["Poster Presentation Number: PP59 Abstract Title: Multidimensional Evaluation Of The Reducer Device In Patients With Refractory Angina Author Names: Americo Cicchetti, Filippo Rumi ([email protected]), Ludovica Siviero, Agostino Fortunato Introduction Treatments for coronary heart disease patients have had major developments in recent decades, both in the pharmacological and interventional fields, and this has helped to prolong the survival of these patients. However, the growing number of patients who show persistent and disabling symptoms of angina proves that at the same time their quality of life has not been equally improved. Methods We conducted a multidimensional assessment coherent with health technology assessment methodology on the Coronary Sinus Reducer System (CSRS). CSRS is the latest line of therapy for patients with coronary artery disease who are ineligible for revascularization, demonstrate reversible ischemia, and have refractory angina pectoris (AP) despite optimal standard medical therapy. We performed a literature review in order to gather evidence on efficacy and safety of the device and on the economic and organizational impact of the procedure. In the economic domain we developed a cost-utility model based on a decision tree and a five-year time horizon budget impact model. Results Several studies in the literature have shown that this therapy is related to an increase in quality of life and an improvement in symptoms of refractory angina. The economic evaluations conducted show how the therapy, despite an increase in the resources absorbed in the first years of implementation, reaches a cost saving profile in the medium term due to positive outcomes, while leading to an increase in the quality of life in patients suffering from refractory angina. Conclusions The treatment of refractory angina remains a challenge for today's medicine. Patients suffering from this condition are often described as \u201cno option\u201d patients. Thus, despite there is a need of further evidence to establish even more robustly the economic sustainability of the device, especially on its effectiveness in the medium-long term, the device should be taking into account in those patients who could benefit from it in terms of relieving the symptoms of angina and improving their quality of life.","Poster Presentation Number: PP61 Abstract Title: Plugging the Gap of Fetoscopy in Congenital Diaphragmatic Hernia Pregnancies: Value for Money? Author Names: Jip Janssen, ([email protected]), Joris van Drongelen, Willeke F Daamen, Janneke Grutters Introduction Fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) fetuses increases the neonatal survival rate. However, FETO also increases the number of preterm prelabour rupture of membranes (PPROM) and preterm deliveries (PTDs) as fetal membrane defects after fetoscopy do not spontaneously heal. To solve this issue, an advanced sealing plug is being developed. Through early-stage health economic modelling, we estimated the potential value of this innovative plug in terms of costs and effects and determined the properties for it to become cost-effective. Methods We applied early-stage health economic modelling to the case of performing FETO in singleton pregnant women whose fetus is prenatally diagnosed with CDH. We simulated a cohort of women using a state-transition model over a 45-year time horizon. In our best-case scenario analysis, we compared the current care strategy to a perfect plug strategy, which reduces PPROM and PTDs by 100 percent, to determine the maximum quality- adjusted life years (QALYs) gained and costs saved. Using threshold analysis, we determined the minimum percentage of reduction in PPROM and PTDs for the plug to be considered cost-effective. Model parameters\u2019 impact on outcomes was investigated in a sensitivity analysis. Results Our model indicated that a perfect plug strategy would yield an additional 1.94 QALYs at a cost decrease of EUR 2,554 per patient per year. These values were strongly influenced by the percentage of very preterm deliveries. Threshold analysis showed that, for EUR 500 per plug, the plug strategy needs a minimum relative reduction of 1.83 percent in PPROM and PTDs (i.e., PPROM: 47.50 to 46.63 %, PTDs: 71.50 to 70.19 %) to be cost-effective. Conclusions Our model-based approach showed clear potential for the plug strategy when applied in the context of FETO for CDH fetuses, as only a small reduction in PPROM and PTDs is needed for the plug to be cost-effective. Its value is expected to be even higher when used in conditions suffering from more very preterm deliveries. Continuation of investment in the innovation\u2019s research and development seems to provide value for money.","Poster Presentation Number: PP62 Abstract Title: Recommendations On Methodologies To Obtain Comparator Efficacy In Health Economic Assessments Of Tumor-Agnostic Drugs Author Names: Reva Efe ([email protected]), Sylvia Vijgen Introduction Guidance 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. Methods A 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 Autorit\u00e9 de Sant\u00e9 (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: \u2018tumor-agnostic\u2019, \u2018histology independent\u2019, \u2018HIT\u2019, \u2018entrectinib\u2019, \u2018larotrectinib\u2019. Results An 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. Conclusions The 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.","Poster Presentation Number: PP66 Abstract Title: Safety, Effectiveness And Cost-effectiveness Of Scalp Cooling Devices For The Prevention Of Chemotherapy-induced Alopecia Author Names: Diego Infante-Ventura, Aythami de Armas-Castellano, Ar\u00e1nzazu Hern\u00e1ndez-Yumar, Himar Gonz\u00e1lez-Pacheco, Tasmania del Pino-Sede\u00f1o, Yadira Gonz\u00e1lez-Hern\u00e1ndez, Lidia Garc\u00eda-P\u00e9rez, Yolanda Ramallo- Fari\u00f1a, Leticia Rodr\u00edguez-Rodr\u00edguez, Antonio Rueda-Dom\u00ednguez, Pedro Serrano-Aguilar, Mar\u00eda del Mar Trujillo- Mart\u00edn ([email protected]) Introduction Chemotherapy-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. Methods A 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. Results Thirteen 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. Conclusions The 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).","Poster Presentation Number: PP68 Abstract Title: Dexcom G6\u00ae Device For Diabetes During Pregnancy Author Names: Vanesa Ramos-Garc\u00eda ([email protected]), Amado Rivero-Santana, Lilisbeth Perestelo-P\u00e9rez, Andrea Duarte-D\u00edaz, Yolanda \u00c1lvarez-P\u00e9rez, Alezandra Torres-Casta\u00f1o, Ana Toledo-Ch\u00e1varri, Ana Mar\u00eda W\u00e4gner, Leticia Rodr\u00edguez-Rodr\u00edguez, Carlos Gonz\u00e1lez-Rodr\u00edguez, Pedro Serrano-Aguilar Introduction Diabetes mellitus (DM) is one of the most frequent metabolic complications associated with pregnancy, affecting both the prognosis of the pregnant woman and the newborn. Pregestational DM type 1 (T1DM) and type 2 (T2DM) and gestational DM (GDM) are associated with an increased risk of pregnancy complications such as miscarriage, fetal malformations, macrosomia, preeclampsia, and neonatal hypoglycemia, among others. The aim of this review was to evaluate the efficacy and safety of using the Dexcom G6 device (Dexcom, Co., USA) to continuously self-monitor blood glucose levels during pregnancy. This report was requested by the Spanish Ministry of Health. Methods We systematically searched for articles published to July 2021 in the MEDLINE, Embase, and Web of Science databases. We included experimental and observational primary studies addressing the safety, efficacy, and cost effectiveness of the Dexcom G6 device for gestational and pregestational diabetes. Results Two non-comparative prospective studies were identified. One study of 25 pregnant women with T1DM, which evaluated glycemic control and complications during pregnancy and postpartum, reported stable hemoglobin A1c levels during gestation in women using the Dexcom G6 device. The percentage of time spent in the therapeutic glucose range (63 to 140 mg\/dL) was 59 percent; 38 percent was in the hyperglycemic range and 3 percent was in the hypoglycemic range. Although some patients reported mild erythematous and edematous reactions to the sensor, no moderate or severe reactions or infections occurred at the sensor insertion site. The other study in pregnant women with T1DM (n=20), T2DM (n=3), or GDM (n=9) showed adequate accuracy of the Dexcom G6 device, compared with the reference method, especially when the sensor is placed on the arm. Conclusions Randomized controlled trials are required to assess the effectiveness and safety of the Dexcom G6 device in maintaining adequate glucose control during pregnancy in women with DM. Studies are also needed to compare the Dexcom G6 device with conventional capillary blood glucose self-monitoring or other monitoring methods. No cost-effectiveness studies have been conducted for the Dexcom G6 device in this patient population.","Poster Presentation Number: PP69 Abstract Title: Supporting Decision Making: A Health Technology Assessment Training Proposal for Decision Makers Author Names: Maria-Jose Faraldo-Valles ([email protected]), Leonor Varela-Lema, Monica Perez-Rios Introduction Health technology assessment (HTA) reports are complex technical documents that address multiple aspects of the incorporation of a technology into the healthcare system applying complicated methodologies coming from different disciplines. The purpose of HTA is to support decision makers, who 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). Methods The education program has been designed through a collaboration between the Public Health Department of the Faculty of Medicine of the University of Santiago de Compostela (USC) and the Galician Health Technology Assessment Agency that belongs to the Spanish HTA Bodies Network. The duration of the course is 200 hours and the methodology will be distance learning, through the virtual classroom of the USC. The teaching collaborators come from the academic field and the HTA area. Results The course will cover the legal, clinical and organizational framework in which the HTA is developed in Spain and in Europe; and will approach the methodology used in HTA. The course is structured in six modules: (i) Research, development and regulation of health technologies; (ii) Role of HTA as a decision support tool; (iii) HTA Methodology; (iv) Health information systems (including use of real world data); (v) Incorporation of HTA into society (stakeholders); (vi) Future challenges (personalized medicine and e-health). Conclusions A specific training about HTA from a practical approach not theoretical could be of interest for different stakeholders involved in the decision-making process across the health systems. This type of educational program will allow decision makers to have a good understanding of the wide range of information they handle.","Poster Presentation Number: PP70 Abstract Title: Enhancing HTA Processes In The Maltese System For Introducing New Medicines Author Names: Simone de Vries ([email protected]), Katharina Abraham, Sylvana Magrin Sammut, Antonia Formosa, Isaac Corro Ramos, Matthijs Verteegh, Rudy Dupree, Annemieke van der Waal, Margreet Franken, Wim Goettsch Introduction Most European countries use Health Technology Assessment (HTA) as input for decisions on reimbursement of (new) medicines. In 2018, following the approval of European Social Funding, the Directorate for Pharmaceutical Affairs (DPA) within the Malta Ministry for Health led a specific Work Package aimed at enhancing knowledge, skills and HTA processes to inform reimbursement decisions. Methods Since the start of the project, the Institute for Medical Technology Assessment (iMTA) and the National Health Care Institute of the Netherlands (ZIN) collaborate in providing guidance and training to DPA on relative effectiveness assessments (REAs) and pharmacoeconomic assessments (PEAs) of pharmaceuticals. Several activities were organized: site visits, face-to face interviews with stakeholders, a qualitative assessment of the core process of the Maltese system, health economics training and tutorials, meetings introducing the European Network for Health Technology Assessment (EUnetHTA) and Dutch HTA processes, development of a new framework for assessment, and a shadow assessment. Results Our assessment identified important methodological challenges and crucial processes\u2019 interdependencies to optimize within the Maltese system. Based on the learnings, DPA created a template based on the EUnetHTA REA assessment format. IMTA created a template to perform PEAs. Currently, a shadow assessment is ongoing in which DPA performs the REA and PEA of a pharmaceutical using the new templates. ZIN and iMTA will provide feedback to DPA on several aspects, including, but not limited to, the PICO, assessment of therapeutic efficacy and safety, identifying uncertainties, input costs and effects, and formulating a clear discussion of the assessment. If necessary, the templates will be adapted during the process. The project will be evaluated and finalized in 2022. Conclusions With the guidance and training provided by iMTA and ZIN, DPA structured and aligned their REA and PEA to enhance their assessment process and to improve the presentation of their HTA report to the two appraisal committees. This project emphasizes the importance of international collaboration to enhance HTA processes within the","Poster Presentation Number: PP71 Abstract Title: Lessons Learned During Analyses Of Appropriate Hearing Care: Building Bridges Between Patient Organisations, Health Professionals And Insurance Companies Author Names: Mariska Stam ([email protected]), Tjitske Vreugdenhil, Marleen Hermens, Hedy Maagdenberg Introduction As part of the cyclic Appropriate Care programme of the National Health Care Institute in the Netherlands, a systematic analyses of hearing health care are taking place. Parties in hearing health care are actively involved throughout the entire process. This abstract focuses on lessons learned from the cooperation as a HTA body with a diverse group of stakeholders. Methods We carried out an in-depth analysis for the patient journey of both children and adults with ear complaints or hearing impairment. Different kinds of information were included in the analyses, including claims data, quantitative and qualitative research, analyses of (international) guidelines and patient information. A range of strategies were used to co-operate and interact with patient organisations, hearing health-care professionals, institutes\/hospitals and insurance companies. Results Close collaboration between the project team and patient organisations turned out to be effective to comprehend patient\u2019 perspectives. Data analyses were often found to be challenging in hearing health care, as the reimbursement data lacked sufficient information. In several cases, building bridges between parties, but also in relation to our HTA body was needed. Conclusions from the analyses were being shared and discussed with a panel of involved stakeholders, leading to support, but not always consensus on potential room for improvement. An internal review process turned out to be helpful in sharing experiences on effective multi- stakeholder management. Conclusions We believe that the process did influence the way stakeholders think about the appropriate use of the different available treatment options. Building bridges, and combining different perspectives from patient organisations, health-care professionals and insurance companies is necessary in a cyclic approach. The cyclic appropriate Care programme proved to be a constructive approach for collaboration with stakeholders.","Poster Presentation Number: PP72 Abstract Title: SARS-CoV-2: A Rapid Review On The Effectiveness Of Face Coverings To Reduce Transmission. Author Names: Thomas Winfield, Gareth Hopkin, Lauren Elston ([email protected]), Claire Davis, Jenni Washington, David Jarrom, Katie McDermott, Susan Myles Introduction At various stages of the COVID-19 pandemic, face coverings have been recommended and encouraged as one of the interventions to reduce transmission of the SARS-CoV-2 virus. However, in the earlier stages of the pandemic, decisions on face coverings relied primarily on evidence based on other viral respiratory infections. More direct evidence on the use of face coverings with COVID-19 developed in tandem with the pandemic. Health Technology Wales undertook an ultra-rapid review to inform national guidelines, the work assessed the evidence on the effectiveness of face coverings to reduce SARS-CoV-2 transmission. We also reviewed evidence on the efficacy of different types of face coverings. Methods We conducted a systematic literature search for evidence to address (i) the effectiveness of face coverings to reduce the spread of COVID-19 in the community, and (ii) the efficacy of different types of face coverings designed for use in community settings. We identified a rapid review in 2021 by Public Health England that closely aligned with our review questions. This provided the main source for identifying relevant studies, supplemented by a search for publications following their search date. Results We identified two evidence reviews (including the Public Health England review) that examined the effectiveness of face coverings on reducing transmission of SARS-CoV-2; reporting on 31 and 39 studies, respectively. Two further primary studies were published after the two evidence review searches were included. Overall, the evidence suggested that face coverings may provide benefits in preventing SARS-CoV-2 transmission, although the higher-quality studies suggested that these benefits may be modest. Medical masks appeared to have higher efficacy than fabric masks, although the evidence was mixed. Conclusions At the time of this review, evidence on the effectiveness of face coverings remains limited and conclusions rely on low-quality sources of evidence with high risk of bias, although higher-quality evidence points to some benefit. Face coverings may play a role in preventing transmission of SARS-CoV-2, particularly as part of a bundle of other preventative measures.","Poster Presentation Number: PP74 Abstract Title: Taking A Lifecycle Approach To Scottish Medicines Consortium Budget Impact Analysis Author Names: Corinne Booth ([email protected]), Maria Dimitrova, Alex Henriquez, Jennifer Hislop, Jan Manson, Helen Wright Introduction The Scottish Medicines Consortium (SMC) conducts early health technology assessment of new medicines in Scotland. While budget impact is not a factor in decisions on reimbursement, budget impact information is provided initially through horizon scanning reports for high impact medicines (estimated net budget impact >GBP500,000 [EUR585,710] per annum) to aid financial planning and implementation of advice at the local level, and later through budget impact templates from the submitting company issued alongside SMC advice. This research aimed to understand how the information is used and to evaluate the benefits of a lifecycle approach to budget impact analysis. Methods Health Board users of the budget impact templates were surveyed to explore the degree of utilization and identify areas for improvement, including the need to cross-validate the horizon scanning estimates with those of the submitting company. Responses were analyzed quantitatively and qualitatively, with comments coded in Nvivo (QSR International) and themes established through thematic analysis. Results The initial responses received (n=17) provided representation from 57 percent of Health Boards (i.e. payers) covering 79 percent of the population. Preliminary results showed that while the budget impact templates were valued, 69 percent of respondents found them \u2018somewhat useful\u2019, suggesting scope for improvement. Almost half (48%) of the respondents used the templates for high impact medicines, with only 30 percent using them for all medicines. The majority (76%) of those surveyed thought there would be value in linking budget impact information throughout the SMC process. An emerging theme was that some users found the templates complex and inflexible, and that a simpler, more adaptable tool to aid the planning process would be welcomed. Priorities identified for improving template included adapting them to the local population and adjusting medicine prices to reflect confidential discounts. Conclusions This research suggests that budget impact information is valued by Health Boards and that there is strong support for linking budget impact estimates and engaging stakeholders throughout a medicine\u2019s lifecycle. Simplifying the templates, increasing their adaptability, and providing guidance and training in their use will be key steps in improving this important part of SMC process.","Poster Presentation Number: PP76 Abstract Title: Database On Evidence-Based Telemedicine In A Hospital Setting Author Names: Ida Wagner Svendsen ([email protected]), Tue Kj\u00f8lhede, Anne Mette \u00d8lholm, Knud Yderstr\u00e6de, Kristian Kidholm Introduction The use of telemedicine services has increased worldwide during recent years because of national strategies for digitalization of health care and the coronavirus disease 2019 (COVID-19) pandemic. However, healthcare professionals often express uncertainty regarding the effectiveness of telemedicine interventions. The TELEMED database (https:\/\/telemedicine.cimt.dk\/) was introduced by the Centre for Innovative Medical Technology (CIMT) at Odense University Hospital to ensure that hospital managers, healthcare professionals, and other stakeholders have access to scientific studies of telemedicine interventions. Methods The database constitutes a structured literature search in PubMed for randomized and non-randomized controlled trials on the use of telemedicine for treating somatic diseases in the hospital setting. The search was conducted by staff members in the health technology assessment unit at CIMT. Identified studies were sorted by first screening titles and abstracts and then by reading full-text versions. The data extracted from the studies included setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. The value of each study was also assessed with respect to effectiveness. Results A total of 510 articles were selected for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the criteria of medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as an information platform for clinical departments who wish to implement telemedicine services. It has great potential for supporting digital transformation during COVID-19 by providing accessible evidence-based information on patient groups and relevant technologies and their effects. More than 95 percent of the studies in the database that compared telemedicine with a control group showed either statistically significant improvements in clinical outcomes with telemedicine or no statistically significant difference between the two groups. Conclusions The TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time.","Poster Presentation Number: PP77 Abstract Title: Safety, Effectiveness, And Cost Effectiveness Of Telemedicine In Neurological Diseases Author Names: Beatriz Le\u00f3n-Salas ([email protected]), Renata Linertov\u00e1, Yadira Gonz\u00e1lez-Hern\u00e1ndez, Diego Infante-Ventura, Aythami de Armas-Castellano, Ar\u00e1nzazu Hern\u00e1ndez-Yumar, Javier Garc\u00eda-Garc\u00eda, Miguel Garc\u00eda-Hern\u00e1ndez, Ana Toledo-Ch\u00e1varri, Montserrat Carmona-Rodr\u00edguez, Mar\u00eda del Mar Trujillo-Mart\u00edn Introduction Telemedicine has been introduced in health services, but uncertainties about the real value of this strategy in the management of neurological diseases remain. Methods A systematic review was undertaken of available scientific literature on the safety, effectiveness, and cost effectiveness of telemedicine combined with in-person visits, compared with usual care, for the treatment and follow-up assessment of patients with neurological diseases. The overall effect size for each neurological disease was estimated using meta-analysis. An economic analysis was performed from the societal and Spanish healthcare system perspectives. Results Two economic studies were included for cost effectiveness and 25 randomized controlled trails (n=8,976 patients) were included for the effectiveness and safety assessment (11 on cerebrovascular diseases, four on Parkinson\u2019s disease, three on multiple sclerosis, two on epilepsy, and one each on brain damage, dementia, spina bifida, migraine, and cerebral palsy). The types of telemedicine evaluated included: virtual visits (11 studies); telerehabilitation (seven studies); telephone calls (three studies); smartphone apps (two studies); and online software for computers (two studies). Subgroup analysis by type of telemedicine indicated no discernible effect for telemedicine combined with in-person visits on most of the outcomes analyzed for the various neurological diseases. Given the heterogeneity of diseases, types of telemedicine, and the results observed, a cost- minimization analysis was conducted. Combining telemedicine with in-person visits would cost EUR 2.55 per patient from the perspective of the healthcare system, but it would result in cost savings (EUR 27.34 per patient) from the societal perspective. Conclusions The safety and effectiveness of combining in-person visits with telemedicine was similar to that of usual care, but it could be a cost-saving strategy in Spain from a societal perspective.","Poster Presentation Number: PP78 Abstract Title: Effectiveness And Safety Of The FreeStyle Libre\u00ae Glucose Monitoring System For T1DM In Childhood And Adolescence Author Names: Himar Gonz\u00e1lez-Pacheco ([email protected]), Yolanda Ramallo-Fari\u00f1a, Amado Rivero-Santana, Yolanda \u00c1lvarez-P\u00e9rez, Lilisbeth Perestelo-P\u00e9rez, Pedro Serrano-Aguilar, Ana Toledo-Ch\u00e1varri Introduction FreeStyle Libre System (FSL) is a minimally invasive technology, which provides frequent information about interstitial glucose levels, which allows adjustment of insulin dose and a reduction in the number of fingersticks. This study aims to evaluate the effectiveness and safety of FSL in childhood and adolescence. Methods Prospective case series in 27 Spanish hospitals. Patients aged 4-17 years with type 1 diabetes mellitus (T1DM) were included. Follow-up was done at 3, 6 and 12 months after starting to use the FSL. Outcome measures were HbA1c levels, acute complications of DM (severe hypoglycemia, ketoacidosis), DM knowledge, health-related quality of life, satisfaction and adverse effects. Biochemical glycemic outcomes (e.g., glycemic variability, time in therapeutic range) were available from 3 to 12 months. Mixed regression models with repeated time measurements were implemented. Results The mean age of patients was 12.6 years, with 56.4 percent had HbA1c values above 7.5 percent at baseline. This subgroup significantly improved their HbA1c levels at 3, 6 and 12 months (-0.46%, -0.44% and -0.35%, respectively). Patients with controlled HbA1c levels significantly worsened at 12 months (0.29%). There was a significant reduction in severe hypoglycemic episodes, but only in the multiple imputation analysis. In patients controlled at baseline, there were significant reductions between 3 and 12 months in the percentage of time under 55mg\/dl (-0.64%), above 250mg\/dl (-1.8%) and glycemic variability (-2.6%). In uncontrolled patients, there was a significant reduction in time above 250mg\/dl (-5.8%) between 3 and 12 months follow-up. There was no significant improvement in knowledge about disease, although general self-perceived health worsened and general satisfaction improved. Mild adverse events such as skin reactions (14%) and discomfort or pain (11.3%) with no significant reductions in follow-up were recorded. Conclusions The use of FSL in childhood and adolescence with T1DM produces a significant reduction in HbA1c levels in patients with uncontrolled HbA1c levels along with a reduction in severe hypoglycemic episodes (in the multiple imputation analysis). FSL-related adverse effects are considered mild.","Poster Presentation Number: Poster Presentation Number: PP79 Abstract Title: Use Of Vagus Nerve Stimulation Therapy In Treatment-Resistant Depression Author Names: Gulzada Bariyeva, Andrey Avdeyev ([email protected]), Valeriy Benberin, Nasrulla Shanazarov, Ruslan Akhmedullin, Makpal Akhmetova, Makhabbat Okesh, Tansolpan Aimanova Introduction Major depressive disorder (MDD) severely limits a person's psychosocial functioning and reduces quality of life. According to world statistics, about 3.8 percent of the population, or about 280 million people, suffer from depression. Approximately one-third of patients with MDD have treatment-resistant depression (TRD). Meanwhile, Vagus Nerve Stimulation (VNS) therapy was approved by the US Food and Drug Administration and received CE marking in Europe for the treatment of chronic or recurrent depression in the early 2000s. The aim of this analysis is to determine the impact of VNS use in the treatment of TRD. Methods A comprehensive literature search was performed in MEDLINE\/PubMed and Google Scholar databases in order to estimate the clinical effectiveness of neurostimulator implantation for treatment of TRD. The main assessment methods were the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale and the Beck Depression Inventory. Results In total, 6 systematic reviews with meta-analyses on the effectiveness of VNS in TRD were studied. The identified meta-analyses did not report any statistically significant differences in treatment outcomes favoring VNS compared to placebo and treatment as usual (TAU). However, the results of two studies demonstrate its positive clinical effect in the form of additional treatment to the TAU with longer follow-up period. An improvement in the clinical response is observed on average after 12 months as a decrease of about 50 percent in the initial estimates of depression. Conclusions Despite the lack of clinical evidence of the benefits of treating depression, VNS therapy should be used as a standard adjunct treatment to antidepressants or other treatments for people with TRD. Many studies tend to suggest that the efficacy and safety of VNC in depression is still unclear, and additional further research is still needed to establish clinically significant effects.","Poster Presentation Number: PP81 Abstract Title: Barriers Io implementation Of Health Technology Assessment Author Names: Lyazzat Kosherbayeva ([email protected]), Ayganym Askarova, David Hailey Introduction The transition from the budget model of the healthcare system to compulsory social health insurance has created a competitive environment among hospitals in Kazakhstan. Managers are interested in introducing the most effective new technologies. Implementation of the health technology assessment (HTA) process in Kazakhstan began in 2010 but few managers have created a structure for HTA development in their hospitals. Our aim was to identify issues in the implementation of new health technologies in hospitals. Methods Structured interviews were held with hospital managers and physicians in June 2020, and September 2021. In the first stage, the needs of hospitals in the implementation of new technologies were considered. In the second stage, the impact of COVID-19 on the introduction of new technologies in the hospital was addressed. Interviews were held on-line by mobile phone or zoom and lasted 25-30 minutes. Results The first interviews involved 8 managers and 14 physicians from 5 hospitals. The needs of HTA for physicians was noted by respondents of both groups. Only a few physicians had been trained in HTA. Hospital staff lacked time and experience in preparing applications for new technologies by a national assessment unit and could not meet deadlines. Managers were interested in use of HTA for hospitals\u2019 technologies in short-term timeframes within existing policies. However, physicians believed that long-term performance of technologies over 5 years or more should also be considered in hospital management. Physicians were aware of the importance of ethical considerations in the HTA of new health technologies. Managers did not consider ethical issues. At the second stage of the project, 5 managers and 8 physicians were interviewed. COVID-19 had shown the importance and necessity of developing the scientific potential of doctors, and of introducing HTA and training medical personnel in its use. Conclusions Positive outcomes from the interviews were the interest of respondents in increasing their knowledge of the HTA process and acceptance of its importance at the hospital level.","Poster Presentation Number: PP82 Abstract Title: First Educational Trainings According To New Health Technology Assessment Guideline For Medicines In Ukraine Author Names: Marharyta Khmelovska ([email protected]), Oresta Piniazhko, Valeriia Serediuk, Alona Masheiko, Iryna Romanenko Introduction The 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. Methods \u0421omprehensive review of the first developed HTA training programs based on the HTA Guideline (Number 593) \u201cThe state health technology assessment for medicines\u201d approved on 29 March 2021 was conducted. Results Leading 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 \u201cHTA as a tool for assessing the value of health technology\u201d 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. Conclusions Development of extended capacity building programs in HTA for users and doers is highly prospective for further steps in HTA institutionalization in Ukraine.","Poster Presentation Number: PP83 Abstract Title: Economic Impact Of Missed Vaccinations On The Italian National Health System Author Names: Eugenio Di Brino ([email protected]), Michele Basile, Filippo Rumi, Americo Cicchetti, Instant Report Group Introduction To 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. Methods Data from the Istituto Superiore di Sanit\u00e0 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. Results Based 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. Conclusions By 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.","Poster Presentation Number: PP84 Abstract Title: Change Management Of Patient Associations In Italy: From Emergency Response To Organizational Learning Author Names: Eugenio Di Brino ([email protected]), Federica Morandi, Americo Cicchetti Introduction The role of associations dedicated to patient advocacy has assumed strategic importance within the most advanced health systems, including the Italian NHS. In this period of strong national and international emergency, the associations of citizens and patients have also changed their actions and have implemented others to alleviate the discomforts of sick people in Italy, collaborating with institutions and health services. Methods Data were collected using a semi-structured survey, with both yes \/ no and open questions, developed and administered by the Patient Advocacy LAB (ALTEMS- Catholic University of Sacred Heart) to 150 patient advocacy associations. The organizational changes and the initiatives adopted by patient associations during the COVID-19 emergency was investigated. Results The majority of the initiatives adopted by patient advocacy associations during the COVID-19 pandemic have been introduced during the first wave (March- June 2020), and that most of them have been maintained to (December 2020). These initiatives included improvements and updating of the communication tools aimed at reaching the higher number of patients. Thanks to these new approaches, the empathy and the assistance to patients have been increased. In addition, a number of training initiatives have been developed online and they have been followed by a large number of patients and caregivers. At an operative level, during the pandemic, many patient advocacy associations have provided their support to distribute masks, gloves, and therapies to patients. Unfortunately the fundraising activities suffered due to the lockdown, and the main problems were related to social distancing and lack of public campaigns. The institutional relationships have increased during the COVID-19 pandemic and they mainly regarded the participation in legislative interventions. Among the initiatives adopted, our sampled associations affirmed that they would like to maintain the social support provided to patients experienced during the pandemic. Finally we calculated a resiliency score and we discovered that the majority of the sampled associations developed an intermediate level of resiliency and that it is positively correlated with their tenure. Conclusions Our results provide a fresh view about the role of patient advocacy associations during the pandemic indicate their important role within the NHS.","Poster Presentation Number: PP85 Abstract Title: The Cost-Effectiveness Of The Anti-COVID Vaccination Campaign In The Italian Healthcare Setting Author Names: Michele Basile ([email protected]), Eugenio Di Brino, Filippo Rumi, Americo Cicchetti Introduction Coronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms of COVID-19 are variable, but often include fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste. Symptoms may begin one to fourteen days after exposure to the virus. COVID-19 transmits when people breathe in air contaminated by droplets and small airborne particles containing the virus. The present analysis aims to define the cost-effectiveness profile of the anti-COVID vaccination campaign in the Italian healthcare setting. Methods The analysis was based on the collection and analysis of data regarding the number of hospitalizations (ordinary regime and intensive care) and infections recorded by the Italian Ministry of Health in vaccinated and unvaccinated patient cohorts. The acquisition costs of the available vaccine alternatives were considered as well as the cost of the personnel involved in the vaccination campaign. The reduction in hospitalizations was considered as a measure of effectiveness. We have compared the current scenario of campaign vaccination versus a scenario in which the total of the eligible population would be vaccinated. Results are reported in terms of Incremental Cost Effectiveness Ratio (ICER). Deterministic and probabilistic sensitivity analyses were carried out in order to test the robustness of the results. Results The vaccination campaign allowed for savings amounting to EUR 9,398,012.10 (EUR 60,499,053.25 vs EUR 69,897,065.35) and 6,647 hospitalizations avoided (715 and 5,932 in the intensive care and ordinary regimen, respectively), thus resulting a dominant strategy as compared with the alternative (no vaccination). The cost- effectiveness profile of the campaign improves should we consider the period (May-July 2021) in which the daily threshold of 500,000 doses administered on a national basis was constantly overcame. Conclusions The analysis underlined how the vaccination campaign represents a cost-saving alternative in the Italian healthcare setting.","Poster Presentation Number: PP88 Abstract Title: Bayesian Joint Models For Cost-Effectiveness Analyses Based On Clustered Participant Data, With Implementation In Stan Author Names: Jonas Esser ([email protected]), Anita Varga, Mohamed El Alili, Johanna Van Dongen, Judith Bosmans Introduction Cost-effectiveness analyses of empirical participant data are frequently complicated by irregularly distributed and correlated observations, which are not well approximated by normal distributions. Things get even more difficult when observations are clustered within higher level units (for example, hospitals) or the participant (that is, multiple measurements at different timepoints). Therefore, we developed a flexible Bayesian approach to jointly model costs and effects of two competing interventions with a multilevel structure. Methods Our new model is presented in mathematical form and discussed in detail. We model costs and Quality-Adjusted Life-Years effects through Gamma and Beta distributions, and account for the dependency between costs and effects by adding the effects as a predictor for the costs. We further include hurdle models to account for costs of for the presence of zero costs and perfect health scores. The full model is implemented in the probabilistic programming language Stan. To compare the performance of our Bayesian model to a frequentist approach (linear mixed model combined with bootstrapping), we simulate 1000 datasets consisting of 400 participants and 20 clusters. Performance of both models is assessed in terms of variance, bias and coverage probability with respect to the costs and effects defined in the simulation. Results We ran a preliminary simulation with high intraclass correlation, strong negative correlation for patient-level costs and effects, and positive correlation of cluster effects on both outcomes. The analysis shows that the Bayesian model exhibits a slightly larger bias for estimated costs, but smaller errors and higher coverage probability compared to the frequentist alternative. We will explore different scenarios where we vary the parameters of the simulations and assess whether the results are robust to change. Conclusions It is very important that economic evaluations in health care produce precise and reliable results. Our Bayesian approach is able to handle multiple statistical complexities at once and performs better than a comparable frequentist model. Whether this conclusion holds for different simulation scenarios will be explored in further stages of this study.","Poster Presentation Number: PP89 Abstract Title: Stimulating And Assuring Evidence Quality From A Dutch Funders\u2019 Perspective \u2013 Introducing The ZonMw Reporting Checklist Author Names: Wendy Reijmerink, Gerjanne Vianen ([email protected]), Margreet Bloemers, Abida Durrani, Annelein Stax Introduction All studies should report methods and findings in full, following credible and justifiable reporting guidelines. According to the guiding principles of the Ensuring Value in Research (EViR) Funders\u2019 Forum (www.evir.org), this applies irrespective of the nature of the findings or whether the study was completed as planned. One way for a public funding agency to address evidence quality and transparency is to adaptively implement EQUATOR reporting guidelines (www.equator-network.org) in its funding procedure to ensure research quality \u2018from proposal to publication\u2019. The Netherlands Organisation for Health Research and Development, ZonMw, has created the ZonMw Reporting Checklist (ZRC), which was derived from EQUATOR reporting guidelines in order to systematically plan, monitor, and evaluate projects. The next step is experimenting with implementing the ZRC in ZonMw\u2019s grant management system and procedures. Customization is possible based on the \u2018comply or explain\u2019 approach (80\/20 rule). Methods We selected 15 EQUATOR reporting guidelines that covered basic research and health technology assessment through to implementation projects, supplemented with the reporting guideline for implementation studies (StaRI checklist). We conducted comparative content analyses (including rearrangement) to provide a greatest common denominator consisting of both standard and modular reporting elements. We completed the ZRC by adding other current requirements for responsible research practices with respect to diversity and gender, data management, open access, systematic reviews, recruitment and inclusion, registration, and impact. Results The ZRC results in structured and validated in-house data on the objectives, design, conduct, and results of ZonMw projects. This is an important source for good research governance, impact assessment, and research on research. Conclusions Implementation of the ZRC by a funding agency optimizes the quality, transparency, relevance, and impact of evidence, which legitimately and effectively improves health care for all.","Poster Presentation Number: PP90 Abstract Title: Startup And Inclusion Problems In Healthcare Efficiency Studies: A Quantitative And Qualitative Analysis Author Names: Jennifer Drenth, Karen Van Liere-visser ([email protected]), Dani\u00ebl Warmerdam, Inge Zijp, Ruud van Zessen Introduction Aging populations and specialized medicine are leading to increasing healthcare costs which are expected to rise in the next decades. The Netherlands Organization for Health Research and Development (ZonMw) funds trials that address the efficiency of healthcare interventions in order to evaluate new and existing interventions. These studies have led to considerable cost savings and increased health outcomes. However, efficiency studies often face setbacks during the start-up and inclusion which limit the available research capacity and postpone the availability of novel findings. Here, we investigate the scope of these problems and identify common causes. Methods Records from efficiency research trials funded by ZonMw from 2014-2020 were combined with information provided by project leaders through a survey. The combined dataset was explored through statistical analysis. Next, a subset of 30 selected projects was evaluated qualitatively to gain a better understanding of the possible underlying reasons for the experienced problems. Results The response rate among project leaders was 73 percent (146\/201). Data indicate that 61 percent of projects started as planned and 35 percent included the first patient as scheduled. The complexity of setting up a multicenter study and legal procedures like local ethical approval were associated with delays in starting inclusions. In addition, 56 percent of studies had to extend the inclusion period by more than 6 months. Possible reasons that were identified include the limited numbers of patients available, and treatment preferences of the doctor, the patient, or the participating center. Conclusions Our results indicate that the majority of trials face setbacks and the main reasons include time to procure legal and ethical approval, limited patient numbers, as well as unforeseen treatment preferences. More streamlined procedures regarding approvals could speed up trial initiation, and better knowledge of eligible patients and treatment preferences could lead to more realistic planning. The results and conclusions from this study can be applied by ZonMw and other relevant stakeholders to resolve the identified problems in order to accelerate healthcare efficiency research.","Poster Presentation Number: PP91 Abstract Title: Developing A Re-assessment Process For Non-medicine Health Technologies In Wales Author Names: Jessica Williams ([email protected]), David Jarrom Introduction Updating of health technology assessments (HTAs) is generally more efficient than starting again when new evidence emerges, but there is no clear guidance on how to do this. Health Technology Wales (HTW) has developed a re-assessment process to ensure that HTAs remain current and relevant to best serve the population and health and care providers in Wales. Methods HTW developed a standard operating procedure (SOP) to create a consistent approach to HTA re-assessment. HTW keep a record of stakeholders who contribute to a HTA and then send them a questionnaire to ascertain whether the research question is still relevant and if there have been any developments to the evidence since publication of the HTA. The input from these stakeholders is collated and taken to HTW\u2019s Assessment Group to decide whether or not the HTA needs updating. If the Assessment Group decides that re-assessment of a HTA is warranted, HTW perform an updated literature search to inform the re-assessment. Results The HTA re-assessment SOP developed by HTW was approved by the organization\u2019s Assessment Group. At the time of writing this abstract, HTW sent questionnaires to stakeholders of three HTAs which had HTW guidance published three years ago, and were therefore due routine consideration for re-assessment as detailed in our SOP. HTW also received a request from a clinician for a more recent HTA to be considered for re-assessment as they believed the evidence-base had changed since original publication. These questionnaires have been collated and will be taken to an upcoming Assessment Group to decide whether HTW should proceed with the re- assessments. Conclusions HTW has developed a consistent process for HTA re-assessment, which ensures that HTAs done by HTW remain current and relevant to best serve the population and health and care providers in Wales. By utilizing expertise from HTA stakeholders and HTW Assessment Group members, an informed decision can be made as to whether a HTA warrants re-assessment after three years following publication or sooner if requested.","Poster Presentation Number: PP92 Abstract Title: Should Missing Data Be Multiply Imputed Prior To Longitudinal Linear Mixed-Model Analyses In Trial-Based Economic Evaluations? Author Names: \u00c2ngela J Ben ([email protected]), Johanna M van Dongen, Mohamed El Alili, Martijn W Heymans, Jos W R Twisk, Janet L MacNeil-Vroomen, Maartje de Wit, Susan E M van Dijk, Teddy Oosterhuis, Judith E Bosmans Introduction For the analysis of clinical effects, multiple imputation (MI) of missing data was shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to cost estimates from trial-based economic evaluations, that are generally right-skewed. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost-effectiveness data. Methods Two-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10 percent, 25 percent, and 50 percent missing data in costs and effects, assuming a Missing At Random (MAR) mechanism. Statistical performance of six different methodological strategies was compared in terms of empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). Six strategies were compared: (i) LLM (LLM), (ii) MI prior to LLM (MI-LLM), (iii) mean imputation prior to LLM (M-LLM), (iv) complete- case analysis prior to seemingly unrelated regression (CCA-SUR), (v) MI prior to SUR (MI-SUR), and (vi) mean imputation prior to SUR (M-SUR). To evaluate the impact on the probability of cost-effectiveness at different willingness-to-pay [WTPs] thresholds, cost-effectiveness analyses were performed by applying the six strategies to two empirical datasets with 9% and 50% of missing data, respectively. Results For costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, CCA-SUR, and M-SUR, as indicated by smaller EBs and RMSEs, as well as CRs closer to the nominal levels of 0.95. However, even though LLM, MI-LLM, and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 percent and 25 percent missing data. At 50 percent missing data, all strategies resulted in relatively high EBs and RMSEs for costs. In both empirical datasets, LLM, MI-LLM, and MI-SUR all resulted in similar probabilities of cost-effectiveness at different WTPs. Conclusions When opting for using LLM for analyzing trial-based economic evaluation data, researchers are advised to multiply impute missing values first. Otherwise, MI-SUR may also be used.","Poster Presentation Number: PP93 Abstract Title: The Impact Of Using Different EQ-5D Scoring Methods On Cost-Utility Outcomes: A Simulation Study Author Names: \u00c2ngela J Ben ([email protected]), Johanna M van Dongen, Aureliano P Finch, Mohamed El Alili, Judith E Bosmans Introduction Patients\u2019 EQ-5D health states are preferably valued using country-specific value sets. If value sets are not available, crosswalks may be used to estimate utility values. However, up until now the impact of using crosswalks instead of value sets on cost-utility outcomes remains unclear. Methods Trial-based cost-utility data were simulated for four conditions (depression, low back pain, osteoarthritis, and cancer), three levels of disease severity (mild, moderate, and severe), and three treatment effect sizes (small, medium, and large), resulting in 36 scenarios. For all scenarios, utility values were estimated using four scoring methods (EQ-5D-3L value set, EQ-5D-5L value set, 3L-to-5L crosswalk, and 5L-to-3L crosswalk) for three countries (the Netherlands, the United States, and Japan). Mean utility values, quality-adjusted life years (QALYs), incremental QALYs, and cost-utility outcomes (incremental cost-effectiveness ratios [ICER], probabilities of cost- effectiveness at willingness-to-pay [WTP] thresholds) were compared between value sets and crosswalks. Results Differences between value sets and crosswalks ranged from -0.33 to 0.13 for mean utility values, from -0.18 to 0.13 for QALYs, and from -0.01 to 0.08 for incremental QALYs. Because of the small differences in incremental QALYs, ICERs between scoring methods were considerably different. For small effect sizes, at a WTP of EUR 20,000\/QALY gained, the largest difference in the probability of cost-effectiveness was found for moderate cancer between the 5L value set and 3L-to-5L crosswalk (difference 0.63) using Japanese valuations. For medium effect sizes, the largest difference was found for mild cancer between the 3L value set and the 5L-to-3L crosswalk (difference 0.06) using Japanese valuations. For large effect sizes, the largest difference was found for mild osteoarthritis between the 3L value set and 5L-to-3L crosswalk (difference 0.08) using Japanese valuations. Conclusions Our findings indicate that reimbursement decisions may change depending on the use of crosswalks. Crosswalks are justifiable in absence of country-specific value sets but should not be considered a sustainable alternative for value sets.","Poster Presentation Number: PP 94 Abstract Title: Exploring The Relationship Between Price And Outcome Of The Health-Economic Assessment In Japan Author Names: Xirong Song ([email protected]), Nehal Sejpal, Rangaraja Konar, Saurabh Patil, Sapana Gusain, Preksha Sonigra, Rutuja Tikone Introduction This study reviewed all publicly available Japanese cost-effectiveness appraisals delivered by the Center for Outcomes Research and Economic Evaluation for Health (C2H) from the national institute of public health (NIPH) and analyzed the relationship between the outcomes of the health-economic assessments and the final price adjustment decisions made by the Ministry of Health, Labour and Welfare (MHLW). Methods Data were extracted from all official health-economic assessments published by C2H website for the analysis. The extractions were structured based on the following items: indication, assessment methodology, appropriate comparators, health-economic outcomes, and key uncertainties identified by C2H. The analysis was performed on 29th November 2021. A threshold of 5 million JPY per Quality Adjusted Life Year gained (JPY\/QALY) was used for the incremental cost-effectiveness ratio (ICER) analysis cut-off. Results Up to the time of this analysis, six health-economic assessments had been conducted for five products: three assessments performed cost-effectiveness analysis, one performed cost-minimization analysis and two performed cost-effectiveness and cost-minimization analysis for different comparators and different patient subgroups respectively. Among the five assessments\u2019 reported ICER values, four of them are under the 5 million JPY\/QALY threshold, ranging from 328,585 JPY\/QALY to 483,056 JPY\/QALY. However, price adjustments were still implemented on three out of the four products which were deemed to be cost-effective, ranging from -0.5 percent to -4.3 percent (mean: -3.0%). For the only product deemed to be not cost-effective, a price adjustment of -4.3 percent was implemented. Conclusions A price discount could be implemented regardless of whether the ICER value falls under the 5 million JPY\/QALY threshold. However, a lower magnitude of price discount is likely to be applied by MHLW for more cost effective treatments. The outcome of this analysis may be limited by the small sample size and continuous monitoring of further HTA publications in Japan is needed.","Poster Presentation Number: PP95 Abstract Title: Health Professionals\u2019 Participation On Health Technology Assessment (HTA) Public Consultation: A Distribution Analysis Of Brazilian HTA In 2021 Author Names: Denis Satoshi Komoda ([email protected]), Carlos Roberto Silveira Correa, Marilia Berlofa Visacri, Daniela Santos, Flavia Maia, Maria Barkola Introduction The Brazilian HTA process includes calls for public consultations, in which society can give its opinion on reports emitted by the National Committee for Health Technology Incorporation (CONITEC). Open and closed queries for public consultation are performed by official formularies and are available online at CONITEC webpage. There are two categories of queries: clinical protocols and guidelines, and incorporation\/exclusion demands. Incorporation\/exclusion queries are subdivided in two additional categories: opinion and experience, or technical. In this study we analyze health professionals\u2019 technical contributions and their opinion (pro or con) on the inclusion or exclusion of health technologies. Methods On November 26th, 2021, formularies concerning concluded public consultations on health technology incorporation\/exclusion reports were extracted from CONITEC website for the period, January 1, 2021 to November 26, 2021. Entries on the technical contributions formularies included a close-ended question about the opinion of participants on health technology incorporation\/exclusion reports (\u201cfavorable\u201d\/\u201dagainst\u201d\/\u201dneither\u201d). Results A total of 63 health technology incorporation\/exclusion queries were carried out during the study period, of which only 4 were exclusions. A total of 7783 contributions were registered. \u201cPatients\u201d, \u201cFamily or caregivers\u201d, \u201cInterest on the theme\u201d, and \u201cHealth professionals\u201d, accounted for 96.4% (10.9, 15.2, 17.1 and 53% respectively). Health professionals\u2019 participation alone accounted for 4130 entries. Concerning the category \u201chealth professionals\u201d, the total number of favorable opinions on the presented documents was 2740 (66.3%), 1306 (31.6%) disagreed, and 84 (2%) had no opinion. Conclusions Health professionals can be considered one of the main stakeholders considering HTA for technology incorporation in public health systems. Brazilian HTA reports are submitted to public consultation through queries, which are available open access at the Brazilian National Committee for Health Technology Incorporation website.","Poster Presentation Number: PP96 Abstract Title: Joint Clinical Assessments \u2013 Implementation And Lessons For The Next Stage Of EU HTA Author Names: Dima Samaha ([email protected]), Max Newton, Eliana Tavares, Robert Kruger, Paula Szawara, Anke van Engen Introduction The European Network for Health Technology Assessment (EUnetHTA) was a voluntary cross-border initiative on HTA harmonization established by European Commission in 2005. Between 2016-2021, EUnetHTA completed 56 Joint Assessments (28 drugs; 28 other technologies) including 14 reviews of COVID treatments. Methods We conducted a review of the 14 EUnetHTA joint assessment reports of drugs in non-COVID 19 indications. We cross-referenced recommendations with national guidance in 30 member countries (including UK) and conducted an analysis of time to national assessment, choice of comparator, direct reference to EUnetHTA assessment, and time to reimbursement decision. Results Six products in oncology, 2 in endocrine and metabolic diseases, 2 in infectious and parasitic diseases, and cardiovascular, digestive system, eye disorders and central nervous system (one each) were identified. On average, EUnetHTA published its recommendation 52 days after market authorization for oncology products and 33 days for non- oncology products. EUnetHTA recommendations considered on average 4 comparators (range 1-8) as part of the assessment. All of the 6 oncology products have been assessed by national HTA bodies, however uptake was low with an average of 5 reports referencing the EUnetHTA report. Similarly for the non- oncology products assessed only 3 of 30 HTA bodies cite the EUnetHTA report. Citing HTA bodies were: AETSA (Spain), HAS (France), INFARMED (Portugal), NoMA (Norway), and TLV (Sweden). There was no clear reduction in the time to reimbursement for these products in these markets. Conclusions According to EUnetHTA, there has been an increased use and dissemination of joint assessment reports since 2016. Our analysis shows that the level of implementation across countries is heterogeneous despite publication of the EUnetHTA reports shortly after market authorization. The future the EU HTA will depend on the timeliness, rigor and transparency of joint clinical assessment reports and improved uptake of these reports at a national level.","Poster Presentation Number: PP97 Abstract Title: Recommendations For Generating South African Health-Related Quality Of Life Data For Cost- Utility Analyses Author Names: Sophia Emmarenzia Marsh ([email protected]), Ilse Truter Introduction Health-related quality of life (HRQoL) data are necessary for conducting cost-utility analyses (CUAs) as part of health technology assessments (HTAs), but the lack of robust HRQoL data may delay or even prevent patient access to medicines when National Health Insurance is introduced in South Africa. This study aimed to make recommendations for evidence generation activities to support national HTA in the public health sector, with a focus on creating South African HRQoL data suitable for CUAs. Methods A systematic review of HRQoL research in South Africa formed the basis for three analyses. The first analysis quantified and evaluated the suitability of HRQoL studies for CUAs. The second analysis determined the performance indicators of the research output and identified collaborative networks through bibliometric analyses. The third analysis critiqued the translation methodology of the HRQoL instruments retrieved in the systematic review. Results Based on the published literature, existing HRQoL data are unlikely to support CUAs because they were derived from observational or cross-sectional studies that lacked the methodological details necessary to determine their scientific merit according to HTA requirements. Overall, there was a lack of research continuity in this field, with numerous isolated research networks. Despite the strong contribution of South African based researchers and organizations in this area, their performance was below that of international counterparts. Since only a few HRQoL instruments suitable for CUAs would be valid in the South African context, HRQoL research output in South Africa could be optimized by using more rigorous study designs and by the expansion of researcher networks to include those working in HTA and related fields. The three-level EQ-5D is the tool best suited for use in South Africa, so its utilization should be encouraged and supported by establishing a South African value set. Conclusions Future data generation activities should incorporate the recommendations from this study because existing South African HRQoL data are likely to be inadequate for conducting CUAs in national HTA.","Poster Presentation Number: PP98 Abstract Title: Occupational Therapy For Adult Persons With Cognitive Impairments: A Systematic Overview On Clinical Efficacy Author Names: Petra Schnell-Inderst ([email protected]), Annette Conrads-Frank, Igor Stojkov, Cornelia Krenn, Lisa-Maria Kofler, Uwe Siebert Introduction Damage to the central nervous system (CNS) in adulthood, may lead to cognitive impairments. In Germany, occupational therapy is most often prescribed for neurological diagnoses, including stroke and traumatic brain injury (351 and 343 cases per 100,000, respectively in 2018). For cognitive impairments, the primarily prescribed remedies are sensorimotor-perceptive, motor-functional and neuropsychologically oriented treatment or training of cognitive performance. Here we report the results of a health technology assessment (HTA) report on the clinical efficacy of occupational therapy for patients with cognitive impairments. Methods To assess clinical efficacy, a systematic overview was conducted based on published systematic reviews and HTA reports from the last ten years summarizing randomized controlled trials (RCTs) retrieved from four bibliographic databases. The target population included adult patients with cognitive impairments caused by diseases of the CNS, excluding moderate to severe dementia. The intervention studied is occupational therapy compared to no occupational therapy. Outcomes were cognitive abilities, independence, self-determination, health-related quality of life (QoL), and participation in activities of daily living (ADL). Results Five systematic reviews comprising 1,316 patients were included. There is evidence for a small statistically significant positive effect on \u201cgeneral cognitive function\\\" (10 RCTs, n=470) and on ADL (4 RCTs, n= 405). A non- quantified positive effect was reported on behavior control (1 RCT, n=96), and conflicting evidence on QoL (2 RCTs, n=214). No effect was found for individual components of cognition (5 RCTs, n=202), self-efficacy (1 RCT, n=98) and social participation (2 RCTs, n=194). The level of the evidence was low for all endpoints due to the high risk of bias and small sample sizes. Conclusions Based on this systematic overview, it cannot be demonstrated but also not ruled out that occupational therapy for cognitive impairment is an effective therapy for adults with cognitive impairments. The evidence is very uncertain due to small effects and high risk of bias, low statistical power, and heterogeneity of interventions and study populations.","Poster Presentation Number: PP100 Abstract Title: Improving The Assessment Of Effectiveness For Digital Applications Using The B Statistic: Using WtsWrng As A Case Study Author Names: Ismail Abbas ([email protected]), Carla Fernandez Barcelo, Blanca Valdasquina, Nicolau Rabasseda, Laura Sampietro-Colom Introduction The performance of diagnostic health technologies is usually assessed by comparing them with standard care using the kappa statistic. These comparisons are made based on comprehensive clinical information (e.g., anamnesis and complementary tests). However, not all digital applications (DAs) execute over complete information, which leads to work under non-uniform distribution of values. Using kappa statistic in this situation has serious methodological limitations. Kappa assumes that the marginal values are uniformly distributed and highly weights the discordant values when calculating concordance, which underestimates the real effectiveness of DAs (i.e., observed concordance). We aimed to present the application of the B statistic to WtsWrng, a symptom triage DA for individuals. Methods WtsWrng was used by 382 patients at the emergency department of a hospital. Diagnoses provided by WtsWrng, given 19 symptoms, were compared with those logged in the hospital\u2019s electronic clinical records at discharge. Observed concordance was calculated using contingency tables. The concordance using the kappa and B statistics were compared for the 12 most frequent diagnoses at hospital discharge. Sensitivity and specificity were also calculated. Results Real observed concordance fluctuated from 0.4 to 0.98 for the 12 most frequent diagnoses, eight of which had a concordance greater than 0.8. The results ranged from -0.005 to 0.37 when using the kappa statistic and from 0.36 to 0.99 when using the B statistic. The sensitivity and specificity of WtsWrng were greater than 0.8 for three and eight of the 12 diagnoses, respectively. Conclusions The results show that the B statistic is closer to the real observed concordance when kappa statistic assumptions are not fulfilled by a DA. Therefore, the B statistic is better suited for assessing the effectiveness of this type of technology. Analysis of WtsWrng using the B statistic showed that its diagnoses were close to those provided by clinicians, which were arrived at using complete clinical information. Moreover, the high specificity of the WtsWrng DA suggests that it is a good tool for determining the appropriate use of healthcare resources.","Poster Presentation Number: PP101 Abstract Title: Development Process Of The Economic Guidelines In Tunisia Author Names: Mouna Jameleddine, Nabil Harzallah ([email protected]), Jaafar Chemli, Hela Grati, Marie Christine Jebali, Chokri Hamouda Introduction Health technology assessment (HTA) has become a critical support to health policy decision-making. The HTA evaluation process requires transparency, formalized processes, clear timelines, and standardization according to international best practice. Tunisia is establishing an HTA-based decision-making system through the National Authority for Accreditation and Assessment in Healthcare (INEAS) to ensure impartiality and fairness in decision- making, which is important for an emerging democracy. INEAS opted for a participatory approach in developing the national health economic guidelines to better engage healthcare sector stakeholders in the HTA process. We aimed to present the main phases of the process used to develop the Tunisian health economic guidelines, the methodological choices for pharmacoeconomic evaluations, and the methodological choices for budget impact analyses. Methods The different phases of developing the guidelines were listed and reported. Results The guidelines were developed under a technical cooperation program of the World Health Organization and involved collaboration between the Institut national d'excellence en sant\u00e9 et en services sociaux (INESSS in Quebec, Canada) and INEAS. The first version of the guidelines was drafted following a review of international HTA guidelines and best practice reference books, taking into account the Tunisian healthcare system context. This first draft was discussed in a workshop with the main health system stakeholders and then peer reviewed by international experts. Based on the feedback from experts, a second version was prepared and published on the INEAS website for public consultation. The Union of Innovative Pharmaceutical Research Companies (SEPHIRE), the National Health Insurance Fund (CNAM), and healthcare professionals provided the majority of feedback. The comments provided by SEPHIRE were discussed during a second workshop. The guidelines were revised and updated based on the comments provided and the final version was published in November 2021. Conclusions INEAS adopted a participatory approach for developing its economic guidelines, which enhanced engagement of the major health system stakeholders in the HTA implementation process in Tunisia.","Poster Presentation Number: PP102 Abstract Title: Selecting The Sequence Of Diagnostic Tests For Leprosy In Brazil Author Names: Bruno Barros ([email protected]), Carlos Alberto Magliano, Marisa Santos Introduction Hansen's disease, or leprosy, is a chronic bacterial infection that affects the nerves, skin, eyes, and nose lining. In 2019, there were 202,256 new cases reported globally, and nearly 28,000 new cases are diagnosed each year in Brazil. The best way to prevent the spread of Hansen\u2019s disease is early diagnosis and treatment of infected individuals. Most diagnoses are done clinically, but only the microscopic analysis of slit-skin smears is funded in Brazil. Serologic and polymerase chain reaction (PCR) tests have also been developed to aid in the diagnosis. The goal of this study was to identify the most cost-effective strategy for increasing the diagnosis of Hansen's disease in Brazil. Methods We examined the impact of the following four strategies using a decision tree model: (i) slit-skin smear only; (ii) PCR test only; (iii) serologic testing followed by slit-skin smear for positive samples; and (iv) serologic testing followed by slit-skin smear for positive samples and PCR test for negative serologic tests and negative slit-skin smears. The accuracy of the tests was determined using a systematic review and meta-analysis and validated by experts. The costs were calculated from the Brazilian health system perspective. Univariate and probabilistic analyses were also conducted. Results Serologic testing or PCR followed by slit-skin smear was dominated in the economic model (more false-negative samples and more costly). The addition of serologic testing and PCR to the diagnostic sequence made the strategy more expensive than slit-skin smears alone, but it significantly reduced the percentage of false negative results (from 7.3 to 2.9%) at an estimated cost of USD 533.61 per incremental diagnosis. Disease prevalence was the most important variable in the sensitivity analysis. Conclusions This is the first cost-effectiveness model undertaken for Hansen's disease. The results indicate that incorporating serology and PCR testing into the Brazilian health system could be an appealing option for reducing the spread of Hansen's disease in Brazil.","Poster Presentation Number: PP103 Abstract Title: Early Health Technology Assessment Of Integrated Care To Increase Employment For Persons With Substance Use Disorder Author Names: Linn Nathalie St\u00f8me ([email protected]), Eline Borger Rognli, Kari Jorunn Kv\u00e6rner, Christian Ringnes Wilhelmsen, Espen Ajo Arnevik Introduction The unemployment rates among people being treated for substance use disorder (SUD) are high, with Norwegian estimates ranging from 81 to 89 percent. A promising method for improving vocational outcome is Individual Placement and Support (IPS), where employment support is integrated into the treatment regimen. However, the expense and economic gain are covered by different societal sectors, which may be a disincentive for implementing this method. Thus, the aim of this study was to model the potential socioeconomic value of a new SUD treatment service. Methods For the simulation study, we made qualified assumptions about costs and socioeconomic gain based on data from scientific and administrative publications, expert opinion, and a randomized controlled trial of treatments for individuals with SUD that was set in a specialized Norwegian healthcare setting. We made assumptions about the proportion of patients likely to obtain employment after participating in the following three interventions: (i) treatment as usual; (ii) a self-help guide and additional workshop; and (iii) IPS. Results Based on early socioeconomic simulation modeling for the three interventions, IPS was found to be cost effective over a period of one to two years. Conclusions In this study we used early economic modeling to demonstrate the potential value of IPS for increasing employment rates among patients with SUD. Since it is important to secure evaluative support for an innovation at the earliest possible stage, early economic modeling may assist the innovator in implementing a health service that meets predefined user needs while also reducing associated risks. Although there is much uncertainty in such early stages due to a lack of valid data sources, early economic modeling may provide health authorities with much needed decision support when planning for future health services.","Poster Presentation Number: PP107 Abstract Title: Scale For Measuring Fatigue In Patients With Parkinson\u2019s Disease: Scientific Technical Report Author Names: Caroline Vieira Figueiredo, Maria Aparecida De Assis Patroclo ([email protected]), Denise Hack Nicaretta Introduction Fatigue in Parkinson's Disease (PD) remains poorly understood. The comprovation derives from and is proven by psychometric scales. The objective is to prepare a Technical Scientific Report on the performance of scales in PD. Methods Based on the Methodological Guideline for the Preparation of Technical Scientific Report, Brazil 2014, we conducted a search on MEDLINE \/ PubMed, Virtual Health Library (BVS) and Cochrane, and then a review and critical evaluation of the studies and the quality of the evidence. Results Nine studies were analyzed: three systematic reviews, one case-control and five cross-sectional studies. The following were evaluated: Fatigue Severity Scale (FSS), Fatigue Assessment of Chronic Illness Therapy (FACIT-F) and Parkinson's Fatigue Scale (PFS-16). In Brazil, FSS and PFS-16 were validated. The studies have methodological weaknesses and moderate, low and very low evidence. However, FSS, FACIT-F and PFS-16 show potential for assessing fatigue in PD but further studies are needed. Conclusions Consensus on fatigue are recommended for Brazilian studies comparing FSS and FACIT-F with PFS-16 and longitudinal monitoring of patients.","Poster Presentation Number: PP108 Abstract Title: Multidimensional Analysis Of Peristeen Plus Medical Device Author Names: Americo Cicchetti, Alessandra Fiore, Filippo Rumi ([email protected]), Maria Giovanna Di Paolo, Agostino Fortunato Introduction Neurogenic bowel dysfunction occurs in people with central nervous system disease or injury and causes loss of bowel control and severe constipation. These problems involve a lot of anxiety and discomfort and can reduce the quality of life of those who suffer from them, therefore the management of symptoms is very important. Peristeen Plus is a transanal irrigation (TAI) system for bowel dysfunction management, used to empty the rectum and distal sigmoid colon, to prevent uncontrolled bowel movements or to relieve and prevent constipation. Methods A literature review was conducted. A total of 14 records were included to evaluate the benefits in terms of efficacy and safety associated with the adoption of the medical device. To assess the economic impact, two different budget impact models have been implemented. The first aimed at evaluating an incremental diffusion in a short-term time horizon (3 years) of the home distribution of the device compared to the direct and indirect distribution methods in the Italian context. The second model aimed at assessing the impact of the diffusion of the device in the clinical practice. Results Overall, most studies demonstrate improved endpoints related to the severity of fecal incontinence, constipation and intestinal disorders in patients using the device. The economic assessments conducted estimate that the increase in the Italian care setting is associated with a saving of resources in each year under analysis. The diffusion of home distribution of the device would potentially be able to offer a lower absorption of resources compared to other distribution methods. In addition to this, there is an incremental saving correlated to the degree of diffusion of Peristeen Plus. Conclusions TAI is considered a safe and more effective method than conventional treatments for reducing fecal incontinence, constipation and improving quality of life. The results of our study confirm the benefits of TAI as a second-line treatment in case of failure of conventional medical therapy in the management of the neurogenic gut.","Poster Presentation Number: PP109 Abstract Title: Efficacy And Safety Of High-Intensity Focused Ultrasound In Parkinson\u2019s Disease Author Names: Amparo Arias-Pacheco ([email protected]), Mar\u00eda del Mar Polo-de-Santos, Setefilla Luengo- Matos, Ana Isabel Hijas-G\u00f3mez, Bego\u00f1a Rodr\u00edguez-Ortiz-de-Salazar, Luis Mar\u00eda S\u00e1nchez-G\u00f3mez Introduction Parkinson\u2019s disease (PD) is the second most common neurodegenerative disease in the world. High-intensity focused ultrasound (HIFU) is a new non-invasive therapeutic option for treating the motor symptoms of PD. HIFU is an imaging-guided procedure for therapeutic brain ablation that has been used for patients with essential tremor and neuropathic pain. It is indicated for patients older than 22 years of age who have PD that is refractory to drug treatment and are ineligible for surgery. The objective of this study was to conduct an early assessment of HIFU subthalamotomy for the treatment of motor symptoms in patients with PD. Methods HIFU was identified by the early awareness and alert system, SINTESIS- nuevas tecnolog\u00edas, of the Agencia de Evaluaci\u00f3n de Tecnolog\u00edas Sanitarias at the Instituto de Salud Carlos III. Relevant literature published to October 2021 was identified by searching PubMed, EMBASE, ClinicalTrials.gov, and the Cochrane Library. Results One prospective study and one randomized controlled trial (RCT) were found that assessed the efficacy and safety of HIFU subthalamotomy for treating the motor symptoms of PD. The Movement Disorder Society-Sponsored Revision of the Unified Parkinson\u2019s Disease Rating Scale Part III (MDS-UPDRS III) was used to measure changes in symptoms (>30% change from baseline was considered clinically relevant). Both studies reported a reduction of symptoms in the intervention group. The MDS-UPDRS III score changed from 16.6 to 7.5 six months after treatment in the prospective study and from 19.9 to 9.9 four months after treatment in the RCT (a decrease of 11.6 points was observed after 12 months). The main adverse events reported were dyskinesia, speech and gait disturbances, and weakness, all of which resolved without treatment. Conclusions The results regarding the efficacy and safety of HIFU for treating the motor symptoms of PD are promising. HIFU is a non-invasive procedure that eliminates the risks associated with surgery. Although rapid diffusion of this technology is expected, further studies and economic evaluation are needed.","Poster Presentation Number: PP110 Abstract Title: An External Combined Occipital And Trigeminal Neurostimulation Device For Migraine Treatment Author Names: Bego\u00f1a Rodr\u00edguez-Ortiz-de-Salazar ([email protected]), Ana Isabel Hijas-G\u00f3mez, Mar\u00eda del Mar Polo de Santos, Amparo Arias-Pacheco, Luis S\u00e1nchez-G\u00f3mez, Seteffilla Luengo-Matos Introduction Migraine is a multifactorial pathology that affects 12 percent of the world\u2019s population. Relivion\u00ae MG (Neurolief Inc., USA) is a non-invasive self-administered device for external combined occipital and trigeminal nerve stimulation that has been recently approved for marketing in Europe and the USA. The objective of this study was to conduct an early assessment of the efficacy and safety of Relivion for the treatment of migraine episodes. Methods Relivion was identified by the early awareness and alert system, SINTESIS- nuevas tecnolog\u00edas, of the Agencia de Evaluaci\u00f3n de Tecnolog\u00edas Sanitarias at the Instituto de Salud Carlos III. An early assessment of the technology was conducted by reviewing relevant clinical studies published to 29 September 2021. The literature was identified by searching PubMed, Embase, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Library. Results Two randomized, sham-controlled double-blind trials were found. They assessed side effects and pain relief, response rate, and pain freedom two hours after treatment. One study included 55 patients and the other (the RIME study) included 131 patients. The rate of pain relief two hours after treatment ranged from 60 to 76 percent in the treatment group and from 31 to 37 percent in the control group (p<0.01). The response rate, defined as at least 50 percent pain reduction two hours after treatment, was significantly higher in the treatment group (67 to 70% versus 32 to 42%). The percentage of patients free of pain two hours after treatment ranged from 42 to 46 percent in the treatment group, compared with 11 to 12 percent in the control group (p<0.0001). No notable adverse events were recorded. Conclusions Preliminary results indicated that Relivion effectively and safely relieves or eliminates acute migraine pain. However, more comparative studies are needed. The use of Relivion could improve the control of symptoms and improve quality of life in patients with migraine.","Poster Presentation Number: PP111 Abstract Title: Reimbursement And Payment Models: A Survey Of Stakeholders\u2019 Current Experiences And Future Outlook Within The Dutch Policy Setting Author Names: Marcelien Callenbach ([email protected]), Rick Vreman, Aukje Mantel-Teeuwisse, Wim Goettsch Introduction The constant evolution of high-priced hospital drugs with large uncertainties are increasingly challenging the sustainability of many healthcare reimbursement systems. Consequently, more attention is paid to exploring innovative payment and reimbursement models that may contribute to sustainable healthcare funding mechanisms yet still ensure timely patient access to health intervention. However, more insight is needed into the experiences of stakeholders involved in making payment and reimbursement arrangements as they may play an essential part in successfully implementing innovative reimbursement and payment models in the future. Methods Between May and July 2021, a survey was sent out to Dutch stakeholders directly or indirectly involved in payment and reimbursement agreements. The survey questioned the current use of and future preferences for reimbursement and payment models for high priced hospital drugs using Likert scales. Results were analyzed using descriptive statistics. Results Our inquiry shows that currently financial-based reimbursement models are applied most often, especially discounts due to their simplicity. In the future, outcome-based reimbursement models are preferred more, particularly pay-for-outcome. The main challenge for implementation is generating evidence in practice. Upfront payment is currently the most frequently applied payment model, according to the respondents, whereas delayed payment models are preferred to be applied more often. Particularly payment at outcome- achieved models are preferred but they can be administratively difficult to arrange. The respondents are moderately satisfied with the payment and reimbursing system in the Netherlands, arguing that especially transparency about the final agreement and mutual trust could be improved. Conclusions Despite the preference healthcare payers have for using outcome-based reimbursement models and delayed payment models, currently they are rarely applied. The insights from our survey can provide Dutch stakeholders with future direction when implementing innovative reimbursement and payment models. Attention should be paid to which barriers are currently perceived and how policy structures can facilitate implementation. Further research should focus on exploring which combinations of reimbursement and payment models are most likely to be successful in the Netherlands.","Poster Presentation Number: PP112 Abstract Title: Reimbursement Decisions for Medical Services in Austria: An Analysis of Influencing Factors for the Hospital Individual Services Catalogue Author Names: Gregor Goetz ([email protected]), Dimitra Panteli, Reinhard Busse, Claudia Wild Introduction This study aims to (i) describe the (evidence-based) reimbursement process of hospital individual services, (ii) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (iii) elaborate potential aspects that play a role in the decision-making process in Austria. Methods The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analyzed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decisionmakers. Results One hundred and eighteen evidence-based recommendations were analyzed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance\/organizational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), \u201cother countries\u201d (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic). Conclusions There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.","Poster Presentation Number: PP113 Abstract Title: Reimbursement Of Oncology Therapies With Limited Clinical Evidence In The Netherlands Author Names: David Smalbrugge ([email protected]), Sophie van Beekhuizen, Bart Heeg Introduction The number of novel therapies that achieve registration in oncology based on limited clinical evidence like non- randomized studies (NRS) is increasing. Dutch health authorities determine the therapeutic value of medicines evaluated in randomized controlled trials based on formal criteria for minimal relative efficacy or clinical treatment guidelines. However, there are no criteria to determine the therapeutic benefit of treatments assessed in NRS, which impacts reimbursement and patient access. Additionally, clinicians in the Netherlands see potential clinical benefit in off-label use but are currently unable to prescribe these because of absent clinical evidence. This review aims to identify and summarize initiatives to improve patient access to oncology therapies with limited or no clinical evidence in the Netherlands. Methods Relevant public reimbursement documents for the Netherlands were identified through a pragmatic literature review. Results The main initiatives to improve access for therapies with limited clinical evidence are outside regular reimbursement pathways. The Drug Rediscovery Protocol (DRUP, initiated 2016) and drug access protocol (DAP, initiated 2021) are two initiatives to improve access in solid tumor oncology. DRUP collects real-world data and provides access for targeted therapies in patients with targetable mutations in off-label indications. At least 25 therapies have been included to date. DAP uses the same data framework to reimburse on-label solid tumor therapies through a managed entry agreement based on response. The first participating therapies are cemiplimab (NRS, failed ZiN reimbursement), entrectinib and larotrectinib (both NRS, tumor-agnostic). Finally, Dutch clinical experts proposed criteria for therapeutic value of therapies studied NRS in oncology. Conclusions Patient access to both off-label and on-label oncology therapies is addressed in DRUP and DAP. New criteria for the therapeutic value of therapies studied in NRS may decrease the relevance of DAP, although these criteria would not address the need for comparative evidence for cost-effectiveness analysis.","Poster Presentation Number: PP114 Abstract Title: The Influence Of Implicit Factors On The Health Technology Assessment Deliberative Process: A Survey In Five European Countries Author Names: Clara Monleon ([email protected]), Mondher Toumi, Hans-Martin Sp\u00e4th, Claude Dussart, Carlos Crespo Introduction Implicit factors can be defined as any criteria that play a role in the health technology assessment (HTA) deliberative process but are not part of the HTA framework. To date, very few studies have explored the influence of implicit factors on this process. This survey of HTA experts in five European countries aimed to analyze the influence of implicit factors on the HTA deliberative process. Methods Semi-structured interviews with 20 HTA experts from five European countries (France, Germany, Italy, Spain, and the United Kingdom) were conducted from February to May 2021. The main topics of the interviews were: the HTA deliberative process; the degree of influence on the HTA deliberative process of a set of factors previously identified in a systematic literature review performed by the authors; and recommendations for improving the deliberative process. Results All but two of the experts concurred that implicit factors played a role in the deliberative process. German experts considered that the factors explored had a low influence on the process. Burden of disease and unmet need scored highest, followed by the professional experience of the people involved in the HTA deliberative process. To improve the deliberative process, experts suggested expanding the external stakeholder perspective (i.e., including patients, the pharmaceutical industry, and the public), increasing transparency when revealing implicit factors, and implementing a methodology to mitigate the influence of implicit factors. Conclusions Our survey indicates a need to increase external involvement in the process and to develop a methodology for unmasking the implicit factors in the deliberative process. This may be achieved by either updating the current frameworks to include these implicit factors or by developing new methods to address them. Further research may explore approaches to acknowledge the implicit factors in the HTA deliberative process in a systematic manner.","Poster Presentation Number: PP115 Abstract Title: Analysis Of Previous Joint Clinical Assessment And Potential Transferability To Four European Countries: Case Study And Conceptual Approach Author Names: Jeanne Kern ([email protected]), Victoria Malek Pascha Introduction The European Network for Health Technology Assessment (EUnetHTA) has led together, with member states, several joint actions, including Joint Clinical Assessments (JCA), under the form of project-based voluntary cooperation, which outputs and transferability of those projects in other European countries remains somehow limited. In June 2021, the European Council has reached an agreement on the European Health Technology Assessment (HTA) regulation, which is entering into force gradually. Initially limited to oncology products, then extended to orphan\/advanced therapy, and after a five to eight-year additional period, it will apply to all centrally approved products. The JCA will consist of a focused scientific analysis on relative effectiveness assessment, including the health condition, technology description, clinical effectiveness, and safety. These analyses will also include information relating to the degree of certainty. We consider that the evidence appraisal might have limitations, and transferability would not be generalizable. We aim to determine the potential drivers and barriers for HTA transferability in EU4, employing the analysis of a case example where JCA was conducted. Methods Employing an oncology JCA, we will compare an HTA analysis conducted in EU4 countries (Germany, France, Italy, and Spain). Overview and background information on countries involved in the JCA, and EU4 HTA system will be provided, followed by HTA outcome and main evidence requirements, reimbursement outcome, and pricing agreements. Results Study results supporting HTA outcomes may focus on the population assessed, the comparator considered, and uncertainty management. A conceptual adaptation about the scope of the EU JCA regulation will be discussed, to understand its potential advantages to individual HTAs in Europe and remaining gaps to effectively inform HTA or decision-making process. Conclusions The analysis of pricing and reimbursement outcomes can further help understand potential barriers and drivers for JCA transferability and potential areas of evidence generation requirements.","Poster Presentation Number: PP117 Abstract Title: Larger Impact Of An Appropriate Care Program By Involving Healthcare Professionals: A Case Report On Cervical Pre-malignancy Author Names: Koen B\u00f6cker ([email protected]), Thom de Bruijn, Maarten Vink Introduction Appropriate care programs differ in the way and the extent to which they involve or collaborate with stakeholders. Here we describe the collaboration of two national appropriate care programs with gynecologists to improve the curative care of women with cervical intraepithelial neoplasia (CIN), a cervical pre-malignancy. Methods The present case report describes the collaboration based on project documentation. Results The Appropriate Care program from the Dutch National Health Care Institute performs a systematic cyclic health technology assessment to examine the degree to which care in the insured package is provided to patients. The full cycle consists of four phases: screening, in-depth analysis, implementation, and evaluation. The results of the in-depth analysis are discussed with the stakeholders. This is followed by written agreements on multiple actions to improve healthcare from the patient perspective. For CIN these actions encompass improvements in a top- down fashion; for example, by updating guidelines to eliminate unwanted practice variation and creating tools for shared decision-making. These actions were supplemented by the development of audit and feedback information on a national and local level. The development was supported by a second national appropriate care program, Healthcare Evaluation and Appropriate Use. The results of the first production run of the audit and feedback information were disseminated by the Dutch Society of Obstetrics and Gynaecology and more than 50 healthcare institutions. This information was used to prioritize modular guideline updates and helped pinpoint the main areas of improvement of individual healthcare institutions. A future production run of audit and feedback information will facilitate the Plan-Do-Check-Act cycle on a local and national level. Conclusions In the case we present, the collaboration between appropriate care programs and healthcare professionals led to a synergy between top-down (updating and disseminating guidelines and tools for shared decision-making) and bottom-up (learning from audit and feedback information) activities to improve curative care for women with CIN.","Poster Presentation Number: PP118 Abstract Title: Cyclic Mental Health Technology Assessment with Priority Setting And Involving Stakeholders - A Case Report From The Netherlands Author Names: Koen B\u00f6cker ([email protected]), Lukas Roebroek Introduction For almost ten years a cyclic appropriate care program has been in place in The Netherlands, known as Zinnige Zorg. The program spanned the full International Classification of Diseases (10th Edition). In 2016 a project on mental health was started. A full cycle consisted of four phases: screening (including priority setting), in-depth analysis, implementation and evaluation. During the in-depth analysis phase, the mental health practice as it was provided was compared to the advice in the guidelines. The mental health project is now in the implementation phase. Professionals, mental healthcare institutions, health insurers and patients are now collaborating to reach the goals that have been set at the closure of the analysis phase. Methods Project documentation was analysed to describe the way stakeholders were involved in priority setting as well as their subsequent involvement in implementation of appropriate care actions. Results The present case report describes two factors that are important in engaging stakeholders: (i) Priority setting started with interviews with different stakeholders. This led to a selection of 9 themes for investigating appropriate care. (ii) For these themes stakeholders formulated 45 issues, together with their consequences for mental health patients, without formulating solutions. If necessary they were reformulated as: [group of patients x] experiences [bottleneck y in mental healthcare], this leads to the patients [negative consequence z]. Next, 9 issues were prioritized and 4 selected, with input from the stakeholders. Finally, two diseases were selected for which the issues were investigated in depth. This focus enables development of specific implementation steps and evaluation of their effects. Conclusions Currently, stakeholders are collaborating in a constructive manner in the implementation phase of this cyclic appropriate care program to improve mental health care for patients experiencing psychosis or post-traumatic stress disorder. Important characteristic of the process that might have supported the present collaborative effort in implementation were (i) early involvement of the stakeholders and (ii) an orientation on problems experienced by patients in the priority setting phase.","Poster Presentation Number: PP119 Abstract Title: Results And Lessons Learned From The Cyclic Appropriate Care Program From National Health Care Institute Of The Netherlands Author Names: Hedy Maagdenberg ([email protected]), Mariska Stam, Tjitske Vreugdenhil, Koen B\u00f6cker, Iris Groeneveld Introduction Since 2013, the National Health Care Institute in the Netherlands has systematically analyzed the appropriateness of care provided under public health insurance. Here we present the method used, the results up to now, and what we have learned from it. Methods The appropriate care program consists of four phases: screening, in-depth analysis, implementation, and evaluation. Stakeholder involvement is a central part of the process. For every ICD-10 area, a screening took place to select care trajectories for in-depth analysis with a potential for wiser choices and more appropriate care. The in-depth analysis indicates which improvements can be made to reach more appropriate care, by assessing guideline adherence. During the implementation phase, which is primarily carried out by clinicians, patients and health insurers, actions are taken to improve care on the identified points. In the evaluation phase, we examine to what extent improvements have been achieved. Results Currently, all ICD-10 areas have been screened and 29 selected care trajectories have been subjected to in-depth analyses. The analyses resulted in the identification of more than a hundred areas for potential improvement of the appropriateness of care. For most topics implementation of changes is currently taking place. The four most important impact-enhancing lessons learned by applying the working method are: (i) ICD-10 areas as a starting point for screening are not the most efficient method to reach the biggest impact. (ii) The screening should take a societal perspective. (iii) All public and private parties involved should fulfill their role and take responsibility. (iv) To fulfill our own role better, the working method should be more connected to health technology assessment for reimbursement decisions. Conclusions The program has resulted in the identification of many valuable points for improvement which could lead to more appropriate care in the coming years. The impact of the program could be increased through priority setting from a societal perspective and improving the connection to our other health technology assessment processes.","Poster Presentation Number: PP 120 Abstract Title: Fluorescent In Situ Hybridization (FISH) Vs Conventional Cytogenetic (CC) For Detecting High-Risk Genetic Mutations In Multiple Myeloma Author Names: Denis Satoshi Komoda ([email protected]), Marilia Berlofa Visacri, Carlos Roberto Correa, Daniela Santos, Flavia Maia, Mayra Ribeiro Introduction The Revised International Staging System (R-ISS) International Myeloma Working Group (IMWG) recommends a minimal panel to detect high-risk cytogenetics (del17p, t[4;14], t[14;16]) for patients with multiple myeloma (MM). In the Brazilian Public Health System, the use of FISH is currently authorized for rare diseases only, not including MM. In 2021, the Brazilian National Committee for Health Technology Incorporation, with the purpose of broadening the use of FISH to MM patients, requested a review to be undertaken by the Health Technology Assessment Center of University of Campinas\u2019 Teaching Hospital. This study presents the results of a meta- analysis comparing FISH vs CC to the detection of the above-mentioned aberrations in MM patients. Methods On 25 June 2021, a pre-structured search on four databases (Embase, MEDLINE, Cochrane and LILACS) was performed to identify studies comparing FISH and CC results in MM patients for the detection of high-risk cytogenetics (del17p, t[4;14], and t[14;16]) in MM patients\u2019 bone marrow samples. Study selection, risk of bias assessment, data extraction (frequency of positive tests) and quality of evidence assessment were performed by two independent researchers. Conflicts were solved in agreement meetings with a third researcher. Meta- analysis was performed using frequency of positives to obtain Risk Difference (RD), a surrogate measure of the surplus positive tests between FISH and CC. Results From a total of 1346 rendered entries, 11 studies were selected. Only observational studies were available. These studies presented an overall high risk of bias (QUADAS-2). A total of 781 patients were assessed (653 evaluated by FISH and 719 by CC). Meta-analysis results showed that, for t(4;14) FISH detected 12 percent more samples (RD:0.12 [95% confidence interval (CI):0.06-0.19]). For t(14;16), FISH detected 0.42 percent more samples (RD:0.00 [95%CI:-0.01-0.02]). And for del17p, FISH detected 1.6 percent more samples (RD:0.12 [95%CI:0.04- 0.20]). Conclusions FISH appears to be more effective than CC on the detection of t(4;414) and del17p aberrations, and can be a useful tool in hematology practice. The results of t(14;16) presented non-superiority, probably due to the low frequency of this aberration.","Poster Presentation Number: PP122 Abstract Title: Magnetic Resonance-guided High-intensity Focused Ultrasound For Non-surgical Treatment Of Prostate Cancer, Uterine Fibroids, Adenomyosis And Pain In Bone Metastases Author Names: Makhabbat Okesh, Andrey Avdeyev ([email protected]), Valeriy Benberin, Nasrulla Shanazarov, Ruslan Akhmedullin, Gulzada Bariyeva, Makpal Akhmetova, Tansolpan Aimanova Introduction Magnetic resonance imaging guided high-intensity focused ultrasound (MR-HIFU) is a non-invasive technique with a low risk of complications for the patient and few side effects. Integration with MRI allows monitoring of the temperature regime of thermal doses, which protects important structures from overheating, and at the same time directing a high thermal dose to the target tissue. MR-HIFU in the treatment of uterine fibroids, prostate cancer and the treatment of pain in bone metastases is compared with both traditional methods of treatment (uterine artery embolization, hysterectomy, prostatectomy, etc.). Methods To assess the clinical effectiveness and safety of non-invasive MR-HIFU, a literature search was performed in the MEDLINE database using the following keywords:\\\"MRgFUS\\\" \\\"MR-HIFU\\\". The following filters were used: (i) article type: meta-analysis, systematic review, guidance; (ii) date of publication: no later than 5 years (from 2016). Results According to the search terms, 104 publications were submitted to MEDLINE for keywords. After using filters, 57 publications were identified to familiarize themselves with research abstracts. The analysis included six publications according to PICO criteria. The use of non-invasive MR-HIFU therapy for the treatment of uterine fibroids, prostate cancer and various forms of metastatic bone lesions does not have convincing evidence of advantages over standard treatment methods (surgical resection, embolization, etc.) and may be used only as an alternative technique or in addition to standard therapy. Conclusions Despite some advantages of the MR-HIFU technology, it is experimental and should only be used as an alternative to surgical treatment. Convincing evidence of the efficacy of MR-HIFU treatment in meta-analyses, systematic reviews, and randomized controlled trials has not yet been published.","Poster Presentation Number: PP123 Abstract Title: Fair Drug Pricing: Review Of Literature And Models Author Names: Olena Wagner ([email protected]), Samia Hurst Introduction Constantly rising costs of pharmaceuticals and biologics spurred a debate in recent years leading to increasingly persistent public calls to overhaul the existing system of pricing and distributing health technologies. The COVID- 19 pandemic exposed the controversies of the current model of access to health commodities in all evidence when the existing discrepancy between the global supply and the global demand in health technology can be viewed as an illustration of a conflict between the neoliberal free market ideal of health innovation genesis and ownership and the original democratic principles of what would now be called sustainable human development. Methods Presented here is an integrative literature review of over 265 publications in peer-reviewed journals on Pubmed and Web of Science, academic and \u201cgrey\u201d literature, mainly publicism, published in English. We reviewed and analyzed included literature for the purposes of identifying leading ideas with regards to ethical frameworks for evaluating or referencing value for pricing health commodities. Results Seven drug pricing models were analyzed in terms of them satisfying the three most common criteria of price adequacy \u2013 its fairness (viewed from the point of view of main schools of ethical thought), accountability-for- reasonableness (including transparency of decisions, relevance, existing mechanisms of revisions and governance to ensure compliance), and price functionality. One of the central ideas under controversy is value, its relative character for different contexts due to the high weight of the willingness-to-pay in the value-based health technology assessment (HTA) decisions and the relative value of money, and the attempts to quantify value in a universal way for institutions, patients, and originators. Conclusions While the review scored the pricing models on their \u201cpublic fairness\u201d with volume-based rather than value-based pricing models leading the rating, the main conclusion of the review is that the main meaningful divide is between value creation and value extraction when pricing health innovation.","Poster Presentation Number: PP124 Abstract Title: The Importance Of Flexible PPI Approaches: Case Study On Flash Glucose Monitoring Author Names: Alice Evans ([email protected]), Jenni Washington, David Jarron Introduction Health Technology Wales (HTW) review guidance 3 years after publication to establish if reassessment is warranted because, for example, new evidence has become available. Since the publication of guidance on flash glucose monitoring (FGM) in 2018, HTW introduced a patient and public involvement (PPI) process with novel approaches to flexible engagement. This enabled HTW to include three streams of patient evidence into the review of FGM devices. Methods HTW\u2019s Patient and Public Involvement Standing Group (PPISG) considered appropriate methods of engagement using the HTW Patient and Public Involvement Mechanism Tool. This tool considers the nature of the health technology, the presence of appropriate patient organizations and questions that can be put to patients, as well as other approaches for obtaining patient evidence. Results HTW contacted Diabetes Cymru and met with them to discuss contributing to the appraisal of FGM devices. Diabetes Cymru produced a patient submission summarizing the experiences of their patient network, with particular focus on the expansion of the technology to closed-loop insulin systems. Diabetes Cymru later attended HTW\u2019s Appraisal Panel committee and gave a presentation. Additionally, HTW conducted a patient evidence literature review. This review summarized published qualitative studies on a range of perspectives, including carer perspectives, family perspectives, children and adolescences perspectives as well as considerations from specific environments, such as schools, workplaces, homes, care homes and communities. In addition to new clinical and cost effectiveness evidence, this PPI input was used to formulate new guidance recommending more widespread adoption of FGM. Conclusions The introduction of flexible approaches to PPI enabled HTW to gain patient evidence from multiple sources. This ensured greater patient representation and a more detailed understanding of the role of FGM devices across different patient communities. This added considerable richness to the patient evidence, which is vital to understand the everyday impacts of FGM and its use amongst patients. Combining flexible PPI with the new clinical and cost effectiveness evidence resulted in a change in the original guidance recommendation."]
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