Treatment patterns, risk factors and outcomes for patients with newly diagnosed hepatocellular carcinoma in France: A retrospective database analysis.

BACKGROUND & AIMS: The aim of this analysis was to describe the nationwide distribution of patients with newly diagnosed hepatocellular carcinoma (HCC) according to treatment patterns, aetiologies, and outcomes in France. METHOD: A retrospective cohort of patients with newly diagnosed HCC was selected over the period 2015-2017 in a French claims database covering 99% of the population. Treatment patterns were described using an algorithm based on a ranking of curative and palliative HCC treatments identified. Survival was analyzed using Kaplan-Meier curves according to major treatments and aetiologies. RESULTS: A total of 20,083 incident patients were identified with a mean age of 69.2 years (SD: 11.0) and 82.4% of men. The mean duration of follow-up was 10.0 months (SD: 9.7). At least one HCC risk factor could be identified in 87.0% of patients. The most frequent aetiologies were alcohol-related liver disease present in 50.8% of patients, a metabolic disease (NAFLD, NASH or diabetes) without alcohol or viral hepatitis (44.5%) and viral hepatitis (20.0%). Only 32.7% of patients received a curative therapy, with a 1-year survival of 89.5%, while 38.0% of patients received only best supportive care, with a 1-year survival of 12.9%. The highest rates of curative treatments were found in patients with viral hepatitis, associated or not with another risk factor. CONCLUSION: Hepatocellular carcinoma was still most often diagnosed at an advanced disease stage as shown by the low rate of curative treatment observed and the very poor prognosis. Viral aetiology was associated with the best survival.

ESPERA study: applicability of the new ILAE criteria for antiepileptic drug resistance of focal epilepsies in current clinical practice.

A European observational cross-sectional study, ESPERA, was conducted in France and Spain in 2010. A random sample of neurologists, including specialists in epilepsy, prospectively enrolled adult patients treated for focal epilepsy with at least two antiepileptic drugs (AEDs) in combination. Investigators were asked to classify AED responsiveness of each enrolled patient according to the new 2009 ILAE criteria. These classifications were then reviewed by three experts. Potential factors of misclassification were then analyzed in order to evaluate the applicability of the new ILAE criteria for antiepileptic drug resistance in current clinical practice. Because of their complexity, use of the new ILAE criteria needs to be supported by relevant information and training to be adequately applied by neurologists in everyday practice.

Epidemiology and disease burden of tuberous sclerosis complex in France: A population-based study based on national health insurance data.

OBJECTIVE: Tuberous sclerosis complex (TSC) is a rare multisystem disorder, often associated with epilepsy. This retrospective study aimed to identify patients with TSC, including those with epilepsy, from a French healthcare claims database, and to report incidence, prevalence, and healthcare costs and resource utilization. METHODS: The anonymized French health insurance database (SNDS) covers almost the entire French population. Patients with TSC were identified as having ≥1 International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code Q85.1 or a long-term disease (LTD) registration over the inclusion period (2006-2017). Patients with an ICD-10 epilepsy code or who were dispensed ≥1 antiseizure medication (ASM) in the same year or after their TSC diagnosis were identified as having TSC with epilepsy. Newly diagnosed patients over the inclusion period constituted the incident cohort. Healthcare costs (patients with recorded costs only), healthcare resource use, and ASM dispensation are reported for patients with 2018 data. RESULTS: In 2018, 3139 prevalent patients with TSC were identified (crude prevalence, 4.69 per 100 000); the incident cohort comprised 2988 patients (crude incidence, 0.44 per 100 000). Among patients with TSC, 67% (2101/3139) had epilepsy (mean [standard deviation, SD] age: 28.8 [18.8] years; male: 48%). Among patients with epilepsy, total mean (SD) annual healthcare costs were €11 413 (27 620) per capita (outpatient, 63%; inpatient, 37%), 46% were hospitalized during 2018 (mean [SD]: 1.8 [10.9] acute care visits per patient), and 65% visited a hospital specialist. Among patients with epilepsy, medication (mean [SD]: €4518 [12 102] per capita) was the greatest contributor (63%) to outpatient costs, and in 2018, 74% were dispensed ≥1 different ASM and 9% were dispensed ≥4 ASMs. SIGNIFICANCE: TSC with epilepsy was associated with substantial healthcare costs and resource utilization, particularly outpatient and medication costs. Many patients with TSC with epilepsy were prescribed multiple ASMs, suggesting refractory epilepsy.

Patterns of Use and Clinical Outcomes with Long-Acting Somatostatin Analogues for Neuroendocrine Tumors: A Nationwide French Retrospective Cohort Study in the Real-Life Setting.

INTRODUCTION: Long-acting somatostatin analogues such as lanreotide autogel (LAN) and octreotide long-acting release (OCT) are recommended as first-line treatment for patients with neuroendocrine tumors (NETs). However, only few real-world studies have compared the two medications. This retrospective, observational cohort study used a French claims database to compare patterns of use with LAN vs. OCT in patients with NETs. METHODS: Data on LAN and OCT patterns of use were obtained retrospectively from the National System of Health Data (SNDS), a national French claims database. Patients 18 years of age or older who initiated treatment for NETs between 2009 and 2016, and who received at least six subsequent dispensings of first-line LAN or OCT during the first year of treatment, were included. A subgroup analysis was performed on patients with gastroenteropancreatic (GEP)-NETs. RESULTS: Patients receiving LAN (n = 2327) vs. OCT (n = 2090) had greater median treatment duration (31.8 months vs. 22.1 months, respectively; p < 0.0001; log-rank test) and were less likely to discontinue treatment; adjusted hazard ratio (HR) 0.74 (95% confidence interval [CI] 0.69-0.80). In year 1, a significantly lower percentage of patients receiving LAN vs. OCT switched treatments (10.4% vs. 22.2%, respectively; p < 0.0001), received an average monthly dose per trimester above recommended dose (3.0% vs. 7.3%, respectively; p < 0.0001), and used rescue medication (3.1% vs. 10.0%, respectively; p < 0.0001). Dispensing of pancreatic enzymes was significantly higher in patients receiving LAN than OCT (16.4% vs. 13.9%, respectively). In the subgroup of patients with GEP-NETs, those receiving LAN (n = 1478) vs. OCT (n = 1278) had greater treatment duration and less treatment discontinuation, switching, dosage above the recommended dose, and rescue medication use, but no significant difference in dispensing of pancreatic enzymes or time to second-line treatment. CONCLUSION: These real-world data suggest potential clinical and economic advantages of LAN over OCT in the management of patients with NETs in the French population.

Management and Health Resource Use of Patients With Metastatic Renal Cell Carcinoma treated With Systemic Therapy Over 2014-2017 in France: A National Real-World Study.

BACKGROUND: The introduction of novel systemic therapies for metastatic renal cell carcinoma (mRCC) over the last decade has significantly improved patient outcomes. Little information is available on treatment modalities and outcomes in everyday practice. The objective of this study was to describe patient characteristics, treatment patterns, and healthcare resource use in mRCC patients receiving systemic therapy in France (2014-2017), using the nationwide claims database. PATIENTS AND METHODS: Patients with a diagnosis of RCC (ICD-10: C64) between 2009 and 2017 and receiving a first systemic treatment for mRCC between 2014 and 2017 were eligible. Patients were divided into two groups at diagnosis, Group A: metastatic RCC and Group B: localized RCC. RESULTS: 4,929 eligible patients were identified (Group A: 2638 patients, 53.5%; Group B: 2,291 patients,46.5%). Median age was 66 years and 73% were men. In patients with incident RCC (N = 3,425), 62.3% underwent nephrectomy (94.4% in Group B). Within the year following mRCC diagnosis, 86.5% were hospitalized at least once; among them 58.1% for RCC. Nearly 31% of patients underwent radiotherapy. First line treatment was sunitinib for 65% of patients and pazopanib for 24%. Twenty five percent and 10% of patients received 2 and 3 lines of systemic treatment, respectively. The 2-year survival rate after mRCC diagnosis was 44%, with median overall survival of 20 [95%CI: 19-21] months (14 and 28 in Group A and B). CONCLUSION: This study documented patient characteristics, treatment patterns and survival outcomes in mRCC patients receiving systemic therapy in France (2014-2017). Estimated survival rates were consistent with real-world studies from other countries.

Frequency of hospitalisations and inpatient care costs of manic episodes: in patients with bipolar I disorder in France.

BACKGROUND: Bipolar disorder is a chronic illness that may involve multiple relapses and result in substantial psychosocial impairment. However, very few recent studies have investigated the economic burden of the disease. OBJECTIVE: To assess the frequency of hospitalisation and the inpatient care costs associated with manic episodes in patients with bipolar I disorder in France. METHOD: A cost-of-illness study was conducted based on available data using a hospital payer perspective. The lifetime prevalence of manic episodes was estimated from published epidemiological data using a random-effects meta-analysis. Data were obtained by a computerised literature search using the main scientific and medical databases. Additional epidemiological references were identified from published studies and textbooks. Data on frequency of hospitalisation and length of stay were collected from a large psychiatric university hospital. Data on unit costs for inpatient care were obtained from the accounting system of the largest hospital group in Paris, France for the year 1999. RESULTS: Extrapolating from international data on the average prevalence of bipolar I disorder, the proportion of rapid cycling patients and the average cycle duration, we estimated the annual number of manic episodes in patients with bipolar I disorder to be around 265,000 in France. Based on hospital data in Paris, the proportion of manic episodes that require hospitalisation was estimated to be around 63%. The average length of stay was 32.4 days and the hospitalisation-related costs were estimated to be around 8.8 billion French francs (Euro 3 billion) [1999 values]. CONCLUSION: Our study highlights the lack of medical and economic data on the frequency and hospitalisation-related costs of manic episodes in patients with bipolar I disorder in France. As the lifetime prevalence of bipolar I disorder may be as high as 3% among adults, further studies are required in order to provide representative national data and to allow economic evaluations of costs related to bipolar I disorder in France.