bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP170 How Can Health Technology Assessment Participate In The Healthcare Quality Improvement?
Authors: Allouche Wafa , Gouddi Sami El , Allouche Emna , Mrabet Ali 
Published: December 2019

IntroductionProviding high-quality and affordable care is a big challenge facing policy makers, especially in low and middle income countries (LMIC). The purpose of this presentation is to illustrate how health technology assessment (HTA) benefits the improvement of the healthcare quality, and to highlight the fact that HTA domains match to the dimensions of health quality: safety, effectiveness, efficiency and patient-centeredness.MethodsThis presentation will be based on explaining the ability of HTA to improve the quality of healthcare. Some countries, mainly LMIC where resources are limited, do not have formal HTA whose goal is to inform the development of safe, effective and patient centered health policies. The theoretical concepts of HTA demonstrate a strong connection between HTA and healthcare quality improvement. By way of illustration an example of successful experiences will be given.ResultsThe presentation items are: - The definition of health technology - Introduction to health technology assessment as a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology. - Why is health technology assessment used, the identification of the HTA report domains including Safety, Clinical Effectiveness, Ethical analysis, Social aspects, Legal aspects and the importance of patient experience in HTA. - The identification of the six dimensions of healthcare quality and the determination of the connection between HTA and healthcare quality improvement. - A presentation of the international Decision Support Initiative (iDSI) experience in some LMIC.ConclusionsHTA has many meeting points with healthcare quality dimensions. HTA is likely to become an increasingly important influence in health decisions.
PP20 Challenges In The Health Technology Assessment Of New/Emergent Non-Pharmacological Technologies
Authors: Garcia Emmanuel Gimenez , Garcia Xavier , Reig-Viader Rita , Romero-Tamarit Arantxa , Gutiérrez-Ibarluzea Iñaki , Espallargues Mireia 
Published: December 2019

IntroductionThe methodological guides for the assessment of new/emerging non-pharmacological technologies differ from the traditional health technology assessment (HTA) guidelines developed by the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). The aim of this study is to identify the special features and challenges of carrying out HTA on new/emergent non-pharmacological technologies.MethodsThe application of traditional and new/emergent HTA guidelines is compared along the consecutive evaluation phases in four practical cases carried out at the Agency for Health Quality and Assessment of Catalonia (AQuAS) in 2017-2018.ResultsMain learning and outstanding challenges: (i) Instead of following a defined protocol, the evaluations are carried out from a preliminary short report which generates a lack of justification and delimitation of its scope. (ii) References’ identification and data extraction are often limited due to lack of studies, and sometimes require the use of grey literature or other sources less informative, for example, trial registries. It can be challenging to exclude references related to other indications. (iii) The assessment of resource use and costs of running the technology is complicated due to the lack of public prices information and specific impacts of use. (iv) The evidence considered during the assessment usually does not meet high quality requirements (risk of bias) because of indirect evidence, lack of comparator or no having clearly defined outcomes, among others. (v) It's difficult to draw conclusions and, consequently, recommendations due to abovementioned aspects and especially for the usual evidence gap that faces this type of technology in early stages of diffusion and/or in a competition situation of manufacturer companies.ConclusionsThe most recent innovation in non-pharmacological technologies merits a differentiated assessment approach. However, there is need to reconsider the methodology applied in order to overcome the challenges and limitations identified.
PP30 Do Conditional Regulatory Pathways Affect Health Technology Assessment Recommendations?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence 
Published: December 2019

IntroductionIn an effort to expedite the approval of drugs treating serious illnesses or addressing unmet medical need, conditional approvals have been used by the European Medicines Agency. In this study, the effects of conditional approvals were investigated in terms of health technology assessment (HTA) recommendations and timing in Europe.MethodsFirst HTA recommendations of new active substances (NASs) issued between 2015 and 2017 were collected from the National Institute for Health and Care Excellence (England), Haute Autorité de Santé (France), Institute for Quality and Efficiency in Health Care (Germany), Scottish Medicine Consortium (Scotland) and Tandvårds-Läkemedelförmånsverket (Sweden). The HTA recommendations were then classified into the following categories: positive, positive with restrictions, negative and multiple and if the regulatory approval pathway had been standard or conditional.ResultsOf this cohort of NASs that received an HTA recommendation, eight of 56 in England, 12 of 83 in France, 11 of 77 in Germany, nine of 58 in Scotland and four of 49 in Sweden were approved via a conditional review. Generally, except in England, there were a higher proportion of positive first recommendations for conditional approvals when compared to standard approvals, with Germany showing the largest proportional difference (43 percent) between the two pathways and also a faster time to recommendation. This may relate to the proportion of conditional assessments that were orphan medicines. With the exception of Germany, the time taken from regulatory approval to first HTA recommendation for products with conditional approvals is higher than those for standard approvals, with the largest difference seen in Sweden (241 days longer).ConclusionsConditionally approved NASs showed a variable HTA outcome; although there was generally a higher proportion of positive recommendations thus enabling more likely access in conditional approvals, the timing from regulatory approval to HTA recommendation was longer compared with standard approvals. This warrants a better understanding of the factors and uncertainties underlying these recommendations, supporting timely access of NASs with conditional approval.
PP41 Cost-Effectiveness Modeling Of Chimeric Antigen Receptor T-Cell Therapies
Authors: Teitsson Siguroli , Macaulay Richard 
Published: December 2019

IntroductionThis study has two key aims. The first is to review cost-effectiveness (CE) models for chimeric antigen receptor T-cell (CAR-T) therapies that have been appraised by health technology assessment (HTA) authorities. The second is to identify the key challenges of CE modeling of CAR-T therapies based on the main points raised in the HTA appraisals.MethodsA targeted HTA review of published CE models for CAR-T therapies in the United Kingdom (UK) and United States (US) was undertaken.ResultsFour relevant CE models were identified – three from the UK and one in the US. Of the three UK models, two were single technology submissions to the National Institute for Health and Care Excellence (NICE) and one was a ‘mock’ appraisal undertaken by NICE with a hypothetical evidence dataset. The one US model was published by the Institute for Clinical and Economic Review (ICER) committee. Two key model structures were adopted across the appraisals: a three-health state partitioned survival analysis model and a short-term decision tree followed by a three-health state partitioned survival model. The key modeling challenges identified can by summarized into five main categories: comparator evidence generation, estimation of long-term survival, curative benefit, health-related quality of life, and infrastructure/training requirements.ConclusionsThere are many challenges associated with the CE modeling of CAR-T therapies, with the most critical issues related to how uncertainty for long-term efficacy and safety can be addressed and mitigated. With more mature evidence sets in the future, stakeholders will get a clearer picture for the long-term benefit and risk of CAR-T therapies, but until then it is likely that HTA authorities will take a conservative stand when appraising the comparative value of CAR-T therapies.
PP54 A Cohort Case Study On Implantable Cardioverter Defibrillators
Authors: Soares dos Santos Augusto Cesar , Horta Maria da Glória Cruvinel , Fernandes Mariana , Rodrigues Luíza , Carvalho Lélia Maria de Almeida , Avelar Sandra de Oliveira Sapori , Pinto Elen Cristina , Scherrer Luciano Rios , Biscione Fernando Martin , Kelles Silvana Marcia 
Published: December 2019

IntroductionMany patients presenting with arrhythmias are treated with antiarrhythmic drug therapy. However, for some patients, usually survivors of previous serious ventricular arrhythmias, treatment implies the use of implantable cardioverter defibrillators (ICDs) and/or Cardiac Resynchronization Therapy (CRT) devices.MethodsThis retrospective study evaluated a cohort of patients with arrhythmia requiring the use of ICDs, CRT or ICDs + CRT from January 2004 to March 2018. Data from a private healthcare organization in Belo Horizonte, Brazil were used to assess all-cause mortality and the need for replacement of the device. Continuous variables were expressed as mean and standard deviation. Cox proportional regression model and Log-Rank test were used to adjust the survival curve.ResultsFive hundred and ninety-three patients were included in the study (median age 67.6 years, range 23 to 89 years; male 62 percent). According to the type of device used to treat these patients, the distribution was 338 (57.0 percent), 169 (28.5 percent), 86 (14.5 percent), for ICDs, ICDs + CRT, CRT, respectively. After a mean follow-up time of 3.12 years (range 0 to 13.6 years), 283 devices were replaced (ICDs n = 140; ICDs + CRT n = 90; CRT n = 53) and 284 deaths occurred (median survival of 6.9 years). The median survival was 7.3, 5.8, 4.8, 5.5 years for ICDs single-chamber, ICDs dual-chamber, ICDs + CRT, CRT, respectively.ConclusionsRandomized trials are often criticized for their enrollment of highly selected patients. Studies on real-word data can provide reliable information regarding the use of ICDs and/or CRT devices in the treatment of patients with serious ventricular arrhythmias.
PP72 Using INTEGRATE-HTA On The Example Of Rasterstereography For Scoliosis
Authors: Buchberger Barbara , Jastrzebski Kaya , Krabbe Laura 
Published: December 2019

IntroductionFull health technology assessment (HTA) reports discuss not only the safety and efficacy of a technology, but also the economic, ethical, legal, socio-cultural, and organizational aspects. INTEGRATE-HTA is a completed European Union project that developed concepts and methods for a patient-centered, integrated assessment of complex technologies. Technologies can be considered complex if they are characterized by a large number of interacting components, a wide variability of outcomes, or a high degree of flexibility. In contrast to the usual linear approach of addressing individual HTA domains separately, the INTEGRATE-HTA methodology is based on the assumption that different aspects of the domains interact. From the very beginning, these interactions are captured systematically using various tools. Continuous reflection and compaction of these relations can lead to an extended perspective on a technology. As a result, complexity and mechanisms of action open up, helping to channel public discussion and implementation. We investigated whether using the INTEGRATE-HTA methodology improves the understanding of individual domains and their interactions.MethodsAccording to the methodology, an initial logic model for rasterstereography in patients with scoliosis was developed and successively expanded. A synoptic table, showing multiple maps of individual aspects to domains, and a complexity checklist were used. In addition, harvest plots were created and the socio-cultural impact of the disease was highlighted as a semantic complex. A final logic model and an interaction figure were established to initiate discussion.ResultsHaving been classified as slightly complex in the beginning, rasterstereography turned out to be highly complex after using a variety of tools and a final graphical representation; the multiple mapping of individual aspects to domains resulted in a high density of interactions.ConclusionsThe INTEGRATE-HTA methodology helped to identify interactions between domains and significantly expanded the perspective on a technology. It improved patient-centered understanding and facilitated the discussion of single aspects.
PP87 Inpatient Drug Reimbursement: Approaches For A Democratic Process
Authors: Wolf Sarah , Wild Claudia 
Published: December 2019

IntroductionIn the context of limited healthcare resources and high healthcare expenditures, the introduction of new, cost-intensive medicines forces decision-makers to prioritize drug funding, especially in the areas of orphan diseases and oncology. In democratic societies, health policy decisions need to be evidence-based, transparent, fair, and efficient. Therefore, in some countries standardized (transparent) processes exist. In Austria, decisions on the reimbursement of new medicines have not been made for a long time. The aim of the present study was to develop different scenarios for a standardized, centralized reimbursement process for expensive hospital drugs in Austria that favors democratic decisions.MethodsA multi-stage approach was undertaken. Firstly, the reimbursement processes (only for original preparations) in Austria and other selected countries were investigated. Secondly, the strengths and weaknesses of these processes were analyzed based on predefined criteria, following the concepts of “accountability for reasonableness” (A4R) and “deliberative decision making”. Thirdly, scenarios for an Austria-wide uniform reimbursement process for hospital drugs were developed.ResultsThree scenarios were identified: (i) a reimbursement process for hospital drugs that follows the existing reimbursement process in the outpatient sector in Austria; (ii) a cooperative of decentralized Pharmaceutical and Therapeutics Committees for procurement, use, and reimbursement decisions for hospital drugs; and (iii) an adaptation of the existing reimbursement process of non-drug, highly specialized technologies to pharmaceutical interventions.ConclusionsAccording to the concepts of A4R and deliberative decision making, a transparent, evidence-based, fair, and efficient allocation of limited healthcare resources is indispensable for justifying decisions on health funding priorities in democracies. However, these criteria can be diametrically opposed. For example, methods, processes, and decisions can be evidence based, transparent, and fair, but also significantly more time consuming. Thus, a balance between the individual options for action is necessary, and priorities must be set.
PP88 Economic Impact Of New Diagnostic Tools In Severe Sepsis
Authors: Neeser Kurt , Oelze Ilse-Barbara , Müller Elvira 
Published: December 2019

IntroductionConstantly rising healthcare costs and the increasing incidence of antimicrobial resistance represent a growing burden on public health, affecting patients, physicians, payers, and health authorities. This analysis assessed the economic impact of improved diagnostic accuracy among septic patients.MethodsA cost-consequence model was developed to evaluate two different scenarios for the treatment of severe sepsis: scenario one represents the current status of diagnostic performance used for an antimicrobial treatment; scenario two is based on the assumption that a more accelerated diagnostic process results in 15 percent more patients being treated with an efficient antimicrobial drug early in their therapy. Data for the average patient-related cost for diagnostics (EUR 1,182) and overall cost (EUR 12,090), length of hospital stay (average 18.7 days), and number of patients affected annually (n = 771) were derived from the German Diagnosis-Related Group Catalog for 2017. Further, the impact of optimal versus inadequate therapeutic approaches on length of hospital stay (38% decrease), hospitalization cost (40% decrease), and mortality rate (28% decrease) were derived from published sources.ResultsBy using more efficient tests to enable earlier detection of sepsis in patients who otherwise would not receive appropriate treatment, 36 additional patients were appropriately treated. The overall annual length of hospital stay can be shortened by 319 days and the number of sepsis-related deaths reduced by three. The overall annual costs in scenarios 1 and 2 amounted to EUR 11.4 and EUR 11.2 million, respectively. The main savings resulted from reduced expenses for hospital stay, drugs, readmissions, and progression to septic shock.ConclusionsIncreasing cost pressure and the rise in multi-resistant germs are a burden, which will increase over the next decade. The present analysis showed that a willingness to intervene early and stop detrimental developments, and to invest in effective technologies, can promote affordable health care.
PP100 Unraveling Hospital-Based Health Technology Assessment In Brazil
Authors: Cardoso Ricardo Bertoglio , Cruz Luciane , Aziz Marina , Miguel Sandro , Cohen Mírian , Lima Ana Flávia 
Published: December 2019

IntroductionIn Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.MethodsThis study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.ResultsImportance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.ConclusionsThe multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.
PP108 Assessing CHA2DS2-VASc Score For Predicting Ischemic Stroke In The Non-Atrial Fibrillation Population
Authors: Wen Qiuyue , Shen Jiantong , Shen Lijuan , Zhang Yi , Jiang Qi , Wu Qianqian , Ying Yiyi , Jiang Jianping , Qian Mingjing , Liu Tian heng 
Published: December 2019

IntroductionCerebrovascular disease is the most common cause of death in China, and the incidence of ischemic stroke (240 per 100,000 people) is higher than that of hemorrhagic stroke (82 per 100,000 people). More than 80 percent of strokes can be prevented by early control of risk factors. Therefore, identifying and managing high-risk groups is a top priority in preventing stroke. The CHA2DS2-VASc score is a key prediction tool for stratifying stroke risk in individuals with atrial fibrillation (AF) as follows: zero score is low risk; one is intermediate risk; and two is high risk. The present study was undertaken to evaluate the accuracy of the CHA2DS2-VASc scoring system for stratifying ischemic stroke risk in the non-AF population.MethodsWe searched PubMed, EMBASE, and the Cochrane Library in June 2018 for relevant diagnostic studies. Study selection, data extraction, and quality assessment (using the QUADAS-2 criteria) were performed independently by two authors. Methodological variation across the selected studies precluded meta-analysis, so the results were synthesized narratively.ResultsSeven prospective studies involving 50,652 patients (6,760 with ischemic stroke) were included. The treatment threshold ranged from two to four across the studies. Three studies reported diagnostic accuracy at a threshold of two, with a sensitivity above 0.8 and a specificity ranging from 0.32 to 0.68. The diagnostic odds ratio was greater than two (seven studies). The two studies using a treatment threshold of four reported a sensitivity of 0.59 to 0.76 and a specificity of 0.43 to 0.69. One study used a threshold of three, with a sensitivity of 0.79 and a specificity of 0.39.ConclusionsThe CHA2DS2-VASc score may be used to predict ischemic stroke in the non-atrial fibrillation population. Treatment thresholds greater than two provide more optimal diagnostic accuracy, although the predictive performance of the CHA2DS2-VASc score may be better in patients with chronic obstructive pulmonary disease but not AF.