Air quality, metal(loid) sources identification and environmental assessment using (bio)monitoring in the former mining district of Salsigne (Orbiel valley, France).

The former mining district of Salsigne is situated in the Orbiel valley. Until the 20th century, it was the first gold mine in Europe and the first arsenic mine in the world. Rehabilitation has been performed during the 20 years that followed closure of the mines and factories, which led to the accumulation of storage of several million tons of waste in this valley. Nevertheless, a detailed description of the air quality of this area is still missing. The goal of the present study is to evaluate atmospheric contamination in the valley and identify the potential sources of this contamination. Active monitors (particulate matter samplers) and passive bioindicators (Tillandsia usneoides) were placed in strategic sites including remote areas. Over the year 2022, we assessed the air quality using microscopic and spectroscopic techniques, as well as environmental risk indicators to report the level of contamination. Results indicate that the overall air quality in the valley is good with PM10 levels in accordance with EU standards. Elemental concentrations in the exposed plants were lower than reported in the literature. Among the different sites studied, Nartau and La Combe du Saut, corresponding to waste storage and former mining industry sites, were the most affected. Chronic exposure over 1 year was highlighted for Fe, Ni, Cu, Pb, Sb and As. Pollution Load Index and Enrichment Factors, which provided valuable information to assess the environmental condition of the valley's air, suggested that dust and resuspension of anthropogenic materials were the principle sources for most of the elements. Finally, this study also highlights that using T. usneoides could be a convenient approach for biomonitoring of metal (loid)-rich particles in the atmosphere within a former mining area, for at least one year. These results in turn allow to better understand the effects of chronic exposure on the ecosystem.

Socioeconomic and cultural factors associated with pap smear screening among French women living in Réunion Island.

BACKGROUND: Réunion Island is a French overseas territory located in the southern Indian Ocean, with a challenging socioeconomic and multicultural context. Compared to mainland France, Réunion has an overincidence and overmortality of cervical cancer. In order to investigate these two issues, it is important to evaluate the barriers and potential levers to Pap smear screening among female inhabitants of the island. We aimed to identify the specific socio-demographic factors, cultural factors, and living conditions associated with Pap smear screening in Réunion, with a view to increasing uptake. METHODS: We conducted a Knowledge Attitude Behavior and Practices (KABP) survey on cervical cancer screening practices among women aged between 25 and 65 years old living in Réunion Island, selected using random digit dialing sampling. Data were collected using Computer Assistant Telephone Interviews. Weighted chi-squared tests and Student's t-tests were used to compare women who had up-to-date Pap smear screening with women who did not. Weighted logistic models were used to identify the factors associated with not having up-to-date screening. RESULTS: A total of 1000 women were included in the study. Of these, 88.1% had a Pap smear test during the previous three years. Factors independently associated with not being up to date were as follows: aged over 55 (AOR 2.3 [1.2-4.3]), no children (AOR 2.5 [1.4-4.3]), having free universal health coverage (AOR 1.7 [1.1-2.7]), an income per unit consumption lower than 1500€ per month (AOR 2.0 [1.1-3.7]), low health literacy (AOR 2.7 [1.7-4.1]), not consulting a general practitioner in the prior 12 months (AOR 3.6 [2.0-6.5]), and a BMI > 30 (AOR 2.6 [1.5-4.4]). CONCLUSIONS: This is the first large-scale survey focusing on recommended Pap smear screening uptake in Réunion Island. Although self-reported screening incidence was higher than in mainland France, national screening policies must take into account the island's diverse social and cultural characteristics (e.g., an ageing population, low health literacy), while implementing actions to fight against poverty and increase general access to healthcare.

Construction and preliminary validation of a tool to measure the needs of adolescents and young adults (AYA) diagnosed with cancer: the QUestionnaire nEEd Cancer AYAs: QUEEC-AYAs.

CONTEXT: In France, 2300 adolescents and young adults (AYAs, 15-25 years old) are diagnosed with cancer each year. As soon as the disease is diagnosed, a number of physical, psychological and social needs may arise. The aim of this study is to develop a tool to measure unmet needs that will allow the specificities of AYAs to be understood while allowing health care staff to mobilise the necessary actors to resolve them. METHODS: We developed the Questionnaire nEEd Cancer AYAs (QUEEC-AYAs questionnaire), from two existing questionnaires: the Cancer Needs Questionnaire Young People and the Needs Assessment & Service Bridge. A main sample of 103 AYAs then received and completed the questionnaire in order to conduct an exploratory factor analysis. RESULTS: The final structure of the QUEEC-AYAs is composed of 7 dimensions and 48 items: information (8 items), cancer care team (6 items), Physical health (4 items), Emotional health (14 items), Sexual & reproductive health (6 items), Health behaviors & wellness (4 items), Daily life (6 items). The questionnaire has a good acceptability and all domains have a Cronbach's alphas value above 0.80. CONCLUSION: The QUEEC-AYAs is the first measure of the psychosocial needs of AYAs available in French. Its systematic use in health care services should improve the coordination of care required by AYAs during and after treatment. TRIAL REGISTRATION: This study was approved by the ethics committee of the Paoli-Calmettes Institute (IRB # IPC 2021-041, 2021 May 20).

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. A longitudinal retrospective study on patients treated with an EA oncology drug between 1 January 2019 and 31 December 2022 was also performed using the French nationwide claims database (Systeme National des Données de Santé [SNDS]) to assess the impact of the reform on the number of indications and patients, and the costs. RESULTS: Among 110 published decisions, the HAS granted 88 (80%) EA indications within 70 days of assessment on average, including 46 (52%) in oncology (67% in solid tumors and 33% in hematological malignancies). Approved indications were mostly supported by randomized phase III trials (67%), whereas refused EA relied more on non-randomized (57%) trials. Overall survival was the primary endpoint of 28% of EA approvals versus none of denied EAs. In the SNDS data, the annual number of patients with cancer treated with an EA drug increased from 3137 patients in 2019 to 18,341 in 2022 (+ 484%), whereas the number of indications rose from 12 to 62, mainly in oncohematology (n = 17), lung (n = 12), digestive (n = 9) and breast cancer (n = 9). Reimbursement costs for EA treatments surged from €42 to €526 million (+ 1159%). CONCLUSION: The French EA reform contributed to enabling rapid access to innovations in a wide range of indications for oncology patients. However, the findings highlight ongoing challenges in financial sustainability, warranting continued evaluation and adjustments.

RISE-Vac-Co-production of Vaccine Education Materials with Persons Living in Prison.

Increasing vaccination knowledge is effective in addressing hesitancy and is particularly important in populations deprived of liberty who may not routinely have access to health information, ensuring health equity. RISE-Vac is a European Union-funded project aiming to promote vaccine literacy, offer, and uptake in prisons in Europe. We consulted persons living in prisons in the United Kingdom (through the Prisoner Policy Network), France, and Moldova to determine their vaccination knowledge gaps, the information they would like to receive, and how they would like to receive it. We received 344 responses: 224 from the United Kingdom, 70 from France, and 50 from Moldova. Participants were particularly interested in learning about the effectiveness, side effects, and manufacturing of vaccines. Their responses guided the development of educational materials, including a brochure that will be piloted in prisons in Europe. Persons with experience of imprisonment were involved at every stage of this project.

An Integrated Cancer Prevention Strategy: the Viewpoint of the Leon Berard Comprehensive Cancer Center Lyon, France.

This article describes some of the key prevention services in the Leon Berard Comprehensive Cancer Center (CLB) Lyon, France, which are based on clinical prevention services, outreach activities, and collaboration with professional and territorial health communities. In addition, research is embedded at all stages of the prevention continuum, from understanding cancer causes through to the implementation of prevention interventions during and after cancer. Health promotion activities in the community and dedicated outpatient primary cancer prevention services for individuals at increased risk have been implemented. The CLB's experience illustrates how prevention can be integrated into the comprehensive mission of cancer centers, and how in turn, the cancer centers may contribute to bridging the current fragmentation between cancer care and the different components of primary, secondary, and tertiary prevention. With increasing cancer incidence, the shift toward integrated prevention-centered cancer care is not only key for improving population health, but this may also provide a response to the shortage of hospital staff and overcrowding in cancer services, as well as offer opportunities to reduce carbon emissions from cancer care.

Assessment of health literacy in a French emergency department.

BACKGROUND: Health literacy (HL) has become a subject of major interest in public health worldwide. It is known to be linked to self-efficacy in care use and to global health status, and a non-negligible frequency of problematic or inadequate levels of HL in populations worldwide is reported. As this has yet to be evaluated in France, the present study aimed to evaluate the HL level of patients in a French emergency department (ED). METHODS: We conducted a descriptive, cross-sectional observational, single center study in the ED of the Lyon Sud hospital (Hospices civils de Lyon, Lyon, France). The primary endpoint was the HL level of the patients determined according to the score obtained using the 16-item European Health Literacy Survey Questionnaire. The secondary endpoint was the identification of sociodemographic factors associated with the HL level. RESULTS: A total of 189 patients were included for analysis. 10% (95% CI [3%; 17%]) of the patients had an inadequate HL, 38% (95% CI [31%; 45%]) had a problematic HL, and 53% (95% CI [46%; 61%] had an adequate HL. In multivariate analysis, age and perceived health status were independent predictors of the HL level; OR =0.82 (95% CI [0.69; 0.97]; p=0.026) for a 10-year increase in age, and OR =1.84 (95% CI [1.22; 2.82]; p=0.004]). CONCLUSIONS: The HL level of the patients in the ED studied herein was similar to that found in the population of France and other European countries and was influenced by age and perceived health status, which are both associated with care needs. It may be therefore interesting to explore in future studies how taking into consideration HL in the general population may lead to a better self-efficacy in care and optimize the use of the healthcare system.

The economic burden of asthma prior to death: a nationwide descriptive study.

Background: In addition to the clinical burden, asthma is responsible for a high economic burden. However, little is known about the economic burden of asthma prior to death. Objective: We performed an economic analysis to describe the costs during 12 and 24 months prior to asthma death between 2013 and 2017 in France. Methods: An observational cohort study was established using the French national health insurance database. Direct medical and non-medical costs, as well as costs related to absence from the workplace, were included in the analysis. Results: In total, 3,829 patients were included in the final analysis. Over 24 and 12 months prior to death, total medical costs per patient were €27,542 [26,545-28,641] and €16,815 [16,164-17,545], respectively. Total medical costs clearly increased over 24 months prior to death. Over 12 months prior to death, costs increased significantly according to age categories, with mean total costs of €8,592, €15,038, and €17,845, respectively, for the categories <18 years old, 18-75 years old, and 75+ years old (p < 0.0001). Over 12 months prior to death, costs were statistically higher in patients with a dispensation of six or more SABA canisters compared to those with a dispensation of five or less canisters (p < 0.0001). In multivariate analysis, comorbidities, hospital as location of death, and dispensation of 12 or more canisters of SABA per year are independent factors of the highest costs. Conclusion: To conclude, the economic burden of asthma death is high and increases with time, age, and SABA dispensation.

Prevalence and disparities in influenza vaccination among patients with COPD: A French nationwide population study.

INTRODUCTION: Despite concordant international recommendations, many surveys found disappointing rates of influenza vaccination in at-risk populations, ranging from 23% in overall COPD population to more than 70% in more severe COPD subjects. Therefore, we assessed the proportion of French COPD patients non-vaccinated for influenza and their clinical and socio-demographic factors. MATERIEL AND METHODS: This was a national retrospective study based on the French health insurance database. We identified "diagnosed COPD", defined as subjects hospitalized at least once in 2017 with a principal or associated diagnosis of COPD, and "suspected COPD" as those who were prescribed at least thrice long-acting bronchodilators (LAB), after exclusion of patients with a principal diagnosis or secondary associated diagnosis of asthma or cystic fibrosis, patients deceased before the influenza season and patients hospitalized in long-term or in palliative care unit. Multivariate logistic regression was used to assess the association between patients' characteristics and the lack of influenza vaccination. RESULTS: From the national database, 1 474 396 subjects were identified as "suspected COPD" of whom 528 114 were excluded because of previous diagnosis of asthma or cystic fibrosis, and 350 566 as "diagnosed COPD". Among the 1 296 848 patients included, 646 687 patients (53.3%) were vaccinated against influenza. Non-vaccinated subjects were significantly younger (62.1 vs 71.6 years old), more often women (47.9% vs 43.1%) and had fewer comorbidities assessed by Charlson's index (3.0 ± 2.2 vs 4.3 ± 2.1). Lack of vaccination was also associated with a lower LAB usage. Also, non-vaccinated subjects neither had severe exacerbation during the study period. Besides there was a significant heterogeneity in vaccination rate by geographic region, from 47% to 57%. In multivariate analysis, variables independently associated with the lack of influenza vaccination were female gender, younger age, fewer comorbidities and lower socio-economic level. CONCLUSIONS: This study using the French exhaustive health insurance database shows that influenza vaccination among COPD patients remains dramatically low and must become a high-priority public-health strategy.

The cost of illness and burden of suicide and suicide attempts in France.

BACKGROUND: With 11,558 deaths and 200,000 suicide attempts in 2019, France is among the European countries most affected. The aim of this study was to determine the costs and burden of suicides and suicide attempts in France (population 67 million). METHODS: We estimated direct costs, comprising healthcare, as well as post-mortem costs including autopsy, body removal, funeral expenses, police intervention and support groups; indirect costs comprised lost productivity, daily allowances; the burden of disease calculations used a monetary value for death and disability based on incidence data. Data was obtained from the national statistics, health and social care database, registries, global burden of disease, supplemented by expert opinion. We combined top down and bottom up approaches. RESULTS: The total costs and burden of suicides and suicide attempts was estimated at €18.5 billion and €5.4 billion, respectively. Direct costs were €566 million and €75 million; indirect costs were €3.8 billion and €3.5 billion; monetary value for death and disability was €14.6 billion and €1.3. The monetary value for death and disability represented 79.1% and 24.8% of total costs for suicide and suicide attempt respectively. Some costs were based upon expert opinion, caregivers' burden was not counted and pre COVID data only is reported. CONCLUSIONS: In France, the total cost and burden of suicides and suicide attempts was several billion €, suggesting major potential savings from public health interventions.

Distribution of rare earth elements and assessment of anthropogenic gadolinium in estuarine habitats: The case of Loire and Seine estuaries in France.

Rare earth elements (REEs), attractive to society because of their applications in industry, agriculture and medicine, are increasingly released into the environment especially in industrialized estuaries. This study compared the REE distribution in the abiotic compartments: water (dissolved phase (<0.45 µm), suspended particulate matter (SPM)) and sediment of the Loire and Seine estuaries (France). A total of 8 and 6 sites were investigated in the Loire and Seine, respectively, as well as 5 additional offshore sites for the Loire. Total REE concentrations were higher in the Loire for the dissolved phase (93.5 ± 63.3 vs 87.7 ± 16.2 ng/L), SPM (173.9 ± 18.3 vs 114.0 ± 17.8 mg/kg dw) and sediments (198.2 ± 27.9 vs 73.2 ± 27.4 mg/kg dw), explained by higher geogenic inputs. Individual REE contributions along with normalization highlighted heavy REE enrichments and Gd positive anomalies in the dissolved phase of the two estuaries, whereas REE distributions in SPM and sediments followed the natural abundance of the REE classes. The calculated Gd anomalies in the dissolved phase were higher in the Seine (9.7 ± 3.4) than in the Loire (3.0 ± 0.8), corresponding to 88.3 ± 5.1 % and 64.4 ± 11.1 % of anthropogenic Gd. This demonstrates a higher contamination of the Seine estuary, certainly due to the difference in the number of inhabitants between both areas involving different amounts of Gd used in medicine. The offshore sites of Loire showed lower total REE concentrations (55.8 ± 5.8 ng/L, 26.7 ± 38.2 mg/kg dw and 100.1 ± 11.7 mg/kg dw for the dissolved phase, SPM and sediments, respectively) and lower Gd anomalies (1.2 ± 0.2) corresponding to only 13.3 ± 3.9 % of anthropogenic Gd, confirming a contamination from the watershed. This study comparing two major French estuaries provides new data on the REE distribution in natural aquatic systems.

Quality Assessment of Smartphone Medication Management Apps in France: Systematic Search.

BACKGROUND: Adherence to medication is estimated to be around 50% for chronically ill patients in high-income countries. Improving the effectiveness of adherence interventions could have a far greater impact on population health than any improvement in specific medical treatments. Mobile health (mHealth) is one of the most effective solutions for helping patients improve their medication intake, notably through the use of mobile apps with reminder systems. With more than 327,000 apps available in the mHealth field, it is difficult for health care professionals and patients alike to choose which apps to recommend and use. OBJECTIVE: We aim to carry out a systematic search of medication management smartphone apps available in France that send reminders to patients and assess their quality using a validated scale. METHODS: Mobile apps were identified in October and November 2022 after a systematic keyword search on the 2 main app download platforms: App Store (Apple Inc) and Google Play Store. Inclusion criteria were free availability, date of last update, and availability in French. Next, 2 health care professionals independently evaluated the included apps using the French version of the Mobile App Rating Scale (MARS-F), an objective scoring system validated for assessing the overall quality of apps in the mHealth field. An intraclass correlation coefficient was calculated to determine interrater reliability. RESULTS: In total, 960 apps were identified and 49 were selected (25 from the App Store and 24 from the Google Play Store). Interrater reliability was excellent (intraclass correlation coefficient 0.92; 95% CI 0.87-0.95; P<.001). The average MARS-F score was 3.56 (SD 0.49) for apps on the App Store and 3.51 (SD 0.46) for those on the Google Play Store, with 10 apps scoring above 4 out of 5. Further, 2 apps were tested in at least one randomized controlled trial and showed positive results. The 2 apps with the highest ratings were Mediteo rappel de médicaments (Mediteo GmbH) and TOM rappel medicaments, pilule (Innovation6 GmbH), available on both platforms. Each app's MARS-F score was weakly correlated with user ratings on the App Store and moderately correlated on the Google Play Store. CONCLUSIONS: To our knowledge, this is the first study that used a validated scoring system to evaluate medication management apps that send medication reminders. The quality of the apps was heterogeneous, with only 2 having been studied in a randomized controlled trial with positive results. The evaluation of apps in real-life conditions by patients is necessary to determine their acceptability and effectiveness. Certification of apps is also essential to help health care professionals and patients identify validated apps.

Clinical and Economic Burden of Antibiotic Use Among Pediatric Patients With Varicella Infection in the Outpatient Setting: A Retrospective Cohort Analysis of Real-world Data in France.

BACKGROUND: Varicella infects 90% of children before age 9. Though varicella is self-limiting, its complications may require antibiotics, though how antibiotics are utilized for varicella in France is not well known. This study assessed antibiotic use and costs associated with varicella and its complications in pediatric patients managed in the outpatient setting in France. METHODS: A retrospective cohort study using the Cegedim Strategic Data-Longitudinal Patient Database, an electronic medical record database from general practitioners and office-based specialists in France, was conducted. Children <18 years old diagnosed with varicella between January 2014 and December 2018 with 3-month follow-up available were included. We used descriptive analysis to assess varicella-related complications, medication use, healthcare resource utilization and costs. RESULTS: Overall, 48,027 patients were diagnosed with varicella; 15.3% (n = 7369) had ≥1 varicella-related complication. Antibiotics were prescribed in up to 25.1% (n = 12,045/48,027) of cases with greater use in patients with complications (68.1%, n = 5018/7369) compared with those without (17.3%, n = 7027/40,658). Mean medication and outpatient varicella-related costs were €32.82 per patient with medications costing a mean of €5.84 per patient; antibiotics contributed ~23% to total costs annually. CONCLUSION: This study showed high antibiotic use for the management of varicella and its complications. A universal varicella vaccination program could be considered to alleviate complications and associated costs in France.

Clinical benefit of anti-PD-(L)1 immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021.

BACKGROUND: In France, the potential benefit of new treatments is initially evaluated by the Haute Autorité de Santé to determine reimbursement and pricing, but rarely afterwards. Although immunotherapies (ITs) have considerably improved the survival of patients, few data are available on their long-term benefit at a population-treated level. The present retrospective study aimed to assess the clinical benefit of ITs compared to the previous standards of care (SoCs) in France from 2014 to 2021. MATERIALS AND METHODS: To do this, we analyzed all ITs from the anti-programmed cell death protein 1/programmed death-ligand 1 [anti-PD-(L)1] class used in monotherapy or in association with another treatment available in early access or reimbursed in France between 2014 and 2021, regardless of indication. The number of patients initiating an IT was retrieved by year, drug and indication. Using extrapolated Kaplan-Meier curves, utility scores and the population treated, the clinical benefit was expressed as the number of deaths prevented (DP), life-years (LYs) and quality-adjusted life years (QALYs) gained compared to previous SoC. RESULTS: Across the period, five ITs were marketed in 21 indications related to eight primary tumor sites. Between 2014 and 2021, 132 924 patients initiated an IT. By December 2021, 16 173 (13 804-17 141) deaths were delayed compared to previous SoC, mainly in lung cancer. Compared to their SoC, ITs provided a gain of 37 316 (33 581-41 048) additional LYs and 27 709 (23 784-30 450) additional QALYs. Lung cancer was the driver indication with 70.6% of LYs and 68.4% of QALYs gained followed by melanoma with 18.7% and 20.4% of the gain, respectively. CONCLUSIONS: Significant gains in DP, LYs and QALYs have been observed in France following the introduction of ITs.

Income and professional inequalities in chronic diseases: prevalence and incidence in France.

OBJECTIVES: In France, almost nine of 10 deaths are caused by non-communicable diseases, and there is significant social inequality in mortality rates. However, it is not easy to collect robust data on the incidence and prevalence of such diseases according to socio-economic status. Based on data from the link between the primary longitudinal population sample and the national health data system, the aim of our study was to compute the standardised incidence and prevalence of seven major groups of chronic diseases according to socio-economic status. STUDY DESIGN: Descriptive retrospective cohort study. METHODS: This was a descriptive retrospective cohort study on a weighted representative sample of the French population, comprising 3.4 million individuals from data collected 2016-2017. Main chronic disease categories include diabetes, cancers, psychiatric disorders, liver and pancreatic diseases, neurological conditions, respiratory and cardiovascular diseases, calculated from the 2016-2017 period by combining health care consumption and diagnoses received during hospitalisations and/or associated with specific full healthcare coverage. Socio-economic status was measured by disposable income from the 2013-2014 tax returns and census-derived socioprofessional groups, and findings were standardised for age and sex. RESULTS: For all disease categories except cancers, standardised incidence rates showed a gradient favouring the wealthiest, with a risk ratio between the first and tenth standard of living deciles ranging from 1.4 (cardiovascular diseases) to 2.8 (diabetes). Incidence of all disease categories, except cancers, was higher for all groups compared with executives and higher academic professions (risk ratios between workers and executives ranged from 2.0 to 1.3 in psychiatric and cardiovascular diseases, respectively). Conversely, cancer incidence rate followed a flat curve, reduced in the two poorest standard of living deciles, and there were no significant differences between socioprofessional groups. Standardised prevalence rates followed the same patterns, although risk ratios were highest for psychiatric diseases, varying according to sex and disease. CONCLUSIONS: Deep social inequalities in incidence and prevalence of chronic diseases were observed in a large representative sample of the French population. The reverse social inequalities in cancer incidence and prevalence calls for more detailed research into cancer types and selection mechanisms, the data from which would allow the long-term monitoring of such disparities.

Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study.

OBJECTIVES: To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA). DESIGN: Retrospective cohort study. SETTING: Oncology drugs and their indications approved by the EMA between 1995 and 2020. MAIN OUTCOME MEASURES: Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the United States, France, Germany, and Italy, two medical oncology societies, and a drug bulletin. All retrieved ratings were recategorised using a four point ranking scale to indicate negative or non-quantifiable, minor, substantial, or major added benefit. Revenue data were extracted from publicly available financial reports and compared with published estimates of research and development (R&D) costs. Finally, the association between added benefit and revenue was evaluated. All analyses were performed within the overall study cohort, and within subgroups based on the EMA approval pathway: standard marketing authorisation, conditional marketing authorisation, and authorisation under exceptional circumstances. RESULTS: 131 oncology drugs with 166 indications were evaluated for their added benefit by at least one organisation within the required timeframe, yielding a total of 458 added benefit ratings; 189 (41%) were negative or non-quantifiable. The median time to offset the median R&D costs ($684m, £535m, €602m, adjusted to 2020 values) was three years; 50 of 55 (91%) drugs recovered these costs within eight years. Drugs with higher added benefit ratings generally had greater revenues. Negative or non-quantifiable added benefit ratings were more frequent for conditional marketing authorisations and authorisations under exceptional circumstances than for standard marketing authorisations (relative risk 1.53, 95% confidence interval 1.23 to 1.89). Conditional marketing authorisations generated lower revenues and took longer to offset R&D costs than standard marketing authorisations (four years compared with three years). CONCLUSIONS: While revenues seem to align with added benefit, most oncology drugs recover R&D costs within a few years despite providing little added benefit. This is particularly true for drugs approved through conditional marketing authorisations, which inherently appear to lack comprehensive evidence. Policy makers should evaluate whether current regulatory and reimbursement incentives effectively promote development of the most effective drugs for patients with the greatest needs.

Access in all areas? A round up of developments in market access and health technology assessment: part 3.

In this latest update, we explore some of the key updates in market access over recent months including the UK's voluntary scheme for branded medicines pricing, access and growth (VPAG), the first drugs funded by the Innovative Medicines Fund in the UK and the Direct Access Scheme in France, and, finally, the new Institute for Clinical and Economic Review (ICER) value assessment framework in the USA.

Optimal intertemporal curative drug expenses: The case of hepatitis C in France.

We study intertemporal tradeoffs that health authorities face when considering the control of an epidemic using innovative curative medical treatments. We set up a dynamically controlled susceptible-infected-recovered (SIR) model for an epidemic in which patients can be asymptomatic, and we analyze the optimality conditions of the sequence of cure expenses decided by health authorities at the onset of the drug innovation process. We show that analytical conclusions are ambiguous because of their dependence on parameter values. As an application, we focus on the case study of hepatitis C, the treatment for which underwent a major upheaval when curative drugs were introduced in 2014. We calibrate our controlled SIR model using French data and simulate optimal policies. We show that the optimal policy entails some front loading of the intertemporal budget. The analysis demonstrates how beneficial intertemporal budgeting can be compared to non-forward-looking constant budget allocation.

Acces to abortion in the Grand Est region in 2023 / L'accès à l'interruption volontaire de grossesse dans la région Grand Est en 2023

Objectives: Although access to abortion is a national priority in France, there is little documented evidence that it is actually respected. In the Grand Est region, the 2021­2023 plan for access to abortion includes a review of family planning practices and health care provision, to update the 2019 report. It raises the question of access to abortion in all its dimensions, and aims to implement improvement actions best suited to the region's problems. Method: An online questionnaire was sent to hospitals, local perinatal centers, sexual health centers, and independent professionals with presumed family planning activity. Of those who responded, only those with actual family planning activity were included. Results: The five-day deadline for the first appointment recommended by the HAS can be met by 73% of those surveyed. During pre- or post-abortion consultations, a psychosocial interview is offered to 92% of patients, and the detection of violence to 97%. Although 14 hospitals (38%) have extended their abortion access time to 16 weeks of amenorrhea, the number of facilities handling abortions beyond 13 weeks of amenorrhea has fallen since 2019. In primary care, 70% of private practitioners and 61% of sexual health centers offer abortions up to 9 weeks of amenorrhea. Conclusions: Access to abortion has weakened in the Grand Est region between 2019 and 2023. New laws and regulations could be a lever for improvement, provided that the professionals involved are given the means.

Objectifs: Si l'accès à l'IVG est une priorité nationale en France, son respect effectif n'est que peu documenté. Dans le Grand Est, le plan d'accès à l'IVG 2021-2023 inclut la réalisation d'un état des lieux des pratiques et de l'offre de soins en orthogénie, pour actualiser celui de 2019. Il pose la question de l'accès à l'IVG dans toutes ses dimensions et vise la mise en place des actions d'amélioration les plus adaptées aux problématiques de la région. Méthodes: Un questionnaire en ligne a été envoyé aux centres hospitaliers, aux centres périnataux de proximité, aux centres de santé sexuelle et aux professionnels libéraux ayant une activité d'orthogénie supposée. Parmi ceux qui y ont répondu, seuls ceux qui avaient une activité d'orthogénie effective ont été inclus. Résultats: Le délai de premier rendez-vous de cinq jours recommandés par l'HAS peut être respecté par 73 % des enquêtés. Lors des consultations pré- ou post-IVG, un entretien psychosocial est proposé à 92 % et un repérage des violences à 97 %. Bien que 14 centres hospitaliers (38 %) aient allongé leur délai d'accès à l'IVG jusqu'à 16 SA, le nombre d'établissements prenant en charge les IVG au-delà de 13 semaines d'aménorrhée a baissé depuis 2019. En médecine de ville, 70 % des professionnels libéraux et 61 % des CSS ont une offre IVG allant jusqu'à 9 SA. Conclusions: L'accès à l'IVG s'est fragilisé dans le Grand Est entre 2019 et 2023. Les nouvelles lois et réglementations pourraient être un levier d'amélioration à condition que des moyens soient donnés aux professionnels impliqués.