TOWARD INTERNATIONAL GOOD PRACTICES IN HEALTH TECHNOLOGY ASSESSMENT

2012 ◽  
Vol 28 (2) ◽  
pp. 169-170 ◽  
Author(s):  
Clifford Goodman

Since the origin of technology assessment (TA) in the 1960s, including TAs of certain medical interventions, and formal recognition and institutionalization of health technology assessment (HTA) in the 1970s, the field of HTA has evolved in programs large and small in the public and private sectors. It has diffused into an increasing number of nations in a range of policy-making and decision-support contexts. Since its inception, the development and diffusion of HTA have been strongly characterized by international collaboration involving sharing of expertise and practical experience, and joint efforts to advance the state of the art. Also during that time, there have been periodic collaborations to identify or develop standard frameworks, good practices, guiding principles, checklists, and other normative, “how-to” documentation for the field. Recognizing the diversity and ongoing evolution of HTA, these efforts have generally sought to balance the appeal of standardization with that of flexibility to accommodate the ranges of HTA program remits and contexts.

2002 ◽  
Vol 18 (2) ◽  
pp. 192-198 ◽  
Author(s):  
John M. Eisenberg ◽  
Deborah Zarin

Governments may perform health technology assessment (HTA) in their roles as a regulator in the public interest, as a source of information for decision makers in the public and private sectors, and/or as a purchaser or provider of healthcare services. The U.S. government's roles in the health sector as a regulator, source of information, and purchaser and provider of services are influenced both by characteristics of that sector and by its stakeholders' effectiveness in influencing national health policy debates.


2017 ◽  
Vol 33 (S1) ◽  
pp. 41-42
Author(s):  
Jani Mueller

INTRODUCTION:South Africa is in the process of providing comprehensive health insurance to all its citizens, thus paving the pathway for Health Technology Assessment (HTA) to play a significant role in provision of safe and effective healthcare. The National Department of Health (DoH) has a published framework and Health Technology Act and strategies since the 1990s to improve health outcomes, and service and delivery of care. The purpose of this study is to explore challenges faced in the implementation of the framework and policies.METHODS:The study will be based on review and analysis of health technology policies and legislations introduced in South Africa since the 1990s. These documents are available from the DoH archive. The review from this grey literature was supplemented by information collected from a self-completion questionnaire, which was distributed to key stakeholders. Respondents were identified by direct contact with ministries of health and professional bodies, and included health professionals from the public and private healthcare sector, for example, practitioners, experts from hospitals, and industry representatives. The questionnaire addressed issues pertaining to decision making regarding health service delivery and the status of HTA in the country.RESULTS:The framework lays out the strategy to facilitate appropriate utilization of health technologies and includes among others, an HTA section. Fragmented use of HTA or parts thereof has been observed in the public and private health care sector. Furthermore, the respondents pointed out that decisions on health technology can be political, institutional or professionally driven whereas they all agreed that a formal and institutional implementation of HTA would improve healthcare service.CONCLUSIONS:The goal to achieve universal health care provides an excellent window of opportunity for formal use of HTA in policy- and decision-making. However, (i) the inadequate number of trained professionals and education and training opportunities (ii) lack of awareness and understanding of the principles of HTA and its impact on the improvement of health care are among the many challenges faced by the system. It has also been observed that national and regional champions can act as change agents and would have a snowball effect.


Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.


2017 ◽  
Vol 33 (S1) ◽  
pp. 156-157
Author(s):  
Sergio Márquez-Peláez ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
José Asua ◽  
Teresa Molina-Lopez ◽  
José Luis Castro-Campos ◽  
...  

INTRODUCTION:The Spanish National Network (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. The necessity of considering a Quality Management System has been detected and, consequently, a common tool for all the members needs to be developed. We describe in this study the process to achieve that goal.METHODS:Based on both a review of previous literature and the proposal for a self-evaluating tool, a group of experts from each agency through consensus have developed a tool for self-evaluation in Health Technology Assessment (HTA) agencies. Through the structure described in the handbook of the Andalusian Agency for Healthcare Quality (ACSA), each standard should have a statement or proposal that needs to also include evidence or good practices, and the corresponding evaluation questions. In separate workgroups, the definition of these proposals, evidence and evaluation questions were developed. One face-to-face meeting and two meetings via teleconference were necessary to achieve a final document with all the quality standards.RESULTS:From a proposed structure of sixty-six standards, the titles, definitions, statements and evidence as well as good practices and evaluation questions were established in workgroups with consensus among all of the members (1 - 3). The final version of the self-assessment tool was composed of sixty-eight standards, grouped in twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process, and IV Resources.CONCLUSIONS:Quality management requires an evaluation tool and this version, based on a systematic review and consensus, is a useful and practical instrument for developing a handbook by each member of REDETS. An online version of the tool is in process of development.


2021 ◽  
Vol 37 (S1) ◽  
pp. 12-13
Author(s):  
Clarice Portugal ◽  
Adriana Prates ◽  
Luiza Losco ◽  
Fabiana Floriano ◽  
Odete da Silva ◽  
...  

IntroductionThe Department of Management and Incorporation of Technologies and Innovation in Health (DGITIS) acts as Conitec's Executive Secretariat. Among its attributions, it promotes the public/patient involvement in the health technology assessment (HTA) process. Recently, Conitec has been working on the inclusion of patient's testimonials about their illness experience in the plenary sessions, that is, the monthly meeting where technologies are assessed.MethodsTo support the action of including patient reporting in Conitec's HTA process, DGITIS developed research on HTA agencies websites worldwide. The main criteria was the inclusion of patients’ reports in their Committee meetings. DGITIS contacted some of these agencies and requested a listserv question to the International Network of Agencies for Health Technology Assessment (INAHTA) members. These findings supported the DGITIS for the inclusion of patient participation in Conitec's meetings, from the selection process to the actual participation.ResultsFor the Conitec's HTA process, the patients’ participation should occur in the prior session to the public consultation, guaranteeing the inclusion of their perspective since the recommendation process beginning. Hence, every demand for incorporation to be discussed at Conitec's meeting should be preceded by a public call for patients with the clinical condition. The DGITIS will also hold preparatory meetings, which will serve as moments for shared construction of knowledge and literacy.ConclusionsThe nomination process, so far, has been grounded as a consensus among the patients. Thus, Conitec acts as a mediator, connecting the involved stakeholders, in a way that they can autonomously organize themselves and indicate the main representative and an alternate one. With the inclusion of the patient's perspective in the Conitec's meeting, another form of patient participation was opened in the HTA process. Therefore, the consolidation of this participation space is feasible and contributes to enrich the Brazilian HTA process.


2015 ◽  
Vol 31 (6) ◽  
pp. 457-465 ◽  
Author(s):  
Laura Sampietro-Colom ◽  
Krzysztof Lach ◽  
Iris Pasternack ◽  
Jean-Blaise Wasserfallen ◽  
Americo Cicchetti ◽  
...  

Objectives: Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units.Methods: A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units.Results: Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project.Conclusions: Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.


2011 ◽  
Vol 129 (4) ◽  
pp. 198-205 ◽  
Author(s):  
Marcos Bosi Ferraz ◽  
Patricia Coelho de Soárez ◽  
Paola Zucchi

CONTEXT AND OBJECTIVES: The health technology assessment (HTA) process has been developed locally. The aim of this study was to describe, analyze and compare the opinions of participants in international health economics symposia about the HTA process used in Brazil. DESIGN AND SETTING: Observational cross-sectional study at the 2006 and 2008 International Health Economics Symposia, in São Paulo. METHODS: A structured questionnaire was applied. For the statistical analysis, the percentage distribution for each category was calculated, and variables were compared using tests for two-sample proportion hypotheses. RESULTS: Totals of 153 and 74 participants answered the 2006 and 2008 surveys, respectively. The response rate was better for the 2006 survey (67.1%) than for the 2008 survey (31.8%). Most interviewees were between the ages of 30 and 49 years and were managers in the healthcare system. Most of them considered that the current HTA process was incomplete and unable to meet the needs of the healthcare system. They mentioned the government, academia and experts as the three main groups of people who should be involved in the process, and selected efficiency/effectiveness, safety and disease relevance as the three main criteria to be considered in the HTA process. There is a trend towards developing decentralized regionalized HTA processes, with separate assessment and decision-making for the public and private systems. CONCLUSIONS: The HTA concept is well known. Healthcare system players feel that the process has methodological limitations. Additional surveys are needed to track the HTA process and its application in Brazil.


2009 ◽  
Vol 25 (S1) ◽  
pp. 156-162 ◽  
Author(s):  
Rafał Niżankowski ◽  
Norbert Wilk

In 1989, Poland started to slowly release itself not only from the burden of a half-century of communist indoctrination and soviet exploitation, but also from the consequences of the Semashko model of healthcare organization: low doctors' salaries, primary care based on multispecialty groups, overdeveloped hospital infrastructure, and limited access to sophisticated interventions overcome by patients' unofficial payments.A few years after the 1998 workshop on health technology assessment (HTA) in Budapest, the first HTA reports were elaborated in the National Center for Quality Assessment in Health Care, which could mark the beginning of HTA in Poland. Several individuals and organizations have been involved in developing HTA, both from noncommercial and commercial standpoints.A goal to establish a national HTA agency appeared among the priorities of the Polish Ministry of Health in 2004 and was realized a year later. The Agency for HTA in Poland published guidelines on HTA and established a sound and transparent two-step (assessment-appraisal) process for preparing recommendations on public financing of both drugs and nondrug technologies. The recommendations of the Agency's Consultative Council were warmly welcomed by the public payer. However, the recent major restructuring of the Agency and new drug reimbursement decisions aroused doubts as to keeping transparency of the decision-making processes.


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