Presse Medicale最新文献_第5页

Taking ethics into account: the HAS perspective 考虑伦理：HAS视角

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-07 DOI: 10.1016/j.lpm.2025.104283

Maxence Lyonnet , Robert Gelli , Hubert Galmiche

{"title":"Taking ethics into account: the HAS perspective","authors":"Maxence Lyonnet , Robert Gelli , Hubert Galmiche","doi":"10.1016/j.lpm.2025.104283","DOIUrl":"10.1016/j.lpm.2025.104283","url":null,"abstract":"<div><div>The HAS is unique in France due to its status as an independent public authority. Its closest equivalent is the National Institute for Health and Care Excellence (NICE) in England and Wales. It stands out from other French health agencies by its independence and wide scope, covering health and the social and medico-social sectors. Its independence, guaranteed by law, is combined with regular dialogue with public authorities and external partners. Independence does not come without accountability; it must report its actions to the state and its control bodies (Parliament ant Justice in particular) and more broadly to society and health actors. Scientific rigor, independence, and transparency are at the heart of its values. The 2011 health law, adopted following the French Mediator scandal, established a common legal framework for preventing conflicts of interest in health. The has also developed its own complementary prevention tools. It ensures that the composition of its expert committees balances different schools of thought. In terms of transparency, the HAS publishes all its opinions and decisions, as well as methodological and practical guides. In a demanding context where scientific expertise is particularly scrutinized and the risk of a health crisis, such as Covid-19, is imminent, the HAS must maintain the highest standards of conflict of interest prevention and transparency. This is essential for the quality of expertise and public trust.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104283"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation 欧洲卫生技术评估：组织比较和欧洲法规介绍

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-07 DOI: 10.1016/j.lpm.2025.104282

Judith Fernandez, Paul de Boissieu, Margaret Galbraith

{"title":"Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation","authors":"Judith Fernandez, Paul de Boissieu, Margaret Galbraith","doi":"10.1016/j.lpm.2025.104282","DOIUrl":"10.1016/j.lpm.2025.104282","url":null,"abstract":"<div><div>Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, social, economic, legal, and ethical aspects of health technologies to determine their value throughout their lifecycle. With rising healthcare costs in Europe, robust HTA processes are crucial for making informed decisions that promote an equitable and efficient health system. HTA practices date back to 1967 in France and have expanded across Europe, with most countries adopting HTA models to guide pricing and reimbursement decisions. An analysis of European Health Technology Assessment bodies (HTAb) was conducted through an online survey to showcase the diversity of HTA systems while highlighting their shared goals. The survey, sent to 33 HTAb from July 8 to August 25, 2024, included 11 multiple-choice questions about their organization and processes, allowing for optional free text responses. Data collected were self-reported and analysed using descriptive statistics, with minimal verification of responses. Despite some differences in remit and scope, European HTAb remain steadfast in their resolve to collaborate. The European Commission and EU member states have fostered collaboration among HTA bodies through initiatives like EUnetHTA, culminating in the adoption of the HTA Regulation (EU) 2021/2282, which will be implemented starting January 12, 2025 with the production on joint clinical assessment and joint scientific consultation for some medicinal products and high-risk medical devices. The HTAR offers numerous opportunities for collaboration. Joint productions will foster a culture of mutual learning, allowing countries to benefit from shared expertise and data while ensuring the rigorous and transparent assessment of new health technologies. Moreover, a more unified approach to HTA could accelerate the adoption of new and effective technologies at the continental level, ultimately improving patient outcomes across Europe.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104282"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143942793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The French way of HTA: Between scientific rigor, independence and transparency 法国的HTA方式：在科学严谨、独立和透明之间。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-05 DOI: 10.1016/j.lpm.2025.104281

Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia

{"title":"The French way of HTA: Between scientific rigor, independence and transparency","authors":"Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia","doi":"10.1016/j.lpm.2025.104281","DOIUrl":"10.1016/j.lpm.2025.104281","url":null,"abstract":"<div><h3>Context</h3><div>The Haute Autorité de Santé (HAS) is an independent body responsible for advising the government on the appropriateness of national funding for healthcare technologies and interventions. To fulfil this role, HAS evaluates their efficacy and safety, especially in comparison to existing alternatives.</div></div><div><h3>Methods</h3><div>We first described how the HAS is organised to carry out this mission, then outlined the different stages of the evaluation process, highlighting specific features according to the type of health technology being assessed We also reviewed the HAS's activities for 2023.</div></div><div><h3>Results</h3><div>The HAS relies on international methodological standards to assess health technologies and interventions, on the expertise of healthcare professionals and patient experiences, and input from various stakeholders where appropriate and necessary.</div></div><div><h3>Conclusion</h3><div>Through this rigorous, independent, and transparent scientific evaluation process, the HAS aims to ensure that patients have access to the best available treatments and care, and, when relevant, to the most efficient options for the French healthcare system, while guaranteeing patient safety.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104281"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Health technology assessment in France 法国的卫生技术评估

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-08 DOI: 10.1016/j.lpm.2025.104278

Lionel Collet , Pierre Cochat

引用次数: 0

French HTA and appropriateness of care: Beyond reimbursement 法国的 HTA 和护理的适当性：超越报销。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-05 DOI: 10.1016/j.lpm.2025.104280

Sophie Blanchard , Valérie Lindecker-Cournil , Bertrand Mussetta , Fréderic Nahmias , Cédric Carbonneil

{"title":"French HTA and appropriateness of care: Beyond reimbursement","authors":"Sophie Blanchard , Valérie Lindecker-Cournil , Bertrand Mussetta , Fréderic Nahmias , Cédric Carbonneil","doi":"10.1016/j.lpm.2025.104280","DOIUrl":"10.1016/j.lpm.2025.104280","url":null,"abstract":"<div><div>Heath Technology Assessment (HTA) is mainly used for reimbursement/disinvestment and access to innovation purposes. In addition, HTA is a useful tool to promote appropriateness of care, as it describes the updated level of validation of assessed health technologies. Thus, several tools (proper use sheets, drug-indexed decision support systems, supervision of practices or use) based on HTA are developed to promote the appropriateness of use of drugs, medical devices or diagnostic and therapeutic procedures among healthcare professionals.</div><div>HTA can also support the development and the update of clinical practice guidelines (CPG) which are the main tool of clinical practice improvement. In addition, HTA can increase CPG implementation through reimbursement of recommended health technologies. Therefore, HTA and CPGs can be perfectly articulated to enable synergistic synchronic or asynchronic action to improve the relevance of care by enabling more dynamic and efficient actions, particularly in terms of robustness and updating.</div><div>However, HTA shares with CPGs the same difficulties of implementation in the field. To face them, whatever the implementation strategy defined, it requires a multifaceted approach involving iterative communication and the involvement of healthcare professionals, patients and stakeholders, both upstream and downstream of the HTA stages.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104280"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

French reimbursement of health technologies: assessment is at the heart of the procedure 法国对保健技术的报销：评估是这一程序的核心

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-06-01 Epub Date: 2025-04-09 DOI: 10.1016/j.lpm.2025.104279

Cédric Carbonneil , Corinne Collignon , Hubert Galmiche , Andrea Lasserre , Charlotte Masia , Floriane Pelon

{"title":"French reimbursement of health technologies: assessment is at the heart of the procedure","authors":"Cédric Carbonneil , Corinne Collignon , Hubert Galmiche , Andrea Lasserre , Charlotte Masia , Floriane Pelon","doi":"10.1016/j.lpm.2025.104279","DOIUrl":"10.1016/j.lpm.2025.104279","url":null,"abstract":"<div><h3>Background</h3><div>In France, health technologies can be reimbursed by the national health insurance system. However, not all are eligible, and several steps are required. This article aims at deciphering the various procedures involved.</div></div><div><h3>Methods</h3><div>We first described the most common steps for reimbursement procedures, from authorisation to health technology assessment, including clinical evaluation and reimbursement decision. We then discussed certain specificities related to the nature of the health technologies (for example, vaccines among drugs, or digital medical devices (DMDs) among medical devices), and to the status of the procedure (derogatory vs. standard).</div></div><div><h3>Findings</h3><div>France benefits from several procedures aimed at reimbursing health products, and their number is increasing over time. They all share one common step, assessment, which is systematically performed from a clinical perspective and sometimes includes an organisational or an economic viewpoint, by a single actor: the French National Authority for Health (Haute Autorité de santé, HAS).</div></div><div><h3>Conclusion and relevance</h3><div>HAS evaluations are essential tools for informing healthcare decision-making, and ensuring that patients have access to safe, effective, and affordable treatments. The system will have to face new challenges in the coming years: the European regulation will pool certain procedural steps, there will be more self-directed DMDs on the market and new organizations set up to support innovation as well as scarce human and financial resources. Ultimately, it is all about constantly adapting to meet patients' needs, introducing new health technologies that offer added value and limited risks, while making the best possible use of available resources.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104279"},"PeriodicalIF":3.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143916741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Primary systemic amyloidosis: A brief overview 原发性系统性淀粉样变性：简要概述。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-03-01 Epub Date: 2024-12-11 DOI: 10.1016/j.lpm.2024.104267

Michael Sang Hughes, Suzanne Lentzsch

引用次数: 0

Imaging in multiple myeloma 多发性骨髓瘤的影像学表现。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-03-01 Epub Date: 2024-12-09 DOI: 10.1016/j.lpm.2024.104263

Jas Virk , Jens Hillengass

{"title":"Imaging in multiple myeloma","authors":"Jas Virk , Jens Hillengass","doi":"10.1016/j.lpm.2024.104263","DOIUrl":"10.1016/j.lpm.2024.104263","url":null,"abstract":"<div><div>Multiple myeloma (MM) is the second most common adult hematologic malignancy, characterized by clonal proliferation of malignant plasma cells mostly in the bone marrow. The presence of destructive changes of the mineralized bone is a hallmark feature of the condition and a sign of end-organ damage. Due to this, imaging plays an integral role in the diagnosis, prognostication, and treatment monitoring of patients undergoing therapy for MM as well as surveillance of patients with early-stage disease. While conventional radiography has traditionally been the mainstay of initial evaluation of patients suspected of having MM, the advent of more sensitive imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) have taken its place in assessing patients. While either CT alone or as part of a PET/CT examination is the initial radiographic method of choice, MRI remains the gold-standard modality in assessing bone marrow involvement, especially in early disease stages. PET/CT also provides valuable information regarding assessment of response to therapy and extramedullary manifestations of the disease. There is however increasing evidence that functional MRI techniques, albeit limitedly available, might be superior to PET/CT for treatment monitoring. This review summarizes current knowledge on the use of different imaging techniques in monoclonal plasma cell disorders and discusses future developments in this area of research.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 1","pages":"Article 104263"},"PeriodicalIF":3.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Kidney disease in multiple myeloma 多发性骨髓瘤肾病。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-03-01 Epub Date: 2024-12-09 DOI: 10.1016/j.lpm.2024.104264

Frank Bridoux , Nelson Leung , Samih H. Nasr , Arnaud Jaccard , Virginie Royal , International Kidney and Monoclonal Gammopathy Research Group

{"title":"Kidney disease in multiple myeloma","authors":"Frank Bridoux , Nelson Leung , Samih H. Nasr , Arnaud Jaccard , Virginie Royal , International Kidney and Monoclonal Gammopathy Research Group","doi":"10.1016/j.lpm.2024.104264","DOIUrl":"10.1016/j.lpm.2024.104264","url":null,"abstract":"<div><div>Renal disease is a frequent complication of symptomatic multiple myeloma, that increases morbidity and reduces quality of life and overall survival. It may result from various lesions, the most frequent being light chain cast nephropathy (LCCN), related to precipitation of monoclonal free light chains (FLC) with uromodulin in distal tubules. Rapid identification of the type of kidney disease with appropriate management is key. LCCN typically reveals the underlying myeloma and manifests with severe acute kidney injury, high serum FLC level (>500 mg/l) and predominant light chain proteinuria (urine albumin/creatinine ratio <10 %). Urgent therapy is required, based on vigorous fluid expansion, correction of precipitating factors and introduction of efficient anti-myeloma therapy which choice should consider renal elimination of each agent and patient frailty. Early and deep reduction in serum FLC level conditions renal recovery, warranting assessment of efficacy by serial serum FLC level monitoring. In newly diagnosed patients, the combination of bortezomib, high-dose dexamethasone and an anti-CD38 monoclonal antibody is commonly used. The benefit to risk balance of quadruplets incorporating cyclophosphamide or an immunodulatory agent requires to be evaluated in prospective studies. In patients with severe acute kidney injury, reinforcing chemotherapy with FLC removal through plasma exchange or high-cutoff hemodialysis may increase the probability of renal response, despite controversial data from randomized trials. Histological assessment of the extent of cast formation and interstitial fibrosis/tubular atrophy may help evaluating renal prognosis and refining therapy. Thanks to improved overall survival, renal transplantation may be considered in selected candidates with end-stage kidney disease.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 1","pages":"Article 104264"},"PeriodicalIF":3.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Patient-reported outcome measures: A key to patient-tailored and outcome-driven care in pulmonary embolism survivors 患者报告的结果测量：肺栓塞幸存者患者定制和结果驱动护理的关键。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-03-01 Epub Date: 2025-01-22 DOI: 10.1016/j.lpm.2025.104271

Sophie N.M. ter Haar , Cindy M.M. de Jong , Francis Couturaud , Thijs E. van Mens , Frederikus A. Klok

引用次数: 0