["Poster Presentation Number: PP78 Abstract Title: Real-world Trends And Medical Costs Of Stroke After Transcatheter Aortic Valve Implantation In Korea: A Nationwide, Population-Based Study Author Names: Sujin Jung ([email protected]), Hyewon Nam, Schezn Lim, Jae Hoon Choi Introduction. Transcatheter aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. While procedural advancements have reduced the risk of stroke, stroke remains a serious complication of TAVI. To date, no study has investigated post-TAVI stroke costs in Korea. This study compared medical costs between patients with and without stroke after TAVI. Methods. This was a retrospective study using claims data from the Korean Health Insurance Review and Assessment Service. Patients who underwent TAVI in certified hospitals between June 2015 to December 2020 were included; patients with SAVR prior to TAVI were excluded. Patients with postoperative stroke within 30 days of TAVI formed the \u2018Stroke\u2019 group; remaining patients formed the \u2018Non-Stroke\u2019 group. A generalized linear model with adjustment was used to compare mean medical costs in the first year after TAVI between the two groups. Exchange rate from xe.com (5 December 2022) was applied. Results. In total, 3,046 TAVI patients were included for analysis (47% male, 85% aged\u226575 years). There were 61 (2%) patients in the \u2018Stroke\u2019 group and 2,985 (98%) in the \u2018Non-Stroke\u2019 group. Compared to the \u2018Non-Stroke\u2019 group, the \u2018Stroke\u2019 group had significantly higher adjusted mean total first-year medical costs (KRW 25,453,725 (95% confidence interval [CI]:15,215,439-42,581,231) [USD 19,640 (95% CI:11,740-32,856)] versus KRW 19,169,447 (95% CI:11,818,973-31,091,340) [USD 14,791 (95% CI:9,120-23,990)], p<0.01). Of these costs, 90 percent (\u2018Stroke\u2019) and 84 percent (\u2018Non-Stroke\u2019) were hospitalization-related (\u2018Stroke\u2019 versus \u2018Non-Stroke\u2019: KRW 6,847,975 [USD 5,284]; p<0.01); the remainder were outpatient costs. Predictors of total medical costs were: gender; hospital type; prior chronic obstructive pulmonary disease; prior diabetes; prior stroke; and postoperative stroke. Conclusions. In Korea, TAVI patients with stroke had higher first-year medical costs compared to those without stroke, driven by hospitalization costs. Stroke poses an immediate, heavy economic burden on healthcare systems. Longer-term (e.g. caregiver, rehabilitation) costs were not captured in this analysis; future studies are needed to provide supplementary evidence on the total economic burden of stroke.","Poster Presentation Number: PP79 Abstract Title: Publication Trends Of Network Meta-analyses In Europe And Asia: A Focus On Cardiovascular Disease Author Names: Alvin Ng ([email protected]), Min Hee Choi, Jennifer S Evans Introduction. The objective of this research was to compare trends in publications of network meta-analyses (NMAs) in cardiovascular diseases (CVDs) in Asia-Pacific (APAC; China, Japan, Singapore, South Korea, Thailand) and Europe (United Kingdom [UK], Germany, France, Spain, Italy), with a focus on volume, collaborations and methods. Methods. Freely available NMAs assessing pharmacological or surgical interventions for CVD in terms of mortality or major adverse cardiovascular events, published in 2012 or later, by authors affiliated with institutions in the target countries were identified via MEDLINE and Embase. CVDs were grouped using the International Classification of Diseases, Tenth Edition (ICD-10). Results. Across the 193 publications identified, heart diseases such as atrial fibrillation, aortic stenosis and heart failure (ICD-10 I30-I52) were the most common indications reported (38%). The majority of publications involved authors in APAC countries (63%) and 40% from Europe. Cumulative numbers of publications from APAC surpassed those from Europe from 2018 onwards. Authors were largely affiliated with institutions in China (50%), the UK (20%) and Italy (20%). One hundred and forty-five publications were by authors affiliated with institutions in a single country; 91 percent of publications from APAC and 44 percent from Europe, indicating different patterns of collaboration within these regions. In terms of reporting methodologies, 39 percent of included publications did not specify whether a frequentist or Bayesian framework was used (43% in APAC, 34% in Europe). Among those that reported, the Bayesian framework was more commonly used. Conclusions. Whilst there is a growing trend in NMA publication counts generally, the rate of increase in APAC was higher than Europe, particularly in the years following adoption of health technology assessment (HTA) procedures in APAC. The volume of publications not reporting the framework used was substantial, despite requirements for this in reporting guidelines e.g., PRISMA. Where reported, the Bayesian framework may have been favored due to its advocacy by some health technology assessment bodies.","Poster Presentation Number: PP80 Abstract Title: The Value of Intraoperative Neural Monitoring During Thyroid Surgery In China: A Literature Review Author Names: Yutong Yang ([email protected]), Yin Song Introduction. Recurrent laryngeal nerve (RLN) injury has been a frequent source of malpractice litigation following thyroid surgery. Intraoperative neural monitoring (IONM) has been widely applied to avoid RLN injury in thyroid surgery in developed countries, but China cannot achieve the same application rate currently. To improve the recognition and application of IONM in China, this literature review aims to synthesize the evidence on the value of IONM in China. Methods. A comprehensive literature review was conducted by searching through PubMed, CNKI and Wan Fang to identify studies about the IONM technology for protecting RLN during thyroid surgery in Chinese clinical data. Results. Nineteen Chinese clinical trials of IONM during thyroid surgery published from 2012 to 2022 were included for review. Almost all studies recruited adults who need thyroid surgery and only one study enrolled geriatric patients. There were three (3\/19) prospective studies and two were randomized controlled trials that both showed that IONM helped surgeons to detect the RLN with less time and reduce the injury of RLN in reoperative thyroid surgery. Major studies (16\/19) conducted retrospective analysis and six of them (6\/16) only had an IONM group that showed that IONM technology can avoid damage to the RLN. The remaining ten studies (10\/16) compared patients with and without IONM during the surgery. Compared with the non-IONM group, nine studies (9\/10) stated IONM technology has an advantage in the reduction of RLN injury rate and seven studies (7\/10) claimed IONM was helpful in reducing the time of surgery. One study believed IONM was beneficial to reducing bleeding during the surgery and another study reported a lower incidence of hypoparathyroidism with the IONM group. Conclusions. The value of IONM for protecting RLN during thyroid surgery and improving operation efficiency has been thoroughly proven by the above Chinese clinical trials. Further economic evaluations and patient-reported outcomes research of IONM with Chinese hospital data will help better assess the value of IONM.","Poster Presentation Number: PP81 Abstract Title: Efficacy Of Transcranial Direct Current Stimulation For Depressive Episode Disorders Author Names: \u00c1lex Brunno do Nascimento Martins ([email protected]), B\u00e1rbara Rodrigues Alvernaz dos Santos, Elder Gomes Pereira, Luana Oliveira Prata, Maiara Silva Araujo, Roberto L\u00facio Muniz J\u00fanior, Ursula Carolina de Morais Martins, Augusto Afonso Guerra J\u00fanior, Francisco de Assis Ac\u00farcio, Juliana \u00c1lvares Teodoro Introduction. Depression is a general term that describes different depressive disorders which are highly prevalent and disabling, characterized by decreases in quality of life. Transcranial Direct Current Stimulation (tDCS) is a non- invasive brain modulation technique used, among other purposes, for the treatment of chronic pain and headache. In order to clarify the effect of this stimulation on depressive disorders, the objective of this review was to evaluate efficacy and safety of treatment with tDCS for depressive disorders. Methods. A systematic research study was carried out on 30 June 2022 in MEDLINE (by Pubmed), Embase, Literatura Latino-Americana e do Caribe em Ci\u00eancias da Sa\u00fade (LILACS), PsycInfo e Global Mental Health databases. Were included systematic reviews (SR) with meta-analysis that selected patients with depression, in use of tDCS, using as comparator sham stimulation (placebo) or any other treatment (pharmacologic or no) or any comparison between pre- and post-intervention. Results. Eight SR with meta-analysis of randomized clinical trials (RCTs) on the efficacy and safety of tDCS in the treatment of depressive disorders were retrieved. Subjects were assessed for clinical response, remission, change in scores on depression scales, occurrence of procedure-related adverse events, and treatment dropout. Three systematic reviews showed results that point to the effectiveness of tDCS for the clinical response outcome and one considering the remission outcome. As for the outcome measured by the change in depression scale scores, all included reviews showed favorable results for tDCS. It is noteworthy that the studies included in the reviews have methodological limitations. With regard to safety, an increased risk treatment-emergent mania or hypomania (TEM) has been observed. Conclusions. The tDCS association with antidepressants showed favorable results to this technology in a sample with depression and varied clinical characteristics. Regarding safety of this technology, tDCS did not show adverse effects of greater severity, but was verified to have an increased risk of TEM.","Poster Presentation Number: PP82 Abstract Title: Comparison Between Informal Caregiver Burden Of Patients With Alzheimer\u2019s Disease Versus Other Chronic Diseases Author Names: Murat Demirbas, Julie Hviid Hahn-Pedersen ([email protected]), Henrik L\u00f8vendahl J\u00f8rgensen Introduction. Alzheimer\u2019s disease (AD) is a neurodegenerative disease with progressive neuropsychiatric symptoms. Patient care is often provided by informal caregivers similarly to various other chronic diseases. This targeted literature review assessed the difference in burden experienced by caregivers of people with AD in comparison to other chronic diseases. Methods. Two separate search strings were developed to identify (i) caregiver burden in AD and (ii) caregiver burden in other chronic diseases using PubMed. Studies published in English (January 2012-October 2022) were included. Comparison of the caregiver burden was done using the weighted mean values (MV) of several questionnaires including the Zarit Burden Interview (ZBI), a 22-item self-report questionnaire for caregivers ranging from 0 to 88 points. ZBI is stratified into four categories of caregiving burden: Little or no burden (0 to 21), mild to moderate burden (22 to 40), moderate to severe burden (41 to 60) and severe burden (61 to 88). Results. ZBI was the most frequently used questionnaire; 13 studies reported data on caregiver burden in AD and 39 studies reported data on 20 other chronic diseases. The caregiver burden ranged from 18 to 48 in AD, measured by ZBI. The MV of AD burden was 36 based on a total of 1,703 participants. The caregiver burden in other chronic diseases ranged from MV of 5 (chronic musculoskeletal pain) to 59 (bipolar disorder). Measured by ZBI, AD burden on caregivers (MV: 36, range: 18-48) was greater than heart failure (MV: 27, range: 16-29) and type 2 diabetes (MV: 26, range: Not reported) but lesser than schizophrenia (MV: 56, range: 52-65) and bipolar disorder (MV: 59, range: Not reported). Conclusions. AD has a significant burden on caregivers. When assessing the value of interventions targeting AD, the impact of AD on caregivers should be considered in addition to the impact of AD on patients. Further studies are required to assess the informal care burden in AD and other chronic diseases.","Poster Presentation Number: PP84 Abstract Title: Evaluation Of The Evidence Level Of Scrambler Therapy For Musculoskeletal Pain Relief: A Systematic Literature Review Author Names: Hye Eun Eom, Seung Jin Han, Kyoung-Hoon Kim ([email protected]) Introduction. Non-invasive Scrambler Therapy (ST) reduces pain by attaching electrodes to neural pathways of major nerves, transmitting information along with microcurrent to the nerves to induce a painless sensation. The ST has been widely used to reduce pain for patients with musculoskeletal pain. However, little is known about the musculoskeletal pain relief effect of the ST. Therefore, this study aims to evaluate the treatment effectiveness of the ST. Methods. A systematic literature review was conducted based on the following search strategy and databases, and all studies published before August 2021 were included in Pubmed, Embase, and Cochrane library, Ovid Medline, Koreamed, kmbase, and Science On. The subjects were patients with intractable and musculoskeletal pain, excluding cancer pain, and intervention methods included non-invasive ST alone or in combination with physical therapy. In addition, the comparative method was not limited. The outcome variables were the degree of pain relief, total analgesic use, health-related quality of life, pressure pain threshold, pain intensity and functional interference scales, and pain sensitivity. Safety-related outcome variables were all side effects. Cochrane Risk of Bias 1.0 was used to assess the risk of bias in the literature. Results. Two hundred forty-one articles were retrieved using a pre-determined search strategy. Of these, 15 duplicate articles, 215 articles after reviewing the abstract and title, and nine articles after checking the full text were excluded. Two studies with randomized controlled trials (RCTs) were finally selected. When comparing ST and placebo groups for musculoskeletal pain, the pain reduction effect of ST lasted for three weeks. Moreover, patients with neuropathic pain treated with ST had a lower pain intensity for one to three months compared to the drug treatment group. Conclusions. Based on this systematic review, the effectiveness of ST is yet sufficient owing to small sample size and possibility of selective report bias. More studies with well-designed RCTs are required to further assess the effectiveness of the ST.","Poster Presentation Number: PP86 Abstract Title: Systematic Review Toolbox 2.0: Rebuilding Toolbox With A Novel Taxonomy To Classify And Share Evidence Synthesis Tools Author Names: Christopher Marshall ([email protected]), Eugenie Evelynne Johnson, Hannah O'Keefe, Anthea Sutton Introduction. Developed in 2014, the Systematic Review (SR) Toolbox has played a critical role in helping researchers to identify appropriate tools to support systematic reviews. Since the resource was launched, the systematic review and wider evidence synthesis process has evolved considerably. The way in which the SR Toolbox originally classified tools at launch had become dated. We updated and rebuilt the SR Toolbox in 2022 underpinned by a novel taxonomy to reflect the latest review and evidence synthesis landscape. Methods. All guidance and software tools contained within the SR Toolbox were manually extracted in February 2022. Information contained from tool records were extracted by a single reviewer into an Excel spreadsheet, with a second reviewer checking a sample. The spreadsheet was translated to a Microsoft Access database underpinned with a new taxonomy to reflect the expansion of evidence synthesis methods and new review types (or \u2018families\u2019). A brief analysis of the remapped tools was conducted to identify current gaps in software and guidance support for evidence synthesis. A new user interface was also developed. Results. The updated version of the SR Toolbox was launched 13 May 2022. At that time, the resource included records on 235 software tools and 112 guidance tools. Regarding \u2018review families\u2019, most software tools (n = 223) and guidance documents (n = 78) were applicable to supporting systematic reviews. Fewer software (n = 66) and guidance (n = 22) tools were applicable to reviews of reviews, while qualitative reviews were less served by guidance documents (n = 19). In terms of \u2018review stages\u2019, most guidance documents were associated with quality assessment (n = 70), while most software was related to searching (n = 84) and synthesis (n = 82). To- date, there is a lack of software (n = 2) and guidance (n = 3) tools to support stakeholder engagement. Conclusions. The SR Toolbox has received a significant update to ensure that tools are classified and shared based on the latest systematic review and evidence synthesis methods. As part of the update, analysis of the contents of the toolbox highlighted potential gaps in tool support for certain review types\/stages.","Poster Presentation Number: PP87 Abstract Title: Glecaprevir\/pibrentasvir (Maviret\u00ae) Remains A Cost-effective Treatment For Chronic Hepatitis C Virus Infection After Changes To The Treated Population Author Names: Belinda Castles ([email protected]), Emma Warren, Gillian Sharratt, Aitor Arteaga Introduction. The first direct-acting antiviral (DAA) therapies for chronic Hepatitis C virus (HCV) infection were reimbursed via Australia\u2019s Pharmaceutical Benefits Scheme (PBS) in March 2016. This was based on the recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) that the regimens would be acceptably cost- effective at an incremental cost-effectiveness ratio (ICER) of AUD15,000\/quality-adjusted life-year (QALY). Broad access to DAA therapies has been a key strategy in driving a national health goal to eliminate viral hepatitis as a major health threat by 2030. Since the initial PBS listings for DAA therapies and subsequent listings of newer DAA treatments such as Maviret, the demographics and disease characteristics of currently treated patients have markedly changed. The aim of our analysis was to reassess the cost-effectiveness of Maviret, accounting for the changes of the treated population characteristics and retreatment in first-line failures and reinfected individuals. Methods. To assess the cost-effectiveness six years after initial listing of Maviret, an update was made to the Markov model used to achieve PBS reimbursement for Viekira-Pak\u00ae in May 2016. Amendments to the Viekira-Pak model include: changes to baseline age and fibrosis distribution of treated patients, and incorporation of retreatment of first-line failures (those not achieving a sustained virologic response (SVR)) and reinfected individuals. Treatment-related inputs including SVR response rates, adverse events, treatment-related disutility and discontinuations were sourced from pivotal glecaprevir\/pibrentasvir clinical trials. Results. Using the published price of Maviret, the ICER is above AUD15,000\/QALY but well below the commonly used ICER threshold in other chronic diseases (AUD45,000\/QALY). When the confidential effective price is used, the ICER is under the AUD15,000\/QALY cost-effectiveness threshold set by the PBAC for DAA therapies. Conclusions. Despite substantial changes to the population seeking treatment in Australia since reimbursement in 2016, Maviret remains a cost-effective treatment for chronic HCV infection.","Poster Presentation Number: PP88 Abstract Title: An Exploratory Analysis Of The Potential Cost-Benefit Of Delaying Kidney Disease Progression In Australia Author Names: John Kim ([email protected]), Francis Dehle, Alex Teal, Scott Brydon, Vanessa Stevens, Anthony Anselmo Introduction. Chronic Kidney Disease (CKD) is a condition that leads to end-stage renal disease (ESRD), characterized by a gradual loss of kidney function. In 2021, the healthcare system expenditure of CKD in Australia was estimated to be over AUD2.3 billion (USD1.5 billion), largely attributed to Kidney Replacement Therapy (KRT, dialysis or kidney transplantation). This exploratory analysis aims to calculate the cost-benefit to the Australian healthcare system should KRT be delayed. Methods. The prevalence of ESRD with and without KRT between 2016 and 2021 was estimated, and a simple linear regression model was created to estimate the prevalence of ESRD with KRT between 2022 and 2026. The projected cost of KRT management in 2022 was calculated, enabling an approximate cost benefit presented as the number of patients needed to reduce expenditure by AUD1 million (USD0.7 million). Results. In 2021, it was calculated that 34,554 patients live with ESRD in Australia, of which 28,542 patients are on KRT. The number of new patients on KRT increases linearly by an average of 943 patients per year and provided a model with a strong goodness-of-fit (R2 = 0.99); predicting that the prevalence of patients on KRT is estimated to increase to 33,417 patients by 2026. Dialysis accounts for the highest cost associated with ESRD management, estimated to be AUD87,975\/year\/patient (USD58,253), and accounts for over AUD1.3 billion (USD0.9 billion) in annual expenditure. When considering the proportion of patients receiving KRT undergoing dialysis (52.6%), first-year renal transplant (3.4%), and post-kidney transplantation (43.9%), in 2022, the average annual cost per patient receiving KRT is estimated to be AUD57,565 (USD38,109). The prevention of KRT in 17.4 patients in 2022, decreasing to 15.4 patients in 2026, has the potential to save AUD1 million\/year (USD0.7 million). Conclusions. The prevalence of ESRD in Australia increases linearly and contributes to a significant cost to the Australian healthcare system. In 2022, preventing KRT in 17.4 patients (0.06%) can equate to a saving of AUD1 million\/year (USD0.7 million), further decreasing to 15.4 patients (0.05%) in 2026.","Poster Presentation Number: PP93 Abstract Title: Health Technology Assessments For Rare Diseases In Australia: A Case Study On Cystic Fibrosis Author Names: Himani Jaiswal ([email protected]), Anna D'Ausilio, Matthew Bending Introduction. Currently, no cure exists for the 1 in 2,500 Australian babies born with potentially fatal cystic fibrosis (CF). The authors conducted a health technology assessment (HTA) case study analysis of all regulatory approved CF treatments in Australia from January 1994 to July 2022. Submissions were also made under the Therapeutics Goods Administration and Pharmaceutical Benefits Advisory Committee (TGA-PBAC) parallel process. Methods. Public summary and source materials were researched to understand relevant clinical and health economic evidence requirements, and access decisions from Australia\u2019s lead HTA body, PBAC. Results. The review found that there are more than seven approved products in Australia. Of those, all four novel CF transmembrane conductance regulator (CFTR) modulating medications, which treat the underlying disease, received an orphan drug designation and were eventually listed. However, initial HTA decisions were mixed, with one recommended (25%), one not recommended (25%), and two deferred (50%). Clinical efficacy, cost- effectiveness, clinical need, as well as patient\/carer-centric perspectives were most influential in HTA recommendations. Like other rare disease treatments, price, high incremental cost-effectiveness ratios (ICERs), uncertainty around cost-effectiveness and\/or efficacy were key barriers to positive decisions. Notably, Australian stakeholders did not recommend CF medicines when their ICERs significantly exceeded a threshold of AUD200,000 (USD134,700) per quality-adjusted life year (QALY) gained. Administratively, Australia addresses risks associated with poor cost-effectiveness and high costs through managed access programs, risk- sharing agreements (RSA) and special pricing arrangements. Recently approved elexacaftor-tezacaftor- ivacaftor would be inaccessible to many Australian patients without inclusion in the Pharmaceutical Benefits Scheme (PBS); this placement increases access by limiting patients\u2019 payments to AUD42.50 (USD28.62) maximum per prescription. Alternatively, manufacturers of therapies for other chronic or rare life-threatening conditions can participate in Australia\u2019s Highly Specialised Drugs Program and\/or Life Saving Drugs Program to facilitate access. Conclusions. Companies can accelerate and optimize market access by using the TGA-PBAC parallel process. Other Asia- Pacific countries can model components of Australia\u2019s approach to advancing access to innovative, live-saving therapies.","Poster Presentation Number: PP94 Abstract Title: Robotic-Assisted Thoracoscopic Surgery Versus Video-Assisted Thoracoscopic Surgery And Open Thoracotomy: A Systematic Review And Meta-Analysis Author Names: Jiyeon Lee ([email protected]), Youjin Jung Introduction. Robot-assisted surgery is one of the minimally invasive surgical approaches that has been increasingly utilized across a wide range of surgeries. However, there is limited evidence of robotic-assisted thoracic surgery (RATS) for patients with lung cancer. This study aims to evaluate the safety and effectiveness of RATS in lung cancer patients compared with video-assisted thoracoscopic surgery (VATS) and open thoracotomy. Methods. A comprehensive search for studies that compared RATS versus VATS or open thoracotomy published until 12 April 2022, was conducted. Two review authors independently assessed studies for inclusion and risk of bias, and extracted data. We used results of reported perioperative outcomes, oncological outcomes, and survival outcomes. When more than two studies contributed data, meta-analyses were performed. Results. Four randomized controlled trials (RCT) were included. Firstly, three RCTs comparing RATS with VATS were identified. Compared with the VATS group, the RATS group had significantly lower blood loss, more harvested lymph nodes and lymph node stations. However, there were no significant differences in operative time, transfusion rates, hospital stay, drainage duration, reoperation, readmission, postoperative pain, and postoperative complications. Survival outcomes were not reported. Secondly, one RCT comparing RATS with open thoracotomy was identified. Compared with open thoracotomy group, the RATS group had significantly lower blood loss, less postoperative pain, and shorter chest drainage duration. On the other hand, there were no significant differences in operative time, hospital stay, postoperative complications, number of harvested lymph nodes and lymph node stations, and survival outcomes (disease-free survival, overall survival). Conclusions. Evidence on the effectiveness and safety of RATS compared with VATS or open thoracotomy for lung cancer is of low certainty, but we suggest that RATS is a feasible and safe alternative to conventional thoracic surgeries for lung cancer patients on the basis of current data. Additionally, more and better studies are required to provide evidence on the benefits and cost-effectiveness of RATS.","Poster Presentation Number: PP95 Abstract Title: A New Organizational Model To Manage Chronic Diseases With Digital Medicine Tools Author Names: Eugenio Di Brino ([email protected]), Roberta Laurita, Michele Basile, Filippo Rumi, Americo Cicchetti Introduction. Technological innovation, in its broadest meaning, is one of the elements characterizing the governance of health systems most susceptible to transformation. The analysis aims to analyze the impact of Digital Medicines on the current model of management of patients with chronic diseases in Italy. Methods. The analysis of the impact of Digital Medicines in the Italian national healthcare context started from a previous review of the state of the art aimed at understanding the readiness of the different regions regarding the implementation of digital therapies in the context of healthcare processes. The ultimate goal was the creation of a \\\"new path\\\" for the management of patients suffering chronic diseases (i.e., type 2 diabetes) integrated by Digital Health technologies. Results. Starting from the current model of management of patients with diabetes, the analysis of the literature and the available evidence emerged underlining the pillars of a new management model were identified: organizational and management assets, skills, platforms enabling new health technologies and regulatory frameworks. Each pillar contains the bricks characterizing the ideal therapeutic pathway. In particular, some of these elements represent the evolution of already available factors that have largely influenced the solutions adopted by the Italian Regions. The bricks defined as \\\"innovative\\\" flank the previous ones and define the new model of diabetic disease management within the National Health Service. Conclusions. The development of a new framework for the management of chronic patients allowed by the new tools of Digital Medicine generates in the clinical care path must consider two major ecosystems: the health data to date available and the health governance they allow to realize.","Poster Presentation Number: PP96 Abstract Title: Continuous Innovation In Neurostimulation Therapies For The Management Of Chronic Pain: Challenges For Health Technology Assessment Policy Author Names: Rashmi Joglekar ([email protected]), Liesl Strachan Introduction. Chronic pain is a debilitating condition with a high burden of disease. Neurostimulation therapy is an established modality for patients with chronic pain refractory to pharmacological based approaches and conservative interventional therapies. The therapy has evolved over the decades, based on improved understanding of the mechanisms of action, as well as technological advancement in device design. Our objective is to conduct a review of the innovation in neurostimulation therapy for chronic pain, in the context of health technology assessment (HTA), and its implications on policies related to patient access. Methods. A qualitative literature review was conducted to identify published HTAs, systematic reviews, clinical guidelines and other relevant articles and reports on neurostimulation therapies used in pain management. Searches were limited to the past 10 years to ensure that a contemporary analysis was conducted. Results. Our review indicates that there has been continuous innovation in neurostimulation therapies for chronic pain. This includes improvements in battery longevity and reduced size, advances in the design of leads, the development of novel stimulation waveforms and personalized programming using sophisticated algorithms including sensing and feedback loops, and remote management to name a few. Clinical research has also enabled an expansion in the range of neural targets and indicated subpopulations. The literature shows that apart from reduction in pain, neurostimulation therapy facilitates improvements in the quality of life, and reduction in opioid dependence, carer burden and disability, which are outcomes important to patients as well as to society at large. Clinical guidelines are largely supportive of neurostimulation for the management of chronic refractory pain in carefully selected patients. Conclusions. The range and complexity of neurostimulation devices and the variety of study designs presents a challenge for evidence synthesis. HTA bodies need to ensure that the methodologies for evaluating a heterogeneous therapy such as neurostimulation for pain management are robust, and that the policies for determining access to such innovative therapies are patient-centric and fit-for-purpose.","Poster Presentation Number: PP97 Abstract Title: How Health Technology Agencies Estimate Target Population Size For Medical Devices: The Example Of Spinal Cord Stimulation Author Names: Apolline Ade ([email protected]), Natalie Hallas, Lydie Vancauwenberghe, Ilona Vogt- Humberg, Astrid Holm, Mette Lundsby, Benny Borgman, Beatriz Pellicer, Francesca Borghetti, Liesl Strachan Introduction. Spinal cord stimulation (SCS) is an effective and safe option for patients with refractory neuropathic pain, with positive health technology assessment (HTA) recommendations across Western Europe, yet SCS uptake remains low. Estimating target patient populations within HTAs may impact upon medical device uptake, pricing and access. However, there is a dearth of information on how this is typically conducted. This study aimed to compare the approaches of Western Europe HTA agencies for estimating the target population for SCS. Methods. A survey was conducted among members of the Health Economics and Reimbursement function from Western Europe to collect country-specific information on how HTA agencies assess the target population of medical devices (MD). The estimations of the target population for SCS were extracted from HTA publications and compared. Results. Eight Health Economics and Reimbursement (HER) Analysts from France, Germany, the United Kingdom (UK), Belgium, Spain, Italy, Sweden and Norway completed the survey. HTA Agencies in France, UK and Belgium routinely ask for epidemiological data in the manufacturer submission, whereas in Germany, Sweden and Norway the request is dependent on the type of HTA submission. All HTA agencies, except NICE (UK), perform an independent estimation of the target population. HTA agencies in Germany and UK typically use epidemiological data from industry. In all countries, the estimation of the target population may indirectly impact the price of the MD, especially when budget impact analysis indicates a potential high use of healthcare resources. Only France, Belgium and UK have published HTA recommendations about SCS, however the estimated target population, nor the number of patients with refractory neuropathic pain, is not always included. Only the French and UK HTA agencies publish an approximation of the target population for SCS using the number of patients implanted every year. Conclusions. This study showed there is a lack of harmonization between Western European HTA agencies\u2019 guidelines on the inclusion and estimation of target patient populations. The new EU HTA Regulation should help to address this situation.","Poster Presentation Number: PP98 Abstract Title: Phelan-McDermid syndrome: Methodology For Creating A Patient Adapted Version Of A Clinical Practice Guideline Author Names: Josune Dominguez ([email protected]), Marta L\u00f3pez-Argumedo, Beatriz Carmona- Hidalgo, Charlotte Gaasterland, Mirthe Klein, Juan Antonio Blasco Introduction. Phelan-McDermid syndrome (PMS) is a chromosomal disorder caused by the loss of the end of chromosome 22, that is manifested as a neurodevelopmental disorder. Providing an adapted version of a guideline was seen as essential, as currently, there are no such booklets based on an international guideline for PMS patients, families and caregivers. The European Reference Networks (ERN) Guidelines programme results from a call for proposals funded (DG SANTE\/2018\/B3\/030) for the development of Clinical Practice Guidelines (CPG) and Clinical Decision Tools in the area of rare diseases. Based on this European consortium, the purpose of this study is to describe how two Spanish HTA agencies, OSTEBA-BIOEF (Basque Office for Health Technology Assessment) and AETSA (Andalusian Health Quality Assessment Department) methodologically support the ERN-ITHACA (Rare malformation syndromes and rare intellectual and neurodevelopmental disorders) in the development of a comprehensive patient booklet based on a CPG to be used as an adjunct in the management of PMS syndrome that will be published in 2023. Methods. A preliminary booklet was created by HTA agencies using the new European guideline for PMS and a Dutch guideline. The booklet structure is an adaptation based on a European Commission template with the guidance of the methodological Handbook#11. Results. Through a comprehensive adaptation, following the PMS guideline and the Handbook #11, a booklet is developed for the PMS patients. Composed by 28 pages in DIN A5 format were introduction, diagnosis, treatment, pregnancy, do\u2019s, supportive care, social networks (including a QR code) and a glossary are included. The selection of a symbol, colors at a chromatic level, a typography and graphical elements as illustrations were created as a corporate identity. Clinical experts and patient representatives that have participated in the creation of the guideline will assess and validate the booklet. Conclusions. Collaboration between agencies, clinicians and patients is critical to obtain evidence-based products adapted to the needs of patients and people involved in their care.","Poster Presentation Number: PP99 Abstract Title: Positron Emission Tomography Combined With Computed Tomography (PET\/CT) Using 11-C Methionine (11C-MET) Author Names: Makpal Akhmetova, Tansolpan Aimanova, Makhabbat Okesh, Andrey Avdeyev ([email protected]), Rustam Albayev, Aigul Saduakassova, Yekaterina Lyugay, Indira Tleulessova, Olzhas Turar, Gulzada Bariyeva, Nasrulla Shanazarov Introduction. Positron emission tomography combined with computed tomography (PET\/CT) using 11C-methionine (11C- MET) is used to detect astrocytomas and low-grade brain tumors, in the primary detection of all malignant and benign neoplasms of the central nervous system (CNS), and in order to monitor staging and evaluate the results of treatment. Methods. To assess the clinical and economic effectiveness of PET\/CT with the use of radiopharmaceutical drugs (RFLP) based on 11C-MET in the diagnosis of CNS neoplasms, a systematic review of literature by keywords in the Pubmed\/MEDLINE database was conducted. The search result was 218 publications. The analysis included 21 publications that met the search criteria, including three meta-analyses and six systematic literature reviews. Results. Diagnostic efficacy in distinguishing gliomas of high and low malignancy has moderate diagnostic accuracy (combined sensitivity and specificity were 80% and 72%, respectively), but higher sensitivity compared to Fludeoxyglucose F18 (18F-FDG). PET\/CT with 11C-MET demonstrated good diagnostic value in detecting brain tumor recurrence (combined sensitivity and specificity of 92% and 87%, respectively) compared with 18F-FDG. Conclusions. PET\/CT diagnostics of CNS neoplasms using the drug 11C-MET is an innovative technology with greater specificity and sensitivity than 18F-FDG, positively influences the subsequent surgery plan and identifies tumors previously undetermined by magnetic resonance imaging (MRI), CT or PET\/CT with 18F-FDG.","Poster Presentation Number: PP101 Abstract Title: Clinical And Economic Impact Of Flushing Vascular Access Devices With Pre-filled versus Manually-Prepared Saline Flush Syringes In Korea Author Names: Smeet Gala, Kristin Hui Xian Tan ([email protected]), Yan Ma Introduction Around 90 percent of hospitalized patients require vascular access devices (VADs) during hospitalization to administer fluids, medications and facilitate blood transfusions. After insertion, it is essential to maintain VADs to achieve optimal dwell time and reduce complications. Flushing of VADs is an integral part of catheter maintenance practices. With increasing cost burden on healthcare systems and nursing shortages, it is crucial to use time- and cost-saving technologies such as pre-filled flush syringes for common procedures namely VAD maintenance. This study aims to compare the clinical and economic impact of using pre-filled saline syringes versus manually-prepared saline syringes for flushing VADs in Korea. Methods. A budget impact analysis was developed using Microsoft Excel to estimate the annual clinical and economic impact of pre-filled saline syringes and a base case scenario of flushing 100,000 VADs was modeled. Clinical impact was estimated for peripheral intravenous catheter (PIVC) failure, central line-associated bloodstream infections (CLABSIs), central line occlusion and nurse time. Economic impact was estimated for costs associated with flushing materials, additional length of stay (LOS) due to CLABSI, VAD replacement, and nurse- time. Global and local data sources were used for inputs. Assumptions include: (i) Distribution of 95 percent peripheral and 5 percent central VADs; (ii) 50 percent peripheral and 50 percent central VADs on intermittent therapy; and (iii) 3 flushes\/catheter-day. Results. Over a one-year timeframe, the model estimated 3,344 fewer PIVC failures, 15 fewer CLABSIs and 157 fewer occlusions with adoption of pre-filled saline syringes. Nurse time was reduced by 3,465 hours. Potential net annual savings from lower device cost, reduced complications, shortened LOS and increased nurse efficiency were estimated to be KRW23.7 million (USD178,957). Conclusions. Using pre-filled saline syringes instead of manually-prepared syringes for flushing VADs may result in fewer complications, lower VAD utilization, nurse time saving and cost savings in Korea. This can potentially help improve patient outcomes, relieve nurses\u2019 stress to some extent and help healthcare decision-makers to reallocate these cost savings to other life-saving technologies.","Poster Presentation Number: PP102 Abstract Title: Impact Of Placing Peripherally Inserted Central Catheters At Patient Bedside Versus Radiology Suite In A Private Australian Hospital Author Names: Kristin Hui Xian Tan ([email protected]), Smeet Gala, Yan Ma Introduction. A peripherally inserted central catheter (PICC) is an important vascular access device to administer certain intravenous (IV) therapies, which is traditionally placed using fluoroscopy in radiology suites. With advancing tip-confirmation technology, PICCs can be placed at the patient bedside by nurses, without any delays arising from wait time for the radiology suite or the need of transferring patients to the radiology suite, leading to time savings and allowing prompt start to IV therapy. This study aims to estimate the cost and time impact of placing PICCs at the bedside using tip-confirmation technology led by nurses versus in the radiology suite using fluoroscopy by radiologists. Methods. A budget impact analysis was developed using Microsoft Excel to estimate the annual impact of inserting PICCs at the bedside versus in the radiology suite. The base case scenario was modelled for 1,000 PICCs placed in a private Australian hospital. Impact on bed days, labor time and overall cost was estimated by using global and local data sources for inputs. It was assumed that 100 percent PICC are placed in a radiology suite in current practice, while 95 percent are placed at the bedside and 5 percent in the radiology suite in future practice. Results. By shifting PICC insertion to the bedside using tip-confirmation technology, the model estimated a reduction of labor time by 221 hours and bed days by 113 days. Despite an increase in the cost of consumables by AUD34,041 (USD22,760) and reduction of Medicare Benefits Schedule rebate by AUD260,730 (USD174,328), overall cost savings of AUD1.01million (USD675,660) was observed due to significant savings due to the t reduced utilization of the radiology suite. Conclusions. PICC insertion at the patient bedside using tip-confirmation technology by nurses may lead to time and cost savings as compared to placing them in the radiology suite. This can help alleviate the burden on radiology suites and reduce their wait times, potentially leading to timely treatment initiation and discharge. Since PICCs at the bedside are typically placed by specialized vascular access nurses, these cost savings can be redirected to employ and train them.","Poster Presentation Number: PP103 Abstract Title: Budget Impact Analysis Of Utilization Of WavelinQ Endo- arteriovenous Fistula System For Hemodialysis Patients: An Australian Hospital Perspective Author Names: Christopher Delaney, Blaise Agresta, Ritu Gupta, George Papadopoulos ([email protected]) Introduction. A high proportion of patients with end-stage kidney disease (ESKD) are treated with hemodialysis (HD). To lower morbidity and maintain overall cost control in patients with ESKD, it is crucial for health systems to establish and maintain durable hemodialysis (HD) access. Our objective was to assess the budget impact of utilizing the \u2018WavelinQ Endo Arteriovenous Fistula (AVF) system\u2019 (WavelinQ) for HD patients. Methods. A one-year economic model from the Hospital (Flinders Medical Centre, FMC) perspective was developed with Australian epidemiological and costing data. Clinical data were collected from real-world sources. The incident (n=50) and prevalent (n=250) cohorts were based on FMC utilization patterns. The current standard of care was surgical AVF (sAVF) and\/or central venous catheters (CVC). With introduction of WavelinQ into practice, the substitution rate was set at 50 percent in new patients and ten percent amongst existing patients. Index procedure and reinterventions costs for the patient were based on the weighted average cost using National Efficient Price Determination 2020 to 21. Total costs preWavelinQ introduction were compared to post WavelinQ substitution to determine the budget impact. Results. Based on FMC expected patient cohort and WavelinQ substitution rates, the mean annual cost savings per incident and prevalent patient were AUD26,873 and AUD3,549, respectively, which lead to overall mean annual cost savings per patient of AUD7,437. The calculated per patient additional upfront cost of AUD7,010 with the WavelinQ index procedure versus sAVF was more than offset by the savings due to less post- procedure reinterventions. Overall, at the assumed substitution rates with WavelinQ, the model predicted a cost saving of approximately AUD2.2 million dollars for FMC. Conclusions. The use of WavelinQ is expected to lead to cost savings of AUD2.2 million dollars from the FMC perspective. Hospitals should consider not just the increase in upfront costs but also potential savings from less reintervention procedures. There is a need for continued research on the budget impact of different HD modalities across multiple settings.","Poster Presentation Number: PP104 Abstract Title: Impact Of New Permbrolizumab Indications After Initial Registration By Brazilian Health Regulatory Agency (ANVISA) Author Names: Silvana Kelles ([email protected]), Camila Pereira, Carina Martins, Daniel Reis, Ernesto Azevedo, Geraldo Ribeiro, Karina Zocrato, L\u00e9lia Carvalho, Marcela Freitas, Maria Horta, Mariana Barbosa, Mariza Talim, Marcus Borin Introduction. Most new drugs have only clinical studies focused on a single population at the time of first registration, hence their indications for use are restricted to this population. For clinical conditions when there are no other treatments available, new drugs have higher costs in Brazil. There is no review of prices when these medications broaden their therapeutic areas, and this can have a significant financial impact. This study's objective is to assess the financial implications of pembrolizumab's incremental indication after its initial registration. Methods. We calculated the annual cost to treat all Brazilian patients with indications for use in the first registration and all incremental indications of pembrolizumb. Populations were estimated by epidemiological data from the pembrolizumab clinical trials called, KEYNOTE studies, and the INCA 2023 cancer estimate for the Brazilian population. Costs were calculated by CMED-ANVISA price value and considering the dosing of 200mg every 3 weeks. Results. In 2016, pembrolizumab was granted registration in Brazil was restricted to patients with advanced melanoma. In 2022 the indication was expanded to more than 20 new indications, with several studies in progress that potentially will lead to further inclusions. The estimate of patients eligible for indications increase of 1,796 to 99,544 patients with an increased total cost from BRL625,802,837 to BRL34,685,366,192 (USD121,185,677.4 to USD6,716,763,399.04). Conclusions. The financial burden of pembrolizumab's expanded uses after it was first approved could significantly rise, endangering the long-term viability of healthcare systems. In Brazil, where medicine costs are not regularly monitored, the annual inflation adjustment is the only factor that causes prices to change. In order to lower medicine prices in response to the addition of new indications, the expansion of therapeutic options for the same condition, or even obsolescence, regulations are required.","Poster Presentation Number: PP105 Abstract Title: Efficacy, Effectiveness And Safety Of Letermovir For Prophylaxis Of Cytomegalovirus Infection And Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation Author Names: Roberto L\u00facio Muniz J\u00fanior ([email protected]), \u00c1lex Brunno do Nascimento Martins, B\u00e1rbara Rodrigues Alvernaz dos Santos, Eduardo Henrique Ferreira Bambirra, Luana Oliveira Prata, Maiara Silva Ara\u00fajo, Marcus Carvalho Borin, PhD Francisco de Assis Acurcio, Juliana Alvares-Teodoro, Augusto Afonso Guerra J\u00fanior Introduction. Clinically significant cytomegalovirus infection (CSI-CMV) is an important factor associated with mortality in patients undergoing hematopoietic stem cell transplantation (HSCT). It is estimated that the incidence of CSI- CMV in the post-HSCT period is 30 percent to 70 percent in transplanted individuals. Therefore, CSI-CMV is considered a complication in allogeneic HSCT, which can trigger Cytomegalovirus disease (CMVD). Letermovir is an antiviral agent indicated especially for the prophylaxis of CMVD post-HSCT. The objective of this work was to evaluate the efficacy, effectiveness and safety of letermovir, comparing it with placebo or other existing prophylactic treatments. Methods. A systematic review was carried out according to PRISMA 2020. A strategy was developed for searching electronic bibliographic databases. Retrieved publications were selected by a pair of reviewers. The same pair performed the data extraction. A qualitative assessment of the efficacy, effectiveness and safety of letermovir was performed. Results. Eighteen studies were included, being experimental and observational. Overall, the pivotal RCT demonstrates the efficacy of letermovir in reducing the incidence of CSI-CMV. However, there was no statistically significant difference in all-cause mortality and letermovir-related overall survival, events of graft versus host disease, neutropenia, acute kidney disease and 48-week mortality. Observational studies, in general, present results similar to those found in the pivotal RCT. The main adverse events associated with letermovir were peripheral edema (14.5%), vomiting (18.5%), headache (13.9%), cough (14.2%), abdominal pain (11.8%) and fatigue (13.4%). Conclusions. The prophylactic use of letermovir in CMV-R+ patients after allogeneic HSCT demonstrates beneficial results in the prevention of CSI-CMV. However, there were no identified improvements for other outcomes. As for safety, it was observed that there is still little information about adverse events related to the drug, and studies assessing this aspect are needed for better comprehension.","Poster Presentation Number: PP106 Abstract Title: Integrating Organizational Impacts Into Health Technology Assessment: How To Take Them Into Account For Medical Devices? Author Names: Estelle Piotto ([email protected]), Emmanuelle Fouteau, Camille Marguerite, Hubert Galmiche, Isabelle Adenot Introduction. The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices. The Medical Device Committee at Haute Autorit\u00e9 de Sant\u00e9 (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee\u2019s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed. Methods. This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI. Results. The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed. Conclusions. With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.","Poster Presentation Number: PP109 Abstract Title: The Use Of Health Technology Assessment In Decision Making: Evidence From The Balkan Countries Author Names: Enkeleint A. Mechili ([email protected]), Elena Petelos, Jorgjia Bucaj, Parisis Gallos Introduction. According to the most recent definition health technology assessment (HTA) \u201cis a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system\u201d. This article aimed to evaluate implementation of HTA in decision making in the Balkan countries. Methods. A scoping review of the existing literature took place to locate relevant scientific articles, policy papers and documents released by the respective Ministries. We searched data for 6 Western Balkan countries (Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia) and didn\u2019t focus on those countries that are part of the European Union (EU). For the literature search key words were used, while documents only in English were included in the analyses. Additionally, the search was conducted for the period January 2010 until October 2022. Results. The Western Balkan countries are in process of integration to the EU and based on this they are trying to make improvement in different sectors including health services. However, the use of HTA in most of the studied countries is in its preliminary phase. Most of the countries have established HTA bodies or specific authorities but with limited resources (both human and financial). Additionally, their reports are non-binding for policy makers and healthcare decisions are taken based on experts\u2019 opinions and not an extensive HTA analyses. Conclusions. Despite their efforts, the Western Balkan countries need to improve and considerably increase the use of HTA in decision-making. Its use can help in provision of better healthcare services as well as to decrease costs. Specific attention should be put on human and financial resources that are lacking in all settings. Western Balkan countries need to put much more efforts for harmonization of their legal framework with that of the EU countries.","Poster Presentation Number: PP110 Abstract Title: Knowledge Transfer From Scoping Review Into Primary Research In The Context Of Clinical Practice Guidelines Update Author Names: Trinidad Sabalete ([email protected]), Juan Antonio Blasco, Ruth Engelhard, Javier Gracia Introduction. In the development and update process of clinical practice guidelines (CPG) is necessary to focus research questions as much as possible to optimize the systematic reviews. We carried out a scoping review as a precursor to a systematic review to update the recommendation of a CPG for the Management of Patients with Autism Spectrum Disorders in Primary Care. To our knowledge, there is limited information in the existing literature on graphical options for visually presenting scales or other available instruments and classification in a timeline graph. Methods. We conducted a systematic search to identify instruments for screening of neurodevelopmental disorders and early detection and diagnosis of autism spectrum disorder (ASD). All studies were analyzed to retrieve scales and other instruments used in the assessment of neurodevelopment in the preschool children, and detection of signs and symptoms of neurodevelopment disorder or ASD. We developed a timeline graphic to compile all of the instruments retrieved. Results. The information about the name of instrument, type, age of application, diagnostic accuracy, and context of validation was transferred to spreadsheet of the software program Microsoft Excel in tabular format. The instruments found were finally categorized according to the role of each of them in the diagnostic of autism, and age in which they are used. We developed a timeline graph for visually presenting classified instruments according to utility in the routine developmental surveillance, detection of specific signs and symptoms of ASD and diagnostics and evaluation of autism. Conclusions. The proposed graphical timeline could assist methodologists and researchers in identifying gaps of evidence and lines of research related to use and validation in different contexts the scales and other instruments actually developed. The process of review of evidence can provide information useful for future research in the context of primary research. The relationship between groups of work of health technology assessment and primary research promote the knowledge transfer and optimization of research.","Poster Presentation Number: PP113 Abstract Title: Common Methodological Issues In Systematic Reviews Supporting Single Technology Appraisal Submissions To The National Institute for Health and Care Excellence Author Names: Anita Fitzgerald ([email protected]), Katy Wilson, Hannah Wood Introduction. This project aimed to identify methodological issues reported by Evidence Review Groups (ERGs) in the systematic reviews (SR) supporting single technology appraisal (STA) submissions to the National Institute for Health and Care Excellence (NICE). STA submissions contain SRs related to the clinical and cost-effectiveness of the proposed intervention and NICE require the methods for these reviews to be clearly detailed in the submission. The intention of this project was to identify methodological aspects of submissions where companies may need additional guidance or support to provide the evidence required for efficient and effective decision-making and in turn facilitate timely access to clinical innovation. Methods. From 2019, 61 STAs were identified from the NICE website, of which 46 were included. We extracted information about the data requests or clarification questions raised by the ERG in relation to the methodological section of both the clinical and cost effectiveness SRs reported in the STA. We then categorized these data and grouped by theme to determine the most common methodological issues faced by companies. We did not assess whether comments made by the ERG were accurate or justified. Results. For both clinical and cost-effectiveness SRs, the most frequent clarification questions arose from the search methods section, specifically seeking information about missing intervention or comparator terms, the use of search filters and search platforms. Clarification questions were also commonly asked about the appropriateness of interventions and comparators. There were very few clarification questions asked about screening, data extraction or risk of bias assessment. Conclusions. Companies looking to submit an STA should align their submission methodology to established best practice guidance for systematic reviewing to ensure their methods are fit for purpose and avoid unnecessary delays to the STA process. Consistency with the PRISMA reporting standards would help ensure that the ERG is provided with the information needed to assess the appropriateness of the STA methodology and is likely to reduce the need for clarification questions.","Poster Presentation Number: PP118 Abstract Title: The Value Of New Antibiotic Treatment Strategies In Zhejiang Province, China Author Names: Yang Wenqianzi, Zhen Xuemei, Yang Danhong, Chen Yixi, Dong Peng, Amer Al-Taie, Dong Hengjin ([email protected]) Introduction. The rising antimicrobial resistance (AMR) and the difficulty in developing new antibiotics are causing a global public health problem. This analysis aims to better understand the clinical and economic value of new antibiotic treatment strategies, in order to inform clinical and antibiotic formulary decisions. Methods. We applied a published and validated dynamic disease transmission and cost-effectiveness model of AMR with a 10-year time horizon and discount rate of five percent to evaluate the clinical and economic outcomes of introducing a new antibiotic, namely, Ceftazidime\/Avibactam (CAZ-AVI) for treating AMR infections in Zhejiang Province, China. Together with piperacillin-tazobactam (pip\/taz) and meropenem, we explored the impact of six treatment strategies across three common infections (complicated intra-abdominal infection (cIAI), hospital-acquired\/ventilator-associated pneumonia (HAP\/VAP) and infections with limited treatment options (LTO)), and pathogens (Escherichia coli, Klebsiella spp., and Pseudomonas aeruginosa). These treatment strategies included (i) current treatment strategy (pip\/taz and meropenem, no CAZ-AVI), (ii) CAZ-AVI at the third line, (iii) CAZ-AVI at the second line, (iv) CAZ-AVI at the first line, (v) first line diversity (i.e., equal pip\/taz and CAZ-AVI at the first line; meropenem at the last line) and (vi) all-lines diversity (pip\/taz, meropenem and CAZ-AVI used randomly and only once). The data with a total of 10,905 patients were collected from a tier-3 hospital from 2018 to 2021. Results. Under the current treatment strategy, the hospital length of stay (LOS) and costs over ten years were estimated to be 1,588,763 days and CNY3,898,198,802 (USD559,781,348), respectively, associated with 142,999 quality-adjusted life-years (QALYs) lost, resulting in the resistance of pip\/taz and meropenem being 42.0 percent and 49.9 percent respectively. In contrast, the other five treatment strategies all have shown improved outcomes, among which the \u201call-lines diversity\u201d carried the greatest benefit, saving CNY1,646.04 (USD236.37) for each additional QALY gained, with the net monetary benefit being CNY24,727,102,215 (USD3,550,811,878). Conclusions. Introducing CAZ-AVI had positive impact on clinical and economic outcomes for treating AMR, and diversifying early the antibiotics might yield the best benefits.","Poster Presentation Number: PP121 Abstract Title: Assessment Of Heart Rate Characteristics Analysis Author Names: Yoo Jin Kim ([email protected]), Worl Sook Lee Introduction. The heart rate characteristics (HRC) analysis is a technique for predicting and monitoring neonatal infectious diseases in infants with a risk for infectious disease, such as sepsis, using the HRC index based on the electrocardiogram (ECG) data transmitted from a HeRO\u00ae device connected to an ECG monitor. Methods. The assessments were performed via a systematic review. Searching five databases (KoreaMed, Ovid- MEDLINE, Ovid-EMBASE, and Cochrane) yielded 284 related studies. Two reviewers independently assessed the quality of these studies, using the Scottish Intercollegiate Guidelines Network checklist and the assessment results were described based on the results of the quality appraisal and level of evidence. Results. The safety and effectiveness of the technique were assessed based on eight non-Korean studies (one randomized controlled trial (RCT), five cohort studies, one case-control study, one case series). The four studies that reported area under the curve (AUC) values, the timing of the analysis and AUC values (0.67\u20130.75) were inconsistent among the studies. The elevation of the HRC index prior to the diagnosis of an infectious disease was not observed for meningitis or for multiple infectious diseases. In addition, although the group with additional monitoring using the technique had a significantly lower mortality rate, whether the HRC index had a direct impact on the infection prevention activities and the possibility of bias arising from the researchers\u2019 precautionary treatment based on the clinical symptoms and other test results as well as the actual time of disease onset are unknown. Conclusions. Therefore, the committee presented the following recommendations based on the available evidence and expert opinion. HRC analysis is a safe technique for predicting and monitoring neonatal infectious diseases in infants with a risk for infectious disease, such as sepsis, using the HRC index based on the ECG data transmitted from a HeRO\u00ae device connected to an ECG monitor; however, further research is needed to determine its effectiveness (Level of evidence C, Technology category \u2161-a).","Poster Presentation Number: PP122 Abstract Title: The Feasibility Assessment For Domestic Introduction Of Newborn Pulse Oximetry Screening For Critical Congenital Heart Disease Author Names: Miyoung Choi ([email protected]), Jimin Kim, Byung Min Choi, Jeonghee Shin, Chanmi Park, Gisu Ha, Hong Joo Shin, Eui Kyung Choi Introduction. Critical congenital heart disease (CCHD) refers to a group of heart defects that cause serious, life-threatening symptoms in the neonatal period and requires timely surgical or catheter interventions. We reviewed evidence for incorporating a mandatory neonatal CCHD screening test as a national public health project for all neonates born in Korea by analyzing the validity and cost-effectiveness of neonatal CCHD screening using pulse oximetry in Korea. Methods. We performed a rapid literature review to establish models for the diagnostic accuracy and economic evaluation of pulse oximetry. Also, we analyzed the prevalence, mortality, and medical expenditure for different types of CCHD using the national health insurance (NHI) data. We analyzed the cost-effectiveness of pulse oximetry by comparing the group of neonates who received a combination of a physical examination and pulse oximetry, and group of neonates who only received a physical examination. For the cost- effectiveness analysis for the CCHD screening test in this study, we used a duration of one year, diagnostic accuracy as the clinical endpoint, and Life Year Gain (LYG) as the effectiveness indicator. Results. We used recent systematic review he pooled sensitivity can be enhanced from 76.5 percent (pulse oximetry alone) to 92% percent (combined with physical examination). We used a total of 2,334 neonates with CCHD data for the economic model. Our analysis revealed that adding pulse oximetry to the routine neonatal physical examination leads to 2.34 of LYG and a cost difference of USD1,080,602, showing a ICER of KRW610,063,240 (USD461,857)\/LYG. Conclusions. Considering the benefit of LYG and cost of reducing the complications and after effects of newborns with CCHD who survived early diagnosis, it is considered to be worthwhile in Korea for a mandatory screening test.","Poster Presentation Number: PP124 Abstract Title: Patisiran For Patients With Hereditary Transthyretin Amyloidosis (hATTR) With Stage 2 Polyneuropathy Or Who Have An Inadequate Response To Tafamidis Author Names: Marcus Borin ([email protected]), \u00c1lex Brunno Martins, B\u00e1rbara Alvernaz, Ludmila Gargano, Roberto J\u00fanior, Wagner Magalh\u00e3es, Francisco Ac\u00farcio, Juliana Alvares-Teodoro, Augusto Guerra Introduction. Hereditary Transthyretin amyloidosis (hATTR) is a rare autosomal dominant, multisystemic, progressive, and potentially fatal genetic disease. Currently, the only drug made available in the Brazilian National Health System to treat hATTR is tafamidis meglumine, indicated for symptomatic adult patients in early stage (stage 1) and not undergoing liver transplantation for amyloidosis associated with hATTR. Methods. A systematic review was conducted in the databases MEDLINE via Pubmed, Embase, The Cochrane Library, and LILACS addressing the question \\\"Is patisiran treatment effective and safe for patients diagnosed with ATTRh amyloidosis with stage 2 polyneuropathy or who have an inadequate response to tafamidis?\\\" Results. The 13 studies included in the review demonstrate the efficacy of patisiran in reducing the neuropathic progression of the disease, as evidenced by decreased mNIS+7 scale scores following 18-month use of the drug. Improvements in the quality of life of patients taking patisiran have been reported, as measured by reduced scores on the Norfolk-QoL-DN scale. Patisiran has also been shown to be effective in reducing NT- proBNP, a marker related to cardiac stress. Improvements in the nutritional status of patients taking patisiran were demonstrated by increasing modified body mass index (BMI). Good tolerability of patisiran was observed by patients using it. Most adverse events were classified as mild or moderate. The studies indicated that the occurrence of deaths is similar between the patisiran and placebo groups. Most deaths were related to cardiac events and were not associated with the use of patisiran. Conclusions. The use of patisiran in patients with hATTR demonstrated efficacy in reducing the neuropathic progression of the disease, evidenced by decreased mNIS+7 scale scores, improvements in quality of life as measured by reduced Norfolk-QoL-D scale scores, and reduced NT-proBNP. The drug patisiran was well tolerated, with most adverse events rated as mild and moderate.","Poster Presentation Number: PP125 Abstract Title: Why Understanding The Burden Of The Population Is Fundamental Author Names: Franziska J. Sch\u00f6b, Julie Hviid Hahn-Pedersen ([email protected]) Introduction. Despite intense efforts in development of new treatments over the last two decades, symptomatic treatments remain the only option for the vast majority patients diagnosed with dementia due to Alzheimer\u2019s disease (AD). There remains a significant unmet need for disease modifying therapies (DMTs) to slow or stop AD progression. DMTs in development are targeting early stages of AD (pre-clinical, mild cognitive impairment and mild dementia stages), thereby creating an entirely new treatment paradigm for patients, clinicians, and payers. A key challenge will be in identifying the appropriate patient for treatment in a very heterogenous population. We have performed a literature review to better understand and define the AD population, with a view to enabling more targeted treatment in future. Methods. Embase, MEDLINE and the Cochrane Library were searched to identify publications between 2010-2021 on observational studies reporting evidence on prevalence and subgroup identification, including clinical feasibility of identification. The search was restricted to English language. Results. We identified 45 studies, mostly from Europe, USA and Asia. Populations were primarily grouped based on generic demographic factors (e.g., age, sex, gender), AD staging, comorbidities or biomarkers. Prevalence data was available for six subpopulations: pre-dementia stage, mild dementia, age, Apolipoprotein E (APOE) genotype, comorbid obesity and hypertension. Across these, data on prevalence were heterogenous depending on study design and country of origin, and ranging between 66 million to 102 million for people with mild AD dementia, or as another example, ranging between 46 million to 92 million for APOE genotype carriers worldwide. Conclusions. The heterogeneity and the uncertainty in prevalence of the AD population represent big challenges to clinicians and payers. Future discussions on target patient identification for new treatments should be aligned and integrated with current clinical practice e.g. leveraging validated biomarkers as diagnostic tools. Additional research on an integrated approach to identify patients who would benefit the most from DMTs will be needed.","Poster Presentation Number: PP127 Abstract Title: Early Health Technology Assessment (HTA) Of Medical Technologies To Inform Subsidy Decision-making In Singapore Author Names: Ada PM Batcagan-Abueg ([email protected]), Swee Sung Soon, Hong Ju, Kwong Ng Introduction. Medical technologies are evolving rapidly, with many new and expensive technologies entering the market constantly, challenging the sustainability of the public healthcare system. Early health technology assessment (HTA) to inform subsidy decision for innovative medical technologies, before they diffuse into the public healthcare system, may drive appropriate early adoption or curtail inappropriate use. This abstract describes the Agency for Care Effectiveness (ACE)\u2019s experience in conducting early HTAs and key challenges faced. Methods. During ACE\u2019s 2021 topic prioritization exercise, ACE took a proactive approach by considering medical technologies identified from horizon scanning (HS) for subsidy evaluation. Two topics were shortlisted from HS. Standard HTA evaluation framework and local clinician consultation were used to define the evaluation scope and clinical pathways. Literature search and appraisal were conducted for safety, effectiveness, and economic evidence. Budget impact estimations and organizational feasibility assessment were additional domains considered for subsidy decision-making by the Ministry of Health Medical Technology Advisory Committee (MTAC). Results. MTAC did not recommend subsidy for the two technologies due to weak evidence base, largely due to a lack of comparative evidence, small samples, short-term follow-ups, or heterogeneity of population. Additional considerations included potentially high budget impact or organizational feasibility issues such as substantial capital and maintenance cost and infrastructure reconfiguration required. During the evaluation, key challenges of assessing such technologies in their early diffusion within the healthcare system were: (i) differing clinical opinions on whether the technology meets an unmet need; (ii) uncertain place in the clinical management algorithm for the relevant indications; (iii) sparse and weak evidence; (iv) uncertain financial implications to the healthcare system due to a lack of available local costs. Conclusions. Early HTA on medical technologies identified from HS can be a useful tool to guide subsidy decisions; however, several challenges exist. Careful selection of technologies and timing of evaluation are critical. Seeking stakeholder inputs earlier would ensure shortlisting appropriate technologies with greater clinical need for HTA.","Poster Presentation Number: PP128 Abstract Title: A Transparent Methodology To Assess Innovativeness Of Health Technologies At Marketing Authorization Time Author Names: Ludmila Gargano ([email protected]), Isabela Freitas, Luila Henriques, Ariane Andr\u00e9, Juliana \u00c1lvares-Teodoro, Francisco Acurcio, Augusto Guerra Jr. Introduction. Defining drug innovation can be challenging and there is no consensus on what a truly \\\"innovative\\\" medicine is. The Italian Medicine Agency (AIFA) has established an approach to assess innovativeness based on therapeutic need, added therapeutic value, and quality of evidence. However, judgment can be subjective and may not be adequate for assessment at the time of marketing authorization, when only preliminary evidence \u2013 often from non-comparative or non-randomized trials \u2013 are available. We developed a transparent methodology for early assessment of innovativeness at the time of marketing authorization, based on AIFA guidelines. Methods. Since the perspective was the marketing authorization date, only data available at agency\u2019s Medical Review or pivotal trial publications were considered. AIFA criteria were revisited, using oncology medicines approved in the last 10 years as a base case. Impact of preliminary evidence and inadequate study design was considered. Results. Each assessment should refer to the first approved specific indication and predefined clinically relevant outcomes. When more than one study was presented, best methodological quality, larger sample and\/or longer follow-up was selected. Four domains were established: Therapeutical need: existence and clinical benefits of alternative therapies; Clinical benefit added when compared to those alternatives; Suitability of study design considering adequate comparator group, relevant outcome assessed and randomization; Risk of bias. For each domain, clear and specific criteria were defined in consensus by a group of experts in health technology assessment (HTA) and were applied to all cancer drugs evaluated. Conclusions. Efficacy evidence available for marketing authorization are often based on preliminary data, arising from single randomized clinical trials or even non-comparative studies, which difficult early assessments of innovativeness. For this reason, transparent and reproducible methodologies can be useful not only to HTA bodies, but also for other key stakeholders in the pharmaceutical market, such as investors, researchers, doctors, and governments.","Poster Presentation Number: PP129 Abstract Title: Health Technology Assessment Adaptation: Pharyngolaryngeal Biopsies (OLB) For People with Suspected Head and Neck Cancer in the Outpatient Setting Author Names: Charlotte Bowles ([email protected]), Rebecca Boyce, Gareth Hopkin, Matthew Prettyjohns, Sophie Hughes, Elise Hasler, Katie McDermott, Susan Myles Introduction. In the UK over 12,400 yearly cases of head and neck cancers are reported (2021). Pharyngolaryngeal biopsies (OLB) may improve the speed of diagnosis and treatment of head and neck cancers under local anesthetic. The Scottish Health Technologies Group (SHTG) published advice on this technology in 2018. Since this, additional evidence has been published to warrant a health technology assessment (HTA) for Wales. The aim of this review was to provide update on the clinical and cost-effectiveness of OLB when compared to undergoing biopsy in an operating theatre (OTB) under general anesthetic to inform decision making in Wales. Methods. A rapid review was undertaken of relevant databases since 2018 of the clinical evidence, health economics and patient perspectives relevant to Wales. Health Technology Wales (HTW) developed a de-novo cost-utility analysis comparing OLB to OTB over a lifetime horizon. Inputs were sourced from the SHTG budget impact analysis, updated with values more relevant to a Welsh setting. Results. From consultation to biopsy procedure, the mean number of days was 1.3 for OLB compared to 17.4 days under OTB (p < 0.05). The mean time from consultation to start of treatment was 27 days for OLB compared to 41.5 days for OTB (p < 0.05). The economic analysis found a resulting ICER of GBP21,011 (EUR23,824.23) in a population with 2,183 at risk patients. As OLB was associated with lower costs (GBP816 per person) (EUR925.26) and fewer quality adjusted life years than OTB (-0.04), this ICER corresponds to OLB being considered a cost-effective diagnostic strategy. Conclusions. HTW guidance was able to recommend use of OLB within the diagnostic pathway for head and neck cancers within Wales. For people with a positive test, OLB is sufficient to confirm a diagnosis but should not be used to rule out a diagnosis due to the potential in reducing the time to diagnosis and treatment in a cost-saving way.","Poster Presentation Number: PP130 Abstract Title: The Effectiveness Of Extracorporeal Shock Wave Therapy For Plantar Fasciitis: A Systematic Review And Meta-analysis Author Names: Youjin Jung ([email protected]), Seul Ki Lee Introduction. Extracorporeal shock wave therapy (ESWT) has been used since the 1990s to treat various musculoskeletal disorders, but there is considerable controversy regarding the effectiveness of ESWT. Our aim was to conduct a systematic review of randomized controlled trials (RCT) to investigate the effectiveness of ESWT for plantar fasciitis. Methods. A comprehensive search was conducted via electronic databases including MEDLINE, Embase, the Cochrane Controlled trials register, and 5 Korean databases from inception date to April 2022. Two review authors independently assessed studies for inclusion and risk of bias, and extracted study data. Major outcomes were pain relief, function, and quality of life. Results. We identified a total of 48 RCTs comparing ESWT with corticosteroid injection (n=14), conventional therapies (n=19), and sham control (n=21). Most studies included participants with chronic heel pain diagnosed as plantar fasciitis. All trials were susceptible to bias. In terms of pain results, ESWT showed no significant difference when compared with the steroid injection group and the conventional therapy group, and significant pain relief was confirmed only compared to the sham control group (Mean Difference -1.71; 95% confidence interval [CI] -2.44,-0.98; I2=70%;). Functional outcomes were significantly improved in the ESWT group compared to the steroid injection group (standardized mean difference 0.45; 95% CI 0.27,0.63; I2=0%) and the sham control group (SMD 0.84, 95% CI 0.23,1.45; I2=91%), but no significant difference was found when compared to the conventional therapy group. Conclusions. Based upon the currently available low certainty evidence because of wide clinical diversity and varying treatment protocols of included trials, ESWT is associated with improved function and may be associated with pain reduction in plantar fasciitis. Further evidence is needed from well-designed studies with a standard dose and treatment protocol.","Poster Presentation Number: PP131 Abstract Title: Health Technology Assessment Agencies\u2019 Expectations Regarding Patient Experience Data in Europe Author Names: Juergen Zschocke, Carolina Alonzo, Ding Ding, Jiat-Ling Poon, Lillbrith Vonarx, Arianna Avitabile, Shane Myrick, Jennifer Hill, Alberto Molero, Nancy Perez, Laure Delbecque ([email protected]) Introduction. Health technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to describe the European Network for HTA (EUnetHTA) and HTA agencies expectations regarding PED to support reimbursement in France, Germany, Italy, Spain and the UK. Methods. Published HTA guidance documents were reviewed to identify recommendations related to clinical outcomes assessment (COA) (including disease-specificity, validation, analyses, endpoints and interpretation) and other forms of PED (e.g., patient preference information) in HTA decision-making. Insights from guidance documents were supplemented with a review of literature and published HTA cases and interviews with key opinion leaders (KOLs) focused on current and future states. Results. The German and French guidance documents include PED recommendations focused on relevant COA and health-related quality of life data, without detailing preferred COA measures. However, key differences were noted between these two countries in the methodological approaches regarding responder definitions, acceptable missing data threshold and multiplicity analyses. These differences were reinforced by the case studies and the KOLs. UK\u2019s sources also focused on COA, in general proposing specific use of the EQ-5D to derive utility values for modelling, but included limited details on other PED-related elements. The Italian and Spanish guidance documents do not detail COA or other PED expectations, but the Italian KOL described that COA is considered if submitted. The currently developed EUnetHTA21 guidelines include PED-related information that bear the signature of certain individual HTA bodies. Globally, there is limited interest in PED beyond COA across the agencies. Conclusions. The level of expectations with regards to PED varies across EUnetHTA and several European HTA agencies. Interest in PED derived from non-COA sources is limited across the countries. Knowing each agency\u2019s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development. Global harmonization would help advancing PED measurement standards.","Poster Presentation Number: PP132 Abstract Title: Health Technology Assessment Agencies\u2019 Expectations Regarding Patient Experience Data in Australia, China, And Japan Author Names: Carolina Alonzo, Ding Ding, Jiat-Ling Poon, Juergen Zschocke, Lei Zhang, Aranishi Toshihiko, Shane Myrick, Jennifer Hill, Louise Larkin, Nancy Perez, Laure Delbecque ([email protected]) Introduction. Health technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to review HTA agencies\u2019 expectations with regards to utilizing PED to support drug reimbursement in Australia, Japan, and China. Methods. Published HTA guidance documents were reviewed in 2021 to identify any PED-specific information. If available, recommendations related to the type of PED (e.g., generic vs. disease-specific clinical outcomes assessment (COA)); COA validation, analyses, endpoints and interpretation; and the interest in PED beyond COA in HTA decision-making (e.g., patient preference information) were reviewed. Literature review and semi- structured interviews with key opinion leaders (KOLs) were conducted to further explore these themes and future trends with regards to PED. Results. Australia\u2019s Pharmaceutical Benefits Advisory Committee guidance document includes a dedicated section on patient-reported outcomes (PRO), providing details on preferred PRO instruments; validation expectations; and recommended methods to explore score interpretation, assess and report PRO results and handle missing data. While PED derived from non-PRO sources are not discussed in the guidance, the KOL noted that they should not be ruled out. Japan\u2019s Center for Outcomes Research and Economic Evaluation for Health guideline includes a section dedicated to PROs without details related to instrument validation, analyses and interpretation, however, is focused on the use of PRO to inform health economic assessments. In China, the HTA center of China National Health Commission drafted two disease-specific technical guidance documents recommending the inclusion of PROs in efficacy assessments and use of instruments relevant in the Chinese population; these points were echoed by the KOL interviewed. Conclusions. There are recommendations on PED use included in country-specific guidance documents, however their level of detail varies greatly. Knowing each agency\u2019s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development.","Poster Presentation Number: PP133 Abstract Title: What Services And Products Should A Health Technology Assessment Agency Provide? Author Names: Maria-Jose Faraldo-Valles ([email protected]), Maria-Carmen Maceira- Rozas, Beatriz Casal-Acci\u00f3n, Patricia Gomez, Yolanda Trinanes Introduction. Health technology assessment (HTA) bodies support healthcare decision-making by producing different kind of products. The high speed of the healthcare innovations and the scenarios such as the COVID-19 pandemic challenge HTA organizations to adapt their services to better respond to these demands. The Spanish Network of HTA Agencies (RedETS) is redefining the services and the products in its portfolio. The first step has been conducting a review in order to identify the most relevant HTA products. Methods. A scoping review with two sections was conducted: (i) analysis of results from a bibliographic search performed in the main biomedical databases; and (ii) analysis of results from a manual review of the official websites of seven international HTA agencies: CADTH (Canada), INESSS (Canada), SBU (Sweden), NICE (United Kingdom), IQWIG (Germany), HAS (France), IECS (Argentina) and IETS (Colombia). The EUnetHTA website was also reviewed. Results. The search identified 1,311 references; 21 studies were considered relevant. The main topic found was about rapid responses services. The standard timeline for these should be less than six months, with even some produced in days. Transparency about methodology and involvement of decision-makers were considered key points to be included. Website analysis revealed similar HTA reports production but variation in the domains and elements considered. The timeframe for conducting a full HTA report can be up to 24 months, with a median of 12 months. Agencies also offer some kinds of rapid response services. Scientific consultation and horizon scanning systems for emerging technologies are other services performed by some agencies. Conclusions. The review reveals that agencies have different products to address different needs throughout the life cycle of technologies: from scientific advice to full HTA. In addition, HTA agencies have incorporated rapid responses into their services. According to literature, these products could support short-term decision-making.","Poster Presentation Number: PP135 Abstract Title: The Cost-Of-Illness Of The Management Of Patients Affected By Hyperparathyroidism In The Italian Healthcare Setting Author Names: Michele Basile ([email protected]), Debora Antonini, Agostino Fortunato, Americo Cicchetti Introduction. Hyperparathyroidism is a medical condition characterized by an excess of parathyroid hormone (PTH) in the blood. This hormone is produced by the parathyroid glands, located behind the thyroid gland. PTH plays a crucial role in regulating calcium levels in the body, which is necessary for muscle activity, nerve transmission, and maintaining bone density. In this study, the authors aimed to determine the parameters necessary for defining the delivery process of interventions for managing hyperparathyroidism. Methods. To achieve this, a group of Key Opinion Leaders (KOLs) was surveyed using a questionnaire to investigate specific drivers such as the duration of interventions, drug therapies employed, and materials required. The authors also estimated the indirect costs associated with patients and caregivers. The economic analysis considered the perspectives of both the Italian National Health Service (SSN) and the community. The analysis was conducted using Activity Based Costing (ABC) methods to determine the full cost sustained for a parathyroidectomy surgery and pharmacological therapies per patient treated, as well as the average resources absorbed by a patient managed through pure surveillance. Results. The results showed that the average annual cost of parathyroidectomy and pharmacological therapies per patient was EUR5,193.20 and EUR1,726.96, respectively. Productivity losses due to the interventions amounted to EUR858.21 and EUR66.80 for the patient and caregiver, respectively. The pure surveillance strategy incurred an average yearly cost of EUR197.42. Conclusions. The study's major limitation was the lack of evidence available concerning the therapies under analysis, particularly in the Italian context. Nonetheless, the survey of clinicians provided useful insights into the expenditures associated with implementing interventions for managing hyperparathyroidism. In conclusion, managing hyperparathyroidism involves considerable costs, and healthcare providers must consider the perspectives of both the SSN and the community when estimating the economic impact of interventions. The authors' analysis provides insights into the cost of different interventions, which could help healthcare providers make informed decisions when managing hyperparathyroidism.","Poster Presentation Number: PP138 Abstract Title: Awareness Of Health Technology Assessment And Its Predictors Among Medical Students In Public Universities In Klang Valley, Malaysia Author Names: Nur Farhana Mohamad ([email protected]), Zawiah Mansor, Aidalina Mahmud, Suriani Ismail, Izzuna Mudla Mohamed Ghazali, Roza Sarimin Introduction. Lack of awareness has been recognized as one of the most important barriers in the implementation of health technology assessment (HTA) across numerous countries. Medical students have been identified as a vital target group to instill an awareness, basic knowledge, and positive attitude towards HTA from the beginning of their medical career. Presently, there was no study found conducted on HTA awareness in medical students in Malaysia. This study aims to determine the level of awareness of HTA, and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia. Methods. A cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. The data on level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Data were analyzed using IBM SPSS version 27 to determine the level of awareness of HTA, its associated factors and predictors. Results. The total number of study participants was 323 and the response rate was 90 percent. The analysis showed that 69 percent of respondents had low level of awareness of HTA while 31 percent had high level of awareness of HTA. Factors associated with the level of awareness of HTA was attitude towards HTA (p < 0.001). The predictors of level of awareness of HTA were attitude towards HTA (Adjusted Odds Ratio (AOR) = 7.417, 95% confidence interval [CI]: 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95% CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95% CI: 1.096, 21.444). Conclusions. The majority of clinical year medical students in public university have low awareness of HTA which can be predicted by the level of attitude, peer interaction and training of HTA. Therefore, it is important to increase awareness among these future medical practitioners to encourage evidence-based decision-making. Early exposure and introduction of HTA in the current university curriculum in collaboration with a local HTA agency can be recommended to increase awareness as well as to improve students\u2019 attitude towards HTA.","Poster Presentation Number: PP140 Abstract Title: Burden of Illness And Health Care Costs In People with Alzheimer\u2019s Disease Author Names: Sophie Edwards ([email protected]), Julie Hahn-Pedersen, Danielle Robinson, Mei Sum Chan, Benjamin Bray, Alice Clark, Milana Ivkovic, Wojciech Michalak, Christian Wichmann, Sasha Berry, Marc Evans Introduction. Alzheimer\u2019s disease (AD), the most common cause of dementia, is becoming increasingly prevalent worldwide. Understanding the current burden of AD is important in health economic evaluations of new therapies. We aimed to estimate the burden of illness, and healthcare costs of people living with AD using a large, comprehensive real-world database in England. Methods. A retrospective cohort study was undertaken in the Discover-NOW dataset, a real-world database containing the linked primary and secondary care electronic health records of ~3 million people living in North West London, England. Patients diagnosed with AD were followed from the later of 1 January 2010 or AD diagnosis date, to the earlier of 31 December 2021 or end of follow up (maximum 10 years). Baseline prevalence of 33 comorbidities, incidence of 7 outcomes (survival, cardiovascular, care home admission, hepatic and renal outcomes), healthcare resource utilisation and total direct healthcare costs (using National Health Service tariffs and unit cost approaches) were calculated. Results. Of 18,116 patients diagnosed with AD, at baseline the mean age was 81 years, 62 percent were female, 65 percent were White, 16.5 percent Asian and 8.9 percent Black. At baseline, hypertension prevalence was 60.2 percent, chronic kidney disease 35.5 percent and Type 2 diabetes 22.4 percent. The highest incidence rates across these outcomes were 13.4 (95% confidence interval [CI]:12.2,14.7) per 1,000 person years for stroke, 7.5 (95% CI: 6.6, 8.5) for myocardial infarction, and 83.6 (95% CI: 80.1, 87.0) for care home admission. Median survival was 4.9 years from diagnosis. Their annual total direct healthcare cost was GBP4,547 per patient, of which 58 percent were from hospital admissions. The majority (75%) of healthcare contacts were from primary care. AD patients had an average length of stay of 11.5 days per inpatient admission, and spent on average one week per year as inpatients. Conclusions. AD is associated with high direct healthcare costs, with patients\u2019 annual costs ~1.7 times that of the UK population. The majority of these costs are associated with inpatient hospital admissions.","Poster Presentation Number: PP145 Abstract Title: The Impacts Of The Corona Virus Disease 2019 Pandemic On Bariatric Surgeries In The Private Healthcare In Brazil Author Names: Silvana Kelles ([email protected]), Camila Pereira, Carina Martins, Daniel Reis, Ernesto Azevedo, Geraldo Ribeiro, Karina Zocrato, L\u00e9lia Carvalho, Marcela Freitas, Maria Horta, Mariana Barbosa, Mariza Talim, Marcus Borin Introduction. The Corona Virus Disease 2019 (COVID-19) pandemic has impacted the functioning of health systems, imposing the need for adaptations. Elective surgeries also needed to adapt, and research has shown higher mortality in newly infected surgical patients after or during procedures. Thus, was recommended the suspension of elective surgeries during the pandemic. Early studies evaluating the effect of COVID-19 pandemic on bariatric surgery have reported a substantial reduction in procedures performed. Methods. This retrospective study evaluated the impact of the suspension of bariatric surgeries for a Brazilian Health Maintenance Organization: UNIMED-BH, based on the analysis of data from before and during the pandemic of COVID-19. Results. There were 2,641 bariatric procedures conducted in 2019 with a 14.1 percent reduction in volume to 2,314 procedures in 2020. In 2021, there were 2,813 bariatric procedures and 1,700 procedures were observed from January to August 2022. Therefore, it appears that in 2022 the demand for bariatric procedures will be similar to the year 2019, which was before the COVID-19 pandemic. Conclusions. From the analysis of the data, a decrease in bariatric surgical volume was evidenced during the year 2020 when compared to 2019. Post-pandemic, monitoring is necessary to assess whether the system was able to meet the demand for bariatric surgical procedures.","Poster Presentation Number: PP146 Abstract Title: Seeing Eye-To-Eye on Real-World Evidence: Are Guidance from Japan and China Consistent with Recommendations from REALISE in Asia? Author Names: Yan Ran Wee ([email protected]), Natsumi Fujita, Jennifer S Evans Introduction. The REAL World Data (RWD) In Asia for Health Technology Assessment (HTA) guidance was developed by a regional working group to facilitate the increasing acceptance of real-world evidence (RWE) in Asia. We compared the consistency of REALISE against guidance from Japan and China. Methods. Country-specific guidance for RWE\/RWD use in pharmaceutical development were identified in May 2022 through governmental websites, with validation searches via Google. Sections from local guidance were mapped onto REALISE and categorized as \u201cagree\u201d, \u201cmixed\u201d, \u201cdisagree\u201d or \u201cmissing\u201d based on coverage and consistency. Results. Five Japanese and three Chinese documents were mapped. Most sections in Chinese guidance (77%) and 36 percent of sections in Japanese guidance were tagged \u201cagree\u201d or \u201cmixed\u201d, with general alignment on definitions and good practice considerations (study design, accountability); however, 63 percent of Japanese sections were tagged \u201cmissing\u201d from REALISE. As local documents took the regulatory perspective, they lacked REALISE\u2019s discussion of translating RWD to RWE for HTA\/economic evaluations specifically. Local guidance focused on practicalities of RWD collection in local contexts, including descriptions of specific actions (e.g., evaluating RWD sources, ensuring data security) rather than overarching principles described in REALISE; specifically, Japanese guidance described how to access and analyze databases\/registries, reflecting Japan\u2019s landscape of robust sources of national healthcare data, but lacked discussion of other RWE study types, data sources and specialized analytical methods. While Chinese guidance had a broader view of RWD types (more similar to REALISE), they also contained discussions on pharmacovigilance and omics data, communication with regulatory bodies, and incorporation of RWE into the approval pathway for traditional Chinese medicines. Conclusions. Despite differing purposes (with no RWE guidance from local HTA bodies), local and regional guidance align on general principles\/good practice in generating\/using RWE, providing common ground for increasing usage of RWE in HTA in Asia.","Poster Presentation Number: PP147 Abstract Title: What Does Real World Evidence (RWE) Offer Health Technology Assessment (HTA) Procedures In Australia? Author Names: Gabrielle Challis ([email protected]), Michelle Hill, Liesl Strachan, Kate King, Shajedur Rahman Shawon, Oluwadamisola Sotade, Louisa Jorm Introduction. Medical device health technology assessment (HTA) in Australia is largely coordinated by the Medical Services Advisory Committee (MSAC). Its remit to improve the public\u2019s health by deciding where to allocate public healthcare funding, can be enhanced by considering real world evidence (RWE). Existing data sources have limitations that can be addressed through RWE, including coverage of Australian patient populations who may not meet trial eligibility criteria, and long-term follow-up through data linkage and datasets. We partnered with a university to explore what information could be gained from an analysis of linked administrative patient data, with a view to addressing current evidence gaps and\/or limitations. The findings can be used as a source of local data to define patient populations, estimate actual costs of care, and enable more comprehensive economic modeling to inform medical device HTA. Methods. The University-developed New South Wales Cardiovascular Cohort dataset, comprising person-level longitudinal NSW administrative data for all patients admitted to hospital with a cardiovascular diagnosis from 2001 onwards, linked to national Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims data, was interrogated. Results. Working with RWE is resource intensive in terms of time and costs. The potential of these data was revealed as the research progressed. It was possible to continually refine the data analyzed and reported,as well as expand the data requested. Varied expertise is required to accurately analyze the administrative datasets, particularly clinical classification skills and expertise in methods for causal inference using observational data. Findings from this study will enable the refinement of information for MSAC submissions, including identifying the most relevant patient population and reporting comprehensive costs, beyond an admitted hospital setting. The data will enhance engagement with clinicians and refine messaging, for example regarding patient risk factors. Conclusions. RWE enhances Australian HTA applications. Local data, extended periods of time and insights not apparent from a focus on admitted hospital episodes can be revealed. Data can be refined during the process for specificity and applicability.","Poster Presentation Number: PP149 Abstract Title: Reengineering Of Processes For The Elaboration Of Health Technology Assessment Reports In Catalonia Author Names: Maria-Dolors Estrada ([email protected]), Jessica Ruiz-Baena, Roland Pastells-Peir\u00f3, Edurne Gallastegui-Calvache, Anna Godo, Laura Llin\u00e0s-Mallol, Pablo Martinez-Diaz, Berta Mestre-Lleix\u00e0, Carolina Molt\u00f3-Puigmart\u00ed, Daniel P\u00e9rez-Troncoso, Laia Ramos-Masdeu, Joan Segur-Ferrer, Gerard Sol\u00eds-D\u00edez, Rosa Maria Vivanco-Hidalgo Introduction. In order to increase the value of its services and activities, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has incorporated in its strategic plan the commitment to improve the processes, quality and people, while ensuring transparency, independence, rigor and efficiency following the guidelines of the European Foundation for Quality Management. We aim to present the standardization processes to improve the efficiency in elaborating health technology assessment (HTA) reports at AQuAS. Methods. Process standardization has been developed in seven stages: (i) definition of scope, objectives and creation of working groups;(ii) mapping and analysis of all ongoing processes to determine whether they needed improvement or were already optimal; (iii) creation of new processes by evaluating the inclusion of automatic tools and their possible digitization; (iv) creation of the process map; (v) communication to the team for its implementation after training; (vi) dissemination on corporate website; (vii) monitoring and evaluation of their impact. Results. The creation of AQuAS\u2019 HTA report development process map has involved 14 people over the past two years. After an initial two-day workshop, the team was organized in working groups of two to three people, with regular monitoring and the creation of a specific knowledge management unit led by the AQuAS\u2019 evaluation manager. The process map was configured based on three axes. The strategic axis contains legal frameworks, ethical principles, good practices and methodological frameworks (29 specific for HTA reports). The key axis presents in an integrated way the process and methodology followed from the request of the HTA report to the final product\u2019s dissemination. The support axis includes, among other, the management of 31 requests, information specialist processes (37 searches), training (51 courses) and 6 internal procedures with their corresponding 26 templates and 27 tools. Conclusions. With a process reengineering approach, HTA reporting has become more efficient. We believe this approach can help other agencies improve their internal processes and subsequently improve team and customer satisfaction.","Poster Presentation Number: PP150 Abstract Title: Cardiovascular Risk In Patients With Rheumatoid Arthritis Receiving Targeted Synthetic And Biological Disease Modifying Antirheumatic Drugs Author Names: Xinning Tong ([email protected]), Chin-Yao Shen, Ha-Lim Jeon, Yihua Li, Yin Zhang, Ju-Young Shin, Shirley CW Chan, Kai Hang Yiu, Nicole L Pratt, Michael Ward, Chak Sing Lau, Ian CK Wong, Xue Li, Edward Chia- Cheng Lai Introduction. Rheumatoid arthritis (RA) is associated with an increased risk of cardiovascular events (CVE). Biological and targeted synthetic disease-modifying antirheumatic drugs (b\/tsDMARDs) may alter the CVE risk in RA through suppression of inflammation. Compared to conventional synthetic DMARDs, tumor necrosis factor inhibitor (TNFi) would decrease the risk of CVE but debatable findings exist for interleukin-6 inhibitors (IL-6i) and JAK inhibitors (JAKi). This study aimed to compare the cardiovascular safety of IL-6i and JAKi to TNFi. Methods. We conducted a retrospective cohort study using population-based electronic databases from Hong Kong, Taiwan and Korea. We identified newly diagnosed patients with rheumatoid arthritis who received b\/tsDMARDs first time. We followed patients from b\/tsDMARDs initiation to the earliest outcome (acute coronary heart disease, stroke, heart failure, venous thromboembolism and systemic embolism) or censoring events (death, transformation of b\/tsDMARDs on different targets, discontinuation, and study end). Using TNFi as reference, we applied generalized linear regression for the incidence rate ratio (IRR) estimation adjusted by age, sex, disease duration and comorbidities. Random effects meta-analysis was used for pooled analysis from three sites. Results. We identified 8,689 participants for this study. Median (interquartile range) follow-up years were 1.45 (2.77) in Hong Kong, 1.72 (2.39) in Taiwan, and 1.45 (2.46) in Korea. Compared to TNFi, the adjusted incidence rate ratios (aIRR) (95% Confidence Interval [CI]) of IL-6i in Hong Kong, Taiwan and Korea are 0.99 (0.25, 3.95); 1.06 (0.57, 1.98); 1.05 (0.59, 1.86) and corresponding aIRR of JAKi are 1.50 (0.42, 5.41); 0.60 (0.26, 1.41); 0.81 (0.38, 1.74), respectively. Pooled aIRRs showed no significant risk of CVE associated with IL-6i [1.05 (0.70, 1.57)] nor JAKi [0.80 (0.48, 1.35)] compared to TNFi. Conclusions. There was no difference in the risk of CVE among RA patients initiated with IL-6i, or JAKi compared to TNFi. The finding is consistent from Hong Kong, Taiwan and Korea. Cardiovascular safety might not be the major safety concern when selecting these drugs.","Poster Presentation Number: PP151 Abstract Title: HTA Of Fast Track Hip And Knee Joint Replacement Author Names: Giuseppe Banfi ([email protected]), Stefano Borghi, Susan Bernareggi, Umberto Restelli, Jacopo Vitale Introduction. This retrospective study was conducted, in accordance with the STROBE guidelines, (Vandenbroucke et al., 2007), considering patients receiving surgical interventions for hip and knee replacement at the IRCCS Orthopedic Institute Galeazzi, located in Milan (Italy), between 1 January 2016 and 31 December 2019 (two years of traditional procedure, and two years of new one). Methods. We evaluated 10,922 patients treated for hip or knee joint replacement; there were 5,085 treated following the traditional procedure and 5,837 treated by fast track procedure. Excluding cases which could not satisfy the study criteria we evaluated finally 697 with traditional procedure and 1120 with the new one. Results. With the new fast track procedure, knee replacement mean costs were decreased by an average of EUR1,112.4 (-19.9%). Excluding the cost of prostheses from the analysis, the mean costs in the pre fast-track period for knee replacement are equal to EUR3,918.1, while the mean cost of the intervention in the fast-track period was equal to EUR3,245.8, being EUR572.3 lower (- 17.2%). Considering the number of days of hospitalization, the adoption of fast-track leads to a decrease of -2.8 days (-37.6%) in knee replacement, from a mean number of days of 7.6 (\u00b1 2.8), to a mean number of days of 4.8 (\u00b1 1.8), and of -2.9 days (-39.2%) in hip replacement, from a mean number of days of 7.3 (\u00b1 2.7) to a mean number of days of 4.4 (\u00b1 2.0). Conclusions. We performed a study over four years, with a wide number of cases treated by various teams in the hospital having the highest workload on hip and knee joint replacements in Italy. The new fast-track procedure is efficient; the length of stay was decreased by the procedure; the direct and indirect costs were decreased; the hospital organization was improved; the increase of care intensity did not modify efficiency and costs; the effectiveness was similar to the traditional procedure as defined by outcomes collected in a registry, including patient reported outcome measures (PROMs); legal and social effects were not modified.","Poster Presentation Number: PP152 Abstract Title: Evaluation Of Reimbursement Periods In The Turkish Biosimilar Product Market (1995-2022) Author Names: Sena Unluler Deger, Elif Hilal Vural ([email protected]) Introduction. Biosimilar products that would enhance the patient\u2019s access to treatments have emerged as a product group that is becoming more widespread globally. Since Turkiye is an emerging market in the pharmaceutical area in the Middle East and North Africa region, and being a reference country in pricing processes for some countries, the number of products in the market and reimbursement decisions are important. The aim of this study is to evaluate duration of inclusion of biosimilars into reimbursement lists after registration in Turkiye. Methods. This study used website-based information (Turkish Medicine and Medical Devices Agency Registered Products List and Detailed Pharmaceutical Price List, Social Security Institution Reimbursed Product List) to analyze the reimbursement approval duration for registered biosimilars in Turkiye after receiving registration approval. A study has been conducted on the launch period of biosimilar products to patients access with reimbursement and the evaluation period of reimbursement applications after registration approval. Even though they might not be active on the reimbursement list right now, products that have previously been approved for payment have been included. Results. Between 1995-2022, biosimilars of 13 active substances in total were registered by the Ministry of Health in Turkiye. Thirty-three different brands and 105 biosimilars with all pharmaceutical forms are registered. As of November 2022, 72 biosimilars were in the reimbursement list. Twenty-two of reimbursed biosimilars were deactivated or excluded from reimbursement. It is calculated that the average evaluation and approval timeline for reimbursement of biosimilars between 2009 and 2022 is 9 months. When biosimilars in the European Medicines Agency (EMA) and Turkiye are compared, 13 biosimilar active substances are licensed in Turkiye compared to 19 for the EMA. When the total number of brands is compared, it has been observed that while 33 brands are registered in Turkiye, this number is 73 for the EMA. Conclusions. This study, in which reimbursement approval dates for registered biosimilars in Turkiye have been compared based on years and access timelines of biotechnological products, shows that biosimilars have been launched to patients access with reimbursement much faster than biotechnological products.","Poster Presentation Number: PP153 Abstract Title: Efficacy And Safety of Onasemnogene Abeparvovec For The Treatment Of Patients With Spinal Muscular Atrophy Type 1: Meta-Analysis Author Names: Stefani Borges ([email protected]), Br\u00edgida Fernandes, Fernanda Rodrigues, B\u00e1rbara Krug, H\u00e9rica N\u00fabia Cirilo, Ida Vanessa Schwartz, Livia Probst, Ivan Zimmermann Introduction. Onasemnogene abeparvovec has been approved for the treatment of spinal muscular atrophy 5q (SMA) type 1 in several countries, which calls for an independent assessment of its evidence regarding efficacy and safety. Methods. This study results from searches conducted on databases MEDLINE, Embase, LILACS and Cochrane Library up to November 2022, supported by additional searches on registry databases and by manual searches of references listed in eligible studies. Outcomes of interest were global survival and mechanical-ventilation-free survival, improvement in motor function and treatment-related adverse events. Risk of bias was assessed via ROBINS-I and certainty of evidence via GRADE. Proportional meta-analysis models were performed when applicable. Results. Four reports of three open-label, non-comparative clinical trials (START, STR1VE-US and STR1VE-EU) covering 67 patients were included in review. Meta-analyses of data available in a 12-month follow-up estimate a global survival of 97.6% (95% confidence interval [CI]: 92.6, 99.9; I2 = 0%, n=67), an event-free survival of 96.5% (95%CI: 90.8, 99.5; I2 = 32%, n=66) and a CHOP-INTEND score of 40 points or less proportion of 87.3% (95%CI: 69.8, 97.8; I2 = 69%, n=67). Proportions of 61.1% (95%CI: 40, 80.2; I\u00b2 = 62%, n=67) of serious adverse events and of 58.4% (95%CI: 46.5, 69.8; I2 = 78%, n=67) of treatment-related adverse events are estimated. Despite the significant effect magnitude, reviewed studies were assessed as high risk of bias and as having very low certainty of evidence due to imprecision and risk of bias. Conclusions. Reduced sample size and follow-up time offer uncertainties as regards the long-term benefits of the gene therapy, which strongly calls for the monitoring and assessment of results in clinical practice.","Poster Presentation Number: PP155 Abstract Title: Should Breast Cancer Patients Avoid Venipuncture In The Ipsilateral Arm? A Rapid Review Of The Evidence Author Name: Keng Ho Pwee ([email protected]) Introduction. This rapid review clarified the evidence supporting avoidance of venipuncture on the ipsilateral arm in breast cancer patients who have had sentinel lymph node biopsy (SLNB) or axillary lymph node clearance (ALNC), as a preventive measure against lymphoedema. Methods. A systematic search was carried out for systematic reviews with the following elements: \u2022 Population \u2013 breast cancer patients who had SLNB or ALNC \u2022 Intervention \u2013 avoidance of venipuncture in the ipsilateral arm \u2022 Comparator \u2013use of either arm for venipuncture \u2022 Outcomes \u2013 risk of lymphoedema in the ipsilateral arm Databases searched included PubMed (MEDLINE), Epistemonikos and the Cochrane Database of Systematic Reviews. Included reviews were critically appraised with the AMSTAR2 instrument and the primary studies were extracted and tabulated in a narrative synthesis. Results. Six reviews were included; none of the reviews self-identified as systematic reviews in their titles\/abstracts. Four reviews did report methods, including systematic search strategies and describing studies in adequate detail. However, all reviews did not meet most criteria on the AMSTAR2 checklist. The reviews concluded that the evidence base for avoiding venipuncture was inconsistent. An evidence table was consequently drawn up of the primary studies included in the reviews as a narrative synthesis of the primary evidence base. The primary evidence base comprised 12 observational studies - six prospective cohort or descriptive studies and 6 retrospective studies. These studies were inconsistent and inconclusive; studies that found an association or reported cases following ipsilateral venipuncture were subject to recall bias or other potential confounders. Guidelines or patient information recommending avoidance of ipsilateral venipuncture do so based on expert opinion rather than consistent findings from empirical studies. Conclusions. All reviews concluded that the evidence base for avoiding venipuncture was inconsistent. Review authors consistently recognized there was no strong basis for the prevalent recommendations to avoid ipsilateral venipuncture to prevent lymphoedema. Such recommendations lead to unnecessary measures that may be detrimental to patients. Stakeholders should reconsider advice to patients in the light of existing evidence and weigh up the uncertain benefits against potential harm to patients.","Poster Presentation Number: PP156 Abstract Title: Choice Of Different Implant Combinations of Total Hip Arthroplasty For Patients With Degenerative Joint Disease Author Names: YuHan Huang, Ta-Wei Tai, Jung-Der Wang, Li Jung Elizabeth Ku([email protected]) Introduction. In Taiwan, people with hip osteoarthritis (OA) receive a total hip arthroplasty (THA). They can apply for National Health Insurance (NHI) coverage for metal-on-polyethylene (MoP) implant or USD1,313.2 co-pay for new bearing surface materials. This study aimed to report the number of first primary THAs, and calculate the costs of THA by different choices of prothesis implant. Methods. A retrospective cohort study of patients aged 50 years or older who had OA (as an indication for THA) from 1 January 2010 through to 31 December 2018 was established from Taiwan\u2019s NHI Claims Data. The cohort was followed-up until 31 December 2019. THA Implant combinations were defined by bearing surface materials e.g., \\\"ceramic-metal\\\" into alumina or composites made from alumina and zirconia, including metal-on- polyethylene (MOP), ceramic-metal composite ceramic-on-polyethylene (c-COP), alumina ceramic-on-ceramic (a-COC), ceramic-metal composite ceramic-on-ceramic (c-COC). Since only MOP was covered by the NHI, patients who chose the COP or COC implant had to pay for additional costs. We used hospital costs comparison data to calculate the average out-of-pocket (OOP) costs for different implant combinations. Results. This study comprised 23,560 patients with first primary THA over 9 years. The number of patients of first primary THA increased from 1,802 in 2010 to 3,251 in 2018. The mean age of patients at baseline was 68 years, and the majority were women (70.6%). The share of users for each THA implant type were: MOP implant (49.2%), c-COC implant, (20.8%), a-COC implant, (6.5%), and c-COP implant, 5.9%. The average OOP costs of each implant were: USD3,578.60 for c-COC (SD=381.80), USD2,073.00 for a-COC (SD=279.80), and USD2,082.1 for c-COP (SD=334.1). Conclusions. Although only MOP was fully covered by NHI, only about 50% of the OA patients chose this type of implant, and 26.7 percent chose alumina and zirconia ceramic composite despite this being a much higher OOP cost. Whether choosing more expensive implants would be cost-effective for THA in Taiwan\u2019s healthcare system requires further analysis."]
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