Nicolas Martelli

Nicolas Martelli
Hôpital Européen Georges-Pompidou (Hôpitaux Universitaires Paris-Ouest) · Service de Pharmacie

PharmD ; PhD

About

79
Publications
13,959
Reads
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890
Citations
Additional affiliations
September 2018 - present
Université Paris-Saclay
Position
  • Professor (Associate)
February 2015 - present
Université Paris-Sud 11
Position
  • Professor (Assistant)
Description
  • Groupe de Recherche et d'Accueil en Droit et Economie de la Santé
February 2015 - August 2018
Université Paris-Sud 11
Position
  • Professor (Assistant)
Education
September 2012 - January 2015
Université Paris-Sud 11
Field of study
  • Economics
November 2003 - May 2007
Université de Montpellier
Field of study
  • Pharmacy
September 1998 - October 2003
Paris Descartes, CPSC
Field of study
  • Pharmacy

Publications

Publications (79)
Article
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 1...
Article
Full-text available
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....
Preprint
Full-text available
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 via...
Article
Objective: We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings. Methods: A systematic review was performed using four electronic dat...
Article
Objectifs Plusieurs études ont déjà porté sur l’intérêt de l’urétéroscope souple à usage unique (URSUU) par rapport aux urétéroscopes réutilisables (URSUM). Afin de prendre en compte l’ensemble des données « en vie réelle » et déterminer la place d’une technique par rapport à l’autre, une évaluation économique comparative doit être menée mais égale...
Article
Objectifs La transplantation rénale est à l’heure actuelle le seul traitement curatif de l’insuffisance rénale chronique à un stade terminal. Dans la plupart des centres, une sonde double J (JJ) est mise en place en fin d’intervention pour prévenir le risque de fistule urinaire. Le but de notre étude a été d’évaluer les impacts liés à l’utilisation...
Article
Introduction et but de l’étude Les modalités principales du traitement de cancer de prostate localisé sont la radiothérapie et la chirurgie. Notre objectif était de réaliser une évaluation médicoéconomique des alternatives thérapeutiques du cancer de prostate localisé, à savoir la radiothérapie stéréotaxique robotisée par comparaison à la prostatec...
Article
Full-text available
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 wh...
Article
Objective Because 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 presen...
Article
Objectives The 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 co...
Article
Background Transcatheter 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...
Article
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 acce...
Article
Résumé La question de l’accès précoce des patients aux technologies de santé innovantes se pose dès lors que l’on considère qu’à partir d’un certain niveau présumé d’efficacité ou d’efficience, attendre une prise en charge de droit commun constituerait une perte de chance pour les patients ou pour la collectivité. C’est sur ce postulat que la table...
Article
Résumé Introduction Le Comité des dispositifs médicaux stériles (CODIMS) de l’Assistance publique–hôpitaux de Paris (AP–HP) évalue les dispositifs médicaux stériles (DMS) innovants en vue de leur référencement à l’AP–HP. Ces mêmes DMS peuvent avoir fait l’objet ou non d’une évaluation au plan national par la Commission nationale d’évaluation des d...
Article
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 reconstru...
Article
Introduction 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. Materials and Methods In this paper, we describe the major transformation that the MDR brings t...
Article
Objectives 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. Methods We conducted a systematic review of articles in English or French listed...
Article
Full-text available
Résumé Le terme « recherche clinique » désigne toute recherche menée sur l’homme en vue du développement des connaissances biologiques ou médicales. Applicable depuis novembre 2016, la loi Jardé a redéfini les contours de la recherche clinique en France. Le changement le plus notable est qu’on ne parle plus de recherche biomédicale mais de « recher...
Article
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...
Article
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...
Article
Objective The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices and to identify reporting guidelines which include these items. Study design and setting A panel of experts identified the most relevant items for evaluating implantable medical devices from an initial list based on referenc...
Article
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 wit...
Article
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...
Article
Health technology assessment (HTA) is largely used to manage the introduction and diffusion of new health technologies. To help hospital decision-makers, several approaches of hospital-based HTA (HB-HTA) have emerged worldwide. The aim of this article was to present the different models of HB-HTA. Four models have been conceptualized: "ambassador"...
Article
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 inter...
Article
L’évaluation des technologies de santé (ETS) en milieu hospitalier est une aide à la décision pour l’intégration de produits de santé à la structure hospitalière. Appliquée aux dispositifs médicaux, elle permet d’appréhender plusieurs aspects pertinents pour ces produits de santé, autres que purement cliniques, et qui intéressent à la fois les auto...
Article
Introduction: The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level...
Article
Background: At the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a not...
Article
Full-text available
Background: Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and disadvantages of 3D printing applied in surgery. Methods: We conducted a systematic review of articles on 3D printing applications in surgery published between 2005 a...
Chapter
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 regi...
Article
Full-text available
Context: Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty. Objective: To assess the level of evidence provided by the available economi...
Data
Hierarchy scale for data sources in economic evaluations from Cooper et al. (DOCX)
Article
Background: Cancer patients represent an at-risk population for Venous Thromboembolic Events (VTE). Following a previous study on two localizations, we intended to determine the incidence and recurrence rate of VTE in breast cancer (BC), colon cancer (CC), lung cancer (LC) and prostate cancer (PC), four of the most frequent cancers in France. We ev...
Article
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 in...
Article
Methods: The French national hospital database (PMSI) and the disease-specific ICD-10 codes were used to identify BC, CC, LC or PC patients diagnosed in 2010 who were hospitalized with a VTE during the following two years. We selected stays during which a VTE occurred but was not the main reason of hospitalization (cancer was classified as primary...
Article
Methods: We used the French national hospital database (PMSI) to select new patients with BC, CC, LC or PC in 2010, who had at least one VTE-related hospitalization during the following two years. VTE-related stays and patients were identified using the disease-specific ICD-10 codes. Hospital costs were calculated over stays for which VTE was cons...
Article
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 (phy...
Article
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 a...
Article
Full-text available
The aim of the present study was to determine the number of admissions and the cost of hospital management of venous thromboembolism (VTE) events occurring in patients with breast cancer (BC) or prostate cancer (PC). The French national hospital database (PMSI) was analyzed to identify patients diagnosed with BC or PC in 2010 and followed for 2 yea...
Article
Full-text available
Innovative medical devices offer solutions to medical problems. However, medical devices arriving on the European market have generally little evidence about efficiency. To manage the uncertainty surrounding the introduction of innovative medical devices, hospitals and university hospitals have developed worldwide hospital-based health technology a...
Article
Background: Venous Thromboembolic Event (VTE) is a common complication for cancer patients, leading to hospitalizations that increase the burden of cancer management. We evaluated the incidence and costs of VTE-related hospitalizations for patients with colon cancer (CC) or lung cancer (LC). Methods: The French national hospital database (PMSI) was...
Article
Background: Cancer patients represent an at-risk population for Venous Thromboembolic Events (VTE). We intended to determine the incidence and recurrence rate of VTE in breast cancer (BC) and prostate cancer (PC) French patients, to evaluate their impacts on the number and the duration of hospitalizations and to calculate their additional cost for...
Article
192 Background: Venous thromboembolic event (VTE) is a common complication for cancer patients, leading to hospitalizations that increase the burden of cancer management. We evaluated the incidence and costs of VTE-related hospitalizations for patients with breast or prostate cancer, two of the most frequent cancers in France. Methods: We used the...
Conference Paper
Aim: Venous thromboembolic event (VTE) is a common complication for cancer patients, leading to hospitalizations that increase the burden of cancer management. We evaluated the incidence and costs of VTE-related hospitalizations for patients with breast cancer (BC) or prostate cancer (PC), two of the most frequent cancers in France. Methods: We use...
Article
Full-text available
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 regulat...
Article
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....
Article
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 pu...
Article
Rationale, aims 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 t...
Article
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....
Article
Related to the good practice contract implemented in hospitals, the prescription dedicated to medical devices, such as pharmaceuticals, could promote safety and good practice. We attempted to implement a computerized prescription for medical devices. In order to illustrate the method, two examples were selected: the Negative Pressure Wound Therapy...
Article
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 analys...
Article
Full-text available
In industrialized countries, acute lymphoblastic leukaemia (ALL) is the most frequent cancer in children aged less than 15 years. High-dose methotrexate is a common component of many chemotherapeutic protocols for childhood with ALL. Our objective was to retrospectively evaluate the pharmacokinetics and plasma levels of high-dose methotrexate as it...
Article
In order to improve its quality-assurance programme based on ISO 9001, the Central Sterile Supply Department of a public university hospital has performed a prospective risk analysis using the Preliminary Risk Analysis method (PRA). The objectives were the achievement of a global risk mapping related to the whole process of sterilising medical devi...
Article
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. To help us in the decision making, we needed a modern tool able to combine several criteria for selecting appropriate med...
Article
This paper focuses on the application of the analytical hierarchy process (AHP) technique in the context of production and distribution of anti cancer drugs within the pharmacy department of a French hospital. This is achieved by evaluating how AHP can support the drug production planning process which aims at minimizing the cost associated with th...
Article
Full-text available
To apply the Hazard analysis and Critical Control Points method to the preparation of anti-cancer drugs. To identify critical control points in our cancer chemotherapy process and to propose control measures and corrective actions to manage these processes. The Hazard Analysis and Critical Control Points application began in January 2004 in our cen...