scholarly journals PCN318 Patient Experience Information (PEI) and Patient Involvement in Health Technology Assessment (HTA) Processes in 7 European Countries Using Immuno-Oncology Examples: How CAN the Patient Voice Make an IMPACT?

2020 ◽  
Vol 23 ◽  
pp. S478
Author(s):  
A. Brogan ◽  
C.K. Patel ◽  
N. Schoenherr ◽  
S. Bobiak
Author(s):  
Konstantinos Zisis ◽  
Panagiota Naoum ◽  
Kostas Athanasakis

Abstract Objective To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. Methods We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. Results A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure—for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. Conclusions The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.


Author(s):  
Ana Toledo-Chávarri ◽  
Yolanda Triñanes Pego ◽  
Eva Reviriego Rodrigo ◽  
Nora Ibargoyen Roteta ◽  
Blanca Novella-Arribas ◽  
...  

Objective The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework. Methods A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors. Results Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future. Conclusions PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.


1997 ◽  
Vol 13 (2) ◽  
pp. 287-332 ◽  
Author(s):  
Richard Cranovsky ◽  
Yves Matillon ◽  
David Banta

The issue of health benefits coverage—and its relation to health technology assessment (HTA)—has gained increasing attention in recent years. Economic constraints on health care, as well as the rapid pace of technological change, have forced European countries to face difficult choices in providing such care. The active use of coverage decision making has been proposed as a tool to help rationalize health care, and HTA has been advocated as a necessary activity to improve coverage decisions.


2015 ◽  
Vol 31 (3) ◽  
pp. 166-170 ◽  
Author(s):  
Mylène Tantchou Dipankui ◽  
Marie-Pierre Gagnon ◽  
Marie Desmartis ◽  
France Légaré ◽  
Florence Piron ◽  
...  

Objectives: We sought to evaluate patient involvement (consultation and direct participation) in the assessment of alternative measures to restraint and seclusion among adults in short-term hospital wards (in psychiatry) and long-term care facilities for the elderly.Methods: We conducted individual semi-structured interviews with thirteen stakeholders: caregivers, healthcare managers, patient representatives, health technology assessment (HTA) unit members, researchers, and members of the local HTA scientific committee. Data were collected until saturation. We carried out content analysis of two HTA reports and four other documents that were produced in relation with this HTA. We also used field notes taken during formal meetings and informal discussions with stakeholders. We performed thematic analysis based on a framework for assessing patient involvement in HTA. We then triangulated data.Results: For the majority of interviewees, patient consultation enriched the content of the HTA report and its recommendations. This also made it possible to suggest other alternatives that could reduce the use of restraint and seclusion and helped confirm some views and comments from healthcare professionals consulted in this HTA. The direct participation of patient representatives enabled rephrasing of some findings so as to bring the patient perspective to the HTA report.Conclusions: Patient consultation was seen as having directly influenced the content of the HTA report while direct participation made it possible to rephrase some findings. This is one of few studies to assess the impact of patient involvement in HTA and more such studies are needed to identify the best ways to improve the input of such involvement.


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.


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