scholarly journals HTA Reshaping: Rethinking the Health Technology Assessment Framework in Portugal

2021 ◽  
pp. 1-12
Author(s):  
João Pereira ◽  
Joana Alves ◽  
Bernardo Rodrigues ◽  
Ricardo Caetano ◽  
Pedro  Brito-Cruz ◽  
...  

<b><i>Introduction:</i></b> Health technology assessment (HTA) aims to provide decision makers with relevant data to make informed choices. Recent changes in the Portuguese HTA framework have altered substantially the assessment methodology with regard to economic evaluation, with potential impacts on access and process efficiency. The HTA Reshaping Project had as its main objective informing the debate on HTA in Portugal, thereby identifying improvement opportunities and solutions to the HTA framework that address future challenges. <b><i>Methods:</i></b> The project comprised several phases, i.e., (1) mapping and evaluation of different HTA frameworks across Europe, identifying best practices and key variables to consider in future frameworks; (2) conduction of in-depth interviews with relevant stakeholders (<i>n</i> = 11); and (3) development of 2 workshops – one with young professionals (<i>n</i> = 12) and another with relevant HTA stakeholders (<i>n</i> = 19) – to consolidate and further explore vital elements of HTA, aimed at brainstorming ideas and developing solutions to improve some of the most critical points, with a view to addressing future challenges. <b><i>Results:</i></b> The comparison of HTA frameworks showed that their purpose and sophistication vary across European countries. For example, the need for economic evidence is not unanimous, and reimbursement agreements vary considerably. Among the stakeholders interviewed there was a high level of agreement on priorities that should be addressed, e.g., expanding and creating national level registries and assuring patient participation throughout the HTA process. The possibility of using managed entry agreements to enhance patients’ access, applying multi-indication pricing for medicines with different therapeutic values per indication, and improvement of registry/system interoperability gathered a moderate level of agreement. <b><i>Conclusions:</i></b> The Portuguese HTA framework might be further adapted to upcoming challenges and should evolve to improve access to innovative therapies. There is still a long path towards the convergence of HTA frameworks in EU member states.

2020 ◽  
Vol 27 (3) ◽  
pp. 274-289
Author(s):  
Verena Stühlinger

Abstract For patients, innovations in healthcare can be both a great blessing (when saving people’s life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health technology assessment (HTA) plays a crucial role at European Union level, forming an evidence-based, transparent basis for decision making through joint assessments. However, pricing and reimbursement aspects are exempt from collaborative assessments, since these are in the responsibility of the EU Member States: according to Art. 168(7) TFEU the ‘organisation and delivery of health services and medical care [… including] the allocation of the resources assigned to them’ remain an exclusive competence of Member States. However, future challenges may require further cooperation.


2000 ◽  
Vol 16 (2) ◽  
pp. 485-519 ◽  
Author(s):  
Michael Bos

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.


Author(s):  
Morteza Arab-Zozani ◽  
Mobin Sokhanvar ◽  
Edris Kakemam ◽  
Tahereh Didehban ◽  
Soheil Hassanipour

This article describes the characteristics of the health system and reviews the history of health technology assessment (HTA) in Iran, including its inception, processes, challenges, and lessons learned. This study was conducted by analyzing existing documents, reports, and guidelines related to HTA and published articles in the field. HTA in Iran has been established since the late 2000s and was first introduced as a secretariat by the Deputy of Health at the Ministry of Health and Medical Education. The mission of the HTA office is to systematically assess technologies to improve evidence-informed decision making. Despite its 10 years of existence, HTA in Iran still faces some challenges. The most pressing problems currently facing HTA in Iran include conflicts of interest among researchers performing the HTAs, the absence of a systematic structure for identifying and introducing new technologies, the lack of interest in HTA results among high-level policy makers, and the lack of external oversight for HTA projects.


2016 ◽  
Vol 32 (3) ◽  
pp. 181-189 ◽  
Author(s):  
Bahareh Yazdizadeh ◽  
Safoura Shahmoradi ◽  
Reza Majdzadeh ◽  
Shila Doaee ◽  
Mohammad Bazyar ◽  
...  

Objectives:This study was carried out to evaluate the opinions of stakeholders on their roles in health technology assessment (HTA) in Iran and to determine the barriers and facilitators existing in the organizations to help increase their involvement in the HTA program.Methods:The study was conducted in two stages, semi-structured interviews, and “policy dialogue” with stakeholders. The data were analyzed through the framework approach.Results:The interviews were held with ten stakeholder representatives from various organizations. In addition, Twenty-one representatives participated in the policy dialogue. Based on the findings, all the stakeholder organizations considered themselves as interest groups in all the stages of the HTA process; however, their tendencies and methods of involvement differed from one another. According to the participants, the most important issue to be considered in the context of HTA was that the structures, stages, and procedures of the HTA process must be made transparent.Conclusions:Stakeholder involvement in the HTA program cannot readily take place. Various stakeholders have different interests, responsibilities, infrastructures, and barriers. If a program does not meet these considerations, its chances of succeeding will substantially decrease. Therefore, to prevent overlooking the needs and expectations of stakeholders from the HTA process, it is essential to create opportunities in which their thoughts and ideas are taken into account.


1998 ◽  
Vol 14 (2) ◽  
pp. 226-236 ◽  
Author(s):  
Wija J. Oortwijn ◽  
Hindrik Vondeling ◽  
Lex Bouter

AbstractPriority setting for the evaluation of health technologies in the Netherlands is exclusively based on the scientific merits of individual research proposals. This process has not resulted in satisfactory allocation of resources. Therefore, societal criteria for setting priorities for health technology assessment have been proposed as an adjunct to scientific criteria. These societal criteria include the burden of disease, uncertainty about the (cost-)effectiveness of the intervention at issue, the potential benefits of the research project, and its potential impact on health care. To realize the full potential of this model for priority setting, a number of methodological issues need to be addressed. Joint efforts of researchers and policy makers in this field are necessary for future progress.


2021 ◽  
Vol 12 ◽  
Author(s):  
Lucia Gozzo ◽  
Giovanni Luca Romano ◽  
Francesca Romano ◽  
Serena Brancati ◽  
Laura Longo ◽  
...  

Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health technology assessment (HTA) bodies. Advanced therapy medicinal products (ATMPs) represent a major issue with regard to the HTA in order to make them available at a national level. These products are based on genes, tissues, or cells, commonly developed as one-shot treatment for rare or ultrarare diseases and mandatorily authorized by the EMA with a central procedure. This study aims to provide a comparative analysis of HTA recommendations issued by European countries (France, Germany, and Italy) following EMA approval of ATMPs. We found a low rate of agreement on the therapeutic value (in particular the “added value” compared to the standard of care) of ATMPs. Despite the differences in terms of clinical assessment, the access has been usually guaranteed, even with different timing and limitations. In view of the importance of ATMPs as innovative therapies for unmet needs, it is crucial to understand and act on the causes of disagreement among the HTA. In addition, the adoption of the new EU regulation on HTA would be useful to reduce disparities of medicine’s assessment among European countries.


2015 ◽  
Vol 31 (1-2) ◽  
pp. 103-110 ◽  
Author(s):  
Graciela Demirdjian

Objectives: To describe the first hospital-based health technology assessment (HTA) program in a public hospital in Argentina, and report some clinical, educational, economic and organizational results after 10 years of its implementation.Methods: A hospital-based HTA program was created in March 2001 at Hospital Garrahan (Buenos Aires, Argentina), a national pediatric facility with a self-managed budget. Its main goal is to promote a rational and evidence-based technologic development. The program consists of HTA reports for technology acquisition, clinical practice guidelines (CPG), capacity building in research and management, and technical support for health services research (HSR). The evaluation cycle comprises: prioritization, evidence synthesis, dissemination and monitoring. We report program performance, comment educational and organizational effects, and discuss unresolved issues and future challenges.Results: During the first 10 years the program produced 18 HTA reports on drugs (6 = 33 percent), therapeutic (6 = 33 percent), preventive (2 = 11 percent) or diagnostic (2 = 11 percent) procedures and institutional programs (3 = 17 percent). The scope covered effectiveness (12 = 67 percent), safety (10 = 56 percent), budget impact (6 = 33 percent), cost-effectiveness (2 = 11 percent) and organizational impact (3 = 17 percent). Mean time from request to report was 10 months. Eleven pediatric CPGs were submitted to expert consensus and disseminated for full-text Web access. A 1-year course on research and management was completed by 225 professionals in 6 years, and twenty-two projects for HSR were coached.Conclusions: Our experience shows that an HTA program is both feasible and useful in a public hospital of a developing country. Promotion of hospital-based HTA, professional integration in HTA activities and network collaboration to discuss unresolved issues with colleagues can multiply the benefits and optimize the use of hospital budgets.


2009 ◽  
Vol 25 (S1) ◽  
pp. 134-139 ◽  
Author(s):  
Joshua Shemer ◽  
Mordechai Shani ◽  
Orly Tamir ◽  
Miriam Ines Siebzehner

Objectives:The aim of this study was to describe the history and present situation with health technology assessment (HTA) in Israel.Methods:The method used in this study was a historical analysis based mainly on the knowledge of the authors, but supplemented by the published literature.Results:HTA originated in Israel as a centralized function conducted under the auspice of research, developing into an active multidisciplinary center. Throughout the expansion of the field, HTA was performed in affiliation with several local and international bodies, while providing direct and indirect support at the national level. Today, mainly as a result of vigorous dissemination of the principles, methodology and tools for HTA by the Israeli Center for Technology Assessment in Health Care (ICTAHC), this discipline is increasingly a decentralized activity conducted by a great variety of institutions. Israeli health policy decisions are increasingly based on the results of HTA.Conclusions:ICTAHC's role and functioning has expanded since its beginnings. HTA has become an important part of health care in Israel.


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