Publications by authors named "Pouvourville G"

Introduction: Treatment landscape in metastatic lung cancer has progressed quickly over the last decade, mainly due to immunotherapies and targeted therapies. This study aimed to describe change in epidemiological data of patients with metastatic lung cancer.

Methods: A cohort of patients identified between 2013 and 2021 with lung cancer and a marker of metastases (ICD-10 code or reimbursement for Bevacizumab or Pemetrexed) was built from the French claims database.

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Purpose: This study aimed to document utility values and the Visual Analog Scale (VAS) with the 5-level version of the EQ-5D questionnaire in a large sample of patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC).

Methods: QALY-MICI was a cross-sectional survey across three sources in France. Data were collected between 2019 and 2022 for patients 18 and over.

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Background: This study aimed to describe treatment patterns in patients with myasthenia gravis (MG) in France.

Methods: A retrospective cohort analysis was performed using the French National Health Data System (SNDS) database between 2008 and 2019. MG patients were identified using ICD-10 codes during hospitalization and/or long-term disease.

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Article Synopsis
  • The study aims to create standardized methodologies and processes for vaccine appraisal in the EU to improve decision-making in health technology assessment (HTA).
  • Researchers identified significant differences in vaccine evaluation practices across EU member states through literature reviews and expert consultations, leading to the development of three guiding principles.
  • The principles emphasize the need for better terminology, inclusive appraisal processes, and improved real-world data collection to support consistent and timely access to vaccines in the EU.
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Background: Ibrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life.

Methods: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS).

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  • Remote patient monitoring (RPM) in cancer care improves quality of life, survival rates, and reduces medical resource use, prompting a budget impact analysis of a nurse navigator-led RPM program based on the CAPRI trial in France.
  • Data from 559 cancer patients indicated that the RPM program saved €377 per patient from the French national health insurance perspective and €504 from an all-payers perspective over an average follow-up of 4.58 months, primarily due to fewer hospitalizations.
  • The findings suggest significant cost savings associated with the CAPRI RPM program, underlining the economic benefits of RPM in cancer care, while further research is needed to evaluate long-term cost-effectiveness and real-world scalability.
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Glycemic management in people with type 2 diabetes mellitus (T2DM) on insulin-secretagogue regimens without insulin is of importance, as this group still represents a significant proportion of patients. Risks for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) or hypoglycemia, using insulin-secretagogue drugs are well established. Few studies have suggested that continuous glucose monitoring (CGM) could be useful for monitoring glucose dynamics associated with the use of such therapies.

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Background: The French cancer control strategy 2021-2030 aims to achieve 80 % human papillomavirus (HPV) vaccination coverage. Since 2021, HPV vaccination is also recommended for boys aged 11-14 years, with a catch-up vaccination recommended for unvaccinated adolescents aged ≤19 years. The PAPILLON study used claims data to monitor the evolution of HPV Vaccination Coverage Rate (VCR) in the French population.

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Background And Objectives: In France, meningococcal serogroup B (MenB) is the most common serogroup causing invasive meningococcal disease (IMD) in infants and young children. Our objective was to illustrate the impact of model choices on health outcomes and the cost-effectiveness of infant vaccination with the multicomponent meningococcal serogroup B vaccine (4CMenB) versus no vaccine in France.

Methods: A previously published dynamic transmission-based cost-effectiveness model was adapted for the French context using updated, French-specific demographic, epidemiological, and cost data.

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Background: GPP is a rare, chronic, neutrophilic skin disease, with limited real-world data characterizing patients with flares and the impact of flares on disease progression and morbidity.

Objective: Describe the clinical characteristics of patients with GPP, comorbidities, disease epidemiology and frequency and severity of flares, and compare patients with GPP with a matched severe psoriasis population.

Methods: In this population-based real-world cohort study an algorithm was developed to identify patients with GPP flares.

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Objectives: To assess the accuracy and validity of the Determination of Diabetes Utilities, Costs, and Effects (DEDUCE) model, a Microsoft-Excel-based tool for evaluating diabetes interventions for type 1 and type 2 diabetes.

Methods: The DEDUCE model is a patient-level microsimulation, with complications predicted based on the Sheffield and Risk Equations for Complications Of type 2 diabetes models for type 1 and type 2 diabetes, respectively. For this tool to be useful, it must be validated to ensure that its complication predictions are accurate.

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Background: Respiratory syncytial virus (RSV) causes lower respiratory tract infections (LRTI) that may lead to hospitalization or death. The present study aimed to assess the burden of RSV infections in hospitalized adults.

Methods: RSV-related hospitalizations were identified from the nationwide hospital claims database in France (PMSI) from 2012 to 2021 using ICD-10 codes J12.

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Background: The objectives of this observational study were to report the incidence and prevalence of myasthenia gravis (MG) in France, describe patients' characteristics and treatment patterns, and estimate mortality.

Methods: A historical cohort analysis was performed using the French National Health Data System (SNDS) database between 2008 and 2020. Patients with MG were identified based on ICD-10 codes during hospitalization and/or long-term disease (ALD) status, which leads to a 100% reimbursement for healthcare expenses related to MG.

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Introduction: Gliflozins have historically been indicated for type 2 diabetes in France. However, their efficacy has recently been demonstrated in heart failure and chronic kidney disease (CKD), with positive recommendations by Haute Autorité de Santé for gliflozin therapies in these indications. The study objective was to investigate the 5-year budget impact associated with the introduction of gliflozins in addition to standard therapy in people with CKD and elevated albuminuria, regardless of diabetes status, from the perspective of the French healthcare system.

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Article Synopsis
  • - The research aimed to understand the evidence needed for assessing the clinical and cost-effectiveness of cell and gene therapies and how these are recognized in health technology assessments (HTA) processes.
  • - A literature review analyzed 46 HTA reports on 9 products in various jurisdictions, revealing positive reactions to evidence related to rare diseases, substantial health gains, and alternative payment models; while they were critical of unvalidated endpoints, inadequate trial reporting, and uncertainty in economic estimates.
  • - The findings indicate that HTA bodies have inconsistent approaches to evaluating cell and gene therapies, suggesting improvements in decision-making and additional analyses to better handle the complexities these therapies present.
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Older people with type 2 diabetes (T2DM) on insulin are at increased risk of hypoglycemia and associated morbidity. Management of T2DM in older people must optimize glycemic control, while minimizing risks for hypoglycemia and diabetic ketoacidosis (DKA). In France, the FreeStyle Libre (FSL) system has been reimbursed since June 2017 for T2DM on intensive insulin therapy.

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  • - The study focuses on the challenges of funding and patient access to combinations of on-patent therapies (CTs) in oncology, especially when they come from different manufacturers.
  • - Through literature review and interviews with experts across seven European countries, seven policy proposals were developed, emphasizing the necessity for coordinated approaches to affordability and funding.
  • - Key findings suggest that while major changes to health technology assessments may be unlikely, establishing bilateral discussions between manufacturers and payers and using usage-specific pricing strategies could improve the financial management of CTs across different countries.
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Objectives: Real-world data (RWD) and real-world evidence (RWE) can provide extensive information on healthcare for use in health technology assessment and decision making. Nevertheless, there is a lack of consensus surrounding the appropriate data governance (DG) practices for RWD/RWE. Data sharing is also a large concern, especially considering evolving data protection regulations.

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Objectives: This study aimed to describe the role of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) in 5 European countries and to identify the hurdles to the acceptance of RWE and suggest directions toward its more effective use.

Methods: Authors from France, Germany, Italy, and Sweden used a common template to extract evidence. For England, the Cancer Drugs Fund was described and analyzed as a particular model for the use of RWD to provide evidence for coverage decisions and managed entry agreements.

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Article Synopsis
  • There has been an increasing demand for real-world evidence (RWE) and data (RWD) in the last decade, aiming to expedite the approval of effective medications for patients, especially in regulatory settings.
  • However, RWE is often met with skepticism by reimbursement agencies, leading to inconsistent acceptance across different regions and hindering its optimal use despite extensive research on its principles.
  • The article proposes creating a repository to document the use of RWD for funding decisions and introduces a structured classification (taxonomy) to help evaluate evidence quality, while also recommending international standards for RWD governance.
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This is one of a series of articles that consider the barriers to optimal use of real-world evidence (RWE) in health technology assessment and how to overcome them. The work was performed as part of EUreccA 2025, in particular with the RWE workstream embodied within that collaboration. Elsewhere in this issue we described the reasoning and process that led us to develop practical tools to support RWE use, including this taxonomy and explained the methods used to do so.

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Article Synopsis
  • * The RWE workstream identifies issues with the inconsistent acceptance of RWE by HTA agencies and payers, which affects the speed and cost of pharmaceutical access for patients.
  • * The article discusses the methodology used to explore these challenges, highlighting four key topics to tackle barriers and proposing strategies through literature reviews, stakeholder engagement, and case studies.
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Purpose: To provide EuroQoL EQ-5D-5L French population norms based on a sample of 15,000 responders.

Methods: Based on the National Health and Wellness Survey, an international, annual, selfadministered Internet-based survey, this study extracted data from France for 2018 involving a sample of 15,000 respondents stratified by age and gender. Responses to the EQ-5D-5L questionnaire and the Visual Analog Scale (VAS) score, together with sociodemographic, health behavior, and disease status variables were collected.

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Article Synopsis
  • * A review was conducted on HPV-related data systems from seven high-income countries (Australia, Canada, France, Italy, Scotland, Sweden, and the US), highlighting various strategies in vaccination and screening programs, as well as differences in data collection methods.
  • * The review reveals challenges in comprehensively monitoring global elimination efforts and offers insights into the strengths and weaknesses of current data systems, which could enhance existing and future cervical cancer prevention initiatives.
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Article Synopsis
  • - The significance of real-world data (RWD) in health technology assessments is increasing, as advancements in connected devices and data collection methods allow for better insights into treatment effects, potentially surpassing traditional clinical trial data in relevance.
  • - A round table of experts aimed to clarify the current role of RWD by identifying its main purposes, evaluation timing, and the stakeholders involved in RWD studies.
  • - The discussion concluded with six recommendations to enhance the application of RWD in health technology assessment and decision-making processes.
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