Cost-effectiveness of emicizumab vs bypassing agents in the prevention of bleeding episodes in haemophilia A patients with anti-FVIII inhibitors in France.

INTRODUCTION: The development of an anti-FVIII inhibitor is the most serious complication of haemophilia A occurring in up to 30% of severe haemophilic patients. The current management of haemophilia A with inhibitor uses bypassing agents (BPA) and represents a significant therapeutic burden together with a limited adherence to prophylactic treatment. Emicizumab is the first monoclonal antibody developed in haemophilia A approved for the prevention of bleeding episodes in patients with anti-FVIII inhibitor. AIM: The purpose of this study is to evaluate the incremental cost-effectiveness ratio (ICER) of emicizumab versus BPAs. METHODS: A Markov model was developed over a five-year time horizon to estimate the comparative costs and benefits of the different therapeutic approaches in this rare disease. Model inputs were clinical, including annual bleeding rate and quality of life, and economical including mainly costs of prophylaxis, bleeds and adverse events. RESULTS: Emicizumab treatment is dominant, ie lest costly and more effective, in the base-case analysis saving 234 191 € for a gain of 0.88 QALY. This is confirmed by both the deterministic and probabilistic sensitivity analyses. The main limit of the study remains the absence of long-term clinical data allowing to relate treatment consumption to clinical benefit, especially in the progression of haemophilic arthropathy. CONCLUSION: Our results show that emicizumab is a cost-effective treatment allowing to consider an easy to implement prophylactic treatment for haemophilia A patients with anti-FVIII inhibitors.

Impact of Next Generation Sequencing on Clinical Practice in Oncology in France: Better Genetic Profiles for Patients Improve Access to Experimental Treatments.

OBJECTIVES: We evaluated how next generation sequencing (NGS) can modify care pathways in an observational impact study in France. METHODS: All patients with lung cancer, colorectal cancer, or melanoma who had NGS analyses of somatic genomic alterations done in 1 of 7 biomolecular platforms certified by the French National Cancer Institute (INCa) between 2013 and 2016 were eligible. We compared patients' pathways before and after their NGS results. Endpoints consisted of the turnaround time in obtaining results, the number of patients with at least 1 genomic alteration identified, the number of actionable alterations, the impact of the genomic multidisciplinary tumor board on care pathways, the number of changes in the treatment plan, and the survival outcome up to 1 year after NGS analyses. RESULTS: 1213 patients with a request for NGS analysis were included. NGS was performed for 1155 patients, identified at least 1 genomic alteration for 867 (75%), and provided an actionable alteration for 614 (53%). Turnaround time between analyses and results was on average 8 days (Min: 0; Max: 95) for all cancer types. Before NGS analysis, 33 of 614 patients (5%) were prescribed a targeted therapy compared with 54 of 614 patients (8%) after NGS analysis. Proposition of inclusion in clinical trials with experimental treatments increased from 5% (n = 31 of 614) before to 28% (n = 178 of 614) after NGS analysis. Patients who benefited from a genotype matched treatment after NGS analysis tended to have a better survival outcome at 1 year than patients with nonmatched treatment: 258 days (±107) compared with 234 days (±106), (P = .41). CONCLUSIONS: NGS analyses resulted in a change in patients' care pathways for 20% of patients (n = 232 of 1155).

From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer.

BACKGROUND: In France during the last 15 years, precariousness among women has increased. In breast cancer, precariousness has been associated with an increase in mortality, but the links between precariousness, stage at diagnosis and care pathway are little explored. Our study aims to evaluate the impact of precariousness on care pathways, treatment and recovery phase according to a multidisciplinary analysis. METHODS AND DESIGN: Comparative prospective observational multicenter study of exposed / unexposed category. Patients with breast cancer are recruited in the Ile de France area. Three scores are used to identify precarious patients. Precarious patients are matched to non-precarious patients by age group. Questionnaires are distributed to patients at different times of care. The main objective is to compare the stage of the disease at diagnosis between two groups. The secondary objectives are: comparison of socio-economic and geographical characteristics, direct and indirect costs, personal trajectories of care and health. Analysis include multidisciplinary approaches. A geographical information systems method will evaluate the accessibility to health facilities and the characteristics of the places of residence of the patients. An anthropological analysis will be conducted through observation of consultations and semi-directed interviews with patients. These methods will allow to analyze the diagnostic and therapeutic routes, placing it in a life history and an economic, socio-cultural and health environment. The economic analysis will include a comparison of direct, indirect costs and out-off pocket costs, from the patient's point of view and from the societal perspective. DISCUSSION: Conducted in a clinical setting and coupled with a qualitative study, this study will provide a better understanding of how contextual factors, combined with individual factors, can influence the course of health and thus the stage of the disease at diagnosis. The multidisciplinary approach, involving clinicians, geographers, an anthropologist, an economist and a health epidemiologist, will allow a multidimensional approach to the impact of precariousness on breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02948478 registered October 28, 2016. ID RCB: 2016-A00589-42. protocol version: 2.1. decembre 13, 2018.

Preoperative clinical pathway of breast cancer patients: determinants of compliance with EUSOMA quality indicators.

BACKGROUND: The European Society of Breast Cancer Specialists (EUSOMA) has defined quality indicators for breast cancer (BC). The aim of this study was to describe the preoperative clinical pathway of breast cancer patients and evaluate the determinants of compliance with EUSOMA quality indicators in the Optisoins01 cohort. METHODS: Optisoins01 is a prospective, multicentric study. Data from operable BC patients were collected, including results from before surgery to 1 year follow-up. Seven preoperative EUSOMA quality indicators were compared with the clinical pathways Optisoins01. RESULTS: Six hundred and four patients were included. European Society of Breast Cancer Specialists targets were reached for indicator 1 (completeness of clinical and imaging diagnostic work-up), 3 (preoperative definitive diagnosis) and 5 (waiting time). For indicator 8 (multidisciplinary discussion), the minimum standard of 90% of the patients was reached only in general hospitals and comprehensive cancer centres. Having more than 1 medical examination within the centre was associated with an increased waiting time for surgery, whereas it was reduced by having an outpatient breast biopsy. The comprehensive cancer centre type was the only parameter associated with the other quality indicators. CONCLUSIONS: European Society of Breast Cancer Specialists quality indicators are a useful tool to evaluate care organisations. This study highlights the need for a standardised and coordinated preoperative clinical pathway.

Clinical effect of molecular methods in sarcoma diagnosis (GENSARC): a prospective, multicentre, observational study.

BACKGROUND: Advances in molecular genetics of sarcoma have enabled the identification of type-specific aberrations. We aimed to assess the clinical effect of systematic implementation of molecular assays to improve sarcoma misdiagnosis. METHODS: In this multicentre, observational study, we recruited patients from 32 centres of the French Sarcoma Group/Reference Network in Pathology of Sarcomas. Eligibility criteria included: biopsy or surgical resection; suspicion of: dermatofibrosarcoma protuberans (cohort 1), dedifferentiated liposarcoma (cohort 2), Ewing's sarcoma family of tumours (cohort 3), synovial sarcoma (cohort 4), alveolar rhabdomyosarcoma (cohort 5), and myxoid or round cell liposarcoma (cohort 6); review by one sarcoma-expert pathologist; availability of frozen material (except for cohort 1 of patients with dermatofibrosarcoma protuberans because anti-CD34 immunohistochemistry is performed on paraffin-embedded tissue); and patient information. For each case, the pathologist made one primary diagnosis followed by up to two differential diagnoses, based on histological characteristics only. Each diagnosis was classified as certain, probable, or possible. For each case to determine the molecular classification, we did fluorescence in-situ hybridisation on paraffin-embedded samples. We also did comparative genomic hybridisation and quantitative PCR (cohort 2) or reverse transcriptase PCR (cohorts 3-6) on frozen and paraffin-embedded samples. We made a final diagnosis based on the molecular results. The clinical effect of diagnosis correction was assessed by a board of experts. FINDING: Between June 22, 2009, and Oct 30, 2012, 395 patients were enrolled in the study, of which 384 were eligible for inclusion. The diagnosis was eventually modified by molecular genetics for 53 patients: eight (16%) of 50 patients with dermatofibrosarcoma (cohort 1), seven (23%) of 30 patients with dedifferentiated liposarcoma (cohort 2), 13 (12%) of 112 with Ewing's sarcoma family of tumours (cohort 3), 16 (16%) of 97 patients with synovial sarcoma (cohort 4), seven (15%) of 46 patients with alveolar rhabdomyosarcoma (cohort 5), and two (4%) of 49 patients with myxoid or round cell liposarcoma (cohort 6), with an effect on primary management or prognosis assessment in 45 cases. INTERPRETATION: Molecular genetic testing should be mandatory for diagnostic accuracy of sarcoma and appropriate clinical management, even when histological diagnosis is made by pathologist experts in this field. FUNDING: French National Cancer Institute and Nice University Hospital.

The patient-breast cancer care pathway: how could it be optimized?

BACKGROUND: A care pathway is defined as patient-focused global care that addresses temporal (effective and coordinated management throughout the illness) and spatial issues (treatment is provided near the health territory in or around the patient's home). Heterogeneity of the care pathways in breast cancer (BC) is presumed but not well evaluated. The OPTISOINS01 study aims to assess every aspect of the care pathway for early BC patients using a temporal and spatial scope. METHODS/DESIGN: An observational, prospective, multicenter study in a regional health territory (Ile-de-France, France) in different types of structures: university or local hospitals and comprehensive cancer centers. We will include and follow during 1 year 1,000 patients. The study consists of 3 work-packages: - Cost of pathway The aim of this WP is to calculate the overall costs of the early BC pathway at 1 year from different perspectives (society, health insurance and patient) using a cost-of-illness analysis. Using a bottom-up method, we will assess direct costs, including medical direct costs and nonmedical direct costs (transportation, home modifications, home care services, and social services), and indirect costs (loss of production). - Patient satisfaction and work reintegration Three questionnaires will assess the patients' satisfaction and possible return to work: the occupational questionnaire for employed women; the questionnaire on the need for supportive care, SCNS-SF34 ('breast cancer' module, SCNS-BR8); and the OUTPASSAT-35 questionnaire. - Quality, coordination and access to innovation Quality will be evaluated based on visits and treatment within a set period, whether the setting offers a multidisciplinary consultative framework, the management by nurse coordinators, the use of a personalized care plan, the provision of information via documents about treatments and the provision of supportive care. The coordination between structures and caregivers will be evaluated at several levels. Day surgery, home hospitalization and one-stop breast clinic visits will be recorded to assess the patient's access to innovation. DISCUSSION: The assessment of care pathways encourages the implementation of new payment models. Our approach could help health care professionals and policymakers to establish other cost-of-illness studies and plan the allocation of resources on a patient basis rather than a visit basis.

[Cost of high-throughput sequencing (NGS) technologies: Literature review and insights]. / Coût des technologies de séquençage haut débit (NGS) : revue de la littérature et enseignements.

Although high-throughput sequencing technologies (Next-Generation Sequencing [NGS]) are revolutionizing medicine, the estimation of their production cost for pricing/tariffication by health systems raises methodological questions. The objective of this review of cost studies of high-throughput sequencing techniques is to draw lessons for producing robust cost estimates of these techniques. We analyzed, using an eleven item analysis framework, micro-costing studies of high-throughput sequencing technologies (n=17), including two studies conducted in the French context. The factors of variability between the studies that we identified were temporality (early evaluation of the innovation vs. evaluation of a mature technology), the choice of cost evaluation method (scope, micro- vs. gross-costing technique), the choice of production steps observed and the transposability of these studies. The lessons we have learned are that it is necessary to have a comprehensive vision of the sequencing production process by integrating all the steps from the collection of the biological sample to the delivery of the result to the clinician. It is also important to distinguish between what refers to the local context and what refers to the general context, by favouring the use of mixed methods to calculate costs. Finally, sensitivity analyses and periodic re-estimation of the costs of the techniques must be carried out in order to be able to revise the tariffs according to changes linked to the diffusion of the technology and to competition between reagent suppliers.

[Time and space in the care pathways of women suffering from breast cancer]. / Temps et espaces dans les parcours de soins de femmes souffrant d'un cancer du sein.

Facing breast cancer, women in precarious situations are more likely to be diagnosed at an advanced stage, and when detected at the same stage, they are more to die as well as faster. In this paper, we analyze a corpus of 40 semi-structured interviews conducted in six cancer services in hospitals of the Paris area on the care pathways of women with breast cancer. The analysis focuses on the beginning of the pathways (until the first treatments) and concentrates on their spatial and temporal dimension in the light of precariousness. Depending on the women's situations with regard to precariousness, the spatial and temporal organization of the pathways differs. There are socially differentiated latency periods that delay diagnosis (prior to meeting a medical professional) or the beginning of treatment (in relation to rights, the responsiveness of the health care system, and the interactions between women and the system). Spatially, the geometry of the pathways is variable and reflects different expectations of health institutions and medical staff according to the social profiles of the women. However, a detailed analysis of the pathways allows us to nuance these differences in terms of precariousness. The women's capacity to be autonomous, their network of contacts, the accessibility and responsiveness of the health care system, as well as the sensitive and emotional dimension of this stressful event affect the pathways both in terms of time and space.

[Impact of precariousness on breast cancer care in the Île-de-France region: Results of the DESSEIN study]. / Impact de la précarité sur la prise en charge du cancer du sein en Île-de-France : résultats de l'étude DESSEIN.

INTRODUCTION: Precariousness has been associated with an increase in breast cancer mortality, but the links between precariousness, stage at diagnosis and care pathways are little explored. The objective of the DESSEIN study was to assess the impact of precariousness on disease and care pathways. METHODS: Prospective observational study in Île-de-France comparing precarious and non-precarious patients consulting for breast cancer and followed for 1 year. RESULTS: In total, 875 patients were included between 2016 and 2019 in 19 institutions: 543 non-precarious patients and 332 precarious patients. Precarious patients had a more advanced stage at diagnosis (55% T1 vs. 63%, 30% N+ vs 19%, P=0.0006), had a higher risk of not receiving initially planned treatment (4 vs. 1%, P=0.004), and participated less in clinical trials (5 vs. 9%, P=0.03). Non-use of supportive oncology care was 2 times more frequent among patients in precarious situations (P<0.001). During treatment, 33% of deprived patients reported a loss of income, compared with 24% of non-deprived patients (P<0.001). At 12 months from diagnosis, lay-offs were 2 times more frequent in precarious patients (P=0.0001). DISCUSSION: Precariousness affects all stages of the cancer history and care pathway. Particular attention needs to be paid to vulnerable populations, considering issues of accessibility and affordability of care, health literacy and possible implicit bias from the care providers.

Treatment patterns, clinical outcomes and health care costs associated with HER2-positive breast cancer with central nervous system metastases: a French multicentre observational study.

BACKGROUND: The population of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) who develop central nervous system (CNS) metastases is growing. Treatment strategies in this population are highly diverse. The objective of the study was to assess health care costs for the management of HER2 positive BC with CNS metastases. METHODS: This multicentre, retrospective, observational study was conducted on HER2-positive BC patients diagnosed with CNS metastases between 2006 and 2008. Data were extracted from patient medical records to estimate health care resource use. A partitioned estimator was used to adjust censoring costs by use of the Kaplan-Meier survival estimate. RESULTS: 218 patients were included and costs were estimated for 200 patients. The median time to detection of CNS metastases was 37.6 months. The first metastatic event involved the CNS in 39 patients, and this was the unique first metastatic site in 31 of these patients. Two years following diagnosis of CNS metastases, 70.3% of patients had died. The mean per capita cost of HER2-positive BC with CNS metastases in the first year following diagnosis was €35,735 [95% CI: 31,716-39,898]. The proportion of costs attributed to expensive drugs and those arising from hospitalisation were in the same range. CONCLUSION: A range of individualised disease management strategies are used in HER2-positive BC patients with CNS metastases and the treatments used in the first months following diagnosis are expensive. The understanding of cost drivers may help optimise healthcare expenditure and inform the development of appropriate prevention policies.

Economic Evaluation of Telerehabilitation: Systematic Literature Review of Cost-Utility Studies.

BACKGROUND: Telerehabilitation could benefit a large population by increasing adherence to rehabilitation protocols. OBJECTIVE: Our objective was to review and discuss the use of cost-utility approaches in economic evaluations of telerehabilitation interventions. METHODS: A review of the literature on PubMed, Scopus, Centres for Review and Dissemination databases (including the HTA database, the Database of Abstracts of Reviews of Effects, and the NHS Economic Evaluation Database), Cochrane Library, and ClinicalTrials.gov (last search on February 8, 2021) was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The inclusion criteria were defined in accordance with the PICOS (population, intervention, comparison, outcomes, and study design) system: the included studies had to evaluate patients in rehabilitation therapy for all diseases and disorders (population) through exercise-based telerehabilitation (intervention) and had to have a control group that received face-to-face rehabilitation (comparison), and these studies had to evaluate effectiveness through gain in quality of life (outcome) and used the design of randomized and controlled clinical studies (study). RESULTS: We included 11 economic evaluations, of which 6 concerned cardiovascular diseases. Several types of interventions were assessed as telerehabilitation, consisting in monitoring of rehabilitation at home (monitored by physicians) or a rehabilitation program with exercise and an educational intervention at home alone. All studies were based on randomized clinical trials and used a validated health-related quality of life instrument to describe patients' health states. Four evaluations used the EQ-5D, 1 used the EQ-5D-5L, 2 used the EQ-5D-3L, 3 used the Short-Form Six-Dimension questionnaire, and 1 used the 36-item Short Form survey. The mean quality-adjusted life years gained using telerehabilitation services varied from -0.09 to 0.89. These results were reported in terms of the probability that the intervention was cost-effective at different thresholds for willingness-to-pay values. Most studies showed results about telerehabilitation as dominant (ie, more effective and less costly) together with superiority or noninferiority in outcomes. CONCLUSIONS: There is evidence to support telerehabilitation as a cost-effective intervention for a large population among different disease areas. There is a need for conducting cost-effectiveness studies in countries because the available evidence has limited generalizability in such countries. TRIAL REGISTRATION: PROSPERO CRD42021248785; https://tinyurl.com/4xurdvwf.

Perioperative time and economic impact of an intracameral combination of mydriatics and anaesthetics in routine cataract surgery.

PURPOSE: The aim of this study was to compare the perioperative time and economic impact of a licensed intracameral anaesthetic/mydriatic combination (Mydrane) during routine cataract surgery. METHODS: A real-life, prospective, comparative study was performed in 3 clinical centres in France. Preoperative, surgical, and post-operative times were determined for two mydriasis strategies using conventional preoperative mydriatics/anaesthetics eye drops (control regimen) or Mydrane administered at time of surgery. Staff, surgery schedules and drugs utilisation were collected over 12 surgery half-days. The total cost of each strategy was estimated based on treatment cost and nursing costs. RESULTS: The analysis included 112 routine cataract surgeries (57 surgeries using Mydrane and 55 using the topical regimen) without protocol deviations or complicated surgery. Overall, the mean time between administration of the first mydriatic eye drops or Mydrane and the end of the surgery was 27.4 ± 21.1 min in the Mydrane group vs. 90.3 ± 30.4 min in the control group (P < 0.0001). The total time of the procedure (from admission to discharge) was not significantly different between groups (P = 0.1611). On average, the extra cost of drugs per patient in the Mydrane group (€5.81) was almost balanced by the reduced nursing time (€5.57) with some variations between centres, due to different organisation including staff resource and consumable. CONCLUSIONS: The Mydrane strategy produced perioperative nursing time saving and cost reduction provided that adaptation and reorganisation of routine cataract surgery are implemented.

Influence of geographic access and socioeconomic characteristics on breast cancer outcomes: A systematic review.

Socio-economic and geographical inequalities in breast cancer mortality have been widely described in European countries and the United States. To investigate the combined effects of geographic access and socio-economic characteristics on breast cancer outcomes, a systematic review was conducted exploring the relationships between: (i) geographic access to healthcare facilities (oncology services, mammography screening), defined as travel time and/or travel distance; (ii) breast cancer-related outcomes (mammography screening, stage of cancer at diagnosis, type of treatment and rate of mortality); (iii) socioeconomic status (SES) at individuals and residential context levels. In total, n = 25 studies (29 relationships tested) were included in our systematic review. The four main results are: The statistical significance of the relationship between geographic access and breast cancer-related outcomes is heterogeneous: 15 were identified as significant and 14 as non-significant. Women with better geographic access to healthcare facilities had a statistically significant fewer mastectomy (n = 4/6) than women with poorer geographic access. The relationship with the stage of the cancer is more balanced (n = 8/17) and the relationship with cancer screening rate is not observed (n = 1/4). The type of measures of geographic access (distance, time or geographical capacity) does not seem to have any influence on the results. For example, studies which compared two different measures (travel distance and travel time) of geographic access obtained similar results. The relationship between SES characteristics and breast cancer-related outcomes is significant for several variables: at individual level, age and health insurance status; at contextual level, poverty rate and deprivation index. Of the 25 papers included in the review, the large majority (n = 24) tested the independent effect of geographic access. Only one study explored the combined effect of geographic access to breast cancer facilities and SES characteristics by developing stratified models.

Absenteeism and indirect costs during the year following the diagnosis of an operable breast cancer: A prospective multicentric cohort study.

BACKGROUND: Diseases consequence on individual work as much as consequences of being absent from work are matters of interest for decision makers. METHODS: We analyzed lengths of absenteeism and related indirect costs for patients with a paid activity in the year following the diagnosis of early stage breast cancer, in the prospective OPTISOINS01 cohort. Both human capital and friction costs approach were considered for the valuation of lost working days (LWD). For the analysis, the friction period was estimated from recent French data. The statistical analysis included simple and multiple linear regression to search for the determinants of absenteeism and indirect costs. RESULTS: 93 % of the patients had at least one period of sick leave, with on average 2 period and 186 days of sick leave. 24 % of the patients had a part-time resumption after their sick leave periods, during 114 days on average (i.e. 41 LWD). Estimated indirect costs were 22,722.00 € and 7,724.00 € per patient, respectively for the human capital and the friction cost approach. In the multiple linear regression model, factors associated with absenteeism were: the invasive nature of the tumor (p = .043), a mastectomy (p = .038), a surgery revision (p = .002), a chemotherapy (p = .027), being a manager (p = .025) or a craftsman (p = .005). CONCLUSION: Breast cancer lead to important lengths of absenteeism in the year following the diagnosis, but almost all patients were able to return to work. Using the friction cost or the human capital approach in the analysis led to an important gap in the results, highlighting the importance of considering both for such studies.

[An economic evaluation of intimate partner violence in France]. / Evaluation économique des violences conjugales en France.

This study aims to carry out an economic evaluation of intimate partner violence in France. Using published data, institutional sources, field studies and expert opinions, the cost of intimate partner violence is estimated in terms of the overall cost to society. A range of different economic approaches are used (micro-economic, meso-economic and macro-economic approaches). The total cost of intimate partner violence in France is estimated at 2.5 billion Euros per year (between 1.7 and 3.5 billion Euros). The total cost of intimate partner violence includes healthcare costs (483 ? million), social and justice services (355 ? million), production losses as a result of deaths, imprisonments and absenteeism (1099 ? million), and the human costs of rape and prejudice (535 ? million). By increasing the budget allocated to the prevention of domestic violence by one euro, it is estimated that the state, health insurance and local authorities could make savings of up to 87 Euros of social spending, including 30 Euros of direct expenses.

Direct medical and non-medical costs of a one-year care pathway for early operable breast cancer: Results of a French multicenter prospective study.

INTRODUCTION: The organization of health care for breast cancer (BC) constitutes a public health challenge to ensure quality of care, while also controlling expenditure. Few studies have assessed the global care pathway of early BC patients, including a description of direct medical costs and their determinants. The aims of this multicenter prospective study were to describe care pathways of BC patients in a geographic territory and to calculate the global direct costs of early stage BC during the first year following diagnosis. METHODS: OPTISOINS01 was a multicenter, prospective, observational study including early BC patients from diagnosis to one-year follow-up. Direct medical costs (in-hospital and out-of-hospital costs, supportive care costs) and direct non-medical costs (transportation and sick leave costs) were calculated by using a cost-of-illness analysis based on a bottom-up approach. Resources consumed were recorded in situ for each patient, using a prospective direct observation method. RESULTS: Data from 604 patients were analyzed. Median direct medical costs of 1 year of management after diagnosis in operable BC patients were €12,250. Factors independently associated with higher direct medical costs were: diagnosis on the basis of clinical signs, invasive cancer, lymph node involvement and conventional hospitalization for surgery. Median sick leave costs were €8,841 per patient and per year. Chemotherapy was an independent determinant of sick leave costs (€3,687/patient/year without chemotherapy versus €10,706 with chemotherapy). Forty percent (n = 242) of patients declared additional personal expenditure of €614/patient/year. No drivers of these costs were identified. CONCLUSION: Initial stage of disease and the treatments administered were the main drivers of direct medical costs. Direct non-medical costs essentially consisted of sick leave costs, accounting for one-half of direct medical costs for working patients. Out-of-pocket expenditure had a limited impact on the household.

Multidimensional impact of breast cancer screening: Results of the multicenter prospective optisoins01 study.

Breast cancer (BC) screening has been developed to detect earlier stage tumors associated with better prognosis. The aim of study was to evaluate the impact of BC screening on therapeutic management of patients with first operable BC, and on costs, patients' needs, and working life. OPTISOINS01 was a multicenter, prospective observational study which aimed to identify the main care pathway of early BC. Among patients aged from 50 to 74 years-old, 2 groups were defined: the "Clinical signs" group and the "Screening" group (national organized screening and individual screening). We compared between these 2 groups: locoregional and systemic treatments, direct medical and non-medical costs from a National Health Insurance perspective, patients' needs assessed by the validated SCNS-BR8 "breast cancer" module of the SCNS-SF34 supportive care needs survey and the duration of sick leave. The "Clinical signs" group included 89 patients, while the"Screening" group included 290 patients. More axillary lymph node dissections and radical breast surgery were performed in the "Clinical signs". The rate of adjuvant chemotherapy was dramatically higher in the "Clinical signs" group. The median direct medical costs of the "Screening" group were €11,860 (€3,643-€41,030) per year and per patient, much lower than in the "Clinical signs" group (€14,940; €5,317-€41,070). Finally, needs specifically assessed by the SCNS-BR8 questionnaire were significantly higher for the postoperative and post-adjuvant periods in the "Clinical signs" group. This study highlighted the benefit of BC screening in terms of reduced therapies and positive impact on work and social life.

Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study.

INTRODUCTION: Return to work (RTW) after breast cancer (BC) is still a new field of research. The factors determining shorter sick leave duration of patients with BC have not been clearly identified. The aim of this study was to describe work during BC treatment and to identify factors associated with sick leave duration. MATERIALS AND METHODS: An observational, prospective, multicentre study was conducted among women with operable BC. A logbook was given to all working patients to record sociodemographic and work-related data over a 1-year period. RESULTS: Work-related data after BC were available for 178 patients (60%). The median age at diagnosis was 50 years (27-77), 87.9% of patients had an invasive form of BC and 25.3% a lymph node involvement. 25.9% had a radical surgery and 24.2% had an axillary dissection. Radiotherapy was performed in 90.9% of patients and chemotherapy in 48.1%. Sick leave was prescribed for 165 patients (92.7%) for a median of 155 days. On univariate analysis, invasive BC (p=0.025), lymph node involvement (p=0.005), radical surgery (p=0.025), axillary dissection (p=0.004), chemotherapy (p<0.001), personal income <€1900/month (p=0.03) and not having received the patient information booklet on RTW (p=0.047) were found to be associated with a longer duration of sick leave. On multivariate analysis, chemotherapy was found to be associated with longer sick leave (OR: 3.5; 95% CI 1.6 to 7.9; p=0.002). The cost of sick leave to French National Health Insurance was fourfold higher in the case of chemotherapy (p<0.001). CONCLUSION: Advanced disease and chemotherapy are major factors that influence sick leave duration during the management of BC. TRIAL REGISTRATION NUMBER: NCT02813317.

Cost of cancer diagnosis using next-generation sequencing targeted gene panels in routine practice: a nationwide French study.

It is currently unclear if next-generation sequencing (NGS) technologies can be implemented in the diagnosis setting at an affordable cost. The aim of this study was to measure the total cost of performing NGS in clinical practice in France, in both germline and somatic cancer genetics.The study was performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost was estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. In addition, we used a top-down methodology for specific post-sequencing steps including bioinformatics, technical validation, and biological validation. Additional non-specific costs were also included. Costs were detailed per step of the process (from the pre-analytical phase to delivery of results), and per cost driver (consumables, staff, equipment, maintenance, overheads). Sensitivity analyses were performed.The mean total cost of NGS for targeted gene panels was estimated to 607€ (±207) in somatic genetics and 550€ (±140) in germline oncogenetic analysis. Consumables were the highest cost driver of the sequencing process. The sensitivity analysis showed that a 25% reduction of consumables resulted in a 15% decrease in total NGS cost in somatic genetics, and 13% in germline analysis. Additional costs accounted for 30-32% of the total NGS costs.Beyond cost assessment considerations, the diffusion of NGS technologies will raise questions about their efficiency when compared to more targeted approaches, and their added value in a context of routine diagnosis.

Correction: Cost of cancer diagnosis using next-generation sequencing targeted gene panels in routine practice: a nationwide French study.

Since the publication of the article, it has been noted that there is an error in Table 2. Where 543€ is listed in the final column of the table, this should have been written as 550€.