international partnerships and system-wide reform - are weighed alongside risks such as funding uncertainty, workforce limitations, and geopolitical instability.

Conclusion: By embedding HTA into national policy processes and ensuring institutional independence, Ukraine can enhance the value of healthcare investments and build long-term resilience into its health system.

Objective: This study aims to systematically identify and summarize the key characteristics of Mini-Health Technology Assessment (Mini-HTA) and assess the completeness of its basic reporting information, providing a theoretical foundation for developing future reporting guidelines..

Methods: A comprehensive search for Mini-HTAs was performed using CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, Web of Science, HTA database, and major HTA-related websites from inception until February 2024. The completeness of basic information reporting in Mini-HTAs was assessed using the INAHTA checklist. The key characteristics of the included Mini-HTAs were summarized descriptively. Microsoft Excel 2019 was used to analyze and visually present the data.

Results: A total of 21 Mini-HTA reports were included, with the highest number published in 2021 (5 reports, 23.8 percent). China contributed the most reports (18 reports, 85.7 percent). The most common assessment purpose was technology comparison (15 reports, 71.4 percent), with general hospitals being the predominant assessment setting (17 reports, 80.9 percent), and drugs being the most frequently assessed technology type (14 reports, 66.7 percent). The INAHTA checklist evaluation identified notable deficiencies in reporting key methodological aspects, including participant roles, conflict of interest statements, data sources, literature search strategies, and methods for data assessment and analysis.

Conclusion: Mini-HTAs have significantly increased in China since 2020, mainly in technology comparison, drug evaluation, and general hospitals. However, gaps remain in reporting key aspects, such as participant roles, conflict of interest, and data sources. Future efforts should focus on refining reporting guidelines to improve consistency and address these reporting deficiencies in Mini-HTA.

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.

Introduction: 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.

Methods: We used administrative data for all publicly funded outpatient prescriptions dispensed to persons aged 65 or older in Alberta in 2023. Through quantitative comparison of funnel plots for Anatomic Therapeutic Chemical (ATC) classes at the fourth level stratified by prescriber specialty, variation in prescription dispensation rates between prescribers was used to estimate three outcomes: the number of prescribers affected, the number of patients affected, and the potential budgetary impact. We ranked combinations of ATC class and prescriber specialty in descending order for each outcome, with use above and below the mean considered separately.

Results: We analyzed data on 17.5 million dispensations, encompassing more than 8,000 prescribers and approximately 600,000 patients. The top ATC class-prescriber specialty combinations for each outcome showed high similarity above and below control limits while exhibiting minimal overlap between outcomes.

Conclusions: Our method successfully identified ATC class-prescriber specialty combinations with marked variation in use, for potential advancement through the HTR process. Depending on the perspective of those undertaking HTR of prescription drugs, different outcomes may be useful in technology prioritization. To make the ATC class-prescriber specialty combinations actionable, future efforts should focus on exploring the patients affected.

Background: 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.

Methods: We conducted a global survey to gather insights into current practices and frameworks used in HTA evaluations of omics technologies.

Results: We gathered responses from thirty-nine participants representing organizations across twenty-nine countries and five continents. Among them, 51 percent (n = 20) reported experience in evaluating omics technologies, including multi-omics tests for early disease detection, biomarker-based cancer diagnostics, and advanced genomic sequencing techniques. Only three organizations employed specific assessment frameworks: the Adelaide Health Technology Assessment Agency in Australia, the Netherlands Cancer Institute, and the Andalusian HTA Agency in Spain. These frameworks address key evaluation aspects such as analytical and clinical validity, clinical and personal utility, organizational impact, and ethical, legal, and social implications of omics technologies.

Discussion: Despite their relevance, the limited adoption of tailored frameworks highlights the need for more structured and context-specific approaches to facilitate the integration of omics technologies into healthcare systems. Collaborative efforts among stakeholders, including patients, healthcare providers, policymakers, and industry representatives, are crucial for devising robust evaluation strategies addressing the complexities of omics technologies comprehensively.

Background: As the variety of specific treatments in a disease area increases, there may be a growing interest in employing treatment sequencing within health economic models. The aim of this review was to identify and thematically analyze patterns regarding the approaches to modeling treatment sequencing in National Institute for Health and Care Excellence (NICE) appraisals.

Methods: A review of NICE technology appraisals (TAs) published between 1 January 2020 and 13 March 2023 was conducted.

Results: A total of twenty-four TAs incorporating treatment sequencing were included, most commonly in autoimmune and oncology indications. Primary justifications for companies employing treatment sequencing were precedence and alignment with clinical practice, whilst lack of appropriate clinical data was cited to justify its exclusion. Relatedly, External Assessment Groups commonly criticized treatment sequences for oversimplifying clinical practice. Notably, almost half of identified TAs assumed that the relative efficacy of an intervention was maintained regardless of disease severity or position within the treatment sequence.

Conclusion: A substantial proportion of TAs employed treatment sequencing, but it is challenging to determine the impact of current approaches on the overall uncertainty associated with any health economic model. The challenges identified in this review could be used to inform future formal guidance and associated methodology for the implementation of treatment sequencing modeling, which could improve the comparability and reliability of models and their results.

Objectives: 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.

Methods: The need for an ethnically and socioeconomically diverse sample was seen as essential. This led to the need for interviewer assistance during completion of the survey instrument and translation of the instrument into multiple languages. English, Zulu, Tswana, and Afrikaans were chosen to allow the vast majority of a community sample people to participate. A sample size of sixty respondents was based on a previous OPUF pilot valuation study for the EQ-5D-5L, and a pilot study of twenty respondents was undertaken using the English language version of OPUF.

Results: There were sixty-one respondents in the main study with most respondent characteristics being well matched with national figures, except for language. Personal utility functions could be calculated for sixty respondents, with the mean tariff showing monotonically declining utility decrements within each dimension. An examination of individual functions showed two contrasting sets of preferences that were driven by the respondents' rating of death. A separate subgroup analysis also showed preference heterogeneity based on the home language of the respondents.

Conclusions: Our study showed that the application of the OPUF approach is possible in a socioeconomically diverse population in South Africa. The examination of individual personal utility functions shows marked heterogeneity of preferences that needs to be explored further so that the source of this can be established.

Objectives: The objective of this study is to evaluate the feasibility of implementing Hospital-Based Health Technology Assessment (HB-HTA) within Ukraine's healthcare system, focusing on its potential to strengthen evidence-based decision-making regarding clinical effectiveness, safety, cost-efficiency, and organizational and strategic impact of health technologies (HTs) in healthcare facilities (HCFs).

Methods: We collected and synthesized key initiatives implemented between 2021 and 2025, outlining the main steps involved in introducing HB-HTA in Ukraine.

Results: The article describes the landscape of the Ukrainian healthcare system and shares the experience of the initial steps of HB-HTA introduction amid tight budgets and increasing demands. Drawing on international models and adapting them to the national context, we outline key implementation strategies, the development of scientific and methodological approaches for HB-HTA, and the integration of a pilot HB-HTA project within a leading national HCF known for its high-level diagnostic and operational capabilities.

Conclusions: The conducted pilot laid the groundwork for integrating HB-HTA into Ukraine's healthcare system and demonstrated its role in empowering HCFs to guide smarter budget allocation and procurement decisions, especially in the context of decentralization. With continued investment in expertise, legal integration, and streamlined methodology, HB-HTA can become a cornerstone of transparent, cost-effective decision-making across the HCFs of the National healthcare system. The experience gained in Ukraine provides valuable insights that can support other countries in effectively adopting and utilizing HTs at the hospital level.

Objectives: 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.

Methods: This study is a narrative policy review of the Dutch CED program and describes the different phases and stakeholder involvement. Additionally, an overview of the medicines included in the CED program is presented and put in an international perspective.

Results: The CED program consists of four phases: candidate prescreening, research protocol drafting, signing of process agreement and financial agreement, and controlled access. Stakeholders are involved intensively throughout the process. Since 2019, six medicines have entered the program. The program is used to fill different evidence gaps for various types of medicines and indications. In other countries, these medicines are often included in restricted reimbursement programs.

Conclusions: The CED program is gathering clinical effectiveness data while providing patient access to OMPs, CMA, and AEC products. Important facilitating factors for the program were identified, including the involvement of all stakeholders, the only-in-research approach of data gathering, and the case-by-case evidence generation requirements and duration. Continuous evaluation is needed as the program does not yet include the expected number of medicines, and no conclusion can be drawn so far on the usefulness of the data collection.