bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP95 An Update On The Economic Value Of A Statistical Life Year In Europe
Authors: Schlander Michael , Schaefer Ramon , Schwarz Oliver 
Published: January 2018

INTRODUCTION:Evaluation of “value for money” is an important component of Health Technology Assessments (HTAs). It is often conceptualized as “cost effectiveness” or cost per (quality-adjusted) life year gained. Whether used in isolation or alongside further drivers of social value (such as priority for younger or more severely impaired patient groups, or for access to effective treatment, even if costly), for example within a multi-criteria decision analysis framework, any reference “value of a statistical life year” (VSLY) should be supported by empirical data capturing the preferences of the population(s) in question. Here we report results based on a systematic review of relevant European economic studies, which were published during the last two decades, that is, from 1995 to 2015.METHODS:Our literature search (using the EconBiz and EconLit databases, supplemented by an analysis of relevant reviews) identified fourty-one European studies providing original data, yielding a total of fourty-eight average estimates for the value of a statistical life (VSL, or fatality prevented). We classified studies by methodology, for example, revealed preference (RP) or stated preference (contingent valuation, CV; discrete choice experiment, DCE) approach. We transformed VSL estimates into VSLY expressed in year 2014 Euros, using the life expectancy of the populations studied, a real discount rate of 3 percent, the national Consumer Price Index (CPI) for inflating, and purchasing power parities for currency conversion. We calculated confidence intervals by means of nonparametric bootstrapping.RESULTS:The median VSLY was EUR158,000 (for RP studies, EUR218,000; DCE, EUR188,000; CV, EUR143,000); we did not identify studies using the human capital approach. Our VSLY estimates showed large heterogeneity, both by methodology and regional origin; thus the differences that we observed did not reach statistical significance.CONCLUSIONS:Our results suggest that the empirical willingness-to-pay for a statistical life year might be substantially higher than benchmarks currently used by the international HTA community.
OP124 Can Registry Failures Be Compensated By Medico-Administrative Database
Authors: Lesquelen Anne , Ghazouani Aziza , Galmiche Hubert , Emery Gregory , Belorgey Chantal , Belghiti Jacques 
Published: January 2018

INTRODUCTION:Post-approval studies (PAS) constitute an important tool in medical devices (MD) assessment usually supported by registries. However, registries are often poorly designed or incomplete. The French health insurance databases are organized since 2003 into a digital data warehouse, the Système national d'information inter-régime de l'assurance maladie (SNIIR-AM), and is the main source of information on patients, hospital activity and associated expenditure. The aim of the study was to determine if these medico-administrative data can be sufficiently relevant to guide a renewal of MD reimbursement in the context of registry failure.METHODS:The initial PAS aimed to assess the impact of the guidelines on practice (characteristics of patients, type of stenosis, indications, use of cerebral protection system, surgical procedure) and to determine the 30-day cumulative morbidity and mortality rate of endovascular procedure associated with stenting. Medico-administrative databases provide information on age, sex, symptomatic or asymptomatic stenosis in-hospital mortality and long-term mortality (with a linkage to epidemiological data) and morbidity estimated by ischemic stroke.RESULTS:The database allowed selection of a cohort of 2,071 patients in whom carotid stenting was performed in 161 centers (40 percent of stents were implanted in 14 centers) with a follow-up of 1 year. Carotid stents were mainly implanted in asymptomatic patients (81.6 percent). Morbi-mortality in symptomatic patients at 30 days (9.2 percent: 5.7 percent stroke and 3.4 percent mortality) was similar with results observed in a French comparative study EVA-3S (9.6 percent: 2.8 percent stroke and 8.8 percent mortality). These data allow the concerned HAS (French Health Authority) committee to renew the reimbursement proposal of these stents.CONCLUSIONS:Medico-administrative database collecting robust criteria can be used to support reimbursement renewal of high risk implantable medical devices. The implementation of other criteria including the disease etiology and the complications imputability may allow to consider the use of these data for non-invasive MD.
OP141 Patient Relevant Outcome Measures As Predictors Of Healthcare Use In Multiple Sclerosis
Authors: Tinelli Michela , Efthymiadou Olina , Mossman Jean , Kanavos Panos 
Published: January 2018

INTRODUCTION:Multiple-sclerosis (MS) is a highly disabling chronic disorder affecting young adults with long term economic consequences on society that escalate as MS disability increases (1,2). In the long-term, progression of MS results in increased level of disability and most patients will eventually experience some degree of functional impairment of the nervous system that impacts on mobility as well as sensory and coordination issues, bladder and sexual functioning, and mood and cognitionon (2). This is usually accompanied by a deterioration of their quality of life. Patient relevant outcome measures (PROMS) are largely used to measure individual disability, and quality of life in MS (2). International evidence from the International Multiple Sclerosis Study (IMPrESS) (2) was used to quantify the relationship between healthcare resources utilisation and disability, quality of life in individuals with MS.METHODS:Multivariable logistic regression was performed in order to identify patient-related variables reporting disability (Barthel) and utility (EQ-5D) that predict use of healthcare services (visits to GP, specialists, nurses, hospitalisation and treatment) and work limitation within the participants of the IMPrESS.RESULTS:Reponses were collected from 1,152 individuals across 21 countries of which 74.3 percent (856) were useful for analysis. Preliminary findings indicated that for the pooled data sets both EQ-5D and Barthel scores were predictors of healthcare resource use, across different categories (p<.05), except for nurse visits (Barthel only; p<.09). Overall the association between PROM data and use of healthcare resources appeared to be stronger with EQ-5D compared to Barthel. EQ-5D appeared to also predict the impact of MS on loss of productivity (in terms of work limitation; p<.05).CONCLUSIONS:PROMs can be used to predict the economic consequences of MS on healthcare providers and society, but more research is needed to confirm the robustness of the evidence and its validity across individual healthcare system settings.
PP006 Ebola In The Netherlands: Costs Of Preparedness And Response
Authors: Suijkerbuijk Anita , Swaan Corien , Mangen Marie-Josee J. , Polder Johan , Timen Aura , Ruijs Helma 
Published: January 2018

INTRODUCTION:Between December 2013 and April 2016, an unprecedented epidemic of Ebola Virus Disease (EVD) took place. This epidemic urged countries all over the world to be prepared for the possibility of having an EVD patient (1). Besides morbidity and mortality of the disease, containment efforts also have economic consequences for society. In this study, costs of preparedness for and response to EVD made by the Dutch health system were estimated.METHODS:We used an activity-based costing method in which cost of personnel time targeted at preparedness, and response activities was based on a time recording system and interviews with key professionals of the organizations involved. In addition, patient days of hospitalizations, laboratory tests, personal protective equipment (PPE), as well as costs for additional cleaning and disinfection were acquired via the organizations. All costs are expressed at the 2015-euro price level.RESULTS:The estimated total costs of EVD preparedness and response in the Netherlands were averaged at EUR14.1 million, ranging from EUR7.6 to EUR24.9 million. There were thirteen possible cases clinically evaluated and one confirmed case, admitted through an international evacuation request, corresponding to approximately EUR1 million per case (2). Preparedness activities of personnel, especially of all ambulance care services and hospitals that could possibly receive a case, and expenditures on PPE, were the main cost drivers.CONCLUSIONS:The estimated total cost of EVD preparedness and response in the Netherlands was substantial. Costs made by healthcare organizations were higher than among public health organizations (3). Designating one ambulance care service and fewer hospitals for the assessment of possible patients with viral hemorrhagic fever or other highly infectious disease of high consequence might improve efficiency and reduce future costs. The experiences and collaboration of healthcare organizations that managed patients with possible EVD can serve as a valuable resource for future outbreaks of other highly infectious diseases.
PP009 Quality Assessment In A Clinical Setting: A Look Upstream From Health Technology Assessment
Authors: Fattal Julie , Goyer Caroline 
Published: January 2018

INTRODUCTION:Health Technology Assessment (HTA) has various areas of application, one of which is quality improvement activities in clinical settings. Using patients' satisfaction as indicator of quality of care can inform the ‘needs assessment’ of a clinical deparment.The principal aim of this study is to quantify patients’ satisfaction with the anesthesia services received perioperatively at our hospital, including physical discomfort and anesthesia care. To this end, we asked the following question: “In adult patients who undergo day surgery at our hospital, what is the level of satisfaction with the anesthesia services received perioperatively?" A second aim is to discuss how quality assessment and HTA can intertwine.METHODS:This is a quality assessment study, using a patient self-administered survey method.We included all patients who had a day-surgery at our hospital and we excluded those who cannot understand English or French, who present cognitive barriers, and those who were admitted the same day.Patients were recruited postoperatively in phase II of recovery, using a nonprobability convenience sampling method. We used a validated questionnaire which addresses the two dimensions of anesthesia care related our research question: (i) physical discomfort and (ii) satisfaction with anesthesia care. We added to this questionnaire, a supplemental question to measure satisfaction with preoperative anesthetic care. Parallel to this, we also gathered the data routinely collected by the recovery nurses during a 24 hour postoperative patient follow-up.RESULTS:We collected data from November 2015 to February 2016. A total of 156 questionnaires was completed. Two respondents (1.3 percent) said they were ‘unsatisfied’ or ‘very unsatisfied’ with the anesthesia care they received in general and thirty-six (23 percent) said they were ‘satisfied’. The most frequently reported physical discomfort symptoms were: thirst (78 percent), pain (72 percent), drowsiness (68 percent), cold (58 percent), and sore throat (54 percent).CONCLUSIONS:Our study suggests that, while reporting patients' level of satisfaction regarding various aspects of the anesthesia care they received, such quality assessment study can identify gaps in the use of existing methods and technologies and help in acquisition prioritizing.
PP032 Holistic Patient Access Processes Of Medical Devices In South Korea
Authors: Lee Sang-Soo , Lee Moo Yeol , Kim Veronica , Lee Kyungja , Kwon Young-Kwan 
Published: January 2018

INTRODUCTION:Historically, patient access processes of new and innovative medical devices including in-vitro diagnostics are made in the sequence of regulatory approval, new Health Technology Assessment (nHTA) approval, reimbursement coverage and coding finally reaching the pricing approval stage in South Korea. Although the individual patient access process has its own distinct objective and perspective, there are still opportunities for the authorities or agencies in charge to streamline their processes by working together to promote earlier patient access of new and innovative medical devices to patients without impacting their own decision making.METHODS:This research examined and analyzed the current policies about: patient access processes with a holistic viewpoint, industry-wide survey about patient access practices; case studies of two innovative medical devices for patient access in South Korea and also proposed new or alternative programs which can contribute to patient access harmonization efforts with a holistic approach.RESULTS:Historically, health authorities play defensive strategies by delaying the adoption of new and innovative medical devices and implementing certain periods (that is, 2 to 5 years) for a patient's out-of-pocket payment scheme. It is well illustrated with the statistic that only twenty-nine percent of new and innovative medical technologies which have successfully gone through the nHTA process were determined for reimbursement coverage in the past 7 years.The survey by the medical device industry to determine the patient access lead-time of innovative medical devices with a holistic perspective indicated significantly delayed patient access even considerabley exceeding the legally required decision-making lead time. The in-depth case studies with two innovative devices indicated the disadvantageous patient access processes to the innovator in terms of both final approval timing and the price level.CONCLUSIONS:The concurrent review process for reimbursement coverage decision making for medical procedures, medical devices and reimbursement coverage payment guidelines committed within the Health Insurance Review and Assessment Service shall be created. New programs to deal with uncertainty in reimbursement coverage decision making shall be considered such as coverage with evidence development, performance-based risk-sharing arrangement, multi-criteria decision analysis and economic evaluation.
PP033 Patient And Public Involvement In Health Technology Assessment: The Brazilian Experience
Authors: Mega Tacila , Silva Aline , Petramale Clarice , Rabelo Roberta 
Published: January 2018

INTRODUCTION:The National Committee for Health Technology Incorporation (CONITEC) (1) was created in 2011, when the participation of civil society in the Health Technology Assessment (HTA) process was formalized in Brazil. According to legislation, patient and public involvement (PPI) in HTA occurs through: public consultations (PC); representation of SUS (Brazilian Public Health System) users in the plenary of CONITEC and by public hearings in relevant cases. Due the incipient culture of social participation in Brazil, strategies involving better communication, direct participation and popular education were developed to broaden and qualify this participation.METHODS:•Case study about PPI strategies developed in 5 years of CONITEC•Analysis of documents and official records from the Brazilian Ministry of Health.RESULTS:Since its creation, the innovations of CONITEC regarding PPI were: creation of specific PC form to reproduce or represent the perspectives of patients and caregivers; summarized versions of technical reports written in a simplified language to improve users involvement; surveys prior to elaborating clinical guidelines, a bi-weekly educational program transmitted by streaming, and the recent launch of an HTA Users Guide and a mobile app.After the implementation of these strategies (which started in 2014), there was an increase of annual contributions, from 2,584 in 2014 to 13,619 in 2015. Most participants were patients, family members or caregivers. Surveys concerning clinical guidelines received about 3,000 contributions. There were thirty-seven published society reports until December 2016. The publication of the HTA Users Guide and other related actions increased the number of accesses to the CONITEC website and its subsection for social participation. The educational program had more than 800 online accesses in five months.CONCLUSIONS:These actions allowed expanding and qualifying PPI beyond what is legally defined, and it is possible to predict an increasingly favorable scenario regarding the patient and public participation in HTA in Brazil.
PP046 Screening In Women Vaccinated Against Human Papillomavirus: Governing Innovation
Authors: Rossi Paolo Giorgi , Carozzi Francesca , Federici Antonio , Ronco Guglielmo , Zappa Marco , Franceschi Silvia 
Published: January 2018

INTRODUCTION:In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age for cervical cancer (CC) screening from 2017. According to the National Prevention Plan 2014–18, HPV-based screening must be implemented for women ≥30 years old, following the Italian Health Technology Assessment (HTA) report recommendations (1). The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention.METHODS:The National Screening Monitoring Centre and the Italian Group for Cervical Screening, following a commitment by the Italian the Ministry of Health (MoH), identified the consensus conference as the most suitable method for addressing this topic. The objective was defining the best screening methods in girls vaccinated against HPV and the knowledge needs for defining evidence-based screening strategies. During the consensus celebration (24 November 2015) a jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews (2).RESULTS:The jury considered changing the screening protocols for girls vaccinated in their 12th year as appropriate. Tailored screening protocols based on vaccination status could be replaced by “one size fits all” protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with the HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5 years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their 15th year or later, the current protocol should be kept.CONCLUSIONS:As further action, in 2016 the Ministry of Health funded a Health Technology Assessment program of the new screening protocol proposed by the consensus conference and a cohort study for determining a safe interval in vaccinated women.
PP075 Has A Drug Replacement An Impact On Hospital Treatment? A Health Technology Assessment-debate
Authors: Riedel Rainer 
Published: January 2018

INTRODUCTION:Drug product changes occur in hospitals for different reasons: improved efficacy or tolerance of a drug, reduced costs, new pharmaceutical innovations or drug shortage (1). The aim of this analysis is to develop a process model for drug product changes and to determine a hospital specific threshold when product change is reasonable, provided that the efficacy and safety of the new product is economically reasonable (2).METHODS:The individual process steps at the Klinikum rechts der Isar in Munich (MRI) were recorded to develop a process model. The required expenditure of time for the different process modules was documented and a process cost calculation undertaken.RESULTS:Product changes can be divided into three groups: generic changes, identical active ingredient but different brand name, and complex drug changes with different active ingredients or changed drug formulation. The later change is associated with a higher demand for information, which is reflected in higher process costs. Relevant costs arise during the process of product purchase and on the ward. The cost per product change inclusive operating expenses at the MRI range (3) from EUR2,300 to EUR6,420 and depend on the frequency of prescription and the complexity of the product.CONCLUSIONS:This Health Technology Assessment (HTA) shows that main costs for a drug product change arise due to additional staff costs on the ward. Reasonable thresholds can aid in decision making when considering cost effectiveness and potential risks of the medication or patient safety.
PP076 Research On Drug Policy Change In China Since 2009 New Medical Reform
Authors: Ye Yingfeng , Ying XiaoHua 
Published: January 2018

INTRODUCTION:Drugs are a special commodity for treating diseases and protecting health. There are problems in China's drug research, production, distribution and use (1) thus the national drug policies, including government long-term frameworks and specific policies, play an important role (2). This study summarized and analyzed drug policies in China since the New Medical Reform, to determine patterns of policy change, and aiming to provide theoretical support for drug policy making for the world.METHODS:We downloaded all drug policies issued between April 2009 to December 2016 on State Council, National Development and Reform Commission, National Health and Family Planning Commission, China Food and Drug Administration websites. These documents were combined with academic articles to extract data, which was processed in Microsoft Excel 2013. We also use the Advocacy Coalition Framework to analyze dynamic factors for drug policy change in China.RESULTS:There are 113 drug policies during last 8 years on 4 websites; 76 of them are released by a single ministry. Thirteen, ten, ten, fifteen, seven, fourteen, twenty-six and eighteen policies are issued each year, respectively. Fifteen are classified in long-term frameworks, while the other ninety-eight are specific policies. And fourteen of ninety-eight policies are focusing on basic drug systems, while six are on centralized purchases, nine on public hospitals reform, seven on drug safety, sixteen on prices, fourteen on distribution, twelve on administration, five on traditional medicine, and fifteen on specific drugs.CONCLUSIONS:After the basic drug system was built in 2009, the government started to focus on its distribution over the next 7 years. Policies on centralized purchases are mainly issued in 2010 and 2015, and creative modes have been coming up since 2015. The Government cares not only about production safety, but also safety in sales. Prices were decided by government at first but then follow the market forces. Work focus shifted from the above contents to drug distribution, price, management and traditional medicine after 2012. The peak of policy releases occurred when the great reform took place, such as 2009 when reform began, and in 2012 the Twelfth Five-year plan began. There was a decrease in 2013 due to national leadership change (3). Overall, dynamic factors for policy change mainly are social conditions, public issues and opinions, and feedback on former policy effects.