Reflector-guided localization compared with wire-guided localization for non-palpable breast cancer resection: organizational impacts and costs analysis.

Background: Wire-guided localization (WGL) for non-palpable breast cancer lesions has drawbacks like wire migration, localization difficulties, and logistical challenges. Wireless methods, such as reflector-guided localization (RGL), address these issues and are compatible with breast MRI. This study evaluates the organizational and cost impacts of RGL compared to WGL.

Organizational and budget impact model (OBIM) of SAME a new autotransfusion medical device.

Objectives: This study aimed to assess the budget and organizational impact of progressively replacing the intraoperative cell salvage centrifugation-based systems currently installed in French hospitals with the SAME system, a new autotransfusion medical device.

Methods: An Organizational and Budget Impact Model (OBIM) was developed based on two methodological guidelines issued by the French Health Authority (Haute Autorité de Santé, HAS). The OBIM was also developed based on a pragmatic literature review, hospital data and hospital pharmacists' expertise.

Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022).

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies.

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.

Background: Artificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking.

Objective: This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices.

Overcoming Barriers in Hospital-Based Health Technology Assessment (HB-HTA): International Expert Panel Consensus.

The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis.

Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.

Background: An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs.

Objective: This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients.

Methods: The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022.

Costs analysis of cochlear implantation in children.

Objectives: The study assessed the direct medical costs of the cochlear implantation pathway from the healthcare payer's perspective, in children with bilateral severe to profound hearing loss, from diagnosis to 3 years' follow-up after first implantation. We also compared costs between two populations: congenital and progressive deafness.

Material And Methods: A retrospective costs analysis was performed for 56 children who received a cochlear implant in one French pediatric ENT center.

Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

Purpose: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA).

Materials And Methods: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092).

Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France.

Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization.

Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use.

Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review.

Introduction: Artificial Intelligence-based Medical Devices (AI-based MDs) are experiencing exponential growth in healthcare. This study aimed to investigate whether current studies assessing AI contain the information required for health technology assessment (HTA) by HTA bodies.

Methods: We conducted a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology to extract articles published between 2016 and 2021 related to the assessment of AI-based MDs.

Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study.

Background: Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter.

Robot-Assisted Surgery vs Robotic Stereotactic Body Radiotherapy in Prostate Cancer: A Cost-Utility Analysis.

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.

[Digital therapeutics: Which barriers for market access?].

Integrated to the e-health field, digital therapeutics can be defined as "software, combined or not to a device, in the purpose of prevention, treatment or monitoring of a disease, participating actively in a mechanism of action and based on strong clinical evidence". The aim of this work was to assess the level of digital therapeutics clinical validation and to reflect on their business model. A qualitative study has been conducted and different health actors have been interviewed.

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review.

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 databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD.

Quality of economic evaluations of ventricular assist devices: A systematic review.

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.

Evaluation of 3D printing costs in surgery: a systematic review.

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 costs associated with its use and highlight the first quantitative data available.

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review.

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 quality of information reported about the learning curve.

Materials And Methods: A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database.

[Not Available].

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.