bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP54 Different Perceptions Of Additional Benefit By Payers And Providers: Discrepant Voting Within G-BA’s Benefit Appraisals
Authors: Rasch Andrej , Julian Elaine , Ruof Jörg 
Published: January 2025

IntroductionAppraisal decisions on additional benefit of new medicines within the German health technology assessment (HTA) body Gemeinsamer Bundesausschuss (G-BA) are made by voting among the member of the G-BA plenary. We identified and analyzed key characteristics of decisions that were not reached by consensus.MethodsG-BA’s homepage was used to identify AMNOG (German Medicines Market Reorganization Act) procedures that started after January 2011 and were finalized before November 2023. Appraisal voting is conducted publicly, and results are documented in the data source of the German Association of Research-Based Pharmaceutical Companies (vfa). Both the payer (National Association of Statutory Health Insurance [GKV-SV]) and provider (National Association of Statutory Health Insurance Physicians, Dentists and the German Hospital Federation) “benches” have an equal number of votes with the independent chair of the G-BA acting as swing vote in case of discrepant decisions. Discrepant voting instances were extracted and analyzed.ResultsFrom January 2011 to November 2023, G-BA conducted 908 appraisals of medicines. In 66 appraisals, (7.3%) decisions were not reached by consensus. Discrepant voting was related to oncological (n=28), metabolic (n=15), infectious (n=12), neurologic (n=3), cardiovascular (n=2), psychiatric (n=2), dermatologic (n=2), musculoskeletal (n=1) and urogenital conditions (n=1) conditions. Fourteen discrepant voting instances related to orphan medicines. The best benefit category reached in the 66 discrepant decisions were: major (n=2), considerable (n=16), minor (n=19), non-quantifiable (n=13), and no benefit (n=16). In all discrepant voting decisions, the provider bench favored a better scoring versus the payer bench.ConclusionsAppraisal decisions within G-BA are reached by voting. The appraisals are a key element within the subsequent price negotiations. In all discrepant decisions, the payer bench suggests less benefit (strength of benefit, respectively) versus the provider bench, indicating a procedural challenge with the GKV-SV being involved in both the voting on the additional benefit and the negotiation of price.
OP67 “Black Box Bottleneck” Paradigm And Transparency Issues On Artificial-Intelligence-Based Tools In Health Technology Assessment: A Scoping Review
Authors: Komoda Denis Satoshi , de Almeida Cardoso Marilia Mastrocolla , Lima Ana Renata , Visacri Marília Berlofa , Silveira Correa Carlos Roberto , Fernandes Brígida Dias 
Published: January 2025

IntroductionOne of the pillars of health technology assessment (HTA) is transparency, which guarantees reproducibility and accountability. Due to the “black-boxness” of artificial intelligence (AI) models, the use of AI-based tools adds new layers of complexity for transparency issues. The aim of this scoping review is to map AI-based tools applied in HTA processes, regarding human supervision and “open-sourceness” aspects.MethodsA search strategy using the terms “AI,” “HTA,” and correlated terms was performed in nine specialized databases (health and informatics) in February 2022. Inclusion criteria were publications testing AI models applied in HTA. Selection of studies was performed by two independent researchers. No filter was applied. Variables of interest included a subset of AI models (e.g., machine learning [ML], neural network), learning methods (e.g., supervised, unsupervised, or semi-supervised learning), and code availability (e.g., open source, closed source). Data were analyzed exploratorily as frequency statistics.ResultsML with one layer of hidden nodes was applied in 48 (78.6 %) studies, while deep learning (DL) (two-plus layers) were applied in eight (13.1 %). ML models that used supervised learning accounted only for half of the reported models, while half used unsupervised learning. Considering supervision methods in DL models, seven used unsupervised learning, and one used supervision. Four studies did not report the AI model, and 14 studies did not report the supervision paradigm. It was not possible to assess “open-sourceness” in 31 studies. Among the identified software, seven models were not open source, and 13 were open source.ConclusionsTransparency and accountability are of utmost importance to HTA. Complexity of AI models may introduce trustworthiness issues in HTA. Transparency provided by open-source code becomes essential in building trust in the automation of HTA processes, as does quality of report. Although progress has been observed in transparency and quality, the lack of a methodological framework still poses challenges in the field.
OP68 Adaptation Of Processes For HTA Of Digital Health Technologies Based On Artificial Intelligence
Authors: Moltó-Puigmartí Carolina , Segur-Ferrer Joan , Herrera Didier Domínguez , Trias Susanna Aussó , Vivanco-Hidalgo Rosa Maria 
Published: January 2025

IntroductionThe advent of artificial intelligence (AI) in digital health technologies (DHT) requires a comprehensive health technology assessment (HTA) to ensure safety and effectiveness and to demonstrate the value of these technologies in healthcare systems. Recognizing the unique requirements posed by AI-based DHT, our agency has undertaken several initiatives to tailor and adapt our processes for effective HTA.MethodsWe started by identifying the processes that were not working optimally and planned a list of actions needed to improve them. These actions were: (i) to develop a new evaluation framework for the assessment of DHT, including those based on AI; (ii) to increase our activity on early HTA; (iii) to seek collaboration with an organization for technical assessment of AI, with a particular emphasis on trustworthy AI requirements; (iv) to adapt our HTA report templates; (v) to create new forms to request information from the technology developers; and (vi) to set up a working group on HTA of AI-based
DHT.ResultsWe have now an evaluation framework that informs on the relevant aspects for HTA of AI-based DHT and the evidence that developers need to generate in order to proof the value of their technology. We designed a circuit to identify promising technologies and increased our early HTA work for timely advice. The evaluation team now involves an additional partner for the technical assessment domain. In addition, we have new templates for early HTA reports, which explain those AI-specific elements to be addressed, as well as industry information request forms that enable collecting specific information like algorithm type and population used for clinical validation.ConclusionsTailoring HTA processes to AI-based DHT is crucial in today’s fast-paced health technology landscape. Our new evaluation framework, the involvement of new partners in the assessment team, the creation of new templates, and enhanced early HTA work helps to evaluate these technologies optimally. We are also setting up a working group to ensure homogeneous evaluation within Spain.
OP72 Patient Organization Submissions Made To A National Health Technology Assessment Agency In Ireland
Authors: O’Callaghan Joan , Tilson Lesley , Adams Roisin , McCullagh Laura 
Published: January 2025

IntroductionThe National Centre for Pharmacoeconomics (NCPE) has a Patient Organisation Submission Process (POSP) enabling patients to communicate their experiences to the drug-reimbursement decision-maker. The NCPE proactively invites and supports patient organizations to make submissions to the decision-maker for ongoing health technology assessments (HTAs). We evaluate uptake of the POSP and determine whether submission trends differ by drug type.MethodsWe reviewed all HTAs completed by the NCPE since 2016 (when the POSP was first introduced) to present (data cut-off date 22 November 2023). Time trends in the proportions of HTAs for which a patient organization submission had been made to the NCPE were analyzed descriptively. We also compared the proportions of HTAs for which a patient organization submission had been made for (i) orphan versus non-orphan drugs and (ii) oncology versus non-oncology drugs.ResultsThe number of patient organization submissions made to the NCPE has increased over time. In 2016, 24 percent (6/25) of completed HTAs were associated with a patient organization submission compared with 50 percent (11/22) in 2023. The proportions of completed HTAs associated with a patient organization submission are comparable between orphan (38%; 24/64) and non-orphan drugs (29%; 34/117) (Chi²; p=0.245). The proportion of completed HTAs for which a patient organization submission had been made was lower for oncology drugs (14%; 14/97) versus non-oncology drugs (52%; 44/84) (Chi²; p<0.001).Conclusions
Patient organization submissions to the NCPE have increased over time. The proportions of HTAs for which patient organization submissions have been made are comparable between orphan and non-orphan drugs. However, the proportion of patient organization submissions for oncology drugs is lower than the proportion for non-oncology drugs. The NCPE will continue to liaise with patient organizations to increase engagement with the POSP.
OP74 A Comprehensive Health Technology Assessment Framework For Omics Technologies In The Spanish Setting
Authors: Garcia-Sanz Patricia Julia , Aguilera-Cobos Lorena , Rosario Lozano María Piedad , Blasco-Amaro Juan Antonio 
Published: January 2025

IntroductionPersonalized precision medicine (PPM) is an innovative approach to disease diagnosis, prognosis, and treatment of individual or group characteristics using diverse data sources. While omics technologies are integral to PPM, they pose challenges. Therefore, developing an appropriate methodology to assess these technologies is crucial for patient safety, resource efficiency, and clinical decision-making within the Spanish National Health System.MethodsThis health technology assessment (HTA) methodology procedure was developed by combining three different approaches: a systematic review (SR); a survey targeting experts in omics technology, ranging from basic science researchers to clinicians, and patient associations; and, finally, a consensus method (RAND Appropriateness Method [RAM]).ResultsThrough data extraction and evidence synthesis of the 38 studies included in SR, 30 existing frameworks for evaluating omics technologies were identified, as well as the elements needed to assess these technologies, leading to the first version of the framework. Two surveys were performed to integrate the perspectives of omics technology experts and patients. Subsequently, this framework version was further developed by a RAM consensus panel of experts from HTA agencies to ensure a rigorous evaluation of gathered data. The final framework was categorized into 94 elements divided into sections, categories, domains, and subdomains.ConclusionsA methodological guide, including the assessment framework, was developed for the Spanish HTA network. The framework is divided into several sections addressing evidence-gathering, provision models, organizational elements, economic evaluation, and ethical and social implications. Compared to other available frameworks, our proposal included aspects such as bioinformatics, technological maturity level, and the patient perspective with the personal utility domain.
OP76 Cost-Effectiveness Of Offering Human Papillomavirus Self-Sampling To Non-Attendees Of Organized Primary Cervical Cancer Screening In Germany
Authors: Sroczynski Gaby , Hallsson Lára R. , Muehler Milena , Hillemanns Peter , Jentschke Matthias , Siebert Uwe 
Published: January 2025

IntroductionIn Germany, organized cervical cancer screening with annual Papanicolaou (Pap) cytology for women age 20 to 34 years and three-yearly co-testing with human papillomavirus (HPV) and Pap for women as of age 35 years is standard. However, about 30 percent of women eligible for screening remain un/under-screened. We systematically evaluated benefits, risks, and cost-effectiveness of offering additional HPV self-sampling (HPV-SS) to non-attendees.Methods
A validated Markov model for the German context was used to evaluate different HPV-SS screening strategies compared to standard clinician-based screening: HPV-SS for non-attendees age 25 to 65, 30 to 65 or 35 to 65 years, every five years with regular invitation, either opt-in (invitation with link to order the test), or send-to-all (test sent with invitation). German clinical, epidemiological, and economic data (index year 2022/23), along with test accuracy and HPV-SS-attendance data from international meta-analyses and trials were incorporated. Outcomes included undiscounted life years gained (LYG) compared to standard screening without HPV-SS in non-attendees, and the incremental cost-effectiveness ratio (ICER; in EUR/LYG). Comprehensive sensitivity analyses were performed.Results
Incremental undiscounted effectiveness (compared to standard screening without HPV-SS) and discounted ICERs (compared to next effective) for non-dominated HPV-SS screening strategies were 0.00090 LYG (EUR22,700/LYG) for offering with five-yearly screening invitation an HPV-SS (opt-in) to non-attendees age 35 to 65, 0.00166 LYG (EUR25,900/LYG) for HPV-SS (send-to-all) age 35 to 65, 0.00167 (EUR726,000/LYG) for HPV-SS (send-to-all) age 30 to 65, and 0.00167 LYG (EUR1.78 million/LYG) for HPV-SS (send-to-all) age 25 to 65 years. Other opt-in strategies were dominated. Results were robust over a wide range of parameter variations.ConclusionsOffering HPV-SS (send-to-all) to non-attendees every five years as an additional strategy within the organized cervical cancer screening program is effective and cost effective in the German context. The results can be used to inform decision-makers and clinical guideline developers regarding incorporation of the specific version of HPV self-sampling into the established organized cervical cancer screening program in Germany.
OD04 The EQ-5D-5L Value Set For Ghana
Authors: Addo Rebecca , Mulhern Brendan , Norman Richard , Owusu Richmond , Viney Rosalie , Nonvignon Justice 
Published: January 2025

IntroductionGhana’s reference case, developed to guide the conduct of economic evaluation as part of health technology assessment (HTA) guidelines, recommends the conduct of cost–utility analysis using outcomes such as quality-adjusted life years (QALYs). There is no national value set available for the Ghanaian population to be used in estimating QALYs. This study aimed to develop a value set for Ghana using the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) instrument.MethodsFace-to-face preference data were collected from 300 adults across three regions of Ghana using the adapted version of the EuroQol Valuation Technology (EQ-VT) standardized valuation protocol developed specifically for EQ-5D-5L valuation studies using composite time-trade-off (cTTO) and discrete choice experiments (DCEs). Different preference models were generated using both the cTTO and DCE data, individually or together to provide complementary results on respondents’ utility preferences. Models explored include generalized least squares, tobit, heteroskedastic, logit, and hybrid. The best-fitting model was selected for the value set based on its logical consistency, ability to account for left-censored and heteroskedasticity data, and statistical significance of parameters.Results
The 300 interviews provided 4,500 cTTO responses and 4,200 DCE responses. The demographic characteristics of respondents were representative of the Ghanaian population for religious background, level of education, and marital status. The preferred model chosen for the Ghana value set was hybrid tobit, random effect heteroskedastic, constrained model. The predicted value for the worst attainable health on the EQ-5D-5L (i.e., health state 55555) was −0.493 and that of the best health state (11112; except full health) was 0.969. The largest decrement was registered for level five mobility (0.369) followed by pain/discomfort (0.312), self-care (0.273), anxiety/depression (0.271), and usual activities (0.268).Conclusions
This is the first Ghanaian EQ-5D-5L value set based on social preference derived for a nationally representative sample in Ghana. The value set will play a key role in the institutionalization of HTA in Ghana and the use of economic evaluation studies to inform priority setting where different health technologies can be compared. A planned findings dissemination to stakeholders is underway.
OD12 Large Language Models As Powerful Tools In Health Technology Assessment
Authors: Segur-Ferrer Joan , Moltó-Puigmartí Carolina , Lleixà Berta Mestre , Pla Anna Godo , Peiró Roland Pastells , Llinàs-Mallol Laura , Sabadell Maria-Dolors Estrada , Vivanco-Hidalgo Rosa Maria 
Published: January 2025

IntroductionIn recent years, large language models (LLMs) have emerged as powerful tools in natural language processing, presenting diverse opportunities across various sectors. In this context, the Agency for Health Quality and Assessment of Catalonia (AQuAS) is actively investigating how LLMs can enhance the development of health technology assessment (HTA) reports.MethodsTo assess the potential of LLMs in the development of HTA reports, our initial step involved a comprehensive review of technical literature to understand the functionalities of existing LLM tools. This effort was followed by a systematic identification of specific HTA report development tasks that these models could potentially facilitate. We then rigorously evaluated the performance of these tools in executing the delineated tasks, with a focus on meticulously recording the applied prompts and areas of high and low effectiveness, alongside any encountered errors and identified risks.Results
Among a range of commercial tools, ChatGPT and Microsoft Copilot were selected for exploration due to their accessibility, ease of use, and versatility. Both tools demonstrated acceptable performance in certain tasks (e.g., data extraction), while their efficacy was notably lower in others (e.g., information search). Additionally, a range of risks requiring mitigation were identified (e.g., hallucination or authority bias). Consequently, we drafted a proposal for an internal guide with directives for the technical staff of the HTA unit on utilizing these two tools. Additionally, we constituted a working group.ConclusionsLLMs have emerged as promising tools in the field of HTA. Over the past months, AQuAS has been investigating the potential of these models to improve the HTA report development process, targeting enhanced efficiency and improved quality. This exploration has led to the identification of numerous opportunities and associated risks within this innovative application.
OD14 Harmonization Of HTA For Digital Health Technologies: The EU-Funded European Digital Health Technology Assessment Project
Authors: Tsiasiotis Emmanouil , Di Bidino Rossella , Sacchini Dario , Cicchetti Americo 
Published: January 2025

IntroductionThe European Digital Health Technology Assessment (EDiHTA), an EU-funded project, aims to deliver the first European digital HTA framework co-created by all relevant stakeholders, validated and ready to use. It responds to the need to harmonize tools, methods, guidelines, and frameworks that are already adopted or under development. All types of digital health technologies (DHTs) and Technology Readiness Levels (TRLs) are covered.MethodsThe EDiHTA project adopts a multistakeholder, multidomain, and modular approach to reach a consensus on a common HTA framework for DHTs (e.g., mApp, telemedicine, artificial intelligence). The currently available HTA frameworks refer to different DHTs (e.g., MAST, DiGA, MAS-AI), include different HTA domains, respond to the needs of different stakeholders, and are applicable in specific local and national contexts. In the majority of cases, they are applicable only in advance TRL. In a few cases, they are already adopted in regulatory/HTA processes. The lack of coordination and harmonization has significant implications for all stakeholders, manufacturers and patients included.ResultsThe EDiHTA project adopts a holistic approach involving all relevant stakeholders for consensus building at national and European levels. Cross-border collaboration among stakeholders will be reinforced by the definition of a common taxonomy based on consensus building, and the development and validation of common methods and the HTA framework. Evidence requirements will be defined and made more transparent to increase support for health technology manufacturers. In addition, the harmonization effort, together with the development of a digital platform for the HTA framework, will allow faster and safer access to DHTs by patients/citizens.ConclusionsThe goal of the EDiHTA project is to provide the first European digital HTA framework for DHTs that will be adopted by all relevant stakeholders along the lifecycle of digital technologies to promote sustainable health systems. A consortium comprising 15 partners from eight countries, including all relevant stakeholders, works to reach these goals within the next four years.
OD16 Assessing Technical Aids In Europe: Are There Any Specific Health Technology Assessment Methods To Assess Technical Aids?
Authors: Bonamour Julie , Marguerite Camille , Bouaraba Feyriel , Fernandez Judith , Galmiche Hubert 
Published: January 2025

IntroductionTechnical aids (TAs) are health devices (e.g., hearing aids, prostheses, wheelchairs) used to restore a body function or compensate for disability. In France, TAs are assessed based on clinical data, as are any medical devices (MDs). Considering that TAs are special MDs (no curative action), specific assessment methods might be proposed. The methods used in Europe were explored.MethodsTo learn about TA evaluation practices in Europe, the French National Authority for Health (HAS) sent a survey to nine identified European health technology assessment (HTA) agencies. The questionnaire was specific to TAs, and the questions asked were about: (i) the reimbursement of TAs (reimbursed or not, at national or local level), (ii) the HTA process (HTA process or not, HTA process description), and (iii) the methods used (any specific methods for assessing TAs other than HTA methods to assess “classic” MDs).ResultsAll the European HTA agencies contacted provided a response. All these countries have a healthcare system that allows TAs to be reimbursed. In Austria, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, and the United Kingdom, TAs must be CE-marked and comply with technical standards to be reimbursed; no clinical data are required. However, the National Institute for Health and Care Excellence provides recommendations for certain TA categories. In Germany, the CE-marking and the respect of technical standards are mandatory, and certain TAs need to show a medical benefit (e.g., orthoses); nevertheless, there are no specific methods to assess TAs.ConclusionsOverall, the feedback obtained does not reveal any specific evaluation method applied to TA assessment in the various European countries analyzed. France stands out from these European countries regarding the assessment of TAs because of its one-stop-shop system for health technology developers and the HAS requirements for technical and clinical data.