scholarly journals Time to Patients’ Access to New Medicines in Greece: Evaluation of Health Technology Assessment (HTA) Process from July 2018 until January 2021.

2021 ◽  
Author(s):  
Georgia Kourlaba ◽  
Alexandra Beletsi
Keyword(s):  
Health Technology Assessment ◽  
Median Time ◽  
Technology Assessment ◽  
Health Technology ◽  
Policy Makers ◽  
Positive List ◽  
Life Years ◽  
Long Time ◽  
Speed Up ◽  
Active Substances

Abstract Background: To present the outcome of the Health Technology Assessment (HTA) process in Greece from its onset back in July 2018 till January 2021 and to quantify the median time from marketing authorization (MA) to listing especially for new medicines. Methods: All products included in the reimbursement positive list from July 2018 to January 2021, were identified through the relevant Ministerial Decisions (MDs) posted on the website of the Ministry of Health (MoH) and the Positive Reimbursement Lists issued this period. The following information were collected for these medicines: date that MDs and Positive Reimbursement lists were issued, the legal basis of the initial MA, the MA date, the date of price registration, and the type of the HTA application. The time from MA to listing was calculated. Results: During the study period, 38 MDs were issued from which 35 (92%) were positive and resulted in the inclusion of 318 medicines and 3 (8%) were negatives that excluded 6 medicines. Focusing on new medicines, the median time from MA to listing was found to be 30 months with an interquartile range of 22 to 39 months. This time was statistically significantly shortened for FDC [19.3 (13-35) months], compared to biosimilars [26 (22-35) months, p=0.09] and on patent [38.5 (29-44) months, p=0.008]. For new generics, the corresponding median time was 22 (IQR: 12.5-31) months, statistically significantly lower than that of new medicines (p=0.028). Focusing on the four most common therapeutics areas, the median (IQR) time from MA to listing for new medicines was 28.3 (24.9–32.9) months and 34.9 (21.9-41.1) months, for oncologic and immunosuppressants (p=0.136), respectively, while on the field of cardiovascular and CNS there was no reimbursement of new active substances during the study period. Conclusions: This study showed that it takes a long time for Greek patients to get access to newly registered medicines. Given that the delay in access might result in potential loss of many life years, actions should be taken by policy makers to speed up patients access to new and innovative medicines.

scholarly journals An Integrated Framework to Measure the Performance of Inter-Organizational Programme on Health Technology Assessment

2021 ◽  
Vol 13 (7) ◽  
pp. 3873
Author(s):  
Milena Vainieri ◽  
Francesca Ferrè ◽  
Stefania Manetti
Keyword(s):  
Health Technology Assessment ◽  
Performance Management ◽  
Technology Assessment ◽  
Collaborative Governance ◽  
Health Technology ◽  
Policy Makers ◽  
Integrated Framework ◽  
Language And Culture ◽  
Health Authorities ◽  
Context Specific

Combining insights from collaborative governance, performance management, and health technology assessment (HTA) literature, this study develops an integrated framework to systematically measure and monitor the performance of HTA network programmes. This framework is validated throughout an action research carried out in the Italian HTA network programme for medical devices. We found that when building up collaborative performance management systems, some elements such as the participation in the design and the use of context specific performance assessment framework, facilitate their acceptance by managers and policy makers especially in high professionalized and sector-specific organizations because it reflects their distinctive language and culture. The hybrid framework may help health authorities and policymakers to understand the HTA network, monitor its performance, and ensure network sustainability over time.

scholarly journals Health technology assessment in sub-Saharan Africa: a descriptive analysis and narrative synthesis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Samantha Hollingworth ◽  
Ama Pokuaa Fenny ◽  
Su-Yeon Yu ◽  
Francis Ruiz ◽  
Kalipso Chalkidou
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Technical Assistance ◽  
Health Technology ◽  
Sub Saharan Africa ◽  
Main Theme ◽  
Narrative Synthesis ◽  
Policy Makers ◽  
Sub Saharan

Abstract Background Countries in Sub-Saharan Africa (SSA) are moving towards universal health coverage. The process of Health Technology Assessment (HTA) can support decisions relating to benefit package design and service coverage. HTA involves institutional cooperation with agreed methods and procedural standards. We systematically reviewed the literature on policies and capacity building to support HTA institutionalisation in SSA. Methods We systematically reviewed the literature by searching major databases (PubMed, Embase, etc.) until June 2019 using terms considering three aspects: HTA; health policy, decision making; and SSA. We quantitatively extracted and descriptively analysed content and conducted a narrative synthesis eliciting themes from the selected literature, which varied in study type and apporach. Results Half of the 49 papers identified were primary research studies and mostly qualitative. Five countries were represented in six of ten studies; South Africa, Ghana, Uganda, Cameroon, and Ethiopia. Half of first authors were from SSA. Most informants were policy makers. Five themes emerged: (1) use of HTA; (2) decision-making in HTA; (3) values and criteria for setting priority areas in HTA; (4) involving stakeholders in HTA; and (5) specific examples of progress in HTA in SSA. The first one was the main theme where there was little use of evidence and research in making policy. The awareness of HTA and economic evaluation was low, with inadequate expertise and a lack of local data and tools. Conclusions Despite growing interest in HTA in SSA countries, awareness remains low and HTA-related activities are uncoordinated and often disconnected from policy. Further training and skills development are needed, firmly linked to a strategy focusing on strengthening within-country partnerships, particularly among researchers and policy makers. The international community has an important role here by supporting policy- relevant technical assistance, highlighting that sustainable financing demands evidence-based processes for effective resource allocation, and catalysing knowledge-sharing opportunities among countries facing similar challenges.

Designing an interactive model of factors affecting the health technology assessment (HTA) in Iran

2018 ◽  
Vol 23 (4) ◽  
pp. 301-311 ◽  
Author(s):  
Mohammadkarim Bahadori ◽  
Ramin Ravangard ◽  
Mahya Tohidi Nezhad ◽  
Naeimeh Pourtaheri ◽  
Sayyed Morteza Hosseini-Shokouh
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Social Dimension ◽  
Ethical Dimension ◽  
Policy Makers ◽  
Content Type ◽  
Factors Affecting ◽  
Health Technologies ◽  
Interactive Model

PurposeAccording to the great importance of community health as well as the ever-increasing development of health technologies, the importance of designing an interactive model of factors affecting health technology assessment (HTA) can be highlighted. The purpose of designing and implementing the framework of health information system assessment is to ensure that the required accurate data which are necessary to measure the main health indicators are available. The purpose of this paper is to design an interactive model of factors affecting HTA.Design/methodology/approachThis is a cross-sectional, descriptive-analytic study conducted in the Iran Ministry of Health and Medical Education in the second half of 2017. A sample of 60 experts and professionals working in the field of health technologies are selected using purposive and snowball sampling methods. Two researcher-made questionnaires are used to collect the required data. The collected data are analyzed using decision-making trial and evaluation laboratory (DEMATEL) and MATLAB R2013a.FindingsThe results showed that “Legal dimension,” “safety,” “Effectiveness” and “Social dimension” were the affecting factors and net causes, and “Current application,” “Knowledge of technology,” “Ethical dimension,” “Costs” and “Organizational dimension” were the affected factors and net effects in the interactive model. Furthermore, “Legal dimension” with the coordinates C: [1.88, 1.27] and “Ethical dimension” with the coordinates C: [1.75, −75] were known as the most affecting and most affected factors in the interactive model, respectively.Originality/valueThe DEMATEL model is an appropriate tool for managers and policy makers to structure and prioritize factors influencing the HTA. Policy makers and decision makers can use this model for identifying relationships among factors and prioritize them. Because health policy makers and managers have a major role in formulating the regulations and guidelines related to the HTA, they should pay more attention to the legal considerations in their decisions and use the management tools to move the available resources toward implementing and enforcing rules and guidelines related to the HTA.

History of Health Technology Assessment in Iran

2020 ◽  
Vol 36 (1) ◽  
pp. 34-39 ◽  
Author(s):  
Morteza Arab-Zozani ◽  
Mobin Sokhanvar ◽  
Edris Kakemam ◽  
Tahereh Didehban ◽  
Soheil Hassanipour
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Conflicts Of Interest ◽  
Health Technology ◽  
Lessons Learned ◽  
Policy Makers ◽  
History Of ◽  
Systematic Structure ◽  
High Level

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.

scholarly journals Implementing health technology assessment in Kuwait: a qualitative study of perceived barriers and facilitators

2019 ◽  
Vol 35 (6) ◽  
pp. 422-426 ◽  
Author(s):  
Basshar Darawsheh ◽  
Evi Germeni
Keyword(s):  
Developing Countries ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Qualitative Interviews ◽  
Healthcare Providers ◽  
Health Technology ◽  
Barriers And Facilitators ◽  
Policy Makers ◽  
Face To Face ◽  
Key Stakeholders

AbstractObjectivesThis study sought to explore main barriers and facilitators to implementing health technology assessment (HTA) in Kuwait from the perspective of key stakeholders.MethodsSemi-structured qualitative interviews were conducted with ten key stakeholders: seven healthcare providers working at various departments of the Kuwaiti Ministry of Health (MOH), and three academics with substantial experience in teaching HTA or related fields. Interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data were analyzed using an inductive thematic approach.ResultsParticipating stakeholders reported several factors that might act as a barrier to building HTA in Kuwait: minimal awareness of HTA, lack of institutional and human capacity, a fragmented healthcare system, poor communication between researchers and policy makers, the country's wealth, politics, as well as data quality, availability, and sharing. Institutionalizing HTA as a politically empowered body, enforcing its recommendation by law, and benefiting from neighboring countries' experiences were suggested as possible ways to move forward.ConclusionStudies exploring the unique challenges that high-income developing countries may face in implementing HTA are still scarce. The results of this study are consistent with evidence coming from other developing countries, while also suggesting that the abundance of financial resources in the country is a double-edged sword; it has the potential to facilitate the development of HTA capacity, but also hinders recognizing the need for it.

Health technology assessment and ill-structured problems: A case study concerning the drug mebeverine

2007 ◽  
Vol 23 (3) ◽  
pp. 316-323 ◽  
Author(s):  
Margriet Moret-Hartman ◽  
Gert Jan van der Wilt ◽  
John Grin
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Problem Definition ◽  
Practical Significance ◽  
Policy Makers ◽  
Semistructured Interviews ◽  
Structured Problems ◽  
Irritable Bowel

Objectives:The practical significance of health technology assessment (HTA) in policy decisions or clinical practice has been challenged. Possibly, problem definitions underlying HTA do not concur sufficiently with the problem definitions held by policy makers or clinicians. We performed an in-depth case study on mebeverine, a drug prescribed to patients with irritable bowel syndrome, to explore this hypothesis.Methods:The theoretical framework was provided by the theory of argumentative policy analysis. We analyzed documents and held semistructured interviews to collect data. We reconstructed interpretative frames to analyze actors' argumentation.Results:The funding and usage problems relating to mebeverine were ill-structured. Actors disagreed on the information needed and the norms at stake. As a result, the problem definition shifted, and the resulting problem definitions failed to correspond with the problems perceived by the target populations.Conclusions:To ensure that future studies on healthcare problems are useful, it is imperative that policy makers take the problem definitions of potential users into account.

scholarly journals INTELLIGENCE AND TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (1-2) ◽  
pp. 3-9 ◽  
Author(s):  
Henry S. Richardson
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Making ◽  
Health Technology ◽  
Quality Adjusted Life Years ◽  
Human Capabilities ◽  
Current Thinking ◽  
Life Years ◽  
Subjective Preference ◽  
Subjective Importance

Current thinking about the methodology of health technology assessment (HTA) seems to be dominated by two fundamental tensions: [1] between maintaining a tight focus on quality-adjusted life-years and broadening its concern out to pay attention to a broader range of factors, and [2] between thinking of the evaluative dimensions that matter as being objectively important factors or as ones that are ultimately of merely subjective importance. In this study, I will argue that health is a tremendously important all-purpose means to enjoying basic human capabilities, but a mere means, and not an end. The ends to which health is a means are manifold, requiring all those engaged in policy making to exercise intelligence in a continuing effort to identify them and to think through how they interrelate. Retreating to the subjective here would be at odds with the basic idea of HTA, which is to focus on certain objectively describable dimensions of what matters about health and to collect empirical evidence rigorously bearing on what produces improvements along those dimensions. To proceed intelligently in doing HTA, it is important to stay open to reframing and refashioning the ends we take to apply to that arena. The only way for that to happen, as an exercise of public, democratic policy making, is for the difficult value questions that arise when ends clash not to be buried in subjective preference information, but to be front-and-center in the analysis.

scholarly journals Health technology assessment in Finland

2009 ◽  
Vol 25 (S1) ◽  
pp. 102-107 ◽  
Author(s):  
Marjukka Mäkelä ◽  
Risto P. Roine
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Evidence Based ◽  
Policy Makers ◽  
Health Technologies ◽  
Based Medicine ◽  
Special Responsibility ◽  
Made In

Since the 1990s, health policy makers in Finland have been supportive of evidence-based medicine and approaches to implement its results. The Finnish Office for Health Technology Assessment (Finohta) has grown from a small start in 1995 to a medium-sized health technology assessment (HTA) agency, with special responsibility in providing assessments to underpin national policies in screening. External evaluations enhanced the rapid growth. In the Finnish environment, decision making on health technologies is extremely decentralized, so Finohta has developed some practical tools for implementing HTA findings. The Managed Uptake of Medical Methods program links the hospital districts to agree on introduction of technologies. The Ohtanen database provides Finnish-language summaries of major assessments made in other countries.

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