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1.
J Infect Dis ; 228(Suppl 3): S180-S188, 2023 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-37703347

RESUMO

The estimated prevalence of anti-HCV was 3.1% in Taiwan. Studies have shown iatrogenic behavior was the major transmission route. It is highest in specific populations including patients with end stage renal disease (ESRD), human immunodeficiency virus infection, who inject drug (PWID), and under opioid substitution treatment. Approximately 405,160 patients were seropositive for HCV RNA and in need of treatment. Taiwan government claims to reach WHO's 2030 goal of HCV elimination by 2025 and works hard to resolve several barriers of HCV elimination including political commitment, sustainable financing, minimize reimbursement restrictions, instituted monitoring, and perform micro-elimination of specific populations. The last stage of HCV elimination is to accelerate the universal HCV screening program of populations aged 45-79 years and resolve the unawareness issue of HCV infection. Hopefully, we can achieve the targets of HCV elimination set by WHO and reach the goal earlier in 2025.


Assuntos
Hepacivirus , Hepatite C , Humanos , Hepacivirus/genética , Taiwan/epidemiologia , Hepatite C/epidemiologia , Hepatite C/prevenção & controle , Políticas , Governo
2.
J Formos Med Assoc ; 122(11): 1213-1218, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37451959

RESUMO

Since government-provided annual cervical cytology testing for all Taiwanese women aged 30 years or older became available in 1995, both cervical cancer incidence and death have decreased significantly. However, with the 2018 introduction of the national immunization program for human papillomavirus (HPV) vaccination in all schoolgirls aged 13-15 years old, the positive predictive value of cytology testing is expected to decrease with rising vaccination rates, and therefore a transition to more sensitive HPV-based testing may be needed. This position paper, derived from discussions by a panel of experts in cervical cancer screening, provides short-, medium-, and long-term policy recommendations to manage the transition between cervical screening methods for Taiwan. The recommendations include concrete suggestions regarding testing procedures, standards, accreditation, monitoring, promotion, and implementation. It is hoped that comprehensive preparation and management of this transition will enable Taiwan to repeat the previous successes of the cervical cytology testing program.


Assuntos
Infecções por Papillomavirus , Neoplasias do Colo do Útero , Feminino , Humanos , Adolescente , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/prevenção & controle , Detecção Precoce de Câncer , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/epidemiologia , Taiwan , Esfregaço Vaginal , Programas de Rastreamento , Políticas
3.
BMC Med ; 20(1): 23, 2022 01 12.
Artigo em Inglês | MEDLINE | ID: mdl-35022047

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Revisão por Pares , Relatório de Pesquisa , Lista de Checagem , Análise Custo-Benefício , Atenção à Saúde , Humanos
4.
Value Health ; 25(1): 10-31, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35031088

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making.


Assuntos
Pesquisa Biomédica/normas , Economia Médica/normas , Pesquisa Biomédica/economia , Lista de Checagem , Análise Custo-Benefício/normas , Feminino , Humanos , Revisão por Pares , Pesquisadores/normas , Participação dos Interessados
5.
Value Health ; 25(1): 3-9, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35031096

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Lista de Checagem , Economia Médica/normas , Análise Custo-Benefício/normas , Humanos , Editoração , Projetos de Pesquisa/normas
6.
BMC Public Health ; 22(1): 179, 2022 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-35081920

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Economia Médica , Relatório de Pesquisa , Lista de Checagem , Análise Custo-Benefício , Humanos , Revisão por Pares
7.
BMC Health Serv Res ; 22(1): 114, 2022 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-35081957

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Revisão por Pares , Relatório de Pesquisa , Lista de Checagem , Análise Custo-Benefício , Atenção à Saúde , Humanos
8.
Int J Technol Assess Health Care ; 38(1): e13, 2022 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-35007499

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals, as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Revisão por Pares , Relatório de Pesquisa , Lista de Checagem , Análise Custo-Benefício , Atenção à Saúde , Humanos
9.
J Formos Med Assoc ; 120(7): 1444-1451, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33516585

RESUMO

BACKGROUND/PURPOSE: This study aims at investigating the epidemiological profile of chronic hepatitis C (CHC) regarding hepatitis C virus (HCV) genotype in Taiwan. METHODS: A total of 29,087 CHC patients with advanced fibrosis who received direct-acting antivirals (DAAs) therapy under Taiwan's National Health Insurance (NHI) during 2017-2018 were recruited. The HCV genotype distribution and its association with patients' demographic factors including age, gender, and geographical areas were examined. RESULTS: The most common genotypes were 1b (59.5%) and 2 (30.1%) with characteristics of older age (mean ± standard deviation (SD): 66.5 ± 10.7 years and 67.3 ± 10.9 years) and female gender predominant (57.1% and 59.4%), which were associated with iatrogenic infection decades ago. Most of patients with genotype 1a (5.9%) and 6 (3.7%) infection were relatively younger (59.2 ± 12.0 years and 60.0 ± 13.8 years) and male gender predominant (59.1% and 61.1%), except Liujia and Liuying districts in southern Taiwan. The youngest group (53.2 ± 11.8 years) and most male gender predominant (74.3%) was genotype 3 (0.37%). These genotypes with characteristics of being younger and male gender predominant were highly related to injection drug use in recent years. The number of genotype 4 patients were extremely rare (n = 25) and efficacy of genotype-4-specific-DAA was significantly poorer than non-genotype-4-specific DAA (P value = 0.0411). CONCLUSION: The significant differences in demographic characteristics among CHC patients with different HCV genotypes found in this study suggest HCV genotype was highly associated with transmission pattern and may be used as a reference for HCV control.


Assuntos
Hepatite C Crônica , Hepatite C , Idoso , Antivirais/uso terapêutico , Feminino , Fibrose , Genótipo , Hepacivirus/genética , Hepatite C/tratamento farmacológico , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , Humanos , Cirrose Hepática/epidemiologia , Masculino , Taiwan/epidemiologia
10.
Int J Technol Assess Health Care ; 36(5): 474-480, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32928330

RESUMO

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.


Assuntos
Medicina Baseada em Evidências , Mecanismo de Reembolso , Avaliação da Tecnologia Biomédica , Ásia , Análise Custo-Benefício , Confiabilidade dos Dados , Tomada de Decisões , Inquéritos e Questionários , Telecomunicações
11.
Int J Technol Assess Health Care ; 35(6): 416-421, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31594553

RESUMO

This paper explores the characteristics of health technology assessment (HTA) systems and practices in Asia. Representatives from nine countries were surveyed to understand each step of the HTA pathway. The analysis finds that although there are similarities in the processes of HTA and its application to inform decision making, there is variation in the number of topics assessed and the stakeholders involved in each step of the process. There is limited availability of resources and technical capacity and countries adopt different means to overcome these challenges by accepting industry submissions or adapting findings from other regions. Inclusion of stakeholders in the process of selecting topics, generating evidence, and making funding recommendations is critical to ensure relevance of HTA to country priorities. Lessons from this analysis may be instructive to other countries implementing HTA processes and inform future research on the feasibility of implementing a harmonized HTA system in the region.


Assuntos
Avaliação da Tecnologia Biomédica/organização & administração , Ásia , Tomada de Decisões , Humanos , Inquéritos e Questionários
12.
BMC Pulm Med ; 18(1): 16, 2018 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-29368608

RESUMO

BACKGROUND: Patients with symptoms of both asthma and chronic obstructive pulmonary disease (COPD) may be classified with the term asthma-COPD overlap (ACO). ACO is of considerable interest as it is currently poorly characterised and has been associated with worse health outcomes and higher healthcare costs compared with COPD or asthma alone. Patients with ACO in Asia remain poorly described, and there is limited information regarding their resource utilisation compared with patients with asthma or COPD only. This study investigated the characteristics, disease burden and medical resource utilisation of patients with ACO in Taiwan. METHODS: This was a retrospective cohort study of patients identified from National Health Insurance (NHI) claims data in Taiwan in 2009-2011. Patients were classified into incident ACO, COPD or asthma cohorts according to International Classification of Disease, ninth revision, clinical modification codes in claims. Eligible patients were ≥40 years of age with 12 months' continuous enrolment in the NHI programme pre- and post-index date (date of the first relevant medical claim). RESULTS: Patients with ACO (N = 22,328) and COPD (N = 69,648) were older and more likely to be male than those with asthma (N = 50,293). Patients with ACO had more comorbidities and exacerbations, with higher medication use: short-acting ß2-agonist prescriptions ranged from 30.4% of patients (asthma cohort) to 43.6% (ACO cohort), and inhaled corticosteroid/long-acting ß2-agonist combination prescriptions ranged from 11.1% (COPD cohort) to 35.0% (ACO cohort) in the 12 months following index. Patients with ACO generally had the highest medication costs of any cohort (long-acting muscarinic antagonist costs ranged from $227/patient [asthma cohort] to $349/patient [ACO cohort]); they also experienced more respiratory-related hospital visits than patients with asthma or COPD (mean outpatient/inpatient visits per patient post-index: 9.1/1.9 [ACO cohort] vs 5.7/1.4 [asthma cohort] and 6.4/1.7 [COPD cohort]). CONCLUSIONS: Patients with ACO in Taiwan experience a greater disease burden with greater healthcare resource utilisation, and higher costs, than patients with asthma or COPD alone.


Assuntos
Corticosteroides/uso terapêutico , Asma/epidemiologia , Custos de Medicamentos/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Corticosteroides/economia , Agonistas de Receptores Adrenérgicos beta 2/economia , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/estatística & dados numéricos , Asma/tratamento farmacológico , Feminino , Recursos em Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Estudos Retrospectivos , Fatores Sexuais , Exacerbação dos Sintomas , Taiwan/epidemiologia
13.
Int J Technol Assess Health Care ; 34(3): 260-266, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29911515

RESUMO

OBJECTIVES: The aim of this study was to describe the historical development of the HTAsiaLink network, draw lessons for other similar initiatives globally, and to analyze key determinants of its success and challenges for its future development. METHODS: This study is based on the collective and direct experiences of the founding members of the HTAsiaLink Network. Data were collected from presentations they made at various international forums and additional information was reviewed. Data analysis was done using the framework developed by San Martin-Rodriguez et al.Results and Conclusions:HTAsiaLink is a network of health technology assessment (HTA) agencies in Asia established in 2011 with the aim of strengthening individual and institutional HTA capacity, reducing duplication and optimizing resources, transfer and sharing of HTA-related lessons among members, and beyond. During its 6 years, the network has expanded, initiating several capacity building activities and joint-research projects, raising awareness of the importance of HTA within the region and beyond, and gaining global recognition while establishing relationships with other global networks. The study identifies the determinants of success of the collaboration. The systemic factors include the favorable outlook toward HTA as an approach for healthcare priority setting in countries with UHC mandates. On organizational factors, the number of newly established HTA agencies in the region with similar needs for capacity building and peer-to-peer support was catalytic for the network development. The interactional aspects include ownership, trust, and team spirit among network members. The network, however, faces challenges notably, financial sustainability and management of the expanded network.


Assuntos
Difusão de Inovações , Avaliação da Tecnologia Biomédica/organização & administração , Ásia , Fortalecimento Institucional/organização & administração , Comportamento Cooperativo , Prioridades em Saúde , Humanos , Disseminação de Informação , Desenvolvimento de Programas/métodos
15.
Qual Life Res ; 23(2): 687-96, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23975377

RESUMO

PURPOSE: In October 2001, a pay-for-performance (P4P) program for diabetes was implemented by the National Health Insurance (NHI), a single-payer program, in Taiwan. However, only limited information is available regarding the influence of this program on the patient's health-related quality of life. The aim of this study was to estimate the costs and consequences of enrolling patients in the P4P program from a single-payer perspective. METHODS: A retrospective observational study of 529 diabetic patients was conducted between 2004 and 2005. The data used in the study were obtained from the National Health Interview Survey (NHIS) in Taiwan. Direct cost data were obtained from NHI claims data, which were linked to respondents in the NHIS using scrambled individual identification. The generic SF36 health instrument was employed to measure the quality-of-life-related health status and transformed into a utility index. Patients enrolled in the P4P program for at least 3 months were categorized as the P4P group. Following propensity score matching, 260 patients were included in the study. Outcomes included life-years, quality-adjusted life-years (QALYs), diabetes-related medical costs, overall medical costs, and incremental cost-effectiveness ratios (ICERs). A single-payer perspective was assumed, and costs were expressed in US dollars. Nonparametric bootstrapping was conducted to estimate confidence intervals for cost-effectiveness ratios. RESULTS: Following matching, no significant difference was noted between two groups with regard to the patients' age, gender, education, family income, smoking status, BMI, or whether insulin was used. The P4P group had an increase of 0.08 (95 % CI 0.077-0.080) in QALYs, and the additional diabetes-related medical cost was US$422.74 (95 % CI US$413.58-US$435.05), yielding an ICER of US$5413.93 (95 % CI US$5226.83-US$5562.97) per QALY gained. CONCLUSIONS: Our results provides decision makers with valuable information regarding the impact of the P4P program of diabetes care through a direct comparison of equivalent groups of patients receiving regular care. Under the single-payer NHI system, the use of financial incentives under the DM-P4P program may be an effective means to ensure the quality of follow-up treatment.


Assuntos
Diabetes Mellitus/economia , Programas Nacionais de Saúde/economia , Reembolso de Incentivo/economia , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Análise Custo-Benefício , Diabetes Mellitus/tratamento farmacológico , Feminino , Inquéritos Epidemiológicos , Humanos , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Estudos Retrospectivos , Taiwan/epidemiologia , Adulto Jovem
16.
Drug Saf ; 47(4): 289-299, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38113017

RESUMO

Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at different points in its lifecycle. Safety issues have become more important since regulatory authorities are increasingly adopting flexible standards, processes, and evidentiary requirements for drug approval. In this article, we compared the different role of regulatory authorities and HTA agencies. Additionally, the experience of regulatory-HTA collaboration for assessment and/or decision-making on safety issues in the lifecycle of a health technology is illustrated, including olmesartan (angiotensin II receptor antagonist) and the direct-acting hepatitis C virus (HCV) antiviral agents. Post-licensing data can be derived from various sources such as electronic health records, medical claims, drug and disease registries, post-authorization safety studies (PASS) or post-authorization safety efficacy studies (PAES), periodic benefit-risk assessment reports, as well as HTA reassessment reports, which incorporate utilization information from patients in a real-world setting and provide crucial evidence for various purposes. With the ongoing accumulation of safety and efficacy information during post-regulatory approval, a standardized process for continuous data collection and active reassessment of risk and benefit becomes crucial for managing the lifecycle of health technologies. In order to define evidence requirements clearly, reduce uncertainty, and minimize delays in HTA approval, early engagement and collaboration of HTA agencies in the regulatory review processes have become more common. However, there is currently limited interaction and collaboration between regulatory authorities and HTA agencies. This article aims to identify the challenges faced by regulators and HTA agencies today, emphasizing the significance of conducting regulatory reviews and health technology assessments throughout a technology's lifecycle, underlining the value of utilizing real-world data and evidence, and emphasizing the necessity of enhancing collaboration between regulatory authorities and HTA agencies, all within the overarching context of drug safety.


Assuntos
Aprovação de Drogas , Avaliação da Tecnologia Biomédica , Humanos , Incerteza , Coleta de Dados , Pacientes
18.
Health Syst Reform ; 9(3): 2330396, 2023 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-38715195

RESUMO

Efforts to advance health technology assessment (HTA) in Taiwan have aimed to optimize the allocation of National Health Insurance (NHI) resources. This study documents and analyzes the historical timeline of Taiwan's efforts in HTA, identifying areas to advance the HTA system, such as gaining broad stakeholder acceptance. We document ambitious plans to establish a larger, independent HTA center and how these plans did not materialize. The historical timeline also describes the primary focus of HTA shifting to serve the needs of decision-making authorities and committees. We argue that these changes resulted in growth of the HTA system, but also led to significant external criticism and potential compromise of its foundational principles. The inability to create a national HTA center can be attributed to several factors, including an immature ecosystem of HTA-Policy-Patient-Provider-Academic collaboration, a lack of a supportive culture, and challenging political and economic conditions. Nevertheless, if effectively managed, Taiwan's current HTA system could play a crucial role in rational decision-making, informed choices, and efficient NHI resource management. We argue that greater autonomy is crucial for enhancing financial sustainability and protecting against external influences to ensure objective and credible assessments. Additionally, we emphasize the importance of fostering a conducive learning environment to improve methodological expertise.


Assuntos
Programas Nacionais de Saúde , Avaliação da Tecnologia Biomédica , Taiwan , Avaliação da Tecnologia Biomédica/métodos , Humanos , Programas Nacionais de Saúde/tendências , Política de Saúde , Tomada de Decisões , História do Século XX
19.
Int J Health Policy Manag ; 12: 6858, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37579427

RESUMO

BACKGROUND: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE. RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.


Assuntos
Formulação de Políticas , Avaliação da Tecnologia Biomédica , Humanos , Projetos de Pesquisa , Inquéritos e Questionários , Ásia
20.
Value Health ; 15(1 Suppl): S132-8, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22265060

RESUMO

This article sought to describe the health-care data situation in six selected economies in the Asia-Pacific region. Authors from Thailand, China mainland, South Korea, Taiwan, Japan, and Malaysia present their analyses in three parts. The first part of the article describes the data-collection process and the sources of data. The second part of the article presents issues around policies of data sharing with the stakeholders. The third and final part of the article focuses on the extent of health-care data use for policy reform in these different economies. Even though these economies differ in their economic structure and population size, they share some similarities on issues related to health-care data. There are two main institutions that collect and manage the health-care data in these economies. In Thailand, China mainland, Taiwan, and Malaysia, the Ministry of Health is responsible through its various agencies for collecting and managing the health-care data. On the other hand, health insurance is the main institution that collects and stores health-care data in South Korea and Japan. In all economies, sharing of and access to data is an issue. The reasons for limited access to some data are privacy protection, fragmented health-care system, poor quality of routinely collected data, unclear policies and procedures to access the data, and control on the freedom on publication. The primary objective of collecting health-care data in these economies is to aid the policymakers and researchers in policy decision making as well as create an awareness on health-care issues for the general public. The usage of data in monitoring the performance of the heath system is still in the process of development. In conclusion, for the region under discussion, health-care data collection is under the responsibility of the Ministry of Health and health insurance agencies. Data are collected from health-care providers mainly from the public sector. Routinely collected data are supplemented by national surveys. Accessibility to the data is a major issue in most of the economies under discussion. Accurate health-care data are required mainly to support policy making and evidence-based decisions.


Assuntos
Coleta de Dados/métodos , Atenção à Saúde/organização & administração , Atenção à Saúde/estatística & dados numéricos , Órgãos Governamentais/organização & administração , Política de Saúde , Ásia , Tomada de Decisões , Humanos , Formulação de Políticas
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