bluuebunny/crossref_metadata_2025_split huggingface dataset:
Regulating Parties by Constitutional Rules in Liberal Democracies
Authors: Santos Botelho Catarina , Garoupa Nuno 
Published: December 2023

AbstractWhen establishing constitutional rules that regulate political parties, liberal democracies struggle between civil liberties—thus tolerating anti-democratic parties—and potential threats of democratic breakdown, which can be reduced by prosecuting and prohibiting anti-democratic parties. We suggest that liberal democracies must balance false positives and false negatives by combining ex ante and ex post regulatory mechanisms. By making use of a unique dataset of thirty-seven liberal democracies collected by the authors, we find empirical results consistent with our positive theory. An extensive review of the normative debate and case law provides additional qualitative support.
Cyber History: Homespun Historians, Ethnonationalism, and Recasting Yorùbá Oral Traditions in the Age of Social Media
Authors: Anọ́ba ibrahim Bàbátúndé 
Published: December 2023

AbstractLike other oral sources of history, oral traditions constantly respond to political incentives. In the social media world, demographics relegated to the peripheries of modern state-making projects are using oral traditions as a genre of political activism to negotiate belonging. Following this trajectory, Yorùbá homespun historians on social media are refining Yorùbá oral traditions with ethnonationalism contaminants to galvanize netizens in opposition to the ethnicity’s marginalization in Nigeria and to demand a sovereign Yorùbá nation. This article interrogates the methods and approaches that Yorùbá homespun historians employ in recasting oral traditions. Consequently, it considers potential ramifications on oral traditions as a tool for historical inquiry.
A New Heuristic for Climate Adaptation
Authors: Hoffman Kate Nicole , Kovaka Karen 
Published: December 2023

AbstractAn influential heuristic for thinking about climate adaptation asserts that “natural” adaptation strategies are the best ones. This heuristic has been roundly criticized but is difficult to dislodge in the absence of an alternative. We introduce a new heuristic that assesses adaptation strategies by looking at their maturity, power, and commitment. Maturity is the extent to which we understand an adaptation strategy’s effects. Power is the size of the effect an adaptation strategy will have. Commitment is the degree to which an adaptation strategy is difficult to test or reverse.
THE TERRITORIAL REACH OF EUROPEAN UNION LAW: A PRIVATE INTERNATIONAL LAW ENQUIRY INTO THE EUROPEAN UNION'S SPATIAL IDENTITY
Authors: Marzal Toni 
Published: December 2023

AbstractThis article offers a reconstruction of how the Court of Justice of the European Union (EU) justifies the territorial scope of application of EU law. Scholarship on this issue tends to advocate for an expansive projection of EU norms in the pursuit of global values, subject to the external limits of public international law. This article will develop a critique of this approach by pointing to its underlying assumptions as to the territorial dimension of the EU's rule, the insoluble practical issues that it leads to, and the need to consider differently the EU's spatial identity and relation to the wider world. It will also be argued that, in fact, other case law sometimes already reflects an alternative vision, by imagining the EU implicitly, not as a ‘global actor’ promoting universal values, but as a concretely situated and spatially bounded community. It will be shown that this is so with the methodological help of private international law, and in particular three doctrines that are traditional to this discipline—the localisation of cross-border relations, international imperativeness, and the public policy exception. This will ultimately allow for a more sophisticated understanding of the EU's territory to emerge—irreducible to the physical coordinates of its acts of intervention, or the mere sum of the physical spaces under Member State sovereignty, but as a distinct space of social relations, informed and delineated by the particular axiology and structure of the EU legal system.
OP11 Cost-Effectiveness Of Atezolizumab Plus Chemotherapy As A First-Line Treatment For Metastatic Non-Squamous Non-Small Cell Lung Cancer
Authors: Liu Liu , Yang Yi , Xiao Dunming , Chen Yingyao 
Published: December 2023

IntroductionTreatment with atezolizumab plus standard chemotherapy can prolong the overall survival of patients with metastatic non-squamous non-small cell lung cancer (NSCLC). However, the economic value of this treatment regimen is unknown. This study aimed to estimate the cost effectiveness of atezolizumab plus chemotherapy in the first-line treatment of metastatic non-squamous NSCLC from a healthcare system perspective in China.MethodsA partitioned survival model consisting of three discrete health states was developed to estimate the cost and effectiveness of atezolizumab plus carboplatin or cisplatin plus pemetrexed (APP) versus carboplatin or cisplatin plus pemetrexed (PP) in the first-line treatment of metastatic non-squamous NSCLC over a 12-year lifetime horizon. Key clinical data were generated from the IMpower132 trial. Local direct medical and non-medical costs were used and health preference data were collected from patients with NSCLC in 13 tertiary hospitals across five provinces in China. Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were measured. One-way and probabilistic sensitivity analyses were performed to assess the robustness of the model.ResultsCompared with the PP regimen, APP therapy yielded a gain of 0.21 QALYs at an increased cost of CNY145,602 (USD22,574), resulting in an ICER of CNY684,894 (USD106,185) per QALY gained. The ICER was significantly higher than three times the gross domestic product per capita for China in 2021 (USD37,663). One-way sensitivity analyses revealed that one of the most influential factors in this model was the cost of atezolizumab. Probabilistic sensitivity analysis showed that there was 14.7% probability that atezolizumab plus chemotherapy was cost effective at a willingness-to-pay value of CNY242,928 (USD37,663) per QALY gained.ConclusionsThe APP regimen could prolong survival and improve health benefits over standard chemotherapy in the first-line treatment of patients with metastatic non-squamous NSCLC, but it is unlikely to be a cost-effective treatment option in China.
OP24 Preferences Of Depressed And Depression-Prone Groups With Regard To Antidepressants In China: A Best-Worst Scaling Survey
Authors: Liu Shimeng , Ren Yanfeng , Liu Jing , Wei Yan , Chen Yingyao 
Published: December 2023

IntroductionAntidepressants are one of the main treatment approaches for depression, and previous evidence suggests that consideration of patient preferences can improve their adherence to medication regimens. The objective was, therefore, to evaluate the preferences of depressed and depression-prone groups in China with respect to antidepressant medications.MethodsAn online survey with best-worst scaling choices was administered in depressed and depression-prone patients. The balanced independent block design generated 13 choice task profiles for each participant to answer, with each choice set consisting of four alternatives out of 13 antidepressant-specific attributes. Count analysis and a conditional logit model were used to estimate the relative importance of the 13 attributes and preference heterogeneity.ResultsThe analytical sample included 210 participants, comprising 49 individuals who had previous experience with depression and 161 who were depression prone. Participants in both groups preferred medications with a low risk of liver or kidney damage, headache or dizziness, and recurrence. There were significant differences in both groups regarding out-of-pocket costs and duration of medication. The K-means clustering further proved preference heterogeneity among the patients.ConclusionsOur study revealed patient preferences for antidepressant medication choices in China. Healthcare decision makers should consider and discuss patient preferences in the treatment decision-making process to improve patient adherence to and satisfaction with medications, and to ultimately improve patient outcomes.
OP29 Impact Of New Drug Indications After Initial Registration By The Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil
Authors: Kelles Silvana , Pereira Camila , Martins Carina , Reis Daniel , Azevedo Ernesto , Ribeiro Geraldo , Zocrato Karina , Carvalho Lélia , Freitas Marcela , Horta Maria , Barbosa Mariana , Talim Mariza , Borin Marcus Carvalho 
Published: December 2023

IntroductionMost drugs have data only from clinical trials focused on a specific population at the time of first registration, so their indications for use are restricted to this population. In Brazil, the prices of new drugs for clinical conditions with no therapeutic alternatives are relatively high. When these drugs expand to other indications their prices are not reviewed, which can have a major financial impact. This study aimed to evaluate the financial impact of expanding the indication for trastuzumab deruxtecan.MethodsWe calculated the annual cost to treat all Brazilian patients with the indications listed for trastuzumab deruxtecan at first registration, and then all additional indications. Populations were estimated from epidemiological data from National Committee for Health Technology Incorporation reimbursement documents and a clinical trial comparing trastuzumab deruxtecan with trastuzumab emtansine. Costs were calculated using the ANVISA Câmara de Regulação do Mercado de Medicamentos price value and a patient weight of 70 kg.ResultsIn January 2022, trastuzumab deruxtecan was introduced in Brazil for patients with human epidermal growth factor receptor (HER2) positive metastatic or unresectable breast cancer who had received two or more anti-HER2 treatment regimens. In June 2022, the indication was expanded to patients with HER2-positive metastatic or unresectable breast cancer who had received one anti-HER2 treatment regimen. In November 2022, the indication was further expanded to patients with metastatic or unresectable low-expression HER2 breast cancer who had received prior systemic therapy. The number of patients estimated to be eligible for the drug increased from 383 to 23,000, with an increased total cost from BRL467,970,786 (USD90,621,763) to BRL26,048,234,160 (USD5,044,197,164).ConclusionsThe expansion of indications for trastuzumab deruxtecan may substantially increase its financial impact and compromise the sustainability of health systems. In Brazil, the lack of monitoring of drug prices means that the only change in prices occurs due to regulated annual inflation adjustments. Regulation is needed to reduce drug prices according to new indications, changes in therapeutic options for the same condition, and obsolescence.
OP39 Real-World Evidence Of Post-Incorporation Use Of Monoclonal Antibodies For Psoriasis In The Brazilian Public Health System
Authors: Neiva Pantuzza Laís Lessa , Lyrio Amanda Oliveira , Ferré Felipe , Mega Tacila Pire , de Freitas Lopes Ana Carolina , Canuto Santos Vania Cristina , Borges Stéfani Sousa 
Published: December 2023

IntroductionPsoriasis is an immune-mediated chronic inflammatory disease that can affect the skin, joints, and nails. The treatment of the disease is offered by the Brazilian Public Health System (SUS) in accordance with the guidelines of the Ministry of Health. The aim of this study was to analyze real-world data (RWD) on the implementation and use of monoclonal antibodies (mAbs) for the treatment of psoriasis in the SUS.MethodsThis is a descriptive study that used national administrative data on drug dispensing from the Open Room for Health Intelligence Situation (SABEIS-SUS) from October 2019 to December 2021. Adult individuals (≥18 years) with vulgar (L40.0), generalized pustular (L40.1), gutata (L40.4) and other (L40.8) psoriasis who used the mAbs adalimumab, etanercept, risankizumab, secukinumab and ustekinumab were included.ResultsThe year of implementation of mAbs for the treatment of psoriasis in the SUS was October 2019 (adalimumab, etanercept and secukinumab) and May 2020 (ustekinumab). Risankizumab was implemented in April 2022. The number of individuals using mAb grew from 366 in 2019 to 10,146 in 2021. In 2019, 2020 and 2021, the proportion of individuals using each mAbs was 62.3 percent, 46.2 percent and 35.4 percent (adalimumab), 7.9 percent, 3.3 percent and 2.7 percent (etanercept), 29.8 percent, 33.8 percent and 30.5 percent (secukinumab), 0 percent, 16.7 percent and 31.4 percent (ustekinumab), respectively.ConclusionsThe number of mAbs users has greatly increased from 2019 to 2021, which may indicate a successful implementation of the psoriasis treatment in SUS. Most individuals used adalimumab in the year of the first implementation. However, the proportion of users of this mAb has greatly decreased after the implementation of ustekinumab. This reduction should not be so expressive since adalimumab and ustekinumab are recommended in different lines of treatment. The low proportion of etanercept use may be due the fact the medication is indicated for individuals up 18 years of age. This study provides important real-word evidence for monitoring the implementation of mAbs for psoriasis treatment in Brazil.
OP40 An Initiative To Identify The Long-Term Effects Of COVID-19: Turkish Ministry Of Health (MoH) COVID-19 Follow-Up Centers
Authors: Şener Olgun , Ayar Banu , Ogras Sultan 
Published: December 2023

IntroductionDuring COVID-19 pandemic Follow-up Centers were established by Turkish Ministry of Health (MoH) to detect possible complications in recovered COVID-19 patients at an early stage and make necessary interventions on time. It was aimed to reveal the short, medium and long-term effects of the disease by monitoring regularly. The Follow-up Center algorithms were designed by 10 clinicians of different branches with the support from United Nations Development Programme (UNDP). The follow-ups were made for one year in two pilot centers by using the health information systems infrastructure. In the dissemination process, Follow-Up centers were established initially in 24 and subsequently in 81 provinces.MethodsIn this study, the establishment, dissemination, operation and patient follow-up process of the COVID-19 Follow-up Centers were examined. The one-year (between 1 December 2021 and 1 December 2022) data obtained were analyzed. The patient follow-up;•was made at 0, 1, 3, 6 and 12 months for the first year,•planned to be made twice in the second year and the following years if needed.In the first year, people who received 3 follow-ups by using the forms and scales in the integrated information system modules were assumed to be followed up regularly.ResultsAmong the one-year data obtained from the COVID-19 follow-up centers, the total number of follow-ups, the distribution of follow-ups by date, gender and age groups and symptoms according to time were examined. In the first year; 11,288 people were included in the follow-ups and 18,328 follow-ups were made; 2,462 people were followed-up regularly. The followed up people consisted of 51.8% women; 48.3% of them were men. The incidence of symptoms decreased from 1,198 people in the first follow-up and to 180 people in the third follow-up.ConclusionsThe establishment of Follow-up Centers is considered to be an important initiative to generate systematic data on the long-term effects of COVID-19. It was concluded that conducting studies using two-year data obtained from the follow-up centers, especially for complications, would be beneficial for management of the COVID-19 pandemic and in preparation for similar pandemics.
OP44 Exploring The Disconnect In Relevant Outcomes For Health Technology Assessment-Related Economic Evaluation Relative To Care Commissioning: Implications For Resource Allocation
Authors: Franklin Matthew , Hinde Sebastian , Hunter Rachael , Richardson Gerry , Whittaker William 
Published: December 2023

IntroductionOutcome-based commissioning – a set of arrangements to define and pay for a service based on pre-agreed outcomes – has been operationalized in some regional care settings (e.g., adult social care). However, it remains largely aspirational due to operational considerations and challenges. Outcomes-based commissioning shares a common goal with economic evaluation alongside health technology appraisal (HTA): to achieve value for money for outcomes from a finite budget.MethodsWe explored the considerations, implications, and challenges regarding the practical role of relevant outcomes in economic evaluation, relative to care commissioning, using England as a case study. Our exploration bridges a gap between economic evaluation evidence and practical resource allocation decision-making, focusing on conceptual (e.g., what are ‘relevant’ outcomes), practical considerations (e.g., quantifying and using relevant endpoints or surrogate outcomes alongside costs), and pertinent issues when linking these to commissioning based payment mechanisms.ResultsFirstly, there is a disconnect between existing economic evaluation approaches and commissioning processes. For example, using a single quality-adjusted life-year (QALY) maximum and limited consideration of affordability relative to cost effectiveness. Secondly, service-focused outcomes (e.g., seeing a specialist team) rather than person-focused outcomes (e.g., QALYs) are often desirable from a practical commissioning and service provider perspective as they make it easier to measure key performance indicators. Thirdly, both person- and service-focused payment structures could lead to market inefficiencies when activity is focused on only people for whom a prespecified outcome can be achieved or service delivered; these approaches require additional efficiency-equity tradeoff considerations (e.g., using distributional cost-effectiveness analyses).ConclusionsWe highlight payment structures as a major and complex consideration for commissioning, for which economic evaluation provides little to no consideration. Service-related outcomes and payments can be used as surrogate outcomes within economic modeling frameworks, while monitoring and evaluation can still be based on economic outcomes (e.g., QALYs and aggregated costs). Accounting for and explaining direct links from payment structures to economic outcomes is a major step to bridging a gap between economic evaluation evidence and practical resource allocation.
OP45 HTA And Gender Medicine: Time To Take Action!
Authors: Ragusa Rosalia , Guardabasso Vincenzo , Bellia Maria Alessandra , Piana Filippo , Quattrocchi Rosalba 
Published: December 2023

IntroductionGender medicine responds to the need for a reassessment of the medical-scientific approach in a gender perspective, to increase knowledge of the different aspects underlying gender differences and the appropriateness/ effectiveness of health interventions.MethodsA policy review of documents prepared by the Italian Ministry of Health on gender medicine was carried out, to investigate the possible areas of intervention of health technology assessment in the development of this interdisciplinary dimension. The areas of highest priority for action have been identified.ResultsIn Italy, the Ministry of Health, with the support of the National Institute of Health, issued a Plan for Application and Dissemination of Gender Medicine in June 2019. Our review shows that for the development of research on the mechanisms of pathogenesis the Italian Plan gives indications on the identification of diagnostic markers, prognostic and predictive response in a gender perspective, but there are no formalized rules that constitute a constraint or an obligation to do so. In Horizon Europe calls, for example, “Pragmatic trials on minimally invasive diagnostics” (HORIZON-MISS-2023-CANCER-01-03) on the other hand, it is required that gender and gender issues should be taken into account in all projects and all data should be disaggregated by gender, socio-economic status and ethnicity. Separating subjects into two groups in the analysis leads to greater complexity. This is even more true when considering the different types of gender. The total number of subjects to be included must likely increase to maintain statistical power in evaluating effects in subgroups. This increase leads to an increase in time and cost, if one needs to provide separate data by sex and even more so by gender. Different statistical tests to be used, according to the type of variables of the primary endpoint, should be considered in the study protocols.ConclusionsIt seems appropriate to suggest reviewing upcoming health technology assessments with an eye to gender medicine. Gender medicine should become a strategic goal of prevention in public health and will strengthen the concept of the patient centrality until the personalization of therapies is achieved.
OP47 The Risk-Based Price: Incorporating Uncertainty And Risk Attitudes In Health Technology Pricing
Authors: Kirwin Erin , Paulden Mike , McCabe Chris , Round Jeff , Sutton Matt , Meacock Rachel 
Published: December 2023

IntroductionDecision makers often use value-based decision rules to determine whether technologies offer good value for money and should therefore be adopted, comparing cost-effectiveness analysis results with a threshold value. This assumes that decision makers are indifferent to interventions with the same expected value but different levels of underlying uncertainty. Such indifference is unlikely to hold in practice. We propose a risk-based price and accompanying decision rules to address this limitation.MethodsWe characterized risk using the per-patient expected value of perfect independent information (EVPII), a modification of a standard output from value of information analysis. The EVPII estimates the expected value of net benefit losses caused by uncertainty related to a technology, independent of the uncertainty related to alternative treatments. ‘Payer risk tolerance’ is then defined as the maximum per-patient risk of making wrong decisions that payers are willing to accept, expressed in monetary terms. The risk-based price is the price at which the EVPII is equal to the payer risk tolerance.ResultsThe risk-based pricing decision rules are as follows: (i) a technology is acceptable for adoption at the submitted price if the incremental net benefit of the technology is greater than or equal to zero and the EVPII is less than or equal to the payer risk tolerance; and (ii) the optimal technology has the greatest expected net benefit at the lowest of the sponsor submitted, value-based, or risk-based price at a given cost-effectiveness threshold value.ConclusionsThe risk-based price incorporates uncertainty and risk attitudes into decision-making. We demonstrate that both risk-averse and risk-neutral payers prefer the outcomes of risk-based pricing. Risk-based decision rules incentivize sponsors to develop evidence. Implementation of the risk-based price improves outcomes for patients by increasing health system net benefits under constrained resources, with better alignment to decision maker risk attitudes.