Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease with an unpredictable course. An observational study was set up using the French hospital discharge database to describe the reasons, ...outcomes and costs of hospitalisations related to this disease. Patients newly hospitalised for idiopathic pulmonary fibrosis (ICD-10 code: J84.1) in 2008 were identified and followed for 5 years. As J84.1 includes other fibrotic pulmonary diseases, an algorithm excluding age<50 years and presence of a differential diagnosis in the following year was defined. Overall, 6,476 patients were identified; of whom 30% were admitted through the emergency unit and 12% died during their first hospitalisation. Most of patients were hospitalised at least once for one or several acute events (n = 5,635; 87.0% of patients), of whom 36.5% of patients with an acute respiratory worsening (in-hospital mortality of 17.0% and median cost of €3,224; interquartile range (IQR €889-6,092)), 43.7% of patients with a respiratory infection (in-hospital mortality of 29.5% and median cost of €5,432 (IQR, €3,620-9,115)) and 51.7% of patients with a cardiac event (in-hospital mortality of 35.7% and median cost of €4,584 (IQR, €2,803-6,399)); 30.2% of these events occurred during the first hospitalisation. Finally, the 3-year in-hospital mortality crude rate was 36.8%. This study is the first providing extensive data on hospitalisations in patients with pulmonary fibrosis, mostly idiopathic, in France, demonstrating high burden and hospital cost.
Objective A survey was performed in 5 European countries (France, Germany, Italy, Portugal, and Spain) to estimate the prevalence of fibromyalgia (FM) in the general population. Methods In each ...country, the London Fibromyalgia Epidemiological Study Screening Questionnaire (LFESSQ) was administered by telephone to a representative sample of the community over 15 years of age. A positive screen was defined as the following: (1) meeting the 4-pain criteria alone (LFESSQ-4), or (2) meeting both the 4-pain and the 2-fatigue criteria (LFESSQ-6). The questionnaire was also submitted to all outpatients referred to the 8 participating rheumatology clinics for 1 month. These patients were examined by a rheumatologist to confirm or exclude the FM diagnosis according to the 1990 American College of Rheumatology classification criteria. The prevalence of FM in the general population was estimated by applying the positive-predictive values to eligible community subjects (ie, positive screens). Results Among rheumatology outpatients, 46% screened positive for chronic widespread pain (LFESSQ-4), 32% for pain and fatigue (LFESSQ-6), and 14% were confirmed FM cases. In the whole general population, 13 and 6.7% screened positive for LFESSQ-4 and LFESSQ-6, respectively. 3The estimated overall prevalence of FM was 4.7% (95% CI: 4.0 to 5.3) and 2.9% (95% CI: 2.4 to 3.4), respectively, in the general population. The prevalence of FM was age- and sex-related and varied among countries. Conclusion FM appears to be a common condition in these 5 European countries, even if data derived from the most specific criteria set (LFESSQ-6) are considered.
Fibromyalgia syndrome (FMS) is an under-diagnosed disorder of unknown aetiology, characterized by chronic widespread muscular pain, often accompanied by somatic and psychological symptoms. Several ...studies have described the impact of FMS on patients' functionality, disability and quality of life. Other studies have reported on the burden to patients, healthcare payers and society. This review brings the existing evidence together and concludes that the patient burden of fibromyalgia is very high in comparison with many other conditions. The burden to healthcare payers and society is important as well, and can be mostly explained by factors not directly related to the treatment of FMS. Data suggest that the cost before diagnosis may even be higher than the cost after diagnosis. It is very likely that the combination of symptoms not only complicates the recognition and treatment of FMS, but also magnifies the burden of FMS. Despite the complex and controversial construct of this syndrome, the results in terms of patient, healthcare payer and societal burden are quite consistent.
Abstract
Background
There is a paucity of data on the epidemiology, survival estimates and healthcare resource utilisation and associated costs of patients with progressive fibrosing interstitial ...lung disease (PF-ILD) in France. An algorithm for extracting claims data was developed to indirectly identify and describe patients with PF-ILD in the French national administrative healthcare database.
Methods
The French healthcare database, the Système National des Données de Santé (SNDS), includes data related to ambulatory care, hospitalisations and death for 98.8% of the population. In this study, algorithms based on age, diagnosis and healthcare consumption were created to identify adult patients with PF-ILD other than idiopathic pulmonary fibrosis between 2010 and 2017. Incidence, prevalence, survival estimates, clinical features and healthcare resource usage and costs were described among patients with PF-ILD.
Results
We identified a total of 14,413 patients with PF-ILD. Almost half of them (48.1%) were female and the mean (± standard deviation) age was 68.4 (± 15.0) years. Between 2010 and 2017, the estimated incidence of PF-ILD ranged from 4.0 to 4.7/100,000 person-years and the estimated prevalence from 6.6 to 19.4/100,000 persons. The main diagnostic categories represented were exposure-related ILD other than hypersensitivity pneumonitis (n = 3486; 24.2%), idiopathic interstitial pneumonia (n = 3113; 21.6%) and rheumatoid arthritis-associated ILD (n = 2521; 17.5%). Median overall survival using Kaplan–Meier estimation was 3.7 years from the start of progression. During the study, 95.2% of patients had ≥ 1 hospitalisation for respiratory care and 34.3% were hospitalised in an intensive care unit. The median (interquartile range) total specific cost per patient during the follow-up period was €25,613 (10,622–54,287) and the median annual cost per patient was €18,362 (6856–52,026), of which €11,784 (3003–42,097) was related to hospitalisations. Limitations included the retrospective design and identification of cases through an algorithm in the absence of chest high-resolution computed tomography scans and pulmonary function tests.
Conclusions
This large, real-world, longitudinal study provides important insights into the characteristics, epidemiology and healthcare resource utilisation and costs associated with PF-ILD in France using a comprehensive and exhaustive database, and provides vital evidence that PF-ILD represents a high burden on both patients and healthcare services.
Trial registration
ClinicalTrials.gov, NCT03858842. ISRCTN, ISRCTN12345678. Registered 3 January 2019—Retrospectively registered,
https://clinicaltrials.gov/ct2/show/NCT03858842
Lung cancer has the highest mortality rate of all cancers worldwide. Non-small-cell lung cancer (NSCLC) accounts for 85% of all lung cancers and has an extremely poor prognosis. Afatinib is an ...irreversible ErbB family blocker designed to suppress cellular signaling and inhibit cellular growth and is approved in Europe after platinum-based therapy for squamous NSCLC. The objective of the present analysis was to evaluate the cost-effectiveness of afatinib after platinum-based therapy for squamous NSCLC in France.
The study population was based on the LUX-Lung 8 trial that compared afatinib with erlotinib in patients with squamous NSCLC. The analysis was performed from the perspective of all health care funders and affected patients. A partitioned survival model was developed to evaluate cost-effectiveness based on progression-free survival and overall survival in the trial. Life expectancy, quality-adjusted life expectancy and direct costs were evaluated over a 10-year time horizon. Future costs and clinical benefits were discounted at 4% annually. Deterministic and probabilistic sensitivity analyses were performed.
Model projections indicated that afatinib was associated with greater life expectancy (0.16 years) and quality-adjusted life expectancy (0.094 quality-adjusted life years QALYs) than that projected for erlotinib. The total cost of treatment over a 10-year time horizon was higher for afatinib than erlotinib, EUR12,364 versus EUR9,510, leading to an incremental cost-effectiveness ratio of EUR30,277 per QALY gained for afatinib versus erlotinib. Sensitivity analyses showed that the base case findings were stable under variation of a range of model inputs.
Based on data from the LUX-Lung 8 trial, afatinib was projected to improve clinical outcomes versus erlotinib, with a 97% probability of being cost-effective assuming a willingness to pay of EUR70,000 per QALY gained, after platinum-based therapy in patients with squamous NSCLC in France.
We aimed to assess the effectiveness and cost of patients with first line tyrosine kinase inhibitors (TKIs) sequence of first (1G) and second generation (2G) followed by osimertinib.
Using the French ...nationwide claims and hospitalization database, we analyzed non-small-cell lung cancer patients who had been treated with osimertinib between April 2015 and December 2017, after a first line treatment with a TKI-1G/2G.
The median time on treatment for sequential TKI-1G/2G followed by osimertinib was 34 months (95% CI: 31-46); 13 and 12months, respectively for TKI 1G or 2G and TKI 3G, respectively. The median overall survival for sequential TKI 1G or 2G followed by osimertinib was 37 months (95% CI: 34-42). The mean monthly costs per patient was €5162.
These results, in line with those observed during clinical trials, confirm the effectiveness of the sequence TKI-1G/2G followed by osimertinib in
-mutated non-small-cell lung cancer.
Abstract Objective To estimate the prevalence of fibromyalgia (FM) syndrome in the French general population. Methods A validated French version of the London Fibromyalgia Epidemiology Study ...Screening Questionnaire (LFESSQ) was administered via telephone to a representative community sample of 1014 subjects aged over 15 years, selected by the quota method. A positive screen was defined as: (1) meeting the 4-pain criteria alone (LFESSQ-4), or (2) meeting both the 4-pain and 2-fatigue criteria (LFESSQ-6). To estimate the positive predictive value of LFESSQ-4 and LFESSQ-6, this questionnaire was submitted to a sample of rheumatology outpatients ( n = 178), who were then examined by a trained rheumatologist to confirm or exclude the diagnosis of FM according to the 1990 American College of Rheumatology criteria. The prevalence of FM in the general population was estimated by applying the predictive positive value to eligible community subjects (i.e., positive screens). Results In the community sample, 9.8% and 5.0% screened positive for LFESSQ-4 and LFESSQ-6, respectively. Among rheumatology outpatients, 47.1% screened positive for LFESSQ-4 and 34.8% for LFESSQ-6 whereas 10.6% were confirmed FM cases. Based on positive screens for LFESSQ-4, the prevalence of FM was estimated at 2.2% (95% CI 1.3–3.1) in the French general population. The corresponding figure was 1.4 % (95% CI 0.7–2.1) if positive screens for LFESSQ-6 were considered. Conclusion Our findings suggest that FM is also a major cause of widespread pain in France since a point prevalence of 1.4% would translate in approximately 680,000 patients.
The economic consequences of the recent COVID-19 pandemic were substantial. However, direct medical costs in France have not been determined.
To describe patient characteristics, intensity of care, ...mortality, and direct medical costs in patients hospitalised for COVID-19 infections in France.
A retrospective study of the French national hospital claims database for 2020.
Hospital care.
All patients hospitalised for COVID-19 in 2020 were included and classified by hospitalisation duration into acute phase and prolonged COVID-19.
Stratification by intensity of care (Level 1: no or low-flow oxygen support; Level 2: non-invasive ventilation; Level 3: mechanical ventilation).
Cost of hospital care in 2020 Euros from a payer perspective.
199,455 patients were hospitalised for COVID-19 in France in 2020. 17,824 patients (8.9%) received mechanical ventilation and 32,602 patients (16.3%) died. Mean per patient cost was €5,510 ± 7,142. This cost was highest in patients receiving Level 3 care, patients aged >80 years and in those with prolonged COVID.
The economic burden of hospitalisations for COVID-19 infections in France during 2020 was substantial. The study provides robust baseline data to benchmark advances in the standard of care and to nurture epidemiological models.
Real-world evidence (RWE) can reinforce clinical trial evidence in health technology assessment (HTA).
Review HTA bodies' (HTAbs) requirements for RWE, real uses, and acceptance across seven ...countries (Brazil, Canada, France, Germany, Italy, Spain, and the United Kingdom) and outline recommendations that may improve acceptance of RWE in efficacy/effectiveness assessments and appraisals processes.
RWE requirements were summarized based on HTAbs' guidelines. Acceptance by HTAbs was evaluated based on industry experience and case studies.
As of June 2022, RWE methodological guidelines were in place in three of the seven countries. HTAbs typically requested analyses based on local data sources, but the preferred study design and data sources differed. HTAbs had individual submission, assessment, and appraisal processes; some allowed early meetings for the protocol and/or results validation, though few involved external experts or medical societies to provide input to assessment and appraisal. The extent of submission, assessment, and appraisal requirements did not necessarily reflect the degree of acceptance.
All the countries reviewed face common challenges regarding the use of RWE. Our proposals address the need to facilitate collaboration and communication with industry and regulatory agencies and the need for specific guidelines describing RWE design and criteria of acceptance throughout the assessment and appraisal processes.
Quantification of COVID-19 burden may be useful to support the future allocation of resources.
To evaluate the public health impact of COVID-19 in French ambulatory patients with at least one risk ...factor for severe disease.
A Markov model was used to estimate life years, costs, number of hospitalisations, number of deaths and long/prolonged COVID forms over a time horizon of 2 years. The hospitalisation probabilities were derived from an early access cohort, and the hospitalisation stay characteristics were derived from the French national hospital discharge database. Several scenario analyses were conducted.
The number of hospitalisations reached 256 per 1,000 patients over the acute phase (first month of simulation), and 382 per 1,000 patients over 2 years. The number of deaths was 37 per 1,000 patients, and the number of long/prolonged COVID forms reached 407 per 1,000 patients. These translated into a reduction of 0.7 days of life per patient in the first month, with an associated cost of €1,578, and a reduction of 27 days of life over the time horizon, with an associated cost of €4,280. The highest burden was observed for patients over 80 years old, and those not vaccinated. The scenarios with a less severe situation or new treatments available showed a non-negligible burden reduction.
This study allowed us to quantify the considerable burden related to COVID-19 in infected patients, with at least one risk factor for severe form. Strategies with the ability to substantially reduce this burden in France are urgently required.
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