bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP61 A Decade Of Enhanced Patient And Citizen Involvement In Health Technology Appraisal In Scotland
Authors: Dickson Jennifer , Cairns Daniel , McCormack Jackie , Russell Kate 
Published: January 2025

IntroductionOver the past 10 years, the Scottish Medicines Consortium (SMC) has strived to strengthen the involvement of patients and citizens in its work and improve public understanding of health technology appraisal (HTA). A series of innovations have been brought in since 2014 to increase levels of engagement and satisfaction of participants. This work describes these and their impact.MethodsSMC has introduced numerous transformational changes since 2014. Innovations include a new Patient Group Partner (PGP) registration system, strengthened patient group submission process, participation of patient representatives at Patient and Clinician Engagement (PACE) and SMC Committee meetings, embargoed early release of SMC decisions to PGPs, provision of Summary Information for PGPs (from submitting company), and revised role of public representatives. The creation of the SMC Public Involvement Network Advisory Group has underpinned these achievements, as has the provision of comprehensive one-to-one support, information and education to PGPs. SMC has continually evaluated the satisfaction of participating PGPs using an online questionnaire.ResultsThere has been a sustained increase over the past 10 years in both the number of patient groups engaging with SMC and the number of PGP submissions that SMC receives. Adopting a continuous improvement approach, working in partnership with PGPs and public representatives, has helped SMC to ensure that stakeholders in the HTA process are effectively engaged and informed about the HTA of new medicines in Scotland. Surveys of public involvement in SMC consistently show an extremely high level of satisfaction from PGPs who work with SMC, with most PGPs consistently rating their experience of working with SMC as excellent.ConclusionsOver the past 10 years, SMC has strived to strengthen how it involves citizens and patient representatives in HTA. Various innovations and a continuous improvement approach have helped to ensure that there are high levels of satisfaction and understanding of the HTA process from patient groups who engage with SMC. This is underpinned by a partnership approach to working.
PP62 Improving Patients’ Access To Medicines Through Health Technology Assessment In Ukraine: Measuring The Impact Of The National HTA Roadmap
Authors: Piniazhko Oresta , Khmelovska Marharyta , Serediuk Valeriia , Babenko Mykhaylo , Lobas Mykhailo , Kosyachenko Kostyantyn , Sucu Rabia , Valuieva Nataliia 
Published: January 2025

IntroductionIn 2020, health technology assessment (HTA) became mandatory for any new medicine covered by public funds. The aim of the review is to present the impact of HTA implementation despite Russia’s full-scale war against Ukraine. Thanks to the introduced reforms, including HTA introduction, the coverage from the public payer in providing patients with medicines increased from 11 percent in 2013 to 34 percent in 2023.MethodsThis review summarizes all Department of HTA conclusions with recommendations made during 2023, decisions made by the Ministry of Health (MOH) based on these recommendations and their impact on patient access, and the steps made to further institutionalize HTA in Ukraine. In 2023, the HTA guidelines for medicines were revised based on the lessons learned and global experience along with knowledge exchange with the United Kingdom HTA agency, NICE International.ResultsIn 2023, the HTA Department prepared 19 HTA conclusions. The majority concerned treatment of oncologic diseases (32%), orphan diseases (21%), and multiple sclerosis (16%). HTA assessments resulted in recommendations for listing (84% cases). Fifty-three percent of medicines were recommended for managed entry agreement, and the MOH decided to forward 10 medicines for negotiations in 2023. Thirty-two percent of recommendations considered inclusion into the National Essential Medicines List (NEML); 16% with further access through the reimbursement program. Almost 70 percent of total need in NEML is currently covered by public funds, compared to 40 percent in 2020 (according to the Support in Market Development (SMD) analytical database).ConclusionsThe HTA function in Ukraine has evolved since 2020 with a visible impact on patients’ access. Introduction of new procedures, such as HTA for medical devices, may improve patient access to health technologies and provide evidence for rational and transparent decision-making processes, with gradual transformation of the Department of HTA at the State Expert Centre into an independent HTA agency by 2026.
PP66 International Horizon Scanning Initiative (IHSI) : Time to Review the Need for Stand-Alone National Horizon Scanning?
Authors: Eames Heather , Harte Marie , Choitir Caitríona Ní , McCullagh Laura , Tilson Lesley , Adams Roisin 
Published: January 2025

IntroductionIreland is a member of the International Horizon Scanning Initiative (IHSI) and has access to the full horizon for medicines across multiple disease areas and specialized reports on high-impact technologies within disease areas (IHSI High Impact Reports [HIRs]). Health technology developers (HTDs) provide a notification to HTA agencies and payers on intent to seek reimbursement for a technology in the preceding two years.MethodsInformation on technologies submitted to the national HTA agency in 2023 was selected for comparison to information in the IHSI database. The IHSI system detects products prior to regulatory approval. The national notification system (NNS) can receive information post-licensing. We examined how many products were received in the NNS that were either in the regulatory process or licensed in the EU. We sought to compare key information in the NNS and the IHSI database to identify areas of duplication. Areas where information from NNS could complement the IHSI database were highlighted. HIRs were not included in this assessment.ResultsIn 2023, 20 percent of products submitted by HTDs via the NNS were already licensed. To compare the information provided in IHSI and the NNS, a sample of 35 technologies common to both systems was selected. The IHSI and the NNS contain multiple data fields (154 in IHSI and 72 in NNS) across domains including information on product characteristics, regulatory information, clinical trial data, and cost. The exceptional fields specific to the Irish context were compassionate access scheme availability in Ireland, Ireland-specific patient population estimates, and local pricing and reimbursement proposals.ConclusionsReceipt of information from HTDs remains important, particularly country-specific information. There are efficiencies in identifying technologies via an independent horizon scanning system, not reliant on submissions by HTDs. Such a system could facilitate joint assessment, joint early advice, and joint problem-solving between countries. Joint efforts can also facilitate broader scope on how horizon scanning can be used to increase health system preparedness.
PP71 Organizations Responsible For The Evaluation Of Health Technologies Globally: A Scoping Review
Authors: MigliavacaCelina Borges Migliavaca Celina Borges , Colpani Verônica , Zago Marcolino Miriam Allein , Falavigna Maicon , Polanczyk Carisi Anne 
Published: January 2025

IntroductionThe process of health technology assessment (HTA) is a valuable tool for the pursuit of equitable and sustainable healthcare systems. Various countries have established organizations dedicated to conducting HTAs, adapting such institutions to local healthcare ecosystems. The aim of this study was to evaluate the structure, methods, and processes of organizations responsible for national-level HTAs globally.MethodsA scoping review was conducted assessing organizations responsible for conducting HTAs for national-level decision-making in any country. Identification of eligible organizations was performed through a review of member organizations of INAHTA, EUnetHTA, RedETSA, and HTAsiaLink networks, as well as organizations evaluated in reviews with a similar scope. For each organization, the following data were searched: country, year of foundation, organizational nature, role in decision-making, funding, technologies assessed, criteria considered for decision-making (such as efficacy and safety, costs, impact on equity, among others), type of economic evaluation, and patient involvement.ResultsWe identified 69 organizations, from 56 countries, mainly European (n=39; 56%). Fifty-three (77%) are government-affiliated; most (n=51; 74%) have a consultative role. Public funding is the main funding, and 12 (17%) organizations charge fees for conducting HTA. Technologies assessed include drugs (n=61; 88%), devices (n=47; 68%), and procedures (n=33; 48%). HTA is usually initiated upon request from the manufacturer (n=45; 65%). Patient involvement is not clearly described in 32 organizations (46%); in 29 organizations (42%), the role of patients is to provide information that is considered during decision-making.ConclusionsAmong the evaluated organizations, it is observed that the majority are government-affiliated, have public funding, and play a consultative role. The results of this study serve as an important reference for the development and improvement of organizations responsible for conducting HTAs.
PP75 Treatment Of Rheumatoid Arthritis In The Single Health System: Profile Of Medication Use And Expenses
Authors: Moreira Adson José , Prata Wallace Mateus , de Assis Acurcio Francisco , Guerra Augusto , Alvares-Teodoro Juliana 
Published: January 2025

IntroductionRheumatoid arthritis (RA) is a chronic inflammatory disease. Treatment aims to improve functional capacity and quality of life. Biological disease-modifying antirheumatic drugs (DMARDs) and oral inhibitor of Janus kinases (JAKs) used in treatment are high cost. The objective of this study was to analyze the profile of use and expenses of these medicines used in Brazil’s Unified Health System (SUS).MethodsThis is a retrospective cohort of users who received at least one biological DMARDs or oral inhibitor of Janus kinases (JAKs) registered in the Open Room on Health Intelligence—Sabeis/Datasus. The valuation of the 11 drugs standardized by the Clinical Protocols and Therapeutic Guidelines (PCDT) was carried out based on public purchases registered in the Price Bank in Health and an active search with the Ministry of Health, between 2017 and 2021. Expenses were calculated based on the number of High Complexity Procedure Authorizations (APACs) registered in the SIA/SUS database.ResultsEvaluation of 195,163 patient dispensing records was undertaken. Spending on medicines was BRL408,146,527 (USD79,012,759) in 2017, BRL237,615,290 (USD46,002,748) in 2018, BRL213,790,222 (USD41,350,815) in 2019, BRL195,626,575 (USD37,837,644) in 2020, and BRL140,096,142 (USD27,109,717) in 2021. It was found that in 2017, adalimumab (33%), etanercept (28%), and golimumab (14%) were the most used biological DMARDs. It is worth noting that in 2017, adalimumab and etanercept represented more than 50 percent of the costs of treating RA in the SUS. In 2021, it was found that 61 percent of total expenses were distributed between the drugs etanercept (23%), golimumab (18%), certolizumab (14%), adalimumab (11%), and tofacitinib (11%).ConclusionsIn the period from 2017 to 2021, changes can be observed in the profile of use and expenditure of biological DMARDs and oral inhibitor JAKs, resulting from the incorporation of new drugs and the entry of biosimilars in the Brazilian market. However, adalimumab, one of the first biological DMARDs incorporated, is the most consumed and least expensive medicine.
PP78 Data Extrapolation With Survival Curves: An Alternative Approach With Aggregated Data
Authors: Zimmermann Ivan Ricardo , Borges Solange 
Published: January 2025

IntroductionRecently, there has been considerable emphasis on survival curves for data extrapolation, especially in the field of economic evaluation in oncology. Common methods for adjusting survival curves are complex and heavily reliant on individual patient data (IPD), which may not be feasible for health technology assessment (HTA). We propose an alternative method for survival curve extrapolation with direct adjustment to aggregated data.MethodsCommon parametric survival analysis models were tested: exponential, Weibull, log-normal, log-logistic, generalized gamma, and Gompertz. We had access to the IPD from a published randomized clinical trial (n=694) testing therapies (anastrozole and fulvestrant) for metastatic breast cancer with 10 years of follow-up on progression-free survival (PFS) and overall survival (OS) outcomes. After adjusting the original IPD, we sought to fit models to published aggregated data (Kaplan–Meier curves) using nonlinear regressions and optimization algorithms. Both methods were compared in terms of visual inspection and statistical fit quality (Akaike information criterion [AIC] and Bayesian information criterion [BIC]).ResultsSurvival curves directly adjusted to aggregated data showed a visually similar profile compared to IPD adjustments. According to AIC/BIC values, Weibull and generalized gamma distributions best fit OS data, both in individualized and aggregated approaches. For PFS, log-logistic and log-normal curves were the best choices for the anastrozole arm, and for fulvestrant, the best choices were log-normal and generalized gamma for individualized data, and Gompertz and generalized gamma for the aggregated method. The proposed R language code proved to be reproducible and amenable to automation in future HTA applications.ConclusionsDirectly adjusting survival curves to aggregated data is a simple and useful alternative in situations where access to IPD is not feasible.
PP81 The Importance Of Networking To Produce Better Health Technology Assessment Evaluations: An HTA Guideline For Orthoses And Prostheses In Brazil
Authors: Martins Ketinlly Yasmyne , Branco Rodolfo Castelo , Galdino Katia , Medeiros Lauriston , Oliveira Eduardo Jorge V , de Souza Monica Vinhas 
Published: January 2025

IntroductionHealth technology assessment (HTA) studies focused on equipment have particularities. The evaluation of orthoses (ORT) and prostheses (PRT) is even more challenging and tends to present more difficulties when compared to technologies such as medicines. Furthermore, in Brazil there are different manufacturing and dispensing processes for these technologies throughout the country; this heterogeneity could also affect the sustainability of the system itself.Objectives
(i) evaluate and disseminate the elements necessary to carry out adequate and sustainable assessments of non-implantable ORT and PRT and; (ii) produce a guideline on HTA assessment for non-implantable ORT and PRT.MethodsVisits were made to ORT and PRT centers throughout Brazil to collect data on the production chain, dispensing, adaptation, and evaluation of the patient’s clinical results. At the same time, systematic literature reviews were carried out on two topics: (i) elements that must be considered in the manufacture, dispensation, and adaptation of non-implantable ORT and PRT; and (ii) HTA guidelines/examples focused on ORT and PRT.ResultsEight of a total of 12 centers throughout different Brazilian regions were visited. A scoping review was carried out on body-sizing methods for manufacturing non-implantable ORT and PRT, and the differences and particularities of each method. Another systematic review on existing HTA guidelines and the HTA assessment of ORT and PRT is ongoing. The data of the three phases will be analyzed and translated in a Brazilian guideline of HTA for non-implantable ORT and PRT.ConclusionsWith the network of regional and national centers and the sum of different actors (such as government agencies, universities, and health centers), working together for common ground and the sustainability of the health system in complex areas such as HTA of ORT and PRT would be viable. Even with this effort, the work to be done and the challenges are significant.
PP82 Prevention And Intervention Software Applications For People At Risk Of Suicide: Effectiveness And Safety
Authors: Rivero-Santana Amado , Duarte-Díaz Andrea , Álvarez-Pérez Yolanda , Linertová Renata , Torres-Castaño Alezandra , González-Pacheco Himar , Guirado-Fuentes Carmen , Sacks Analía Abt , García Vanesa Ramos , Toledo-Chávarri Ana , Acosta-Artiles Francisco Javier , Serrano-Pérez Pedro , Carrion Carme , Guillén Marta , Perestelo-Pérez Lilisbeth 
Published: January 2025

IntroductionSuicide poses a severe public health challenge worldwide, impacting individuals, families, work, and society. The multifaceted nature of suicide demands a complex approach involving psychological, biological, social, cultural, and environmental factors. Recognizing suicide’s status as the leading external cause of death in Spain, prevention increasingly incorporates technology, specifically mobile and software applications.MethodsA systematic review of the effectiveness and safety of mobile and software applications was conducted (MEDLINE, Embase, CINAHL, and PsycINFO databases). Outcome variables included: suicide; suicidal behavior; suicidal intent; suicidal ideation/thinking; self-perceived suicide risk; using/seeking mental health services; associated mental symptoms; mental health-related quality of life; satisfaction of the user and the health professional; adverse events related to the app, as defined in the included studies. Studies that do not include suicidal behavior, intention, or ideation were excluded. Where available data allowed, a meta-analysis was conducted for each outcome variable.ResultsOne systematic review and 13 randomized controlled trials (n=2,952) were analyzed. No significant differences were found in deaths by suicide or suicide attempts. At post-intervention, small but significant reductions were observed in suicidal ideation, hopelessness, depression, and worry, with anxiety reduction slightly above statistical significance. At follow-up (8 to 52 weeks), these variables also obtained significant results, except depression and suicidal ideation. Regarding safety, there was no significant difference in safety phone calls for participants with suicidal ideation.ConclusionsThe evidence on suicide prevention app effectiveness is of low quality, precluding conclusive findings. Attempt reduction is suggested at 21 percent, but the confidence interval includes a potential 60 percent increase. Evidence on suicide-related psychological variables (suicide ideation, depression, hopelessness, and anxiety) is of higher quality (low–moderate), but effects are small and clinically uncertain. Safety findings are uncertain, impacting risk/benefit balance.
PP86 Development Of A Tool To Assist In The Identification Of Study Designs For The Purposes Of Health Technology Assessment
Authors: di Ruffano Lavinia Ferrante , Reddish Katie , Bishop Emma , Watkins Deborah , Edwards Mary , McCool Rachael 
Published: January 2025

IntroductionAs the most internally rigorous design, randomized controlled trials (RCTs) are the gold standard for assessing the efficacy and safety profile of interventions. Increasingly, health technology assessment (HTA) considers evidence from non-randomized studies. Guidance recommends synthesizing different study designs separately due to their different inherent biases/limitations. But when authors or reviewers misclassify studies, this could affect which studies are included and therefore have an impact on review results.MethodsWe are conducting a methods project to (i) identify a clear study design classification system, (ii) explore whether its use produces consistent study design categorizations among reviewers, and (iii) iteratively improve the classification system. We performed a pragmatic web-based search for study design categorization tools and used the resulting schemas to develop a clear algorithm for use by reviewers of all levels of experience, specifically in reviews of treatment interventions. Next, we tested tool consistency and user experience by web-based survey in a small internal sample of reviewers, each independently using the system to categorize 18 published studies.ResultsA median of seven reviewers (range four to eight) categorized each study. Rater agreement using the chart varied widely, with 100 percent agreement on the designs of three studies (17%), and at least 75 percent of reviewers agreeing on one design for nine studies (50%). The most common agreement was reached on RCTs and non-randomized controlled trials. The most common sources of disagreement were between different types of cohort studies and between case series and controlled cohort studies, largely due to inconsistent reporting. We also identified several improvements: the wording of prompt questions, the ordering of designs, and the addition of new elements.ConclusionsThe classification system as initially designed led to too much variation in study design categorization to be useful. Consequently, we present a revised version that we now aim to evaluate in a larger sample of reviewers. Further research will also investigate whether using the tool would change the results of systematic reviews, using a small sample of published reviews.
PP89 Artificial Intelligence And Health Technology Assessment: Playing Catch-Up
Authors: England Clare , Washington Jenni 
Published: January 2025

IntroductionThe use of artificial intelligence (AI) in health care has the potential to improve clinical and patient outcomes and to reduce rising costs. There is an exponential increase in health technologies that use AI. We present a health technology assessment (HTA) case study demonstrating that the rapid rise in publications presents challenges for HTA bodies seeking to provide robust, timely assessments.MethodsWe conducted an HTA of AI-assisted endoscopy in the detection and characterization of lower gastrointestinal (GI) cancer. Searches were conducted up to October 2023. Unusually, the search targeted only the intervention: artificial intelligence and lower-GI-tract endoscopy (including colonoscopy, proctoscopy, etc.). The search strategy was peer reviewed. MEDLINE, Embase, KSR Evidence, CINAHL, Cochrane Library, and the INAHTA HTA database were searched, as well as ongoing trial registers and key websites. A date limit of 2010 onwards was applied, as Xbox Kinect launched in 2010 and was the first mainstream device used for healthcare imaging.ResultsTwo network meta-analyses, 15 meta-analyses, one systematic review of meta-analyses, and three systematic reviews published since 2020 were identified. One review conducted searches to January 2020, identifying three randomized controlled trials (RCTs); a review that searched up to February 2023 identified 21 RCTs. There was substantial overlap regarding included primary studies, but not all reviews included the same outcomes. An additional seven RCTs were published in 2023. We also identified 12 cohort studies published between 2021 and 2023. We prioritized higher quality meta-analyses of clinical RCTs to include all outcomes of interest and updated the meta-analyses for primary outcomes.ConclusionsThis case study of an HTA of an AI-related technology demonstrates how rapidly the field is moving. It is necessary to use well targeted but not overly exclusive search strategies, limit by date, and prioritize inclusion of identified evidence according to quality and availability of outcomes. Time should be allowed to update existing meta-analyses.