Real-world economic burden of hepatitis C and impact of direct-acting antivirals in France: A nationwide claims data analysis.

BACKGROUND AND AIMS: The economic impact of managing patients with hepatitis C virus (HCV) infection remains unknown. This study aimed to assess the economic burden of chronic HCV infection from a national health insurance perspective and the impact of direct-acting antivirals (DAAs) using nationwide real-world data. METHODS: Patients with chronic HCV infection were identified from the French Health Insurance Claims Databases (SNDS) and matched for age and sex to the general population. Health resource utilization and reimbursements were summarized according to healthcare expenditure items from 2012 to 2021. The economic burden attributable to chronic HCV infection was evaluated over a 10-year period. Finally, the impact of DAAs was estimated using economic data derived from the SNDS. RESULTS: A total of 145 187 patients with chronic HCV infection were identified. Among the patients eligible for DAA therapy, 81.5% had received DAA by the end of 2021. Over a 10-year period, managing patients with chronic HCV infection resulted in an additional cost of €9.71 billion (95% confidence interval [CI]: €9.66-€9.78 billion) or €9191 (95% CI: €9134-€9252) per patient per year compared to the general population. After DAA therapy, patients with chronic HCV infection had a higher economic burden than the general population, with an additional cost of €5781 (95% CI: €5540-€6028) per patient at the fifth-year post-DAA therapy. CONCLUSIONS: A significant economic burden persists among patients with HCV infection after DAA treatment. The high proportion of patients not treated with DAA therapy supports reinforcing policies for universal access.

Performance of algorithms for identifying patients with chronic hepatitis B or C infection in the french health insurance claims databases using the ANRS CO22 HEPATHER cohort.

The validity of algorithms for identifying patients with chronic hepatitis B or C virus (HBV or HCV) infection in claims databases has been little explored. The performance of 15 algorithms was evaluated. Data from HBV- or HCV-infected patients enrolled between August 2012 and December 2015 in French hepatology centres (ANRS CO22 HEPATHER cohort) were individually linked to the French national health insurance system (SNDS). The SNDS covers 99% of the French population and contains healthcare reimbursement data. Performance metrics were calculated by comparing the viral status established by clinicians with those obtained with the algorithms identifying chronic HBV- and HCV-infected patients. A total of 14 751 patients (29% with chronic HBV and 63% with chronic HCV infection) followed-up until December 2018 were selected. Despite good specificity, the algorithms relying on ICD-10 codes performed poorly. By contrast, the multi-criteria algorithms combining ICD-10 codes, antiviral dispensing, laboratory diagnostic tests (HBV DNA or HCV RNA detection and quantification, HCV genotyping), examinations for the assessment of liver fibrosis and long-term disease registrations were the most effective (sensitivity 0.92, 95% CI, 0.91-0.93 and specificity 0.96, 95% CI, 0.95-0.96 for identifying chronic HBV-infected patients; sensitivity 0.94, 95% CI, 0.94-0.94 and specificity 0.85, 95% CI, 0.84-0.86 for identifying chronic HCV-infected patients). In conclusion, the multi-criteria algorithms perform well in identifying patients with chronic hepatitis B or C infection and can be used to estimate the magnitude of the public health burden associated with hepatitis B and C in France.

Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial.

INTRODUCTION: Many smoking cessation aids such as nicotine replacement treatments and e-cigarettes have been proven effective in aiding smoking cessation attempts. Encouraging smokers with low socioeconomic position (SEP) to choose their smoking aid tool based on their preferences, and giving that tool free of charge, might increase the odds of smoking cessation. This trial examines the effectiveness of the 'STOP' (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking cessation using preference-based tools), a preference-based smoking cessation intervention for smokers with low SEP. METHODS AND ANALYSIS: The STOP study is a randomised, multicentre, controlled trial (RCT). Smokers with low SEP and wishing to quit will be randomised to either the intervention or the control group (standard care). Participants in the intervention group will be asked to choose between different types of nicotine substitutes (patches, inhalers, gum, tablets, etc) and/or an electronic cigarette which will be delivered free of charge to aid their smoking cessation attempt.The primary outcome will be smoking abstinence at 6 months after inclusion, defined as self-reported 7-day point prevalence of tobacco abstinence. Secondary outcomes include the total number of days of abstinence at 6 months after inclusion, 7-day point prevalence tobacco abstinence at 1 and 3 months after inclusion and number of relapses.The study will also include an economic evaluation, and a process evaluation using a mixed methods approach. ETHICS AND DISSEMINATION: The study was approved by the 'Île de France II' Institutional Review Board on 8 September 2020 (CPP Île de France II; Ref No: 20.01.31.65528 RIPH2 HPS), and results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04654585.

Model-based cost-effectiveness estimates of testing strategies for diagnosing hepatitis C virus infection in Central and Western Africa.

BACKGROUND: Whereas 72% of hepatitis C virus (HCV)-infected people worldwide live in low- and middle-income countries (LMICs), only 6% of them have been diagnosed. Innovative technologies for HCV diagnosis provide opportunities for developing testing strategies more adapted to resource-constrained settings. However, studies about their economic feasibility in LMICs are lacking. METHODS: Adopting a health sector perspective in Cameroon, Cote-d'Ivoire, and Senegal, a decision tree model was developed to compare 12 testing strategies with the following characteristics: a one-step or two-step testing sequence, HCV-RNA or HCV core antigen as confirmative biomarker, laboratory or point-of-care (POC) tests, and venous blood samples or dried blood spots (DBS). Outcomes measures were the number of true positives (TPs), cost per screened individual, incremental cost-effectiveness ratios, and nationwide budget. Corresponding time horizon was immediate, and outcomes were accordingly not discounted. Detailed sensitivity analyses were conducted. FINDINGS: In the base-case, a two-step POC-based strategy including anti-HCV antibody (HCV-Ab) and HCV-RNA testing had the lowest cost, €8.18 per screened individual. Assuming a lost-to-follow-up rate after screening > 1.9%, a DBS-based laboratory HCV-RNA after HCV-Ab POC testing was the single un-dominated strategy, requiring an additional cost of €3653.56 per additional TP detected. Both strategies would require 8-25% of the annual public health expenditure of the study countries for diagnosing 30% of HCV-infected individuals. Assuming a seroprevalence > 46.9% or a cost of POC HCV-RNA < €7.32, a one-step strategy based on POC HCV-RNA dominated the two-step POC-based strategy but resulted in many more false-positive cases. CONCLUSIONS: POC HCV-Ab followed by either POC- or DBS-based HCV-RNA testing would be the most cost-effective strategies in the study countries. Without a substantial increase in funding for health or a dramatic decrease in assay prices, HCV testing would constitute an economic barrier to the implementation of HCV elimination programs in LMICs.

Model-based cost-effectiveness estimates of testing strategies for diagnosing hepatitis C virus infection in people who use injecting drugs in Senegal.

BACKGROUND: Scaling-up the access to hepatitis C virus (HCV) diagnostics for people who use injecting drugs (PWID) is essential to reduce the HCV incidence in low and middle-income countries. METHODS: A decision tree model was developed to compare the cost-effectiveness of 12 strategies for diagnosing HCV in Senegal with a health sector perspective. Strategies included HCV-Ab screening and confirmation of viraemia (based on HCV-RNA or HCV core antigen detection) or only the latter step. Laboratory assays and decentralized tools (point-of-care (POC) tests and dried blood spot (DBS) samples) were included. The base-case assumed a 38.9% seroprevalence, as reported in the PWID population of Dakar. RESULTS: Compared to the cheapest strategy (POC HCV-Ab followed by POC HCV-RNA (S5)), one strategy remained un-dominated in the base-case: POC HCV-Ab followed by venepuncture-based laboratory HCV-RNA (S3). Above a lost to follow-up testing rate of 2.3%, combining POC HCV-Ab with HCV-RNA on DBS (S4) became more cost-effective than S3. Above this threshold, a single-step POC HCV-RNA (S12) was also found un-dominated (ICER to S5=€3,297.50). S5, S12 and S4 cost €14.21, €17.03 and €36.55/screened individual. Incremental cost-effectiveness ratios (€/additional true positive case) were 2,164.82 (S12 versus S5) and 3,297.50 (S4 versus S12). Whenever HCV seroprevalence reached 55.5%, S12 became more cost-effective than S5. Moreover, S4 required a budget 2 to 2.5 times higher than S5 or S12 for diagnosing 90% of HCV-infected PWID in Dakar. CONCLUSION: A two-step POC-based strategy (S5) would be the most cost-effective option among those proposed in this study for diagnosing HCV in PWID in Senegal. This study illustrates how the lack of secure financing and of data on PWID in LMICs, render difficult to identify the most sustainable strategy in those countries, as well as its implementation.

Structural features shared by ICUs belonging to research networks an international survey. "Critical care research network survey".

PURPOSE: Major acute care research is conducted within critical care research networks (CCRN). Our aims were to describe CCRN and participating ICUs. METHODS: A cross-sectional survey was conducted among all CCRNs belonging to the International Forum of Acute Care Trialists. A network questionnaire was sent to CCRN directors and an ICU e-questionnaire was sent to participating ICUS. RESULTS: Survey was answered by 366 ICUs from 17 CCRNs (median response rate 21% [12-38]). CCRNs have different organizations (ownership, memberships, funding). The number of studies conducted, patients included and publications varied a lot across CCRNs. The collaboration with other research networks or health authorities was very frequent (n = 13, 76%). Most ICUs (n = 315; 86%) are located in large teaching hospitals in high income countries with a mean volume of 968 (842-1102 (95% CI)) annual admissions. The recognition at the academic level (n = 133; 70%), the collaboration with experts (n = 284; 85%), and improving practices (n = 286; 86%) are incentives reported to belong to a CCRN. CONCLUSIONS: Despite different organizations, CCRN share similar ventures including the value of improving quality of critical care delivery. Participating ICUs share several structural and managerial patterns. These observations enlighten the importance of CCRN to enhance quality of critical care delivery.

Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial.

STUDY OBJECTIVE: This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments. METHODS: In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis. RESULTS: During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis. CONCLUSION: The combined strategy of targeted screening and diagnostic testing was effective.

Simulation-Based Estimates of the Effectiveness and Cost-Effectiveness of Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease in France.

BACKGROUND: The medico-economic impact of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) is poorly documented. OBJECTIVE: To estimate the effectiveness and cost-effectiveness of pulmonary rehabilitation in a hypothetical cohort of COPD patients. METHODS: We used a multi-state Markov model, adopting society's perspective. Simulated cohorts of French GOLD stage 2 to 4 COPD patients with and without pulmonary rehabilitation were compared in terms of life expectancy, quality-adjusted life years (QALY), disease-related costs, and the incremental cost-effectiveness ratio (ICER). Sensitivity analyses included variations of key model parameters. PRINCIPAL FINDINGS: At the horizon of a COPD patient's remaining lifetime, pulmonary rehabilitation would result in mean gain of 0.8 QALY, with an over disease-related costs of 14 102 € per patient. The ICER was 17 583 €/QALY. Sensitivity analysis showed that pulmonary rehabilitation was cost-effective in every scenario (ICER <50 000 €/QALY). CONCLUSIONS: These results should provide a useful basis for COPD pulmonary rehabilitation programs.

The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

BACKGROUND: In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. METHODS/DESIGN: DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in the control and targeted groups respectively, a sample size of 140,000 patients was estimated corresponding to 8,750 patients per ED and per period. Inclusions started in June 2014. Results are expected by mid-2016. DISCUSSION: The DICI-VIH study is the first large randomized controlled trial designed to assess nurse-driven targeted HIV screening. This study can provide valuable information on HIV screening in health care settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02127424 (29 April 2014).

Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study.

OBJECTIVE: To describe epidemiology and outcome of critically ill homeless patients, as compared with those of nonhomeless patients. DESIGN: Homeless and nonhomeless admissions were matched on the basis of a 1:4 ratio, using a propensity score-based procedure involving age, sex, date, and main diagnosis at ICU admission. SETTING: A 18-bed closed medical ICU of a French tertiary care university hospital. PATIENTS: All consecutive admissions from July 2000 to December 2012. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 421 homeless and 9,353 nonhomeless admissions. Considering homeless admissions, 50% patients had no health insurance, 56% had no financial resource, 91% were socially isolated, and 69% lived in street. In a multivariable analysis of homeless admissions including age, sex, and Simplified Acute Physiology Score II, living in street was significantly associated with hospital mortality (odds ratio=2.94; 95% CI, 1.30-7.10; p=0.012). As compared with nonhomeless, homeless admissions more frequently concerned men (89% vs 57%; p<0.0001) and younger patients (49 yr [43-57] vs 62 yr [46-76]; p<0.0001), whereas Simplified Acute Physiology Score II (37 [24-50] vs 37 [25-52]; p=0.99) and distribution of the number of organ supports (p=0.49) were similar. ICU mortality concerned 19.1% and 18% of matched homeless and nonhomeless admissions, respectively. The corresponding figures for hospital mortality were 20.8% and 20.6%. In multivariable analysis, homeless status was associated with neither ICU (odds ratio=1.27 [0.92-1.73]; p=0.14) nor hospital mortality (odds ratio=1.07 [0.77-1.49]; p=0.68), while it was independently associated with longer ICU (means ratio=1.16 [1.01-1.34]; p=0.035) and hospital (means ratio=1.30 [1.12-1.49]; p=0.0002) stay of survivors. CONCLUSIONS: Critically ill homeless patients benefit from the same level of care and have globally the same prognosis than housed patients but experience longer lengths of stay. Most precarious patients living in street have a higher mortality rate. The study perspective is not ICU centered but also concerns the global organization of healthcare since homeless patients are referred by numerous sources and discharged to different wards.

EpiBasket: how e-commerce tools can improve epidemiological preparedness.

BACKGROUND: Should an emerging infectious disease outbreak or an environmental disaster occur, the collection of epidemiological data must start as soon as possible after the event's onset. Questionnaires are usually built de novo for each event, resulting in substantially delayed epidemiological responses that are detrimental to the understanding and control of the event considered. Moreover, the public health and/or academic institution databases constructed with responses to different questionnaires are usually difficult to merge, impairing necessary collaborations. We aimed to show that e-commerce concepts and software tools can be readily adapted to enable rapid collection of data after an infectious disease outbreak or environmental disaster. Here, the 'customers' are the epidemiologists, who fill their shopping 'baskets' with standardised questions. METHODS: For each epidemiological field, a catalogue of questions is constituted by identifying the relevant variables based on a review of the published literature on similar circumstances. Each question is tagged with information on its source papers. Epidemiologists can then tailor their own questionnaires by choosing appropriate questions from this catalogue. The software immediately provides them with ready-to-use forms and online questionnaires. All databases constituted by the different EpiBasket users are interoperable, because the corresponding questionnaires are derived from the same corpus of questions. RESULTS: A proof-of-concept prototype was developed for Knowledge, Attitudes and Practice (KAP) surveys, which is one of the fields of the epidemiological investigation frequently explored during, or after, an outbreak or environmental disaster. The catalogue of questions was initiated from a review of the KAP studies conducted during or after the 2003 severe acute respiratory syndrome epidemic. CONCLUSION: Rapid collection of standardised data after an outbreak or environmental disaster can be facilitated by transposing the e-commerce paradigm to epidemiology, taking advantage of the powerful software tools already available.

Simulation-based estimates of effectiveness and cost-effectiveness of smoking cessation in patients with chronic obstructive pulmonary disease.

BACKGROUND: The medico-economic impact of smoking cessation considering a smoking patient with chronic obstructive pulmonary disease (COPD) is poorly documented. OBJECTIVE: Here, considering a COPD smoking patient, the specific burden of continuous smoking was estimated, as well as the effectiveness and the cost-effectiveness of smoking cessation. METHODS: A multi-state Markov model adopting society's perspective was developed. Simulated cohorts of English COPD patients who are active smokers (all severity stages combined or patients with the same initial severity stage) were compared to identical cohorts of patients who quit smoking at cohort initialization. Life expectancy, quality adjusted life-years (QALY), disease-related costs, and incremental cost-effectiveness ratio (ICER: £/QALY) were estimated, considering smoking cessation programs with various possible scenarios of success rates and costs. Sensitivity analyses included the variation of model key parameters. PRINCIPAL FINDINGS: At the horizon of a smoking COPD patient's remaining lifetime, smoking cessation at cohort intitialization, relapses being allowed as observed in practice, would result in gains (mean) of 1.27 life-years and 0.68 QALY, and induce savings of -1824 £/patient in the disease-related costs. The corresponding ICER was -2686 £/QALY. Smoking cessation resulted in 0.72, 0.69, 0.64 and 0.42 QALY respectively gained per mild, moderate, severe, and very severe COPD patient, but was nevertheless cost-effective for mild to severe COPD patients in most scenarios, even when hypothesizing expensive smoking cessation intervention programmes associated with low success rates. Considering a ten-year time horizon, the burden of continuous smoking in English COPD patients was estimated to cost a total of 1657 M£ while 452516 QALY would be simultaneously lost. CONCLUSIONS: The study results are a useful support for the setting of smoking cessation programmes specifically targeted to COPD patients.

Economics of treatments for non-small cell lung cancer.

The purpose of this article is to review the economics of treatments for non-small cell lung cancer (NSCLC). We systematically analysed the cost effectiveness of treatments for the different stages of NSCLC, with particular emphasis on more recently approved agents. Numerous economic analyses in NSCLC have been conducted, with a variety of methods and in a number of countries. In patients with localized disease, adjuvant chemotherapy appears to have greater cost effectiveness than observation; however, there are few published data. In locally advanced disease, combined modalities (chemotherapy, surgery and/or radiotherapy) are probably cost effective, but high-quality economic analyses are lacking. In advanced NSCLC, third-generation chemotherapies used in the first-line setting can be administered with acceptable incremental cost effectiveness. In the second-line setting, new agents (docetaxel, pemetrexed and erlotinib) have acceptable cost effectiveness. The lack of cost-utility analyses for elderly patients and patients with a poor prognosis rules out firm conclusions. This review suggests that most therapies for NSCLC are cost effective when the patient has a good performance status, with an incremental cost-effectiveness ratio under USD 50,000 per life-year gained in the majority of cases.

Cost-benefit analysis of a simulated institution-based preoperative smoking cessation intervention in patients undergoing total hip and knee arthroplasties in France.

BACKGROUND: The literature on preoperative smoking cessation indicates that smoking patients are more likely to have postoperative complications. However, the economic implications of such complications are unclear. In particular, the balance between the cost of a preoperative intervention for smoking cessation (PISC) and the benefit resulting from the potential decrease in hospitalization costs is not known. METHODS: Only one previous study, a randomized trial involving smokers scheduled for hip or knee replacement surgery, provides sufficient data to simulate the hospital course of patients subjected or not subjected to a PISC. We used a multistate Markov-type model and official French hospital costs for 2008 to simulate this situation. The cost-benefit analysis adopted the payer's perspective. RESULTS: The mean benefit, corresponding to the decrease in the cost of the hospital stay for a reference case patient having followed a PISC, was estimated at 313 euros, with a corresponding mean cost of the PISC estimated at 196 euros. Therefore, the PISC was associated with a cost saving of 117 euros per patient. The results were most sensitive to the cost of ICU care as a proxy for cost of smoking-related complications, and to the relative risk of complication between patients with and without a PISC. CONCLUSION: Under the conditions simulated by this cost-benefit model, potential modest cost savings may accrue with implementation of an institution-based smoking cessation program through reduced total hospitalization costs that exceed the cost of the intervention.