bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP27 Reusing And Adapting Health Technology Assessments (HTAs): An Example From The COVID-19 Time
Authors: Faraldo-Valles Maria-Jose , Regueira-Castro Alba , Triñanes Yolanda 
Published: December 2022

IntroductionHealth technology assessment (HTA) reports are complex technical documents that address multiple aspects of the incorporation of a technology into the health care system applying complicated methodologies coming from different disciplines. The purpose of HTA is to support decision-makers and these should have an adequate level of training to fully understand these assessments. However, most HTA education programs and courses are intended for HTA doers and there is a lack of practical guidance training aimed at preparing health managers or policy makers in HTA. The objective is to describe an HTA training program developed for decision-makers of the three levels (health care administration, hospital management and clinical practice).MethodsRolling Collaborative Review (RCR) 01 of convalescent plasma was identified and selected because it complied with our Population Intervention Comparator Outcome Design Question. The EUnetHTA HTA adaptation Toolkit was used to check the relevance (about research question); reliability (quality of the report) and transferability (application of information to the target setting). Additional considerations regarding the local context were examined. A panel of four professionals and one patient was formed to rate the importance of the outcomes and to carry out the external reviewResultsAccording to the toolkit, information on RCR01 Convalescent Plasma could be adopted for the safety and effectiveness domains. The technical characteristics and current use domains were adapted and extended. It was considered of interest to include the domains of organization and ethics. The organizational aspects were answered through the information retrieved in a search for systematic reviews and guides, and with the collaboration of experts. The ethics domain was answered through a specific literature search on ethical issues related to COVID-19 and transfusions.ConclusionsThe use of the EUnetHTA Toolkit has been helpful in supporting the adaptation process. The adoption of the effectiveness and safety domains from already developed HTA assessments is an efficient way to provide useful information for the decision-making process. However, contextual elements should be included in the adaptation process to ensure a complete framework for the decision.
PP28 Is My Medicine Suitable For An Outcomes Based Agreement? The Feasibility Conundrum
Authors: de la Fuente Graciela Sainz , Halsby Kate , Burton Jessica R. 
Published: December 2022

IntroductionOutcomes Based Agreements (OBAs) are financial arrangements that offer the opportunity to align payment to health outcomes in the real-world, and share the financial risk by providing long-term solutions that grant access to medicines, with reimbursement only when performance is achieved. OBAs are most likely to be useful when there is high uncertainty in the clinical data, but they are difficult to design and implement, and other financial options are usually preferred by payers. As a result, OBAs have been more the exception than the norm, and there is not a clear pattern that indicates if an OBA is likely to succeed in practice.MethodsThrough a retrospective OBA exercise with NHS Wales (Project IDEATE: Innovation in Data to Evolve Agreements That Enhance patient health outcomes), we have explored the circumstances under which an OBA might be most appealing to payers, and assessed implementation challenges and solutions, to propose a framework to evaluate the feasibility of a medicine for an OBA.ResultsAlong with mitigating some of the clinical uncertainties associated with a lack of mature data at the time of launch, an OBA must also consider other factors: the commercial viability of the agreement, the associated administrative burden, and its cost of implementation. Also, the Health System commitment to a Value-Based Healthcare agenda and, most importantly, its willingness to offer long-term sustainable solutions to optimise treatment, are key to support this approach.Practical considerations include: how the relevant outcomes are going to be selected and tracked in the real-world, how the whole model is going to fit within the current procurement and finance infrastructures, and how industry works in collaboration with the Health System.ConclusionsInsights from Project IDEATE will be used to explore how our OBA feasibility framework might be applied in the future.
PP36 Joint Replacement Under Computer Navigation And Robotic Systems
Authors: Akhmedullin Ruslan , Avdeyev Andrey , Benberin Valeriy , Shanazarov Nasrulla , Bariyeva Gulzada , Okesh Makhabbat , Akhmetova Makpal , Aimanova Tansolpan 
Published: December 2022

IntroductionOsteoarthritis (OA) is a heterogeneous group of diseases of various etiologies based on the defeat of all components of the joint. OA is one of the main causes of disability in older people. To date, joint replacement is the most clinical and cost-effective method of the terminal stage treatment. The short and long-term success of total joint replacement is closely related to the accuracy of the prosthesis implantation. Published studies show that the accuracy of prosthesis implantation can be intraoperatively controlled by computed navigation and robotic systems better than by traditional methods.MethodsIn order to assess the clinical effectiveness of the technologies, we have conducted a literature search in the MEDLINE database. We included studies that reported a comparison of outcomes between conventional methods, computer navigation and robot-assisted surgery.ResultsThe results of this literature review are based on six systematic reviews with meta-analyses (101 studies representing 482,367 cases) and one national joint replacement registry. The outcomes compared included Knee Society Score (KSS)-function, alignment correction, mechanical axis (varus and vagus deviance >3°), prosthesis positioning, soft tissues balancing and functional outcomes. Thus, the cumulative success rate in the computed navigation and robotic systems group was reported to be 86.7 percent, which is crucial considering its lowered rate of revision (3%), correct mechanical axis (≤3%) and functional status.ConclusionsThe literature review demonstrates a high potential of the computed navigation and robotics systems in the intraoperative monitoring of important surgical parameters for achieving the best intervention outcomes. All the clinical endpoints were significantly better by comparison with conventional method.
PP42 Impact Of The COVID-19 Pandemic On Scottish Medicine Consortium Submission Characteristics, Acceptance Rates, And Time To Advice
Authors: Leslie Iain , Berg Guy 
Published: December 2022

IntroductionScottish Medicine Consortium (SMC) meetings were suspended in March 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. This led to a high number of submissions awaiting appraisal, prompting interim process changes to ensure minimal disadvantages to patient access. We expanded the eligibility criteria for the shorter (abbreviated) submissions process and expedited advice for submissions the New Drugs Committee (NDC) intended to accept. This study aimed to evaluate the impact of the COVID-19 pandemic and these interim process changes on the characteristics of submissions received, acceptance rates, and time to advice publication.MethodsData for all submissions received between January 2015 and November 2021 (n=720) were extracted from an organizational database. Characteristics of and acceptance rates for submissions received before and after the start of the pandemic were compared using chi-squared and one-proportion Z-tests, respectively. Additional analyses explored the number of submissions received per month and the time from receipt of submission to NDC and SMC decision.ResultsThe numbers of full and abbreviated submissions increased from March 2020 (6% in each case), with a corresponding decrease in the number of medicine-indication pairs (e.g., pembrolizumab for breast cancer) for which companies did not submit (8%; p=0.01). An increase in the SMC acceptance rate was also observed (62 to 72%; p=0.03). Fewer submissions were received in 2020 (n=65), compared with the pre-pandemic average (mean=79.6), whereas the total in 2021 to date was higher than average (n=92). Time series analysis suggested an increasing trend in monthly submissions (from approximately 6 to 9), which is the likely reason for the increase in average time to decision (146 versus 170 days).ConclusionsProcess changes in response to the pandemic have been effective in expediting advice for submissions with sufficiently robust evidence. This demonstrates agility and efficiencies for submitting companies and patient groups, with no perceived impact on process rigor. The average number of submissions has increased since March 2020, and further work is warranted to understand the influence of process improvements on reducing time to advice.
PP57 Collaborating In Times Of COVID: The Launch Of The National Wales COVID-19 Evidence Centre
Authors: Elston Lauren , Winfield Thomas , Washington Jenni , Jarrom David , Myles Susan , Lewis Ruth , Cooper Alison , Gal Micaela , Edwards Adrian 
Published: December 2022

IntroductionThe COVID-19 pandemic has had a dramatic impact on the health and social care landscape, both in terms of service provision and citizen need. Responsive, evidence-based research is essential to develop and implement appropriate policies and practices that manage both the pandemic itself, and the impact COVID-19 has on other health and social care issues.To address this, the Wales COVID-19 Evidence Centre (WCEC) was launched in 2021 with the aim of providing the best available, up-to-date, and relevant evidence to inform health and care decision making across Wales.MethodsFunded by the Welsh Government, the WCEC comprises of a core team and several collaborating partner organizations, including Health Technology Wales, Wales Centre for Evidence-Based Care, Specialist Unit for Review Evidence Centre, SAIL Databank, Public Health Wales, Bangor Institute for Health & Medical Research in conjunction with Health and Care Economics Cymru, and the Public Health Wales Observatory. Over the last year, WCEC has developed its rapid review processes and methodology informed by best international practice and aims to provide around 50 reviews each year. WCEC works alongside various stakeholder groups from health and social care across Wales, and they form an integral part of the review process, from scoping to knowledge mobilization.ResultsTo date, the WCEC has produced reviews on a diverse range of COVID-19 topics, including transmission, vaccination uptake (barriers, facilitators and interventions), mental health and wellbeing, as well as face coverings and other preventative interventions. The topics have also covered a wide range of populations, from general public, to healthcare workers, to children. These reviews have been used to inform policy and decision-making, including the Welsh Government’s Chief Medical Officer 21-day COVID-19 reviews.ConclusionsThe WCEC has brought together multiple specialist centers with a diverse range of skills to produce timely reviews of the most up-to-date research to support decision makers across health and social care. These reviews have informed policy and decision-making across Wales.
PP58 SARS-CoV-2: A Rapid Review Of The Transmission Risk From Vaccinated Populations
Authors: Barrate Sasha , Elston Lauren , McDermott Katie , Washington Jenni , Hasler Elise , Jarrom David , Bowles Charlotte , Tom Winfield Jessica Williams , Myles Susan 
Published: December 2022

IntroductionSince the vaccine roll out, research has focused on vaccine safety and efficacy, with large clinical trials confirming that vaccines are generally effective against symptomatic COVID-19 infection. However, breakthrough infections can still occur, and the effectiveness of vaccines against transmission from infected vaccinated people to susceptible contacts is unclear.Health Technology Wales (HTW) collaborated with the Wales COVID-19 Evidence Centre to identify and examine evidence on the transmission risk of SARS-CoV-2 from vaccinated people to unvaccinated or vaccinated people.MethodsWe conducted a systematic literature search for evidence on vaccinated people exposed to SARS-CoV-2 in any setting. Outcome measures included transmission rate, cycle threshold (Ct) values and viral load. We identified a rapid review by the University of Calgary that was the main source of our outcome data. Nine studies published following the rapid review were also identified and included.ResultsIn total, 35 studies were included in this review: one randomized controlled trial (RCT), one post-hoc analysis of an RCT, 13 prospective cohort studies, 16 retrospective cohort studies and four case control studies.All studies reported a reduction in transmission of the B.1.1.7 (Alpha) variant from partial and fully vaccinated individuals. More recent evidence is uncertain on the effects of vaccination on transmission of the B.1.617.2 (Delta) variant. Overall, vaccine effectiveness in reducing transmission appears to increase with full vaccination, compared with partial vaccination. Most of the direct evidence is limited to transmission in household settings therefore, there is a gap in the evidence on risk of transmission in other settings. One UK study found protection against onward transmission waned within 3 months post second vaccination.ConclusionsEarly findings that focused on the alpha variant, showed a reduction in transmission from vaccinated people. There is limited evidence on the effectiveness of vaccination on transmission of the Delta variant, therefore alternative preventative measures to reduce transmission may still be required.
PP62 Recommendations On Methodologies To Obtain Comparator Efficacy In Health Economic Assessments Of Tumor-Agnostic Drugs
Authors: Efe Reva , Vijgen Sylvia 
Published: December 2022

IntroductionGuidance on appropriate methods to obtain a comparator arm for the cost-effectiveness analysis of tumor-agnostic drugs is needed. In recent years, multiple tumor-agnostic drugs have been submitted to health technology assessment (HTA) bodies based on data from single-arm basket trials. These target a specific genetic mutation, as opposed to targeting a specific tumor type. Since HTA bodies are interested in the comparative effectiveness of a treatment, manufacturers have used several methods to obtain a synthetic control arm in their submissions. This study provides an overview of the recommendations by HTA bodies on the methodology to obtain comparator efficacy.MethodsA targeted literature review will be conducted focusing on the methodology used to obtain a comparator arm in the context of tumor-agnostic drugs. The search will cover key HTA organizations; including the National Institute for Health and Care Excellence (NICE), Haute Autorité de Santé (HAS) and the Canadian Agency for Drugs & Technologies in Health (CADTH). Methodologies used in entrectinib and larotrectinib submissions will be extracted. Particular focus will be given on the impact of the applied methodology to the reimbursement decision, as well as key critiques by the HTA bodies. Key search terms will include the following: ‘tumor-agnostic’, ‘histology independent’, ‘HIT’, ‘entrectinib’, ‘larotrectinib’.ResultsAn overview of the results will be presented. These will include the applied methodology for obtaining a comparator arm, critiques and recommendations from HTA bodies, and the impact these methodologies had on the overall reimbursement decision. This will enable comparison of HTA decision-making across regions, and key evidence gaps that need to be further explored.ConclusionsThe results of this study could be useful in the future assessment of tumor-agnostic drug submissions, focusing on the methodology used to obtain comparator efficacy.
PP66 Safety, Effectiveness And Cost-effectiveness Of Scalp Cooling Devices For The Prevention Of Chemotherapy-induced Alopecia
Authors: Infante-Ventura Diego , de Armas-Castellano Aythami , Hernández-Yumar Aránzazu , González-Pacheco Himar , Pino-Sedeño Tasmania del , González-Hernández Yadira , García-Pérez Lidia , Ramallo-Fariña Yolanda , Rodríguez-Rodríguez Leticia , Rueda-Domínguez Antonio , Serrano-Aguilar Pedro , del Mar Trujillo-Martín María 
Published: December 2022

IntroductionChemotherapy-induced alopecia (CIA), although reversible, is one of the most common and distressing side effects of cancer therapy, affecting approximately 65 percent of all patients and influencing treatment decisions in some of them. Scalp cooling (SC) is a method aiming to prevent CIA. Our study aims to evaluate the real value of SC devices.MethodsA systematic review of the available scientific literature on the safety, effectiveness and cost-effectiveness of the use of SC compared with no intervention was performed. Overall effect size was estimated through a meta-analysis. An economic analysis in the Spanish context from the Spanish National Healthcare System (NHS) and social perspectives was performed.ResultsThirteen randomized controlled trials (n = 832) were included but only nine contributed to the meta-analysis. A large effect in favor of SC reducing hair loss was found (RR=0.57; 95% CI: 0.46-0.69). No differences were observed according to the type of cancer, although there was a small positive effect for breast cancer. A higher effect was found in patients treated with a combination anthracyclines/taxanes treatment compared to those treated only with anthracyclines. The only economic evaluation found in the literature was conducted in The Netherlands and concluded that Paxman system was less costly than usual care from societal perspective and no differences in quality adjusted life years (QALYs) were observed. The de novo economic analysis showed that the strategies including SC devices generated more costs and QALYs (given some assumed utility values) than usual care (not SC), presenting incremental cost-effectiveness ratios below the threshold calculated for Spain (EUR 25,000 /QALY), from both perspectives.ConclusionsThe results suggest that SC are effective for the prevention of CIA. Furthermore, assuming the utility values used in the model, SC devices are cost-effective compared to usual care (not SC).
PP82 First Educational Trainings According To New Health Technology Assessment Guideline For Medicines In Ukraine
Authors: Khmelovska Marharyta , Piniazhko Oresta , Serediuk Valeriia , Masheiko Alona , Romanenko Iryna 
Published: December 2022

IntroductionThe success of the health technology assessment (HTA) implementation depends on the level of communication efficiency between all stakeholders. Taking this into consideration, the leading HTA experts of HTA Department of State Expert Center of the Ministry of Health of Ukraine launched the new educational initiative which includes training programs for pharmaceutical companies.MethodsСomprehensive review of the first developed HTA training programs based on the HTA Guideline (Number 593) “The state health technology assessment for medicines” approved on 29 March 2021 was conducted.ResultsLeading HTA experts of the HTA Department developed a training program, which was conducted for industry representatives according to the provisions of the HTA Guideline. In 2021 over twelve training sessions and two webinars were conducted. These learning events reflect harmonized international recommendations and approaches to HTA training programs, The Professional Society for Health Economics and Outcomes Research, ISPOR short courses in particular, European Network for Health Technology Assessment (EUnetHTA), The National Institute for Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), Agency for Health Technology Assessment and Tariff System (AOTMiT) guidelines. Two-hour webinars were aimed at giving theoretical and practical bases for building a Markov model with the help of Excel and TreeAge Software. Training sessions titled “HTA as a tool for assessing the value of health technology” differ by duration (7-hour, 4-hour, 3-hour) and cover core topics adapted to the needs of the audience. The main program components include HTA Roadmap in Ukraine, clinical section, economic section and practical case studies of building a Markov model. All training options included questionnaires at the beginning and i end to assess the quality of each program. Questionnaires are the tool that gives presenters the possibility to trace progress and transform the training material accordingly.ConclusionsDevelopment of extended capacity building programs in HTA for users and doers is highly prospective for further steps in HTA institutionalization in Ukraine.
PP83 Economic Impact Of Missed Vaccinations On The Italian National Health System
Authors: Di Brino Eugenio , Basile Michele , Rumi Filippo , Cicchetti Americo ,   Instant Report Group
Published: December 2022

IntroductionTo provide a complete picture of the economic impact of the coronavirus disease 2019 (COVID-19) emergency for the Italian National Health System (NHS), an estimate was made of the costs to the NHS of vaccination hesitation. The concept of economic impact was investigated with reference to the volume of hospitalizations and days of intensive care required for patients with COVID-19 related to missed vaccinations, considering a vaccine efficacy of less than 100 percent.MethodsData from the Istituto Superiore di Sanità were analyzed with respect to the number of people vaccinated in the general population, and the number of people with severe acute respiratory syndrome coronavirus 2 infection who were hospitalized or died in a one-month period stratified by vaccination status. The costs for unvaccinated patients admitted to a general hospital ward (Medical Area) or the intensive care unit were calculated.ResultsBased on the number of preventable hospitalizations among unvaccinated people, the economic impact of missed vaccinations on the NHS in the 30-day period from 13 August 2021 to 12 September 2021 was estimated. Among the unvaccinated hospitalized patients, 5,932 would have avoided hospitalization in the Medical Area and 715 would have avoided admission to the intensive care unit. Thus, each unvaccinated hospitalized patient had an average per capita cost of EUR 17,408. The total costs amounted to EUR 69,894,715, comprising EUR 51,166,079 for hospitalizations in the Medical Area and EUR 18,728,636 for hospitalizations in intensive care.ConclusionsBy evaluating the weekly incidence of hospitalizations per 100,000 people stratified by vaccination status (unvaccinated, partially vaccinated, and fully vaccinated), it is possible to see that we are facing two distinct pandemics running together.