bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP96 Assessing Impact Of UK Health Technology Assessment Programme Trials
Authors: Carroll Christopher , Tattersall Andy 
Published: December 2019

IntroductionCitation analysis is a standard tool for measuring the impact and influence of scientific work. One purpose behind controlled trials is to answer clinical and policy questions and to contribute directly or indirectly (contributing to systematic review and meta-analyses) to the production of practice guidance. The citation of trials within systematic reviews and policy or guidance documents therefore represents an authentic and meaningful measure of impact.MethodsAll 136 randomized controlled trials published by the United Kingdom (UK) Health Technology Assessment (HTA) programme in a 10-year period (2006-2015) were identified. Web of Science citation index was used to collect citation data relating to each trial. Altmetrics were used to identify additional policy and guidance documents. Citation data were collected and tabulated, and descriptive statistics produced. Additional data were collected for principal ‘spin-off’ publications.ResultsEighty-eight percent of trials were cited by at least one Cochrane or non-Cochrane systematic review or meta-analysis; 37 percent by at least one Cochrane review (90 Cochrane reviews in total); 85 percent by at least one non-Cochrane systematic review or meta-analysis (365 in total). Forty-four percent of trials were cited by at least one unique piece of published policy or guidance. Mean number of review citations per published trial: 25.30; mean number of systematic reviews/meta-analyses per trial: 3.34; mean number of guidance documents per trial: 0.85. Trial investigators published the primary clinical outcome data in 27 additional peer-reviewed journal articles, generating citations in a further 66 unique reviews and 22 unique guidance documents.ConclusionsBased on the payback model, this sample of 136 UK HTA trials represent meaningful impact: 88 percent of trials were cited in systematic reviews and 44 percent in guidance documents. Chronological data indicate that there might be a sizeable time-lag between publication and impact, especially for policy documents and Cochrane reviews.
OP103 Incorporating Health Technology Assessment In The Development Of A Clinical Care Pathway
Authors: Benkhalti Maria , Dagenais Pierre 
Published: December 2019

IntroductionClinical care pathways (CPWs) provide a step-wise multidisciplinary care plan for patients with a particular health condition. Their aim is to optimize patient outcomes and organization of care by supporting evidence-based practice. It therefore seems inevitable that health technology assessment (HTA) should be incorporated within the development process of a CPW. As CPWs become increasingly utilized, there is a need to understand the added value and strategies to integrating HTA in the development of a CPW.MethodsThrough a case study of an HTA on treatments for chronic low back pain requested as part of the development of a CPW for chronic musculoskeletal pain, we demonstrated the three key strategies to include HTA in CPWs described by Rehaluk 2016 and added a fourth one. We then showed how these strategies contribute to the development of a CPW which answers the quality criteria outlined by the Cochrane Effective Practice of Care group through a strength, weaknesses, opportunities, and threats analysis.ResultsWe confirmed four key strategies to including HTA in CPWs (organizational positioning of the HTA unit, partnership and communication with stakeholders, tailoring the integration of contextual data with evidence from the literature, explore tools to facilitate the use of HTA findings). The inclusion of HTA through these strategies contributes to the development of a CPW which meets the ten criteria to evaluate the quality of a CPW outlined by the Cochrane Effective Practice of Care group. Through a strength, weaknesses, opportunities, and threats analysis, we describe how each of the criteria were met and how this led to recommendations influencing our regional organization of care.ConclusionsThe inclusion of HTA in CPW development increases its capacity to directly influence organization of care. HTA can represent a pivotal vehicle to ensure good quality CPWs.
OP124 Disinvestment – A Global Challenge Requiring Collaboration?
Authors: Warner Mary 
Published: December 2019

IntroductionAustralia has had some success at utilizing Health Technology Assessment (HTA) to disinvest and reassess medical services. This has been achieved through a range of methods including identifying services through initiatives such as ‘Choosing Wisely’, examining real world service data and seeking expert clinical opinion. This presentation will discuss how better international collaboration in disinvestment and reassessment methods using HTA could lead to more efficient health care systems.MethodsBoth the Australian and South Korean governments have a particular interest in disinvestment and reassessment in their health care systems. These countries have been sharing information over the past two years with a common goal of improving their health systems through a rigorous reassessment process. The Australian Government is in the process of reviewing all publicly funded services utilizing expert clinical committee advice, often referring the reassessment of services to a HTA process. A similar process is also being undertaken in South Korea.ResultsAustralia has disinvested in a wide range of services using HTA, including hip arthroscopy, lipectomy and hyperbaric oxygen therapy. It is also undertaking an extensive reassessment of 5,700 services. Reassessment may not lead to HTA, but it often includes an examination of whether a service should be subjected to HTA to remain publicly funded. Australia and South Korea have similar approaches in undertaking disinvestment and reassessment. HTA disinvestment and reassessment strategies have generated good outcomes for consumers, health care providers and funders in both countries.ConclusionsDisinvestment and reassessment of medical services require funders that support the continual improvement of health care systems. Disinvestment and reassessment HTA can be difficult, mainly due to external interests - an issue experienced by many countries. Further international collaboration in this area may provide a more supportive environment to undertake HTA for disinvestment.
OP152 Pharmacoeconomic Assessment And Drug Expenditure Reduction In Ireland
Authors: Kennedy Cormac 
Published: December 2019

IntroductionAll new products to be reimbursed from the Irish health budget are subject to a rigorous assessment by the National Centre for Pharmacoeconomics (NCPE). Following assessment, a recommendation is made regarding its cost-effectiveness at the submitted price. This may lead a reduction in the drug price. This study aimed to determine the reduction in expenditure due to the pharmacoeconomic assessment process in Ireland.MethodsProduct details, submitted price and gross budget impact were recorded for each NCPE submission from 2012 to 2015. The latter was chosen as reimbursement data are currently available until 2016. A product was included if its assessment suggested price reduction was required and the product was reimbursed under the High-Tech Drug Scheme (HTDS), a scheme for high cost drugs in a primary care setting. The utilization and actual expenditure of each product was extracted from national reimbursement data for the year after approval. The expected expenditure, calculated using the submitted price, was then compared to the actual expenditure.ResultsA total of 162 products were assessed during the study period. There was a potential price reduction for 65 products based on the assessment outcome. Of these, 15 were reimbursed under the HTDS. A reduction in expenditure was evident for eight of the 15 products (53 percent). The average reduction was eight percent of the expected expenditure. All products showed an actual expenditure greater the predicted budget impact submitted by the applicant.ConclusionsTo the authors’ knowledge, this is the first report of expenditure reduction due to a pharmaco-economic assessment process. With the ever-increasing utilization of high cost drugs, the study demonstrates the importance of a process to assess and negotiate cost-effective drug prices. However, the study underestimates reductions, as it is yet to include commercial rebates returned to a central budget. Future research will aim to capture these reductions.
OP169 Implementation Of A Quality Management System In The Spanish Network Of Health Technology Assessment
Authors: Márquez-Peláez Sergio , Viguera-Guerra Isabel , Molina-Lopez Teresa , Amaro Juan-Antonio Blasco ,   Workgroup REDETS
Published: December 2019

IntroductionThe Spanish network of health technology assessment (HTA) agencies (REDETS) is a collaboration of eight agencies, units and services, commissioned by the national and regional governments. The network coordinates work within a common methodological and work framework, guided by the principles of mutual recognition and cooperation. In 2016, a common self-assessment quality tool was developed for the implementation of an overall Quality Management System. Currently we are working on the second step that deals with actions about management, joint activities as a network, and organizational aspects of the network.MethodsA structured search strategy in the main electronic databases and a manual search in websites of networks national and international agencies were carried out in June 2017, in order to gather previous knowledge and developed standards. Through the information included in this review, and with the collaboration of all members, a group of standards for REDETS was developed. Finally, standards proposed were discussed in a face-to face meeting until an agreement was reached.ResultsA proposal of 31 standards was put forward taking all the collected information. The aim of each standard was defined, and its level of compliance was specified. Those standards were grouped under nine quality criteria structured in four dimensions: (i) Responsibility and Resources, (ii) Performance and Membership, (iii) Procedures, and (iv) Relations.ConclusionsBased on the gathered information and the agreement of the all members, we developed a toolkit embracing a group of standards for the joint activities within the Spanish Network, network administration and management. It is a complementary instrument of the previous self-evaluating tool, following the establishment of an overall quality management system and under the philosophy of continuous improvement processes.
PP21 High Risk Class Medical Devices Evaluation In Germany: Another Arzneimittelmarkt-Neuordnungsgesetz?
Authors: Müller Elvira , Oelze Ilse-Barbara , Neeser Kurt 
Published: December 2019

IntroductionIn 2011 the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) evaluation process for new drugs was implemented in Germany. Since then, the evidence requirements follow high standards and results impact reimbursement price negotiations. More recently, in 2016, a legal norm (§137h SGBV) to evaluate new treatment and diagnostic methods (MDs) of high risk classes by the Federal Joint Committee (G-BA) was introduced. The requirements, involved stakeholders, timing and results for both processes are outlined and compared.MethodsMethodological guidelines from G-BA and Institute for Quality and Efficiency in Health Care (IQWiG), consultations and evaluations for MDs according to §137h and for drugs according to AMNOG were reviewed and compared. Published assessment results were analyzed according the decision criteria and impact on price negotiations with Statutory Health Insurance.ResultsHospitals need to submit jointly with the manufacturer comparative evidence on clinical efficacy, safety and cost when applying for additional compensation (Neue Untersuchungs- und Behandlungsmethoden [NUB] application) for new high risk class MDs being subject to §137h. A fast track assessment by IQWiG/G-BA follows within four months resulting in benefit proven, potential benefit or no benefit compared to alternatives. The latter can lead to exclusion from reimbursement. Until now one MD was granted a benefit, two treatments were assigned a potential benefit and six MDs no benefit, while 55 percent of drugs evaluated under AMNOG were granted an additional benefit. Compared to drugs, the required evidence for MDs is similar. Whereas assessment time is shorter, manufacturers can seek advice from G-BA upfront for free and need to collaborate closely with hospitals.ConclusionsHalf of MDs examined did not qualify for an assessment under §137h. Unlike for drugs evaluated under AMNOG, the majority of new MDs failed to be granted potential benefit as a treatment alternative and might be excluded from reimbursement. Manufacturers are challenged to generate high quality, comparative evidence within their studies.
PP26 Shift From Regional To Federal Funding: Methodological Considerations
Authors: Newton Skye , Kessels Sharon , Vogan Arlene , Merlin Tracy 
Published: December 2019

IntroductionAustralia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.MethodsSeveral HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.ResultsEvery HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.ConclusionsThe benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.
PP28 Adoption Of Non-Pharmaceuticals In Galicia: Beyond Conventional Health Technology Assessment
Authors: Varela-Lema Leonor , Zapata-Cachafeiro Maruxa , Pego Yolanda Triñanes , Vallés Maria José Faraldo 
Published: December 2019

IntroductionThe specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.MethodsIn depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.ResultsA multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).ConclusionsRigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.
PP31 Medical Device Regulation: What Is New?
Authors: Oelze Ilse-Barbara , Neeser Kurt , Müller Elvira 
Published: December 2019

IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.
PP66 Increasing Burden Of Out-Of-Pocket Healthcare Expense On Patients
Authors: Arora Rhythm , Dugar Nikhil , Saxena Vandit , Jaiswal Sunil K. , Kumari Chitresh , Cook Nigel , Furio Olga 
Published: December 2019

IntroductionWe conducted an analysis of the key factors triggering cost-sharing mechanisms to understand the status of out-of-pocket (OOP) healthcare expense in the United States (US), Europe, and emerging markets and better appreciate the implications of OOP healthcare expense on patients’ health management.MethodsA review of literature and databases including The Organisation for Economic Co-operation and Development (OECD) and World Bank was performed to understand different cost-sharing mechanisms, factors triggering OOP expenditure and the country-wise trends of OOP expenditure. Additionally, the impact of OOP expenditure on healthcare budget and on patients in terms of medication adherence, uptake of newer therapies and generic substitution was explored.ResultsThe findings reveal that patients are concerned about rising healthcare OOP costs, and we observed an increase of 134 percent in the number of articles published on OOP from 2005 to 2017. The percentage of household spending that goes OOP as healthcare expense is higher in Brazil, Russia, India, and China (BRIC countries; ~11 percent) compared to France, Germany, Italy, United Kingdom, US, Japan, and Canada (G7 countries; ~2 percent). In addition, OOP expenditure increased with age (1.9 percent of take home income in 55-64 age group versus 1.2 percent in 18-25 age group) and is higher in the low-income population (2.8 percent of take home income versus 1 percent in high-income group). Whereas, increasing OOP expenditure reduces the overall healthcare expenditure due to generic substitution (28 percent reduction) and reduction in excessive consumption of supplementary medicines, it also reduces patient adherence (~20 percent decline in dispensed prescriptions) and may foster a reluctance to adopt newer therapies.ConclusionsThe population groups most impacted by increasing OOP expense are the older population, those in the low-income bracket and in poorer countries. While OOP expense may help in the effective and judicious utilization of healthcare system resources and medicines usage, its implementation requires a cautious and considered approach.