HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY

2017 ◽  
Vol 33 (2) ◽  
pp. 297-302 ◽  
Author(s):  
Camille Dutot ◽  
Grégoire Mercier ◽  
Isabelle Borget ◽  
Côme de Sauvebeuf ◽  
Nicolas Martelli

Objectives:Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers’ insights into Hb-HTA processes.Methods:A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers’ market access strategies was administered.Results:Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity.Conclusions:Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

2016 ◽  
Vol 40 (3) ◽  
pp. 257 ◽  
Author(s):  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Patrice Prognon ◽  
Judith Pineau ◽  
Nicolas Martelli

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders’ perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as ‘new’, ‘safe’ and ‘effective’, whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital-based health technology assessment has been developed to support decisions. However, little is known about the different perceptions of innovative medical devices among practitioners and how different perceptions may affect decision making. What does this paper add? This paper compares and understands the perceptions of two groups of health professionals concerning innovative devices in the university hospital environment. What are the implications for practitioners? Such a comparison of viewpoints could facilitate improvements in current practices and decision-making processes in local health technology assessment for these medical products.


2017 ◽  
Vol 33 (2) ◽  
pp. 307-314 ◽  
Author(s):  
Nicolas Martelli ◽  
Capucine Devaux ◽  
Hélène van den Brink ◽  
Mathilde Billaux ◽  
Judith Pineau ◽  
...  

Background: The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs.Methods: A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients.Results: Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices.Conclusions: Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.


2015 ◽  
Vol 31 (1-2) ◽  
pp. 12-18 ◽  
Author(s):  
Nicolas Martelli ◽  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Judith Pineau ◽  
Patrice Prognon ◽  
...  

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.


2016 ◽  
Vol 32 (4) ◽  
pp. 246-255 ◽  
Author(s):  
Sabine Fuchs ◽  
Britta Olberg ◽  
Dimitra Panteli ◽  
Reinhard Busse

Objectives: To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions.Methods: A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution.Results: Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit.Conclusions: Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.


2013 ◽  
Vol 29 (2) ◽  
pp. 185-191 ◽  
Author(s):  
Nicolas Martelli ◽  
Anne-Sophie Lelong ◽  
Patrice Prognon ◽  
Judith Pineau

Objectives: Several models of hospital-based health technology assessment (HTA) have been developed worldwide, for the introduction of innovative medical devices and support evidence-based decision making in hospitals. Two such models, the HTA unit and mini-HTA models, are widespread in university hospitals and involve various stakeholders. The purpose of this work was to highlight the potential role of hospital pharmacists in hospital-based HTA activities.Methods: We searched for articles, reviews, and letters relating to hospital-based HTA, as defined by the Hospital-Based Health Technology Assessment Worldwide Surveypublished by the Health Technology Assessment International (HTAi) Society, in the Health Technology Assessment database, MEDLINE, EMBASE, and hospital pharmacyjournals.Results: The number of university hospitals performing hospital-based HTA has increased since the 2008 Hospital-Based Health Technology Assessment Worldwide Survey. Our own experience and international findings show that hospital pharmacists already contribute to hospital-based HTA activities and have developed study interpretation skills and a knowledge of medical devices.Conclusions: Promoting multidisciplinary approaches is one of the key success factors in hospital-based HTA. Hospital pharmacists occupy a position between hospital managers, clinicians, health economists, biomedical engineers, and patients and can provide a new perspective. In the future, hospital pharmacists are likely to become increasingly involved in hospital-based HTA activities.


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.


2021 ◽  
Vol 37 (S1) ◽  
pp. 21-21
Author(s):  
Andrey Avdeyev ◽  
Valeriy Benberin ◽  
Nasrulla Shanazarov ◽  
Larissa Makalkina ◽  
Aigul Kaptagayeva ◽  
...  

IntroductionThe experience of implementing a hospital-based health technology assessment (HB-HTA) system in Kazakhstan is currently represented by only one organization, an independent HB-HTA unit established in 2015 in the Medical Center Hospital of the President's Affairs Administration (the Hospital). Despite the demonstrated positive experience of the Hospital, the widespread implementation of the HB-HTA system in Kazakhstan has experienced some barriers that must be considered before further development can occur.MethodsTo determine the barriers to developing and implementing HB-HTA in Kazakhstani hospitals, data from the Hospital's experience were obtained through a survey of Kazakhstan hospitals, conducted on behalf of the Ministry of Health Care. An official response was received from 29 hospitals. During the survey and discussions with hospital staff using the “brainstorming” method, several barriers to the development of HB-HTA in Kazakhstan were identified.ResultsBarriers at the system level included the lack of monitoring of the HB-HTA system at the national and regional levels and a lack of methodological support. Organizational barriers included a critically small number of HTA experts and the need for additional logistical support and funding from hospitals. The subjective factors we attributed to the rejection of the HB-HTA system by hospital management were the underestimation of lost profits and that HTA is a tool for promoting a transparent and open system for making managerial decisions.ConclusionsDespite some barriers, the development of HB-HTA in Kazakhstan is a promising area. The heads of key hospitals in Kazakhstan demonstrated a readiness and understanding of the need to use the principles of health technology assessment and clinical and economic analysis to promote the active transfer and implementation of innovative medical technologies.


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