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Within the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process.

Aim: The evaluation of a health technology determines the clinical and non-clinical value of the technology. Among the non-clinical criteria, evaluation models include the organizational impact (OI) of the technology. The objective of this study is to highlight the types of OIs of 3D printing in a hospital setting. Materials & methods: A panel of 12 experts was assembled based on their knowledge of 3D-printed medical devices and then interviewed individually. Results: A strong consensus was reached for three types of impacts out of the 12 types of OIs associated with medical devices: the need for training, cooperation and communication and the logistics circuit. Conclusion: It seems very relevant to integrate these three types of impacts in future evaluations of 3D printing in healthcare.

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US). Areas Covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored. Expert Opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers’ evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

BackgroundTranscatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.Materials and methodsA systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.ResultsA total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.ConclusionMany prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

The question of early patient access to innovative health technologies arises from the assumption that, once a certain level of effectiveness or efficiency is achieved, waiting for mainstream coverage would represent a loss of opportunity for patients or for the community. This was the premise on which the round table based its dialogue. Early access is understood as the funding of a technology that comes within this field and is CE-marked but has not yet attained "mainstream" coverage. There are several early access schemes in France ("forfait innovation", early coverage, exceptional coverage, RIHN). This round table was an opportunity to establish mapping, extended to devices not dedicated to early access but which could nevertheless provide some patients with access to non-mainstreamed technologies (Article 51, ETAPES experiments, DGOS call for projects, local schemes). It is an initial step that would need to be further developed and complemented by the dissemination of common communication materials available to all, including patients. The existing schemes are in fact still poorly known. Consideration would also have to be given to the advisability of developing these schemes in order to adapt them to the new European requirements. More generally, early access schemes must be integrated into an ecosystem that is conducive for their relevance: consideration of procedures associated with medical devices benefiting from early access; short time frames of examination; patient information. Finally, the round table proposes the creation of a new early access scheme, complementary to those that exist and that would be positioned, after CE marking, between the "forfait innovation" and mainstreaming: PRESTO (Prise En charge Securisee et Temporaire de technologies innOvantes) (secure and temporary coverage for innovative technologies).

Resume La question de l’acces precoce des patients aux technologies de sante innovantes se pose des lors que l’on considere qu’a partir d’un certain niveau presume d’efficacite ou d’efficience, attendre une prise en charge de droit commun constituerait une perte de chance pour les patients ou pour la collectivite. C’est sur ce postulat que la table ronde a fonde ses reflexions. L’acces precoce est entendu comme le financement d’une technologie entrant dans ce champ et disposant du marquage CE mais ne beneficiant pas encore d’une prise en charge dite « de droit commun ». Plusieurs dispositifs d’acces precoce existent en France (forfait innovation, prise en charge precoce, prise en charge derogatoire, referentiel des actes innovants hors nomenclatures de biologie medicale et d’anatomopathologie [RIHN]). Cette table ronde a ete l’occasion d’en dresser une cartographie, elargie a des dispositifs non dedies a l’acces precoce mais pouvant neanmoins permettre a certains patients d’acceder a des technologies non prises en charge dans le droit commun (Article 51, experimentations de telemedecine pour l’amelioration des parcours en sante [ETAPES], appels a projets Direction generale de l’offre de soins [DGOS], dispositifs locaux). Cet exercice constitue une premiere etape qu’il conviendrait d’approfondir et de completer par la diffusion de supports de communications communs et a destination de tous, y compris des patients. Les dispositifs existants sont en effet encore mal connus. Il faudra egalement s’interroger sur l’opportunite de faire evoluer ces dispositifs pour qu’ils s’adaptent aux nouvelles exigences europeennes. Plus generalement, les dispositifs d’acces precoce doivent etre integres dans un ecosysteme propice a garantir leur pertinence : prise en compte des actes associes aux dispositifs medicaux beneficiant d’un acces precoce ; delais courts d’instruction ; information des patients. Enfin, la table ronde propose la creation d’un nouveau dispositif d’acces precoce, complementaire de ceux qui existent et qui se situerait, apres le marquage CE, entre le forfait innovation et le droit commun : PRESTO (Prise En charge Securisee et Temporaire de technologies innOvantes).

Prostate cancer is the most common men cancer in France. Continuous progress in oncology led to develop robot-assisted Radical Prostatectomies (rRP) and robot-assisted stereotactic body radiotherapy (rSBRT). The present study aims at comparing economic and clinical impacts of prostate cancer treatments performed either with rSBRT or rRP in France. A Markov model using TreeAge Pro software was chosen to calculate annual costs; utilities and transition probabilities of localized prostate cancer treatments. Patients were eligible for radiotherapy or surgery and the therapeutic decision was a robot-assisted intervention. Over a 10-year period, rSBRT yielded a significantly higher number of quality-adjusted life years than rRP (8.37 vs 6.85). In France, rSBRT seemed more expensive than rRP (€19,475 vs €18,968, respectively). From a societal perspective, rRP was more cost-saving (incremental cost effectiveness ratio = €332/QALY). The model was sensitive to variations of costs of the initial and recurrence state in one-way sensitivity analyses. Robot-assisted stereotactic body radiotherapy seems more cost-effective than Radical Prostatectomy in terms of QALY despite the slightly higher initial cost due to the use of radiotherapy. It would be interesting to conduct comparative quality of life studies in France over longer periods of time.

Background In 2020, the first mRNA COVID vaccine was approved by the with six doses from single vial. In the context of material shortages, the aim of the study was to compare different protocols to extract doses using uncrimped materials with good trueness and reproducibility. Methods To optimize the extraction of the sixth dose from a single vial with uncrimped materials, alternative protocols of preparation were tested, derived from the drug information. Results The repeatability of injected volume was acceptable for all protocols (CV

International audience; Background: Three-dimensional (3D) printing has changed surgical practice over the past few years, especially in maxillofacial surgery. However, little is known about its real clinical impact. The objectives of our study were to identify clinical outcomes that have been evaluated in the literature regarding 3D printing applications in jaw reconstruction, and to quantify the impact of this technology on operating times.Methods: A systematic review was conducted by searching PubMed and EMBASE to collect comparative studies on 3D printing applications in jaw reconstruction. A meta-analysis of operating times was then performed. A Cochran's Q test was used to determine heterogeneity, and the overall effect size was calculated using a random effects model.Results: Fourteen studies were included in our review. Eighteen clinical end-points were identified, of which the most frequently reported were operating time (n = 5; 35.7%) and the final aesthetic result (n = 4; 28.6%). Operating times were significantly lower in the 3D printing groups, with an overall estimated effect of 21.2% (95% CI 10-33%; p < 0.001).Conclusion: The use of 3D printing in jaw reconstruction was associated with a significant reduction in operating times. The end-points evaluated differed largely among the studies. More studies with higher levels of evidence are needed to confirm our results.

Introduction: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage

ObjectiveBecause of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.MethodsA systematic review was performed using four electronic databases to identify health economic evaluation studies dealing with VADs. The methodological quality and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.ResultsOf the 1,258 publications identified, thirteen articles were included in this review. Twelve studies were cost–utility analyses and one was a cost-effectiveness analysis. According to the Cooper hierarchy scale, the quality of the data used was heterogeneous. The level of evidence used for clinical effect sizes, safety data, and baseline clinical data was of poor quality. In contrast, cost data were of high quality in most studies. Quality of reporting varied between studies, with an average score of 17.4 (range 15–19) according to the CHEERS checklist.ConclusionThe current study shows that the quality of clinical data used in economic evaluations of VADs is rather poor in general. This is a concern that deserves greater attention in the process of health technology assessment of medical devices.

ObjectivesThe use of three-dimensional (3D) printing in surgery is expanding and there is a focus on comprehensively evaluating the clinical impact of this technology. However, although additional costs are one of the main limitations to its use, little is known about its economic impact. The purpose of this systematic review is to identify the costs associated with its use and highlight the first quantitative data available.MethodsA systematic literature review was conducted in the PubMed and Embase databases and in the National Health Service Economic Evaluation Database (NHS EED) at the University of York. Studies that reported an assessment of the costs associated with the use of 3D printing for surgical application and published between 2009 and 2019, in English or French, were included.ResultsNine studies were included in our review. Nine types of costs were identified, the three main ones being printing material costs (n = 6), staff costs (n = 3), and operating room costs (n = 3). The printing cost ranged from less than U.S. dollars (USD) 1 to USD 146 (in USD 2019 values) depending on the criteria used to calculate this cost. Three studies evaluated the potential savings generated by the use of 3D printing technology in surgery, based on operating time reduction.ConclusionThis literature review highlights the lack of reliable economic data on 3D printing technology. Nevertheless, this review makes it possible to identify expenditures or items that should be considered in order to carry out more robust studies.

Resume Le terme « recherche clinique » designe toute recherche menee sur l’homme en vue du developpement des connaissances biologiques ou medicales. Applicable depuis novembre 2016, la loi Jarde a redefini les contours de la recherche clinique en France. Le changement le plus notable est qu’on ne parle plus de recherche biomedicale mais de « recherche impliquant la personne humaine ». Ainsi, toutes les recherches doivent etre autorisees par un comite de protection des personnes (CPP) avant de pouvoir debuter ; cela inclut aussi les recherches observationnelles telles que les cohortes retrospectives. Autre nouveaute, le CPP est attribue de maniere aleatoire, sur un site internet dedie. Seules les recherches sur donnees (obtenues dans le cadre strict du soin) font exception parce qu’elles n’impliquent pas la personne humaine ; il s’agit en general des donnees extraites de l’entrepot de donnees ou du dossier patient informatise. L’objectif de cet article est d’aider les radiologues interventionnels a comprendre et a optimiser leurs activites de recherche clinique dans le respect du cadre legal nouvellement defini.

RATIONALE, AIMS, AND OBJECTIVES There is at present no standard methodology to analyse the organizational impacts (OIs) of medical devices (MDs), and the field is still in its infancy. The aim of the present study was to assess, at a hospital level, the organizational and economic impacts of the introduction of a new MD, specifically the single-use flexible bronchoscope (FB). METHODS Both the organizational and economic impacts of the single-use FB were evaluated in comparison with the reusable FB currently used as standard practice in our institution. First, process maps were created for both devices (reusable and single use). Based on the 12 types of OI defined by Roussel et al, interviews were conducted with all stakeholders, and the positive and negative aspects of the reusable and single-use processes were analysed. In a second step, microcosting analysis was conducted to determine the most economical balance in use of the 2 technologies. RESULTS Process maps highlighted the complexity of the reusable device process when compared with the single-use device process. Among the 12 types of OI, the single-use FB process scored better than the reusable FB process in 75% of cases. With the "fleet" of 15 reusable FBs available in our institution, using single-use FBs would represent an extra cost of €154 per procedure. Single-use and reusable devices would have the same cost (€232 per procedure) with a theoretical annual activity of 328 bronchoscopies, which is much lower than our current activity (1644 procedures per year). CONCLUSIONS Organizational impact should be considered when assessing MDs. We show in this study that from an organizational viewpoint, there are many advantages to using single-use bronchoscopes. However, in economic impact, it is more cost-effective for our institution, with more than 1500 bronchoscopies performed annually, to use reusable devices.

3D printing plays an increasingly important role in the medical sector and particularly in surgery. Nowadays, numerous manufacturers benefit from this technology to produce their medical devices and some hospitals have also purchased 3D printers. In this context, the aim of the present study was to study the distribution and the use of 3D printing in French hospitals in order to its main features in surgery. By conducting a national survey, we targeted hospitals equipped with 3D printers and those using external providers to benefit from this technology. Forty-seven hospitals were identified as using 3D printing including eight equipped with in-house 3D printers. This work gives us a first picture of 3D printing for hospital use in France and it raises questions about hospital pharmacists' involvement in 3D printed medical device production.

Hospital-based health technology assessment (HTA) guides decisions as to whether new healthcare products should be made available within hospital structures. Its extension to medical devices (MDs) makes it possible to analyse several relevant aspects of these healthcare products in addition to their clinical value, and such evaluations are of interest to national health authorities, other healthcare establishments and industry. The aim of this work was to formulate several recommendations for a blueprint for hospital-based HTA for MDs in France. Five themes based on the work of the European Adopting hospital-based HTA in the EU (AdHopHTA) project were defined. Each member of the roundtable was then allocated a documentation task based on their experience of the theme concerned, and a literature review was carried out. An inventory of hospital-based HTA was performed and six recommendations aiming to strengthen and improve this approach were put forward: (1) encouragement of the spread of the hospital-based HTA culture and participation in communications and the promotion of this approach to hospital decision-makers; (2) adaptation of hospital-based HTA to the needs of decision-makers, taking into account the financial timetable and strategic objectives of the healthcare establishment; (3) harmonisation of the dossiers requested from industry between healthcare establishments, based on a common core; (4) promotion of the sharing of hospital-based HTA data under certain conditions, with data dissociable from the HTA report and the use of a validated methodology for the literature review; (5) creation of a composite indicator reflecting data production effort and the sharing of HTA activities, to be taken into account in the distribution of funds allocated for teaching, research and innovation missions considered of general interest; (6) the transmission of information directly from local to national level by pioneering centres. This work highlights the major issues at stake in hospital-based HTA and the need to valorise such activities in France.

Resume L’evaluation des technologies de sante (ETS) en milieu hospitalier est une aide a la decision pour l’integration de produits de sante a la structure hospitaliere. Appliquee aux dispositifs medicaux (DM), elle permet d’apprehender plusieurs aspects pertinents pour ces produits de sante, autres que purement cliniques, et qui interessent a la fois les autorites de sante nationales, les autres etablissements de sante ou encore les industriels. L’objectif de ce travail etait de proposer plusieurs recommandations capables de soutenir un schema cible de l’ETS hospitaliere appliquee aux DM en France. Apres avoir defini cinq thematiques s’inspirant du projet europeen Adopting hospital-based HTA in the EU (AdHopHTA), chacun des membres de la table ronde s’est vu confier un travail documentaire fonde sur leur experience d’une thematique donnee et une revue de la litterature a ete entreprise. Apres un etat de lieux de l’ETS hospitaliere, six recommandations visant a renforcer la demarche ont ete proposees : (1) diffuser la culture de l’ETS hospitaliere et contribuer a sa communication/promotion aupres des decideurs hospitaliers ; (2) adapter l’ETS hospitaliere au besoin de prise de decision en tenant compte du calendrier financier et des objectifs strategiques de l’etablissement ; (3) harmoniser entre les etablissements de sante, selon un socle commun, les dossiers demandes aux industriels ; (4) promouvoir le partage des donnees de l’ETS hospitaliere sous certaines conditions : donnees dissociables du rapport d’ETS et application d’une methodologie validee pour la revue bibliographique ; (5) creer un indicateur composite traduisant l’effort de production et de partage des activites d’ETS et pris en compte dans la repartition de la « dotation socle de financement des activites d’enseignement, de recherche et d’innovation » allouee au titre des missions d’interet general (MIG) ; (6) avoir recours a des centres pionniers pour la remontee des informations directement entre l’echelon local et national. Ce travail souligne l’enjeu majeur que represente l’ETS hospitaliere et la necessite de valoriser cette activite en France.

The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.

Resume Introduction Le Comite des dispositifs medicaux steriles (CODIMS) de l’Assistance publique–Hopitaux de Paris (AP–HP) definit la liste des DM steriles (DMS) innovants et/ou couteux dont l’utilisation est preconisee dans les etablissements de l’AP–HP. Ce travail qualifie retrospectivement le niveau de preuve des etudes cliniques (EC) relatives aux dispositifs evalues par le CODIMS en 2012 et 2013 et leur correlation aux avis emis. Materiel et methode Les notes de synthese realisees en 2012 et 2013 des DM etudies ont ete analysees. Le niveau de preuve des EC constitutives de chacun des dossiers a ete qualifie en etudes de haut/faible niveau de preuve et correle aux avis emis. Resultats Soixante et un dossiers de DMS (72,1 % de DM implantables) ont ete evalues (225 EC). Les resultats montrent : 18 % de dossiers sans EC et seulement 28 % d’EC haut niveau de preuve (et 28,6 % pour DM les plus a risque). Le CODIMS a emis un avis defavorable pour 16 DMS : seulement 28 EC venaient etayer les dossiers de ces DMS, soit 1,75 etudes par dossier. Parmi ces 28 etudes, 6 etudes avaient un haut niveau de preuve. Discussion et conclusion Le nombre et le niveau de preuve des EC sont logiquement correles a l’admission ou non d’un DMS. La preuve de l’efficacite et de la securite des DMS les plus a risque s’etablit toujours en grande majorite sur la base d’EC de faible niveau de preuve, rendant ainsi difficile l’evaluation des DMS a l’hopital en vue de leur acquisition. Le developpement d’un outil multicriteres d’aide a la decision pourrait permettre d’ameliorer le processus de l’evaluation des DMS par le CODIMS.

Resume L’evaluation des technologies de sante (ETS) est en pleine evolution et l’interet de prendre en compte des domaines non cliniques est croissant. Si l’aspect medico-economique est communement reconnu, l’evaluation de l’impact organisationnel n’a pas ete autant etudiee. L’objet de ce travail etait de proposer une definition de l’impact organisationnel dans le secteur du dispositif, d’en delimiter les contours et d’explorer les methodes d’evaluation propres a ce domaine. Apres une analyse de la litterature relative a l’impact des technologies sur les organisations et de la litterature medicale, ainsi qu’une revue des textes reglementaires s’y rapportant, le groupe d’experts a identifie 12 types d’impact organisationnel. Plusieurs dispositifs medicaux ont ete passes au crible de cette grille de criteres qui s’est revelee discriminante et operante. Le groupe a ensuite degage de l’analyse de la pratique et des methodes decrites, quelques lignes directrices pour mener a bien l’evaluation de l’impact organisationnel. Ce travail montre que la prise en compte de l’impact organisationnel peut s’averer essentielle en complement des autres criteres privilegies actuellement (cliniques et economiques). Reste a lui trouver une place dans la decision et qui tienne compte du principe d’economicite.

Introduction et but de l’etude Les modalites principales du traitement de cancer de prostate localise sont la radiotherapie et la chirurgie. Notre objectif etait de realiser une evaluation medicoeconomique des alternatives therapeutiques du cancer de prostate localise, a savoir la radiotherapie stereotaxique robotisee par comparaison a la prostatectomie totale robot-assistee, afin d’estimer l’impact sur la qualite de vie du patient et fournir un outil d’aide pour les decideurs en sante. Materiel et methodes L’analyse cout–efficacite en perspective societale a compare ces deux alternatives therapeutiques, en integrant des informations issues de sources bibliographiques multiples pour estimer les couts et les resultats attendus avec des donnees dispersees entre plusieurs etudes. Le modele de Markov a quatre etats a ete modelise sur un horizon temporel de dix ans avec le logiciel TreeAge Pro version 2019. La population d’analyse correspondait aux patients atteints de cancer de la prostate localise a bas risque selon la classification de D’Amico et pour lesquels la decision therapeutique etait l’intervention robot-assistee. Resultats et analyse statistique Nous avons constate une difference de cout (2079€) et d’utilite (0,653 quality-adjusted life year [QALY]) sur 10 ans correspondant a un ratio differentiel couts–resultats de 3184€/QALY. Selon l’analyse de sensibilite probabiliste de Monte-Carlo, la dispersion des 1000 iterations de ratio differentiel couts–resultats est faible. La conclusion selon laquelle la radiotherapie stereotaxique robotisee est plus chere et plus efficace que la prostatectomie totale robot-assistee est donc robuste dans notre scenario. Selon l’analyse de sensibilite unifactorielle, les parametres ayant le plus d’impact sur le modele sont les couts de l’etat initial quelle que soit l’intervention choisie. Enfin, la courbe d’acceptabilite met en evidence qu’a partir du seuil de 3184€ sur 10 ans (correspondant a une « volonte de payer » du decideur financier), la strategie de la radiotherapie stereotaxique robotisee en perspective societale devient efficace en termes de couts par rapport a la strategie de prostatectomie totale dans notre modele. Conclusion Cette evaluation medicoeconomique des strategies therapeutiques comparant la radiotherapie stereotaxique robotisee et la prostatectomie totale robot assistee est un travail preliminaire d’analyse et d’evaluation de technologies de sante utilisees dans le traitement du cancer de la prostate en France. Elle suggere que la radiotherapie stereotaxique robotisee peut etre une technique efficace en termes de cout par rapport a la prostatectomie totale robot assistee, malgre des couts initiaux legerement plus eleves de la radiotherapie.

The objective of the present work was to assess the level of evidence in economic evaluations of percutaneous left atrial appendage closure devices, and to test the complementarity of three different tools for assessing the quality of economic evaluations. We conducted a systematic review of articles in English or French listed in MEDLINE, Embase, Cochrane, the Cost-Effectiveness Analysis registry and the National Health Service Economic Evaluation Database. We included only economic evaluations concerning left atrial appendage closure devices. Data were extracted from articles by two authors working independently and using three analysis grids to measure the quality of economic evaluations [the British Medical Journal (BMJ) checklist, the hierarchy scale developed by Cooper et al. (J Health Serv Res Policy 10:245–50, 2005) and the Quality of Health Economic Studies (QHES) instrument]. Seven economic evaluations met our inclusion criteria. All were published between 2013 and 2016. All were cost-utility analyses, and fully complied with the BMJ checklist. According to the hierarchy scale developed by Cooper et al., the quality of data used was heterogeneous. Finally, the mean score for the seven economic studies was 90/100 with the QHES instrument. Despite the recent development of left atrial appendage closure devices, most economic evaluations conducted here were well-designed studies. Furthermore, different tools used to assess the quality of these studies were complementary, but none gave a global vision of the quality of economic studies.

International audience

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.

Objectives The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. Study Design and Setting A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Results Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. Conclusion To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.

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.

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.

International audience; Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational.

Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.

Rationaleaims and objectives Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA. Methods We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale. Results We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1–2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device. Conclusions Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the ‘gold standard’ for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations.

International audience; Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.

International audience; 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.

Hospital-based health technology assessment is aimed at improving decision-making regarding investments for new health technologies in hospitals. In the worldwide context of budget constraints, HB-HTA is gaining momentum as a tool considered interprofessional and favoring evidence-based managerial decisions. The acknowledged limitations of the regional-/national-level HTA processes in terms of scope, complexity, cost, and timeliness reinforce this recent trend.

Resume Introduction Avec la mise en œuvre du contrat de bon usage dans les etablissements de sante, la prescription medicale dediee aux dispositifs medicaux (DM), par analogie aux medicaments, pourrait permettre de securiser et de garantir leur bon usage. Materiel et methode Nous avons cherche a mettre en place une prescription informatisee en nous appuyant sur deux exemples de DM aux caracteristiques distinctes : la therapie des plaies par pression negative (TPN) et les endoprotheses coronaires a liberation de principe actif. Resultats En partenariat avec les equipes medicales, nous avons elabore un protocole informatise integrant l’ensemble des informations indispensables a la bonne utilisation de la TPN. Pour les endoprotheses coronaires a liberation de principe actif, nous nous sommes bases sur un questionnaire informatique preexistant que nous avons optimise afin que les informations portant sur le prescripteur, le patient, les caracteristiques de la lesion, le type de stents et surtout l’indication soient mentionnees. Discussion et conclusion La prescription informatisee de DM potentiellement a risque comme la TPN apparait etre premierement, un support interessant pour la planification et la mise en œuvre des soins, deuxiemement, un element cle du dossier patient. Pour les dispositifs medicaux implantables (DMI) hors groupe homogene de sejour (GHS), tels que les endoprotheses coronaires a liberation de principe actif, la prescription nominative, meme a posteriori de l’implantation, apparait desormais comme incontournable pour suivre les indications en vue de leur remboursement. Enfin, a travers cette nouvelle approche, les pharmaciens hospitaliers responsables des DM introduisent une nouvelle activite de pharmacie clinique.

International audience; To conduct a risk analysis of the negative pressure wound therapy (NPWT) care process and to improve the safety of NPWT, a working group of nurses, hospital pharmacists, physicians and hospital managers performed a risk analysis for the process of NPWT care. The failure modes, effects and criticality analysis (FMECA) method was used for this analysis. Failure modes and their consequences were defined and classified as a function of their criticality to identify priority actions for improvement. By contrast to classical FMECA, the criticality index (CI) of each consequence was calculated by multiplying occurrence, severity and detection scores. We identified 13 failure modes, leading to 20 different consequences. The CI of consequences was initially 712, falling to 357 after corrective measures were implemented. The major improvements proposed included the establishment of 6-monthly training cycles for nurses, physicians and surgeons and the introduction of computerised prescription for NPWT. The FMECA method also made it possible to prioritise actions as a function of the criticality ranking of consequences and was easily understood and used by the working group. This study is, to our knowledge, the first to use the FMECA method to improve the safety of NPWT.

International audience; We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers.

Rationale Due to the increase of new cancer cases, our chemotherapy compounding unit must face with ever-growing production needs. To support this increasing workload, we decided to anticipate the preparation of several anti-cancer drugs. Aims and objectives To help us in the decision making, we needed a modern tool able to combine several criteria for selecting appropriate medications for an anticipated preparation. The aim of this study was to assess the decision-making software, FabAct® (Version 1.0). Methods FabAct® ranked all of the anti-cancer drugs used in our chemotherapy compounding unit according to price, chemical stability, compounding difficulties, dosage and production per year. Then, we started to anticipate currently the preparation of four medications and conducted a follow-up of destroyed preparations between January and May 2007. We tried to identify the destruction causes and calculated the time saved for the patients and for the pharmacy technicians. Results According to the decision-making software, the first four drugs for an anticipated preparation were: fluorouracil, cisplatin, carboplatin and paclitaxel. A total of 3913 (50.2%) anticipated preparations were performed and among those, 470 (12%) were destroyed. The main cause of destruction was due to the preparation expiration. Finally, the mean waiting time per patient was reduced from 118 minutes to 68 minutes after the application of the anticipated model. Conclusion According to this 5-month follow-up, FabAct® helped us to select appropriate anti-cancer drugs to anticipate the compounding. Most of the anticipated preparations were administrated to patients and the patient waiting time was significantly reduced.