Health technology assessment of biosimilars worldwide: a scoping review

RESUMO A Avaliação de Tecnologias em Saúde (ATS) respalda políticas públicas na gestão de tecnologias em diversos países. No Brasil, a institucionalização da ATS se iniciou em 2000, no Ministério da Saúde, e contou com a participação da Agência Nacional de Saúde Suplementar (ANS). Contudo, o sistema público e a saúde suplementar trilharam diferentes caminhos. Processos distintos de ATS podem gerar retrabalho, ineficiência e aumentar as inequidades entre o público e o privado. O objetivo desta pesquisa foi identificar a dualidade entre o público e o privado relativa aos modelos de ATS implantados no País. Realizou-se uma revisão de escopo da literatura no período de 2000 a 2019 nas bases de dados Medline, Scopus, Web of Science e Lilacs. Também se realizou análise de documentos da ANS relativos ao processo de ATS na saúde suplementar. A revisão da literatura constatou a escassez de artigos sobre o tema, enquanto a análise documental permitiu traçar uma linha do tempo com os principais marcos referentes ao processo de ATS da Agência. Concluiu-se que a coordenação nacional de um modelo de ATS é desejada, visando a aumentar a transparência das instituições, a maior credibilidade das suas decisões, maior eficiência do processo e proporcionar maior equidade.

Download Full-text

Picturing ELSI+: a visual representation of ethical, legal, and social issues, and patient experiences in Health Technology Assessment in Canada

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319000722 ◽

2019 ◽

Vol 36 (1) ◽

pp. 40-49

Author(s):

Murray D. Krahn ◽

Joanna M. Bielecki ◽

Karen E. Bremner ◽

Claire de Oliveira ◽

Nisha Almeida ◽

...

Keyword(s):

Health Technology Assessment ◽

Scoping Review ◽

Technology Assessment ◽

Concept Maps ◽

Social Issues ◽

Health Technology ◽

Academic Disciplines ◽

Conceptual Clarity ◽

Concept Systems ◽

Patient Burden

ObjectivesConsideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA.MethodsWe conducted a scoping review (Medline and EMBASE, 2000–2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters.ResultsOur final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.ConclusionsThis study suggests an alternative approach to ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.

Download Full-text

Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature

PharmacoEconomics ◽

10.1007/s40273-017-0509-1 ◽

2017 ◽

Vol 35 (7) ◽

pp. 727-740 ◽

Cited By ~ 38

Author(s):

Maarten J. IJzerman ◽

Hendrik Koffijberg ◽

Elisabeth Fenwick ◽

Murray Krahn

Keyword(s):

Product Development ◽

Health Technology Assessment ◽

Scoping Review ◽

Technology Assessment ◽

Health Technology ◽

Medical Product ◽

Review Of The Literature ◽

Early Health Technology Assessment ◽

Early Health

Download Full-text

Differences between health technology assessment topics in high- and middle-income countries: a scoping review

Archives of Public Health ◽

10.1186/s13690-021-00754-6 ◽

2021 ◽

Vol 79 (1) ◽

Author(s):

Sepehr Ghazinoory ◽

Basireh Majidi ◽

Shohreh Nasri ◽

Ehsan Zandi ◽

Hosein Farrokhi ◽

...

Keyword(s):

Decision Making ◽

Health Technology Assessment ◽

Scoping Review ◽

Technology Assessment ◽

Policy Making ◽

Health Technology ◽

Awareness Training ◽

Middle Income ◽

Middle Income Countries ◽

Raising Awareness

Abstract Background The Health Technology Assessment (HTA) has encountered different issues and challenges over the last two decades. The main purpose of this research is to review the issues and challenges in high- and middle-income countries through reviewing studies related to the HTA. Methods The HTA area literature of different countries was collected from 2009 to 2020 and analyzed using scoping review, based on Scopus and WoS databases. Results Given the fact that the HTA is practically done in high- and middle-income countries, the results of reviewing the studies and articles of countries reveal that high-income countries seek to increase the participation of stakeholders and enhance the transparency of processes, policy-making, and regulation of the HTA, as well as the systematization of various participant institutions in this area. Middle-income countries, on the other hand, are mostly involved in raising awareness, training and skill development of HTA-related staff, institutionalizing the concept of HTA, and allocating appropriate resources for effective and safe decision-making in their health system. Conclusion The problem of incoordination between stakeholders (participant institutions) in the HTA, and thereby, problems in decision-making were found in many of the studied reports and articles. Thus, one of the useful efforts to be made by different countries to maintain the integrity of this system would be the process of involving all members of this system and the formation of a healthy ecosystem in the HTA.

Download Full-text

Methods for the health technology assessment of complex interventions: a protocol for a scoping review

BMJ Open ◽

10.1136/bmjopen-2020-039263 ◽

2020 ◽

Vol 10 (11) ◽

pp. e039263

Author(s):

Abdolvahab Baghbanian ◽

Tracy Merlin ◽

Drew Carter ◽

Shuhong Wang

Keyword(s):

Health Technology Assessment ◽

Scoping Review ◽

Technology Assessment ◽

Grey Literature ◽

Relevant Literature ◽

Secondary Analysis ◽

Evaluation Criteria ◽

Complex Interventions ◽

Health Technology ◽

Developed Countries

IntroductionIn healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.Method and analysisThis protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O’Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted.Ethics and DisseminationThis scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

Download Full-text

Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

Zeitschrift für Neuropsychologie ◽

10.1024/1016-264x.19.4.253 ◽

2008 ◽

Vol 19 (4) ◽

pp. 253-269 ◽

Cited By ~ 3

Author(s):

Sabine Heel ◽

Sonja Fischer ◽

Stefan Fischer ◽

Tobias Grässer ◽

Ellen Hämmerling ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Empirische Forschung

Zunächst führt dieser Artikel in die wesentlichen Begrifflichkeiten und Zielstellungen der Versorgungsforschung ein. Er befasst sich dann mit der Frage, wie die einzelnen Teildisziplinen der Versorgungsforschung, (1) die Bedarfsforschung, (2) die Inanspruchnahmeforschung, (3) die Organisationsforschung, (4) das Health Technology Assessment, (5) die Versorgungsökonomie, (6) die Qualitätsforschung und zuletzt (7) die Versorgungsepidemiologie konzeptionell zu fassen sind, und wie sie für neuropsychologische Anliegen ausformuliert werden müssen. In diesem Zusammenhang werden die in den einzelnen Bereichen jeweils vorliegenden versorgungsrelevanten Studienergebnisse referiert. Soweit es zulässig ist, werden Bedarfe für die Versorgungsforschung und Versorgungspraxis in der Neurorehabilitation daraus abgeleitet und Anregungen für die weitere empirische Forschung formuliert. Der Artikel bezieht sich – entsprechend seines Anliegens – ausschließlich auf Studien, die sich mit der Situation der deutschen Neurorehabilitation befassen.

Download Full-text