2020-07-30 Final Poster Abstracts_EK

Poster Abstracts

Abstract Number: 21 Abstract Title: Use Of Real-World Evidence For Healthcare Decision Making: Infliximab Versus Etanercept And The Risk Of Tuberculosis Abstract Status: Accepted Poster Presentation Author Name: Paola Andrea Rivera-Ramirez ([email protected]), Fabián Alejandro Fiestas- Saldarriaga Introduction In the absence of direct evidence from randomized controlled trials (RCTs), real-world evidence (RWE) can play an important role in healthcare decision making. As part of a health technology assessment, we assessed the comparative risk of tuberculosis (TB) associated with using infliximab and etanercept in patients with rheumatoid arthritis. Methods We performed a systematic literature search using the PubMed database to identify relevant meta- analyses. Results We located two relevant meta-analyses: one based on RCTs and one based on observational studies. Evidence from seven RCTs on infliximab (2,686 patients; 12 TB events) and two RCTs on etanercept (663 patients; 2 TB events) suggested no significant differences in the risk of TB between the two treatments, compared with placebo. In contrast, evidence from ten observational studies that directly compared the two treatments (443,941 patients; 253 TB events) indicated a significantly higher risk of TB with infliximab than with etanercept. Conclusions Although RWE is prone to confounding and bias, in this case it had the advantage of providing direct comparisons with larger sample sizes and longer follow up than evidence from RCTs. As a result, RWE was used to inform decision making on the risk of TB with infliximab and etanercept in patients with rheumatoid arthritis.

Abstract Number: 138 Abstract Title: Current Status Of Healthcare Decision Making And Future Perspective Of The Health Technology Assessment Implementation Roadmap In Turkey Abstract Status: Accepted Poster Presentation Author Name: Enver Kagan Atikeler ([email protected]), Ahmad Nader Fasseeh, Bert Leufkens, Wim Goettsch Introduction Turkey’s health reforms, which started in 2003, have led to increased access to health care and pharmaceuticals as well as rising public pharmaceutical expenditures. The need to improve healthcare decision making by implementing health technology assessment (HTA) has become an important priority for Turkey. This study sought to provide a tailor-made HTA implementation roadmap, drawing on insights from national stakeholders. Our study aimed to describe the current HTA environment in Turkey and to explore long-term perspectives and suggestions from a wide spectrum of Turkish stakeholders regarding the preferred status of HTA in ten years (by 2029). Methods We conducted an online survey using a questionnaire previously applied in other HTA research. We assessed the current evaluation of medical and economic decision-making processes and examined the need for HTA. We also ascertained stakeholder perspectives on potential developments that can be done together with policymakers, representatives of pharmaceutical companies, and patient organizations. We also included general information about the pharmaceutical market and decision making processes in Turkey. Results The survey was sent to various stakeholders from different areas within the health system. Additional face-to-face interviews were conducted with a few respondents to clarify some of their answers. A total of twenty-seven Turkish stakeholders completed the survey. Of these, twenty-one (78%) participants were employed in the public sector and six (22%) were from the private sector. The majority of the participants would introduce HTA for all new health technologies being considered for public reimbursement and institute an additional review process for currently reimbursed technologies. Most of the respondents considered that only new technologies with significant budget impact should be evaluated in the next ten years. Conclusions It is clear that Turkey needs to implement an HTA process in the future. Our study shows stakeholder expectations, which will be helpful for creating an HTA implementation roadmap, and it is clear that different stakeholders have different views and expectations about HTA implementation in Turkey. The experiences of other countries will also be helpful during the implementation process.

Abstract Number: 143 Abstract Title: TeCHO+ Program In Gujarat, India: A Protocol For Health Technology Assessment Abstract Status: Accepted Poster Presentation Author Name: Somen Saha ([email protected]), Priya Kotwani, Apurvakumar Pandya, Deepak Saxena, Tapasvi Puwar, Shrey Desai, Gaurav Dahiya, Prakash Vaghela, DM Patel, Chintan Patel, Devang Rawal, Jayanti Ravi Introduction The Health and Family Welfare Department of the Government of Gujarat is implementing a program called Technology for Community Health Operation (TeCHO+) to address the state’s priority health issues. This paper details the protocol for using health technology assessment to assess the impact of the TeCHO+ program on data quality, service delivery coverage, rates of morbidity and mortality, and cost effectiveness. Methods This mixed-method study will be conducted in five districts. Data will be validated in a phased manner over a three-year period, along with an assessment of key outcome indicators. Additionally, key informant interviews will be conducted and cost data will be gathered. Results Early implementation of TeCHO+ has highlighted mixed impact at an operational level, with gaps in implementation. Despite some gaps in the available evidence, TeCHO+ solutions can significantly improve health service delivery through increased accuracy of data management, high-risk identification, and quality and accessibility of care. However, implementation challenges require even greater efforts to establish comprehensive systems for troubleshooting and corrective measures for improving data quality. Positive experiences encourage grassroots teams for continuing the use of TeCHO+. Conclusions TeCHO+ is expected to improve service coverage and reduce rates of morbidity and mortality by improving the population’s nutritional status, the timeliness of care for high-risk cases, and the non- communicable disease profile of the community.

Abstract Number: 146 Abstract Title: Cost Effectiveness Of Aripiprazole Orally Disintegrating Tablets For The Treatment Of Schizophrenia In China Abstract Status: Accepted Poster Presentation Author Name: Ziyi Lin ([email protected]), Jianwei Xuan Introduction Although antipsychotic medications have been a cornerstone in the treatment of schizophrenia for decades worldwide, the orally disintegrating tablet (ODT) formulation is a new concept in China. Only four brand names exist in the Chinese market, three of which were launched recently. Patients taking ODTs have a higher rate of medication adherence and consequently experience better treatment outcomes than patients taking the same medication in standard oral tablet (SOT) formulation. This study aimed to analyze the cost effectiveness in China of aripiprazole in ODT form, compared with the SOT forms of aripiprazole and olanzapine. Methods A discrete-event simulation model was built to represent the one-year progression of schizophrenia. On entry into the model, 100,000 people for each treatment arm were labeled fully adherent, partially adherent, or non-adherent based on medication possession ratios, and then experienced events including relapse, adverse events, changing adherence levels, and treatment switching and quitting. Parameters for adherence rates, medical costs, and utility values were derived from the published literature. The switching pattern was acquired through interviews with fifty-seven Chinese psychiatrists. Results The total annual costs per patient in the aripiprazole-ODT, aripiprazole-SOT, and olanzapine-SOT arms were CNY 9,817 (USD 1,388), CNY 15,278 (USD 2,160), and CNY 10,298 (USD 1,456), respectively. The annual quality-adjusted life-years (QALYs) gained per patient in the aripiprazole-ODT, aripiprazole-SOT, and olanzapine-SOT arms were 0.73, 0.71, and 0.72, respectively. According to the probabilistic sensitivity analysis, the probability of aripiprazole-ODT being cost effective was ninety-nine percent, when compared with aripiprazole-SOT and sixty-nine percent when compared with olanzapine-SOT. Conclusions Aripiprazole-ODT was associated with lower costs and higher gains in QALYs than either aripiprazole-SOT or olanzapine-SOT in patients with schizophrenia in China. While the sensitivity analysis confirmed the robustness of the result that aripiprazole-ODT was better economic value than aripiprazole-SOT, there is some uncertainty in the comparison between aripiprazole-ODT and olanzapine-SOT. The main limitation of this study is that some parameters were sourced from studies on Western populations because of a lack of data in China. Local data on the use of antipsychotics, especially adherence rates, is needed.

Abstract Number: 154 Abstract Title: Funding Of Treatments For Rare Diseases In Singapore Abstract Status: Accepted Poster Presentation Author Name: Fiona Pearce ([email protected]), Liang Lin, Kwong Ng Introduction A national multi-stakeholder charity fund has been established in Singapore to provide targeted support to patients with rare genetic diseases whose treatment costs remain unaffordable despite government subsidies and insurance. This presentation will provide an overview of the evaluation, price-setting, and stakeholder engagement processes established to inform the first list of drugs eligible for funding under the Rare Disease Fund (RDF). Methods The local prevalence of “rare” and “ultra-rare” conditions was defined in line with international rates (≤4 in 10,000 and <2 in 50,000, respectively) to facilitate an analysis of the rare disease landscape in Singapore, and to identify patients most likely to benefit from the RDF. Public healthcare institutions proposed drugs for consideration, which underwent technical evaluation and were then assessed in line with eligibility criteria by an expert clinical group and prioritized by decision makers for funding. Results The number of patients with select rare diseases in Singapore was lower than global estimates contextualized to the local setting. Supporting clinical evidence, funding decisions from overseas health technology assessment agencies, reference pricing considerations, and local budget impact analyses informed the first tranche of drugs (n=5) recommended. Extensive engagement with pharmaceutical companies was needed to negotiate fair drug prices relative to overseas countries. Additional treatments will be included in the RDF once sufficient funds are raised. Conclusions As the evaluation process evolves, wider considerations of disease and treatment experiences from a multi-stakeholder standpoint should be included to inform RDF listings. There is also a need to balance the sustainability of the fund in the longer term with the number of emerging treatments that may require coverage in the future.

Abstract Number: 159 Abstract Title: Telemedicine In Paraguay: Contributions Of The Institute Of Health Sciences Research, National University Of Asunción Abstract Status: Accepted Poster Presentation Author Name: Ronald Rivas ([email protected]), Pedro Galván Introduction The modalities of telemedicine that have been developed and applied so far by the Department of Biomedical Engineering and Imaging at the National University of Asunción (IICS-UNA) are as follows: (i) telediagnosis: the remote sending of data, signals, and images for diagnostic purposes; (ii) general telediagnostic imaging; (iii) telemonitoring (including telemetry): remote monitoring of vital parameters to provide automatic or semi-automatic surveillance or alarm services in emergencies, epidemiology, or tele-public health; and (iv) tele-education: the use of telematic networks to provide virtual platforms for educating and training health professionals. Methods We conducted a comprehensive review of the scientific works developed by the IICS-UNA in order to evaluate the systematic implementation of Telemedicine in Paraguay. Documents, pilot projects (satellite telegraphy), telediagnostic research, telematics, tele-education, published articles, and statistical data (number of patients attending or studies performed, etcetera) relating to the implementation of the National Telemedicine System by the Ministry of Public Health and Social Welfare since 1999 were reviewed. Results Implementation of the telemedicine system has meant that 472,038 patients have attended referral centers nationwide, with 297,999 electrocardiographs, 165,323 computed tomography scans, and 8,697 electroencephalograms being conducted. Projects developed within the framework of the Telemedicine Research Line have included the following: (i) Development and validation of a clinical telemicroscopy system based on cellular telephony; (ii) Implementation of a telemetry system for temperature monitoring of the collection of biological samples from a biomedical research center; and (iii) Production and development of a virtual campus at the National University of Asunción. Conclusions Given the current healthcare environment, developing a line of research based on telemedicine is a proactive step, since telemedicine provides an alternative solution to the problem of access to the health system. That is why the IICS-UNA Biomedical Engineering and Imaging Department has developed telemedicine as one of its main lines of research.

Abstract Number: 162 Abstract Title: Digital Medication Health Service Platforms of Pharmaceutical Companies as Novel Sources of Real-World Data for Health Technology Assessment Abstract Status: Accepted Poster Presentation Author Name: Jian Li, He Wang, Carolina Oi Lam Ung, Hao Hu ([email protected]) Introduction Digital medication health service (DMHS) platforms are increasingly used by pharmaceutical companies to provide direct medication health services through digital methods like apps, hotlines, and web services, etcetera. However, the implications of such platforms in supporting health technology assessment (HTA) are rarely discussed in the literature. This presentation sets out the opportunities for using the DMHS platforms of pharmaceutical companies as real-world data sources for HTA. Methods A mixed-method qualitative study combining literature review and case study was conducted. Relevant literature was identified by searching the Web of Science and PubMed databases. A case study on current DMHS platforms in China was carried out using an inductive approach to identify the key elements emerging from these platforms. Results DMHS platforms of pharmaceutical companies can identify multiple attributes of medication information needs regarding medical products, including effectiveness, safety, and economic factors. The platforms can respond to different stakeholders, including patients and their carers, doctors, nurses, pharmacists, etcetera. As one kind of interactive process, DMHS platforms can provide further services, including patient education, consultation, and evaluation, follow-up visits, chronic disease management, promotion of the rational use of drugs, therapeutic drug monitoring, and adverse drug reaction surveillance and reporting. Conclusions The DMHS platforms of pharmaceutical companies provide a unique and valuable real-world data source for HTA. These types of self-reported outcomes have not gained enough attention in HTA. Collective efforts by HTA agencies and pharmaceutical companies are needed to set strategies for integrating DMHS platforms into HTA.

Abstract Number: 164 Abstract Title: Prescribed Medication Use, Complications, And Cost of Type 2 Diabetes Mellitus In The Real World Abstract Status: Accepted Poster Presentation Author Name: Shengqi Chen, Carolina Oi Lam Ung, Hao Hu ([email protected]) Introduction Type 2 diabetes mellitus (T2DM) is one of the major diseases threatening the health of Chinese residents. Insufficient glycemic control results in inevitable and sometimes irreversible complications. The condition can be more complicated for patients with comorbidities. To maintain appropriate glycemic control, patients may need to add or switch to different classes of drugs as the disease progresses. The complicated drug treatment for diabetes poses a high risk for drug-drug interactions and challenges patient compliance, which is the most important factor affecting the ability to achieve glycemic control. In addition, T2DM is a life-long disease that is associated with a heavy economic burden for patients’ families and for society. Therefore, this paper aims to characterize the complexity of prescribed medications used to treat T2DM and to assess the trends in the number of complications, medications used, and costs incurred among these patients. Methods Data were retrieved from two tertiary hospitals. The population consisted of patients receiving at least one diagnosis of diabetes (International Classification of Diseases-10 codes: E11, E12, E13, and E14) between October 2007 and May 2017. Three measures were assessed, including the number of patients with different complications, concomitant drug use, and costs. Patients with a short disease duration (< 5 years) were compared with patients who had a longer disease duration (≥ 5 years). Results Of 31,071 patients, about half of those with a longer disease duration had at least five concomitant diseases, compared with nine percent of patients with a shorter disease duration. The maximum number of concomitant diseases was nine for both disease duration groups. Patients with longer disease duration were more likely to use multiple classes of drugs, compared with patients in the short disease duration group. The average annual medical costs for patients without concomitant disease was CNY 1,894 (USD 265). Conclusions Overall, the results demonstrated that T2DM is a relatively complex disease. Firstly, patients have up to nine concomitant diseases and use twenty-two classes of drugs. Secondly, patients with more complications tended to use more medications. Thirdly, patients with a longer disease duration tend to have a higher number of concomitant diseases, use more classes of drugs, and have higher medical costs than patients with a shorter disease duration.

Abstract Number: 181 Abstract Title: Direct Comparison Of The Effectiveness And Safety Of Apixaban, Dabigatran, Rivaroxaban, And Warfarin: Subgroup Analyses Of Medicare Beneficiaries Abstract Status: Accepted Poster Presentation Author Name: Lanting Yang ([email protected]), Maria M. Brooks, Nancy W. Glynn, Yuting Zhang, Samir Saba, Inmaculada Hernandez Introduction No studies have directly compared the effectiveness and safety of direct oral anticoagulants (DOACs) and warfarin in patients with atrial fibrillation (AF), with or without a history of ischemic stroke and transient ischemic attack (TIA). This is important for two reasons: first, previous research reports important differences between DOACs and warfarin across other patient subgroups, and second, patients with previous stroke or TIA have a high risk of recurrent stroke. Methods Using 2012-2014 Medicare claims data, we identified patients newly diagnosed with AF in 2013-2014 who started taking apixaban, dabigatran, rivaroxaban, or warfarin. We categorized the patients according to whether they had a history of stroke or TIA. We constructed Cox proportional hazard models that included indicator variables for treatment groups, a history of stroke or TIA, and the interaction between them, and controlled for demographic and clinical characteristics. Results The hazard ratio (HR) for stroke with dabigatran, compared with warfarin, was 0.64 (95% confidence interval [CI]: 0.48 - 0.85) for patients with a history of stroke or TIA and 0.94 (95% CI: 0.75 - 1.16) for patients without a history of stroke or TIA (p-value for interaction = 0.034). In patients with previous stroke or TIA, the risk of stroke was lower with dabigatran (HR 0.64, 95% CI: 0.48 - 0.85) and rivaroxaban (HR 0.70, 95%CI: 0.56 - 0.87), compared with apixaban, but there was no difference for patients in the other subgroup. Conclusions DOACs were generally more effective than warfarin for preventing stroke. The superiority of dabigatran was more pronounced in patients with a history of stroke or TIA. The comparative effectiveness of DOACs differed substantially between patients with and without a history of stroke or TIA; specifically, apixaban was less effective in patients with a history of stroke or TIA. Our results reinforce the need to tailor anticoagulation to patient characteristics and to support the investigation of the underlying mechanisms associated with DOACs.

Abstract Number: 185 Abstract Title: Oral Health Status And Food Consumption Patterns In Selected Primary School Children Abstract Status: Accepted Poster Presentation Author Name: Nabhira Aftabi Binte Islam ([email protected]), Mahmudul Haque Introduction Nutrition is critical to the oral health of the individual. From gestation through to end of life, nutrition influences the integrity and function of the dentition and supporting oral structures and has a direct effect on health in general. According to the World Health Organization, diet has an important role in the prevention of oral diseases such as dental caries, dental erosion, defects in oral development, diseases of the oral mucosa, and periodontal disease. Methods A study was conducted to assess the oral health status and food consumption patterns of students attending the Rotary School and College at Mirpur-14, Dhaka on November 2018. Consent was provided by the school headmaster and guardians. A purposive sample of seventy students was taken. A semi- structured questionnaire and checklist was developed in the English and Bengali languages. Data were presented in simple frequency tables. Results Among the respondents the following eating habits were reported: (i) Thirty-one percent drank milk and twenty-eight percent consumed chocolate four to six times per week; (ii) Forty-three percent consumed fast food least seven times per week; and (iii) Forty-two percent ate vegetables and thirty-four percent ate fruits one to three times per week. In terms of oral hygiene practices, sixty-one percent of respondents used toothpaste and thirty-nine percent used tooth powder. Seventy-eight percent of respondents brushed their teeth once a day and twenty-four percent brushed twice daily. The mean number of decayed, missing (due to caries), and filled permanent teeth was 1.47. Conclusions The relationship between oral health, dietary practices, nutritional status, and general health is complex, with many interrelated factors. To help children develop healthy eating patterns from an early age, it is important that the food and eating patterns to which they are exposed, both inside and outside the home, promote positive attitudes to good nutrition.

Abstract Number: 188 Abstract Title: Prevalence And Severity Of Erectile Dysfunction In Patients With Benign Prostatic Hyperplasia In China: A Cross-Sectional Survey Abstract Status: Accepted Poster Presentation Author Name: Liqun Zhou, Zhengcun Pei, Xingqiao Wen, Yanlei Zhang ([email protected]), Peng Li, Siyan Zhan¶ Introduction Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) are highly prevalent among aging men. However, the rate of coexistence of these two conditions in China is still unclear, especially among men aged 45 to 60 years. Instruments such as the abbreviated five-item version of the International Index of Erectile Function (IIEF-5) and the International Prostate Symptom Score (IPSS) can be used to determine the presence of ED and the symptoms and severity of BPH, respectively. This study aimed to estimate the prevalence of ED in men with BPH and to assess its impact on the quality of life (QoL) of these patients. Methods Between October 2018 and March 2019 we enrolled 650 patients aged 45 to 65 years who were diagnosed with BPH by a urologist in nine first- and second-tier cities in China. Information on patients’ demographics, lifestyle, comorbidities, and medication use was collected through an electronic clinical outcome assessment tool. Patients with an IIEF-5 score of less than twenty-two were considered to have ED. The IPSS and the five-level EuroQol questionnaire (EQ-5D-5L) were used to assess BPH severity and overall health-related QoL. Results We enrolled 650 patients with BPH. Of these, only the 607 men who reported sexual intercourse attempts (mean age of 56.6 years, standard deviation 5.5) were included in the analysis because it was assumed that the other patients did not have ED. Signs of ED were present in ninety-seven percent of patients (IIEF-5 score < 22), and eighty-four percent had at least mild to moderate impairment (IIEF score < 17). Up to nineteen percent reported having physician-diagnosed ED previously, and twenty- eight percent had used medication for ED in the past six months. Compared to men without ED, those with ED and BPH had higher IPSS scores (13.2 versus 6.7, p < 0.05) and lower EQ-5D-5L scores (0.90 versus 0.97, p < 0.05). Conclusions Although the prevalence of ED in men with BPH in China is high, it is still underdiagnosed and undertreated. Co-existing ED in patients with BPH is associated with more severe BPH symptoms and lower quality of life.

Abstract Number: 189 Abstract Title: Operational Evaluations Of Laminar Flow Cabinets Abstract Status: Accepted Poster Presentation Author Name: Benicio Grossling Vallejos ([email protected]), Ronald Rivas, Pedro Galván Introduction Laminar flow cabinets (LFC) are designed to maintain an area free of particles and contaminants that could damage the environment during the preparation of sensitive materials. Several regulations detail the types and frequency of tests that must be performed to ensure the proper functioning of LFCs. The objective of this work was to evaluate the operational and functional status of LFCs. Methods A descriptive study was carried out in which three tests were selected for evaluating LFCs: the high- efficiency particulate air (HEPA) filter integrity test; the air speed and uniformity test; and the general physical verification test. In selecting these tests, we relied on recommendations established in international standards and the manufacturers’ technical manuals. Results During testing it was possible to verify the existence of leaks in the periphery of the HEPA filters due to a mismatch in their assembly, as well as a poor seal in the side panels of the cabinet through which particles were entering the work area. It was also discovered that the equipment lighting system (fluorescent tubes) was inadequate. Conclusions The use of these tests was very important for detecting certain faults in the equipment, which allowed us to introduce corrective actions to maintain sterile conditions in the cabinet. It is recommended to include these tests in the maintenance regimen of LFCs to pre-empt future failures.

Abstract Number: 193 Abstract Title: Research On The Correlation Mechanism Between The Psychological Contract Of Physicians In Public Hospitals And Their Medical Professionalism Abstract Status: Accepted Poster Presentation Author Name: Chao Lyu ([email protected]), Ping Zhou Introduction Guiding and motivating doctors' attitudes and behaviors in the public welfare of public hospitals is the key to promoting medical reform. This study explored the correlation between the hospital responsibilities perceived by physicians and their medical professionalism practices in Chinese public hospitals, and the moderating effects of variables such as sex, hospital level, working period, department, and reason for career choice on the correlation model. Methods A pre-developed, reliable, and valid scale for the physicians’ psychological contract was developed. Survey data from 123 public hospitals in three provinces in the east, central, and west areas of China were analyzed. The authors constructed and tested the correlation mechanism model and then analyzed the effects of particular variables. Results The fulfillment of hospital ideological responsibility has a significant positive effect on physicians' medical professionalism practices, with occupational satisfaction mediating the effect. In addition, hospital transactional, developmental, and relational responsibility can improve physicians’ medical professionalism practices through fairness perception and work pleasure. Hospital level, working period, department, and reason for career choice had a moderating effect on the correlation mechanism model, with the effects varying between different paths. Conclusions The fulfillment of hospital responsibilities can have a positive effect on physicians’ practices of medical professionalism, especially in the domain of ideological responsibility where the largest and most direct impact was observed. Furthermore, the results suggested that hospital administrators need to consider the differences between various types of physicians in order to improve the effects of guidance and motivation in these health professionals.

Abstract Number: 194 Abstract Title: Research On The Correlation Mechanism Between The Psychological Contract Of Physicians In Public Hospitals And Their Turnover Intention Abstract Status: Accepted Poster Presentation Author Name: Chao Lyu ([email protected]), Ping Zhou Introduction Guiding and motivating doctors' attitudes and behaviors in the public welfare of public hospitals is the key to promoting medical reform. This study explored the correlation between the hospital responsibilities perceived by physicians and their turnover intention in Chinese public hospitals, as well as the moderating effects of variables such as sex, hospital level, working period, department, and reason for career choice on the correlation models. Methods A pre-developed, reliable, and valid scale for the physicians’ psychological contract was developed. Survey data from 123 public hospitals in three provinces in the east, central, and west areas of China were analyzed. The authors constructed and tested the correlation mechanism model and then analyzed the effects of particular variables. Results The fulfillment of hospital transactional and developmental responsibility had a significant negative effect on the intent of physicians to leave the hospital and front-line clinical practice, respectively. Working pleasure, fairness perception, and occupational satisfaction were mediator variables in the impact. In addition, hospital level, working period, department, and reason for career choice had a moderating effect on the correlation mechanism model, with the effects varying between different paths. Conclusions The fulfillment of hospital transactional responsibility had a more negative effect on the intent of physicians to leave the hospital than other responsibilities, whereas fulfillment of hospital developmental responsibility had a more negative impact on the intent of physicians to leave front-line clinical practice. Furthermore, the results suggested that hospital administrators need to consider the differences between various types of physicians in order to improve the effects of guidance and motivation in these health professionals.

Abstract Number: 229 Abstract Title: Surrogate Outcomes In Health Technology Assessments Of Oncology Drugs: The Osimertinib Case Abstract Status: Accepted Poster Presentation Author Name: Milton Rodriguez-Zuniga ([email protected]), Paola Rivera-Ramirez, Fabian Fiestas- Saldarriaga Introduction Decision making in publicly funded healthcare systems must rely on patient-relevant outcomes that directly measure clinical benefit, such as overall survival and quality of life (QoL). However, studies that support market authorization of oncology drugs usually assess surrogate outcomes, without having previously demonstrated that these intermediate outcomes reliably predict clinical outcomes. As part of an HTA process, we evaluated the clinical benefit of osimertinib, compared with platinum-pemetrexed combination chemotherapy, in patients with epidermal growth factor receptor (EGFR) T790M mutation- positive advanced non-small cell lung cancer (NSCLC) that has progressed after first-line EGFR tyrosine kinase inhibitor (TKI) therapy. Methods We conducted a systematic search of the PubMed database for randomized controlled trials (RCT) published from inception to January 2019. The clinical outcomes of interest were overall survival and QoL. Where trials reported surrogate outcomes, we conducted additional PubMed searches for evidence of validity for predicting clinical outcomes and used guidance on surrogate outcome validation in oncology from the Institute for Quality and Efficiency in Health Care. Results Evidence on osimertinib, compared with chemotherapy, for patients with T790M-positive advanced NSCLC that has progressed after EGFR-TKI therapy was obtained from the AURA3 trial. In this study, overall survival data were immature and the results for QoL and symptom domains were not clinically meaningful. In addition, median progression-free survival (PFS) was six months longer for osimertinib than for chemotherapy. However, to date, no study has demonstrated that PFS reliably predicts longer survival or better QoL. Conclusions Our HTA suggested that, unless proven, PFS should not be used as a valid surrogate outcome for decision making in public health. For example, the results of the AURA3 trial showed that osimertinib has an effect on the surrogate outcome of PFS in patients with EGFR T790M-positive advanced NSCLC that has progressed after first-line EGFR-TKI therapy, but not on the clinically relevant outcomes of overall survival and QoL. Furthermore, currently available evidence has failed to prove that PFS reliably predicts outcomes that are clinically relevant. Despite this, osimertinib has been given marketing authorization and is widely recommended in clinical guidelines.

Abstract Number: 255 Abstract Title: Epigenetic Profile Predicts Response To Immunotherapy In Patients With Non-Small-Cell Lung Cancer: An Early Assessment Abstract Status: Accepted Poster Presentation Author Name: Ana Isabel Hijas-Gómez ([email protected]), Mª Mar Polo-de-Santos, Setefilla Luengo- Matos, Montserrat Carmona-Rodríguez, Luís María Sánchez-Gómez Introduction Epigenetics is an innovative discipline that aims to provide biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. The identification of therapeutic targets is of particular interest in cancer therapy for selecting groups of patients who may benefit most from an intervention. Understanding the relationships between the immune system and tumor cells has led to new immunotherapy-based therapies that provide a promising alternative to conventional cancer therapies. The aim of this study was to conduct an early assessment of a novel epigenetic signature (EPIMMUNE) that could predict response to programmed cell death protein 1 (PD-1) inhibitor immunotherapy in patients with non-small cell lung cancer (NSCLC). Methods We identified the novel epigenetic signature EPIMMUNE through the Early Awareness and Alert System, “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS- ISCIII). A literature search of PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, The Cochrane Library, and the Centre for Reviews and Dissemination databases was conducted. Clinical studies on EPIMMUNE published in English or Spanish up to August 2019 were reviewed. Results Only one retrospective study was found. Identification of EPIMMUNE was accomplished through interrogation of the DNA methylation status of CpG sites in 142 samples from adult patients with NSCLC who were treated with PD-1 inhibitors. EPIMMUNE was defined by 301 CpG sites whose methylation status was significantly associated with clinical response (progression-free and overall survival). No studies assessing the long-term clinical utility, impact on therapeutic decision making, or economic implications of EPIMMUNE were found. Conclusions The EPIMMUNE signature could provide an accurate and valid biomarker for identifying patients with NSCLC who may benefit from treatment with PD-1 inhibitors. However, the technology is under development, and there is only a single study on detecting the EPIMMUNE epigenetic profile and identifying the DNA methylation profiles associated with increased survival after PD-1 inhibitor therapy. More diagnostic accuracy studies and prospective, long-term trials are needed to evaluate the clinical impact this technology may have on therapeutic decision making. Given the limited evidence available, further research is needed before the technology can be disseminated.

Abstract Number: 256 Abstract Title: Cost-Utility Analysis of Robot-Assisted Partial Nephrectomy Versus Open Or Laparoscopic Radical Nephrectomy In Korean Patients With Renal Cancer Abstract Status: Accepted Poster Presentation Author Name: Jeonghoon Ahn ([email protected]), Yejee Kang, Juyeon Lee, Seowoo Bae, Minkyung Shin, Ataru Igarashi Introduction Partial nephrectomy is recommended over radical nephrectomy for the surgical treatment of patients with stage cT1 renal cancer in multiple guidelines. The objective of this study is to examine the cost effectiveness of robot-assisted partial nephrectomy (RAPN), compared with open radical nephrectomy (ORN) or laparoscopic radical nephrectomy (LRN), for treating stage cT1 renal cancer in Korea. Methods A Markov model was applied in patients with cT1 renal cancer that consisted of the following six health states: post-surgery, normal, chronic kidney disease (CKD), dialysis, death from renal failure, and natural death. Utilities and transition probabilities were obtained from systematic literature reviews. Costs were obtained from the current Korean National Health Insurance fee schedule, the Korean medical literature, and 2016 Health Insurance Review and Assessment Service inpatient claims data. Univariate and probabilistic sensitivity analyses were performed to check for uncertainty. Results RAPN was the dominant treatment, costing KRW 2.1 to 3.6 million (USD 1,700 to 2,900) less than the comparators while providing 0.45 to 0.61 more utility. Univariate sensitivity analysis showed that the most sensitive parameter was the relative risk reduction of CKD after partial nephrectomy. The sensitivity analysis also showed that the acceptability of RAPN at a cost-effectiveness threshold of KRW 30.5 million was high relative to both comparators (85.9% against LRN and 78.9% against ORN). Conclusions Though there might be uncertainties in non-Korean utility data and some transition probabilities derived from Japanese data, the current study suggested that partial nephrectomy is a more cost-effective option than ORN or LRN in Korea for patients with stage cT1 renal cancer.

Abstract Number: 262 Abstract Title: PapSEEK: Liquid Biopsy For Endometrial And Ovarian Cancer Screening Abstract Status: Accepted Poster Presentation Author Name: Ana Isabel Hijas-Gómez ([email protected]), Mª Mar Polo-de-Santos, Setefilla Luengo- Matos, Luís María Sánchez-Gómez Introduction Endometrial and ovarian cancer are the first and second leading causes of death from gynecological cancer in Spain. Survival is generally determined by stage at diagnosis, but there is no test currently used for early detection of both tumor types. PapSEEK is a test developed to diagnose endometrial and ovarian cancer by detecting aneuploidies and somatic mutations commonly associated with both tumor types through DNA next-generation sequencing (NGS) of liquid from Papanicolaou test (Pap smear) samples. The objective of this work was to assess the effectiveness and safety of PapSEEK. Methods PapSEEK was identified by the Early Awareness and Alert System, “SINTESIS-new technologies”, of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). An early assessment of the technology was conducted through a literature search of the following databases: PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and The Cochrane Library. Clinical studies on the effectiveness and safety of PapSEEK published up to February 2019 were reviewed. Results The evidence comprised proof of concept and diagnostic accuracy studies, which showed good preliminary results regarding the accuracy of the test for diagnosing endometrial cancer (sensitivity ranged from 0.81 to 0.93), but not for ovarian cancer (sensitivity ranged from 0.33 to 0.45). The specificity for both tumor types ranged from 0.99 to 1.00. Since PapSEEK uses a sampling method that is routinely used in clinical practice (the Pap smear), no evidence was found in the literature on the safety of the test. Conclusions PapSEEK is a novel technology developed to diagnose endometrial and ovarian cancer by means of DNA- NGS of Pap smear samples. The identified studies showed good preliminary results regarding the ability of the test to diagnose endometrial cancer, but not ovarian cancer. PapSEEK may be useful as a screening tool for endometrial cancer. However, further research on PapSEEK is needed to prospectively evaluate its diagnostic accuracy, compare it with current tests used in the early diagnosis of both cancer types, evaluate its effect on patient survival and disease progression, and measure its economic impact.

Abstract Number: 264 Abstract Title: Effectiveness And Safety Of Pressurized Intraperitoneal Aerosol Chemotherapy For Peritoneal Carcinomatosis: A Systematic Review Abstract Status: Accepted Poster Presentation Author Name: Ana Isabel Hijas-Gómez ([email protected]), Nadia Lingán-Cubas, Mª Mar Polo-de-Santos, Esther García-Carpintero, Setefilla Luengo-Matos, Luis María Sánchez-Gómez Introduction Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a minimally invasive therapeutic option for stage IV or terminal stage peritoneal carcinomatosis, which has a very low survival rate. PIPAC is aimed at patients whose only therapeutic alternative is systemic chemotherapy because they are unable to undergo other treatments, such as cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. PIPAC consists of a micro-pump connected to a double-contrast injector, which is used to apply cytotoxic agents laparoscopically using pressurized aerosols. The objective of this study was to update the evidence regarding the effectiveness and safety of PIPAC. Methods A systematic review (SR) was conducted by searching PubMed, Embase, and The Cochrane Library database. ClinicalTrials.gov and the European Union Drug Regulating Authorities Clinical Trials Database were consulted to identify registered clinical studies. All articles published up to April 2019 were considered for inclusion. Abstracts, letters, single case studies, non-clinical and animal studies, and studies published in languages other than English or Spanish were excluded. Validated checklists were used to assess the quality of the included studies. Results Seventeen studies were included (three SRs and fourteen cases series) and eighteen ongoing clinical trials were identified. The quality of the SRs and cases series studies was low and moderate, respectively. Adverse events were categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events as grade 1-2 (mild-moderate: 11% to 40% of patients) and grade 3-4 (severe-fatal: 0% to 37% of patients). Overall complete histological regression according to the Peritoneal Regression Grading Score and the Peritoneal Cancer Index occurred in at least sixty percent of patients. The survival time ranged from 11 to 16 months. Conclusions Effectiveness data for PIPAC were promising, with high carcinomatosis regression rates. Most studies showed a moderate safety profile, with generally mild to moderate complications (nausea, abdominal pain, and vomiting). This is an advantage over systemic chemotherapy, which has severe systemic side effects. Economic evaluation studies are needed to estimate the cost effectiveness and cost utility of this technology. Diffusion of PIPAC is expected, but the criteria used to select patients in the studies carried out so far must be considered, as well as the need to follow strict safety protocols for preventing leakage of aerosolized cytotoxic drugs.

Abstract Number: 265 Abstract Title: Application Of A Case-Mix Method For Medical Consumables Management in Anhui Province, China Using Healthcare Big Data Abstract Status: Accepted Poster Presentation Author Name: Lin Tong ([email protected]), Qing-hua Xu, Hong Ye, Shuang Zhang, Chen Cao Introduction The case-mix method involves combining cases with similar complexities and medical services. The process of treating one episode of the disease and receiving treatment is the research unit, thus achieving different medical units. The feasibility of the calculation method is verified by calculating the public hospital consumption ratio, medical income, health materials expenditure indicators, and the differences between the various types of surgical combinations. A decision-making basis can then be provided for the creation of government indicator standards. Methods Medical records and data on the expenditure of medical consumables for the first and fourth quarters of 2017 were collected from seven third-class provincial hospitals. The medical consumption ratio for different diseases and surgical methods was calculated for the case-mix groups using a weighting method. Data were analyzed by descriptive statistics and the independent samples t-test. Results There were significant differences in the proportions of combined use for different types of diseases. The same combination also had significant differences between different hospitals. In the fourth quarter of 2017, the operating group's consumption ratio was significantly lower than in the first quarter (p = 0.000). Conclusions It is reasonable to calculate the proportion of consumption by combined weighted analysis, which is also fairer for hospitals with better technical levels. This calculation method can be used by governments to manage the use and cost of medical consumables in hospitals.

Abstract Number: 268 Abstract Title: Eliciting Meaningful Patient Preferences In Rare Diseases – Swing Weighting With Immunoglobulin A Nephropathy Patients In The United States And China Abstract Status: Accepted Poster Presentation Author Name: Kevin Marsh, Nancy Zaour, Kerrie-Anne Ho ([email protected]), Ankit Joshi, Rachel Lo, Aneesh Thomas George, Nigel S. Cook Introduction Reimbursement agencies are increasingly using patient preference data to evaluate health technologies. Discrete choice experiments (DCE) are commonly used to elicit patient preferences, but they require large sample sizes to obtain meaningful results. For this reason, it is often not possible to use DCE to elicit patient preferences in rare diseases. This study assessed a swing weighting method for eliciting preferences from a small sample: patients with immunoglobulin A nephropathy (IgAN) in the United States (US) and China. Methods Attributes and levels were selected based on a review of clinical studies and qualitative research on patients. Computer-assisted, interview-based swing weighting exercises were piloted in a focus group with five participants each from the US and China. Preferences were then elicited in interviews with twenty-five patients in the US and fifteen patients in China. Consistency tests were used to assess internal validity. Qualitative data were collected on the reasons for patients’ preferences. Results Preference consistency: The weights for one attribute were elicited twice. The difference between initial and consistency test weights was not statistically significant (p < 0.1), although this may partly reflect the small sample sizes. Trade-offs: Qualitative data were used to demonstrate the validity of interpreting participants’ ratings as trade-offs. Using the partial value function for end-stage renal disease as an example, qualitative data demonstrated that patients were able to provide face-valid reasons for different shaped, non-linear preference functions. Robustness of treatment evaluation: Three hypothetical treatment profiles (using the attribute swings) were constructed. Preferences for these treatment profiles were robust to variations in patients’ preferences; all patients preferred one specific profile. This finding was not sensitive to changes in weights. Conclusions This study supports the feasibility of collecting valid and robust preference data from small groups of patients using swing weighting. Further work could be done to test the performance of swing weighting in larger sample sizes.

Abstract Number: 277 Abstract Title: Analysis Of The Current Situation Of Using Hospital-Based Health Technology Assessment In Kazakhstan Abstract Status: Accepted Poster Presentation Author Name: Andrey Avdeyev ([email protected]), Aigul Kaptagayeva, Valeriy Benberin, Nasrulla Shanazarov, Larissa Makalkina, David Hailey Introduction Hospital-based health technology assessment (HB-HTA) in Kazakhstan is currently at the initial stage of development. The Medical Center Hospital of the President’s Affairs Administration, Nur-Sultan is one of the first examples of implementing and using an HB-HTA system in practice, having included in its structure an HB-HTA unit in 2015. Methods In order to evaluate the current situation of using the principles of HB-HTA in Kazakhstan hospitals, a special questionnaire was developed. The questionnaire was sent in the form of an official request on behalf of the Ministry of Health Care. An official response was received from twenty-nine hospitals, of which nine were at the federal level, thirteen at the regional level, and seven at the city level. Results Of the twenty-nine hospitals that participated in the survey, only half (52%) indicated that they were aware of the principles of using the HB-HTA system and of the structure and functions of mini-health technology assessment reports (55%). Nonetheless, most hospitals (90%) noted that the results of HB- HTA may affect the final decision on implementing new technologies in practice, and that using the systematic approach of technology assessment is necessary. Conclusions In assessing the clinical and economic effectiveness of new health technologies in hospitals, and the viability of implementing them, there is a lack of standardized processes in managerial decision making. The assessment of clinical effectiveness and safety when implementing technologies is carried out mainly by technology applicants or by the main specialists who are responsible for the profile of evaluating technology. This can be regarded as a conflict of interest, since the applicant’s wish to introduce the new technology may bias the evaluation process.

Abstract Number: 284 Abstract Title: Volume-Result Relationship Analysis In Digestive Oncological Surgery In Spain By Using Health Data Records Abstract Status: Accepted Poster Presentation Author Name: Laura Muñoz, Elisa Puigdomènech, Xavier Garcia Cuscó ([email protected] ), César Velasco, Mireia Espallargues Introduction In order to improve patients’ health outcomes, it is important to know the available evidence regarding centralization of surgical interventions for digestive cancer in hospitals with the highest volume of cases. We aim to describe and identify the number of annual interventions recommended by hospitals in order to maximize the health outcomes and efficiency for patients undergoing digestive cancer surgery during 2013-2016 in centers belonging to the Spanish National Health System (SNS). Methods The study design was a retrospective cohort study (patients aged ≥18 years). Data from Spanish public hospitals’ basic minimum set of data at hospital discharge for esophagus, stomach, liver, pancreas and rectum cancers was used. Age, sex primary/secondary diagnosis and procedures (Charlson index) were included. Reinterventions, hospital stay and in-hospital mortality were considered as the outcomes and measures of efficiency. Hospitals were grouped as low-/medium-/high-volume according to the number of annual procedures. Descriptive analysis and logistic and Poisson regression models with Stata16 were undertaken. Results High-volume hospitals performed between 67.4 (rectum) and 88.6 (liver) percent of interventions. The percentage of in-hospital mortality for all cancers was lower in high-volume centers (9.6% esophagus, 6.6% stomach, 7.1% pancreas, 4.2% liver and 2.2% rectum), showing a negative association between center volume and in-hospital mortality, which was statistically significant for esophagus (odds ratio [OR]=0.48; 95% confidence interval [CI]: 0.28-0.81), stomach (OR=0.51; 95% CI: 0.39-0.68) and rectum (OR=0.63; 95% CI: 0.48-0.83) cancers. A non-statistically significant lower in hospital stay was observed in high-volume hospitals. Conclusions These results indicate that in Spain there is a negative association between the number of digestive oncological interventions per hospital and in-hospital mortality. This could help to define a threshold or cut-off point for the concentration of digestive cancer surgery in the SNS that might result in an improvement of lower in-hospital mortality and/or hospital stay.

Abstract Number: 288 Abstract Title: Health Technology Assessment In Universal Health System: A Network At The Brazilian Capital Abstract Status: Accepted Poster Presentation Author Name: Johnathan Portela Da Silva Galdino ([email protected]), Everton Macêdo Silva, Valdenize Tiziani, Daniella Cristina Rodrigues Pereira, Erika Barbosa Camargo, Flávia Tavares Silva Elias Introduction Collaborative networking is adopted to implement health technology assessment (HTA) in academic and research institutions and exchange knowledge with hospitals and health services. Since 2016, the District Network for Health Technology Assessment (ReDAPTS) has been dedicated to generating and promoting evidence that supports decision-making, promoting continuous qualification, supporting and guiding managers in priorities and demands, analysing the economic, ethical and social implications of problems and situations, and contributing to healthcare quality at the Unified Health System. The objective of this study is to present the construction process of ReDAPTS from 2016 to 2019. Methods This experience report about ReDAPTS considered three main actions: (i) situational diagnosis in 2016 and 2017, (ii) agreements of internal regulation and governance and (iii) HTA training strategies for professionals. The scientific events and executive group meetings were described to identify the strategies for the implementation of a collaborative network in the Federal District (FD), Brazil. Results In total, fifteen institutions were identified with a potential to develop the HTA field at the district level. Between 2016 and 2019, three scientific events, eighteen technical meetings for network governance and two scientific meetings were carried out, organized by ReDAPTS and with 269 participants, highlighting assistance and university hospitals, FD Department of Health and academic and research institutions. Four HTA courses were offered and 319 professionals from the FD were trained. Conclusions Collaborative networking provided strengthening capacity for study production and debates on institutional processes for public health policies at the FD. Networking encouraged collaboration between institutions and promoted sharing HTA experiences. The network faces challenges to operate with full capacity. Political and institutional commitment, physical infrastructure and trained personnel sustainability are key to maintaining the HTA process at the FD. Institutions can develop HTA-teams to promote continuous qualification, study production and the rational use of technologies.

Abstract Number: 289 Abstract Title: Impact Of Regional Human Immunodeficiency Virus Therapeutic Pathway On Prescriptions: The Experience Of The Lazio Region In Italy Abstract Status: Accepted Poster Presentation Author Name: Rossella Di Bidino ([email protected]), Cauda Roberto, Andreoni Massimo, Antinori Andrea, Mastroianni Claudio, Vullo Vincenzo, Cicchetti Americo Introduction In 2017, the Lazio Region (Italy) published a care and therapeutic pathway (Percorso Diagnostico Terapeutico Assistenziale [PDTA]) to guide the choice of treatments for human immunodeficiency virus (HIV) patients. Recommendations were based on clinical and economic criteria to guarantee the most appropriate care and sustainability of the regional National Health Service. Our pilot study was conducted to assess how the PDTA impacts clinical decisions and expenditure. Organizational and economic analyses were based on four HIV treatment centers at the regional level. Methods An ad hoc data collection was conducted. Each center provided data on the volume of prescriptions for each treatment option for the first semester of 2017 and 2018. The period January-June 2017 (H1-2017) represents the scenario pre-PDTA, while January-June 2018 (H1-2018) provides evidence on the first impact of the PDTA. Expenditure was estimated considering prices reported in the PDTA document. For each center, a semi-structured survey collected evidence on which factors influence treatment decisions. Results Between H1-2017 and H1-2018 the number of experienced patients increased 10.1 percent (6,580 versus 7,249, respectively), while that of naive patients decreased 3 percent (227 versus 220). More than 80 percent of naive patients were treated with regimes recommended by the PDTA versus 36 percent in H1-2017 and 62 percent in H1-2018 of experienced patients. Regimes with a monthly cost > EUR 700 were preferred. The survey showed that the PDTA is a useful tool for supporting clinical decisions. Conclusions Our pilot study provides a snapshot on the impact of a regional HIV PDTA and identifies key aspects for its future update. Personalization of HIV therapies for an aging (5-29% of patients were >65 years in the four centers) and complex (>65% of patients had at least one comorbidity) population should be discussed for a PDTA update. Posology and treatment adherence should be further investigated.

Abstract Number: 290 Abstract Title: Exploratory Investigation On Innovative Business Models Of Internet Hospitals In China: A Focus Group Study Of Key Stakeholders Abstract Status: Accepted Poster Presentation Author Name: Hao Hu, Shengqi Chen, Meng Li, Carolina Oi Lam Ung, Yunfeng Lai ([email protected]) Introduction Under the national guidance of Internet Plus Healthcare, Internet hospital was officially recognized in 2018 by the Chinese government, however, how to innovate the business models of Internet hospitals remains controversial. This study sought to explore key stakeholders’ perspectives on key dilemmas about innovative business models of Internet hospitals in China. Methods A focus group study of key stakeholders was performed. Twelve key stakeholders (six senior officials from related ministries, two industry practitioners of Internet medicine, one hospital leader, two healthcare researchers (financing and policy), and one venture capital manager) participated in the focus group, in 2019. Thematic content analysis was applied for data analysis. Results Themes highlighted six key dilemmas when developing a business model of Internet hospitals, including (i) value proposition (medical treatment versus entire health management); (ii) leading party (hospitals versus third parties such as Internet companies); (iii) level of healthcare (tertiary versus primary); (iv) scope of service (provide full range versus part of traditional hospital service); (v) primary source of revenue (medical services versus drug sales); and (vi) legal liability (web-based unit versus physical hospital). Conclusions The healthcare industry is currently in search of innovative business models of Internet hospitals in response to the unprecedented form of healthcare in China. However, the core aspects of the model design still remain debatable. At this revolutionary stage, policies are important to allow the implementation of different model designs that support the successful transformation of the entire health care system in China.

Abstract Number: 297 Abstract Title: Rethinking The Gap Between Technology And Implementation: A Framework For Socially Embedded Technoscience Abstract Status: Accepted Poster Presentation Author Name: Chad Andrews ([email protected]) Introduction In 1964, Jacques Ellul framed the history of technology as one defined not just by the introduction of new machines, but by the social and institutional practices that guide their use and implementation. He called this integrated system “la technique,” believing that the word “technology” had come to emphasize physical tools at the cost of social ones. There is a strong critical component in Ellul, who opposed the dehumanization apparent in technological systems and their associated forms of utilitarian thinking. Remaining aware of this critical history, this study relies on Ellul and similar technological theories to conceptualize a framework for rethinking the distinction between health technologies and their implementation in the context of health technology assessments (HTAs). It does so by considering how HTAs could be modified within the proposed framework to better consider the social and human factors that determine how a drug or technology exists within a “live” social environment. Methods The study is conceptual and driven by an analysis of existing HTAs. It details potential ways that reviews could be adjusted in line with the presentation's proposed framework. Results By collapsing the distinction between technology and implementation, we can guide HTAs that are more cognizant of the essential human and social components of implementation, helping to avoid the crises that arise when technologies are introduced without considering their fundamental social factors. Conclusions Many modern HTAs already take implementation into account, but their findings treat technologies as conceptually distinct from practices and procedures, leaving the latter to local institutions to determine. By challenging the traditional gap between technological and sociological factors in traditional HTA practices, it is possible to develop new approaches to reviewing health technologies—not as distinct objects, but as complex sociotechnical phenomena in line with Ellul’s “la technique.”

Abstract Number: 298 Abstract Title: Comparison Of Quality Of Life Between Colposcopy And Human Papillomavirus Testing In Thai Women With Atypical Squamous Cells Of Undetermined Significance Abstract Status: Accepted Poster Presentation Author Name: Tanita Thaweethamcharoen ([email protected]), Irene Ruengkhachorn, Prapaporn Noparatayaporn Introduction Cervical cancer is the second most common cancer for Thai females. After screening, women diagnosed with atypical squamous cells of undetermined significance (ASC-US) are referred for colposcopy or human papillomavirus (HPV) testing for further diagnostics. The impact of colposcopy and HPV testing on quality of life (QOL) is not well documented. The objective of this study was to evaluate the impact of both diagnostic procedures, to fill the knowledge gap and inform healthcare professionals and decision makers. Methods This was a cross-sectional study conducted between August 2017 and January 2019 at a university hospital. One hundred and twenty-four and forty-two women were referred for colposcopy and HPV testing, respectively. QOL was assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) and the 5-level EuroQol questionnaire (EQ-5D-5L). Socio-demographic details were collected. The WHOQOL-BREF and EQ-5D-5L scores were compared between colposcopy and HPV testing using independent t-test or Mann-Whitney test, depending on data distribution. Results The EQ-5D-5L score and four domains (mobility, self-care, usual activity, anxiety/depression) of EQ-5D- 5L responses of the colposcopy and HPV testing groups were not significantly different (p>0.05). However, the pain/discomfort domain of EQ-5D-5L in the colposcopy group was significantly higher than the HPV testing group (p=0.032). The overall QOL and four domains (physical, psychological, social relationships, and environmental) of WHOQOL-BREF were not significantly different (p>0.05). Conclusions The QOL scores between the colposcopy and HPV testing groups were similar. HPV testing is more expensive and is not included in all health benefit packages, thus most ASC-US patients are referred to colposcopy according to reimbursement. Some women in the colposcopy group judged their social and working impact worse from the pain. Nevertheless, HPV testing would be alternative option in terms of less pain. The findings from this study may assist in promoting QOL in this group of women.

Abstract Number: 309 Abstract Title: Accuracy Of Automated Wrist Blood Pressure Monitors: Systematic Review Abstract Status: Accepted Poster Presentation Author Name: Nila Albuquerque ([email protected]), Thelma Araujo, Samantha Borges, Liana Queren Silva, Lais Vitoria da Silva, Talita Rabelo, Maria Kecia Lino, Fabian Elery da Rocha, Luzia Sibele de Freitas Introduction The use of automated blood pressure monitors is recommended by current guidelines; however, the accuracy of the device must be validated according to standardized protocols. Wrist blood pressure monitors have been undergoing technical improvements; nonetheless, their reliability is not unanimously recognized. No systematic review to date has analyzed the accuracy of wrist blood pressure monitors according to standardized protocols. This study aims to summarize the evidence on the accuracy of wrist blood pressure monitors in adults. Methods Three databases (PubMed, Scopus and SciELO) were searched on 9 September 2019. The PICO (Patient, Intervention, Comparison and Outcome) strategy was used to outline the research question: Do automated wrist blood pressure monitors have accuracy equivalent to mercury sphygmomanometers in adults? Validation studies of wrist blood pressure monitors were included. Two reviewers independently screened abstracts and full texts. Summary data was extracted for each device, including mean difference of systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the monitor and the mercury sphygmomanometer. Results The review identified twenty-nine validation studies. Most of them were developed in China (44.82%), followed by Italy (20.68%). The most commonly used validation protocol was from the British Society of Hypertension. The mean difference between the devices and the mercury sphygmomanometers was 0.47 (±5.75) mmHg for SBP and 0.17 (±4.75) mmHg for DBP. The percentage of wrist blood pressure monitors that passed validation protocols was 93.1. Conclusions Most automated wrist blood pressure monitors showed accuracy equivalent to the reference standard for blood pressure measurement, with mean differences less than 0.5 mmHg for SBP and 0.2 for DBP. This evidence supports the recommendation to adopt this technology for the measurement of blood pressure in adults. However, wrist blood pressure monitors have patient positioning specificities, which, if not followed, may lead to measurement errors. Therefore, the adoption of these monitors should consider not only their accuracy, but also aspects of patient use and preferences.

Abstract Number: 313 Abstract Title: Patient Preference For Blood Pressure Measurement: Sphygmomanometers Or Automatic Monitors? Abstract Status: Accepted Poster Presentation Author Name: Nila Albuquerque ([email protected]), Thelma Araujo, Samantha Borges, Liana Queren Silva, Lais Vitoria da Silva, Talita Rabelo, Maria Kecia Lino, Fabian Elery da Rocha, Luzia Sibele de Freitas Introduction The development of more accurate algorithms has encouraged the replacement of sphygmomanometers with automatic blood pressure (BP) monitors in adults. From the perspective of health professionals, these technologies are advantageous for their practicality and are less susceptible to observer errors, and many devices validated by standardized protocols are available for both clinical and home use. However, adherence to these technologies also depends on patient acceptance. No studies to date have examined patient preference for BP measurement in the Brazilian population, although Brazil has undertaken initiatives to replace auscultatory measurement with oscillometric measurement. This study aims to analyze patient preferences between sphygmomanometers and automatic monitors for BP measurement. Methods An analytic study was conducted with 93 subjects in a Brazilian outpatient care facility. A random sampling method was used to select participants. After obtaining informed consent, all subjects had their BP measured using a sphygmomanometer and then an automatic monitor for clinical use, both in a quiet room after 10 minutes rest. A structured interview on discomfort and preferences was then conducted. An unpaired t-test and a chi-square test were used. Results The mean age was 39.11 (±14.22) years. Minor discomfort was identified when an automatic monitor was used (2.34 versus 2.52). Confidence was higher with the sphygmomanometers (73.11%), and 60.21 percent preferred this technology. There was no association between gender and preferences (p=0.88), but an association with age was identified. The average age of subjects who preferred sphygmomanometers was higher compared to those who preferred automatic monitors (p<0.05). Conclusions This study revealed that, although BP measurement using automatic monitors is less uncomfortable, patients rely more on sphygmomanometers. Results show that preference is related to age, as younger people tend to prefer automatic monitors. The findings of this study indicate the need to widely disseminate information regarding the accuracy of automatic monitors among patients, especially older ones, in order to make them part of the decision-making process for replacing sphygmomanometers with automatic monitors.

Abstract Number: 316 Abstract Title: Efficacy And Usability Of eHealth Technologies In Stroke Survivors For Improvement Of Self-Management: Clinical Trial Abstract Status: Accepted Poster Presentation Author Name: Eunate Arana Arri ([email protected]), Leire Ortiz-Fernández, Janire Orcajo, Rubén García Fernández, Joana Sagastagoya, Natale Imaz-Ayo, Ander Alava-Menica Introduction Stroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, most due to modifiable risk factors. Several reviews have shown that interventions mediating eHealth technologies can reduce the risk of suffering a stroke episode, improving the control of risk factors; nevertheless, all of them conclude that new and well-designed studies are needed. Methods We performed a prospective, randomized, parallel group and open, pilot trial. The study was carried out based on an initial sample of forty-three patients between 18 and 80 years old who have had an ischemic stroke. The control group got conventional treatment and the intervention group got conventional treatment and the assistance of STARR (the Decision SupporT and self-mAnagement system for stRoke survivoRs), as well as commercial wearables. The principal variable of the study was to evaluate the usability of the decision support system. Results At month nine, the average score on the System Usability Scale in the intervention group was 64.7 and in month 12, 67.4, exceeding in both cases the margin of acceptability (50) and in the limit of “good” (68). When we analyzed clinical factors (systolic/diastolic blood pressure) as well as the analytical parameters related to prevention of reinfarction, we observed that the intervention group had good control of blood pressure and better analytical parameters, compared to the control group. Conclusions Technological support allowed participants to feel comfortable using the devices as well as resolving technical incidences by themselves after a training period. The self-management platform can be efficient in stroke survivors’ management of their disease condition, improving analytical and clinical parameters, which eventually can influence a decrease in associated comorbidities and, therefore, improvement of the disease. However, it should be noted that this type of platform is not useful for every patient profile, and studies in this regard should be expanded.

Abstract Number: 317 Abstract Title: Smart Living Homes - Whole Interventions Demonstrator For People At Health And Social Risks Abstract Status: Accepted Poster Presentation Author Name: Eunate Arana-Arri ([email protected]), Iñigo Gabilondo, Juan Carlos Gómez Esteban, Alain Luna, Tamara Palacios Bretón, Pedro de la Peña, Luis Castaño Introduction Over the past decades, mortality rates have fallen significantly around the world, leading to considerable changes in the age distribution of societies. If these added years are dominated by rapid declines in physical and mental capacity without support, the implications for older people are further negative. European healthcare systems are struggling with how to tackle the significant cost burden of chronic diseases relating to the aging population and its impact on their sustainability. Innovations could bring support to achieve better diagnosis, treatment and management across the continuum of care and prevention. Methods GATEKEEPER is a European multi-centric large-scale pilot on smart living environments. The main objective is enabling the creation of a platform that connects healthcare providers, businesses, and elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for aging populations. By 2022, GATEKEEPER will be embodied in an open source, standard-based, interoperable and secure framework. Results GATEKEEPER will demonstrate its value by scaling up, over 42 months, toward the deployment of solutions that will involve 40,000 elderly citizens in eight regional communities, from seven European Union member states. One of the main objectives is to deliver a Gatekeeper Ecosystem Transaction Space, where services for data storage and processing, big data analytics and advanced visualization of business-oriented key performance indicators are provided for the exchange of solutions, based on data sharing and value-based healthcare paradigms. Quality of life can be improved by self-management interventions that accomplish more than a single domain of change. The intervention is expected to promote a lifestyle change, not only promoting therapeutic physical activity, but also healthy lifestyles and smart homes, by empowerment of patients and their context. Conclusions GATEKEEPER will allow intervention at all levels of promotion and prevention in chronic patients. The success of these interventions depends on participation, impairment, health services use, health behavior, costs and participant satisfaction.

Abstract Number: 326 Abstract Title: Health Economic Value Of The Midline Catheter Versus Peripherally Inserted Central Catheter In Korean Inpatient Setting Abstract Status: Accepted Poster Presentation Author Name: Smeet Gala, Hana Shim ([email protected]), Sook-Young Jeon, YoonJe Euh, KwonSun Lee, KyungWoo Kwon Introduction It is estimated that over 90 percent of hospitalized patients will receive some form of vascular access device (VAD) for their treatment. Currently, patients requiring medium-term catheterization often have peripherally inserted central catheters (PICCs) placed, which are expensive, time consuming and usually for long-term catheterization. Midline catheters (MCs) are VADs placed in deep peripheral veins, with a dwell time of up to 29 days. The study aimed to evaluate if using MCs over PICCs has any clinical and economic benefits. Methods A cost-calculator was developed in Microsoft Excel 2013 to demonstrate the clinical and economic differences of using MCs over PICCs in an inpatient setting in Korea. A literature review was conducted and included eighteen studies that showed MCs have positive clinical, patient, economic, and institutional outcomes. The model captured clinical outcomes such as usage duration, complications, and costs. The time horizon was one year, and various model inputs were derived from the literature review. Results For an annual catheter utilization of MCs over PICCs, the total cost-saving was USD 3,764,994. Total treatment costs for MCs were USD 7,230,825 and for PICCs were USD 8,987,922. The total treatment costs included device cost, complication cost and labor cost related to using both MCs and PICCs. For MCs versus PICCs, device costs were USD 6,554,317 versus USD 6,563,356, complication costs were USD 106,749 versus USD 982,417, and labor costs were USD 569,759 versus USD 1,442,149. Conclusions In both the base and sensitivity analyses, results showed that MCs can be an impressive cost-saving option among patients with unnecessary PICC use in Korea. Among patients who require medium-term catheterization and use PICCs even when not targeted for central line insertion, MCs are a more cost- effective option, and MCs will benefit these patients with lesser complication rates. MCs are a suitable alternative with clinical and economic benefits that could lead to lower burden on patients and healthcare systems.

Abstract Number: 329 Abstract Title: An Australian Cost-Effectiveness Analysis Of The EluviaTM Drug-Eluting Stent For Treatment Of Symptomatic Lower-Limb Peripheral Artery Disease Abstract Status: Accepted Poster Presentation Author Name: William A. Gray, Thathya V. Ariyaratne ([email protected]), Robert I. Griffiths, Peter W.M. Elroy, Stacey L. Amorosi, Ronald L. Akehurst, Alysha M. McGovern, Stefan Müller- Hülsbeck Introduction Despite advances in endovascular interventions, including the introduction of drug-eluting stents (DES), high target lesion revascularization (TLR) rates still burden the treatment of symptomatic lower-limb peripheral arterial disease (PAD). EluviaTM, a novel, sustained-release, paclitaxel-eluting DES, was shown to further reduce TLRs when compared with the paclitaxel-coated Zilver® PTX® stent, in the IMPERIAL randomized controlled trial. This evaluation estimated the cost-effectiveness of Eluvia when compared with Zilver PTX in Australia, based on 12-month clinical outcomes from the IMPERIAL trial. Methods A state-transition, decision-analytic model with a 12-month time horizon was developed from an Australian public healthcare system perspective. Cost parameters were obtained from the Australian National Hospital Cost Data Collection Cost Report (2016-17). All costs were captured in Australian dollars (AUD), where AUD 1 = USD 0.69 (June 2020). Complete sets of clinical parameters (primary patency loss, TLR, amputation, and death) and cost parameters from their respective distributions were bootstrapped in samples of 1,000 patients, for each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed. Results At 12 months, modeled TLR rates were 4.5 percent for Eluvia and 8.9 percent for Zilver PTX, and mean total direct costs were AUD 6,537 [USD 4,511] and AUD 6,908 [USD 4,767], respectively (Eluvia average per patient savings; overall cohort=AUD 371 [USD 256]; diabetic cohort=AUD 625 [USD 431]). In probabilistic sensitivity analyses, Eluvia was cost-effective relative to Zilver PTX in 92.0 percent of all simulations at a threshold of $10,000 per TLR avoided. Eluvia was more effective and less costly (dominant) than Zilver PTX in 76.0 percent of simulations. Conclusions In the first year after the intervention, Eluvia was more effective and less costly than Zilver PTX, making Eluvia the dominant treatment strategy for treatment of symptomatic lower-limb PAD, from an Australian public healthcare system perspective. These findings should be considered when formulating policy and practice guidelines in the context of priority setting and making evidence-based resource allocation decisions for treatment of PAD in Australia.

Abstract Number: 339 Abstract Title: A Budget Impact Model of The EluviaTM Drug-Eluting Stent from The Australian Public Hospital And National Payer Perspective Abstract Status: Accepted Poster Presentation Author Name: Nishath Altaf; Thathya V. Ariyaratne ([email protected]); Adrian Peacock; Irene Deltetto; Jad El-Hoss; Shannon Thomas; Colman Taylor; Patrice Mwipatayi Introduction Improving long-term outcomes like target lesions revascularizations (TLRs) is a focus for endovascular interventions aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). EluviaTM, a paclitaxel-eluting drug-eluting stent (DES) was shown to further reduce TLRs when compared with the paclitaxel-coated Zilver® PTX® stent in the IMPERIAL trial, a global, randomized controlled study. This budget-impact evaluation investigated cost-savings from Eluvia-use when compared with Zilver PTX, relying on the 12- to 24-month outcomes from the IMPERIAL trial. Methods A budget-impact model comparing Eluvia and Zilver PTX was developed from the Australian public healthcare payer, and an individual hospital perspective, with a 5-year time-horizon. Observed trial results were applied to each year’s incident population and associated costs, and no extrapolation was conducted. The analysis used publicly available Australian national hospital cost data, population estimates, procedural statistics, epidemiological literature, and data from public hospital audits to verify eligible population for endovascular procedures (EVP) including DES. All costs were captured in Australian dollars (AUD), where AUD 1 = USD 0.69 (June 2020). Results Assuming 80-percent EVP eligibility, and a DES-use range of 10-28 percent, the 5-year model estimated potential national savings of AUD 4.3-12.1 million (M) [USD 3-8.3M] to the public healthcare payer, driven by reduced TLRs from Eluvia-use compared with Zilver-PTX. The model projected potential national savings of AUD 33.1-92.6M (USD 22.8-63.9M) to individual hospitals through reduced hospital bed days for adverse events (AE). The model forecasted 14,428-40,399 treated patients; 1,499-4,198 fewer TLRs; and 16,515-46,243 fewer hospital days for AE. At a state level, projected hospital savings were: New South Wales AUD 10.9-30.7M [USD 7.5-21.1M]; Victoria AUD 8.4-23.4M [USD 5.8-16.1M]; Queensland AUD 6.5-18.3M [USD 4.5-12.6M]; Western Australia AUD 3.4-9.5M [USD 2.3-6.5M]; South Australia AUD 2.3-6.4M [USD 1.6-4.4M]. Conclusions Treatment of symptomatic lower-limb PAD with the Eluvia DES could lead to potential savings for the Australian healthcare system, at the national, state, and the local hospital level, based on improved patient outcomes.

Abstract Number: 349 Abstract Title: Use Of Applications For Mobile Devices In Asthma Control: A Systematic Review Of Literature Abstract Status: Accepted Poster Presentation Author Name: Caroline Pavin Lacerda, Katiuce Tomazi Kny ([email protected]), Maria Angélica Pires Ferreira Introduction Cell phones and information technology can be allies in the care of chronic diseases. Despite the wide availability of mobile device applications (apps), many offered by industry and providers, questions remain about the real efficacy of these technologies. The objective of this study was to evaluate the efficacy of mobile device apps designed for use by outpatients in treatment for asthma and describe its main characteristics and functionalities. Methods A systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) protocol was conducted. MEDLINE and EMBASE were searched for randomized clinical trials (RCTs) evaluating the adoption of mobile apps on Android or iOS systems compared to the usual care, published in the last five years. Asthma control rate was defined as the primary outcome, and visits to emergency departments, hospitalizations and adherence to pharmacological treatment were secondary outcomes. Results Four RCTs (n=415) met the inclusion criteria, two involving children and adults, and two only adults. Methodological quality was low to moderate. Common functionalities were asthma action plans, registration of the usual treatment, symptom diaries and educational alerts. Results were heterogeneous with respect to all outcomes evaluated. Study dropouts and lack of follow-up were frequent. Conclusions The clinical utility of mobile apps for asthma was evaluated in a few randomized studies; more data are necessary to establish the value of these technologies for asthma control.

Abstract Number: 350 Abstract Title: Study On The Awareness, Willingness To Pay And Satisfaction With Non-Invasive Prenatal Testing Among Pregnant Women Abstract Status: Accepted Poster Presentation Author Name: Changjia Fan ([email protected]), Wenru Shang, Jiayan Huang, Yang Wan Introduction Birth defects seriously affect children's survival and quality of life and bring great suffering and financial burden to children and their families. Down's syndrome is one of the most common birth defects. Compared with traditional serological screening methods, non-invasive prenatal testing (NIPT) has higher sensitivity and specificity in the screening of Down's syndrome. In April 2017, the People's Government of Fuyang City, Anhui Province launched a NIPT free screening program. From the perspective of the beneficiary, this research investigated the awareness, willingness to pay and satisfaction of pregnant women in Fuyang City, Anhui Province, to better improve the use of NIPT. Methods A questionnaire survey was conducted on 1,221 pregnant women who experienced this program in Fuyang City, Anhui Province. Multivariate ordered logistic regression models were established to analyze the factors affecting the satisfaction of NIPT. Results A total of 1,217 valid questionnaires were collected. Research indicated 82.5 percent knew about NIPT and 81.9 percent were willing to pay personally when its price was CNY 800 (USD 113.88) per test among pregnant women. The satisfaction of pregnant women with NIPT showed that the waiting time for test results was relatively low (4.5 out of 5 points) compared with other aspects of satisfaction. The higher the education level of the pregnant women, the lower their satisfaction with NIPT. Conclusions It is necessary to pay attention to the characteristics of education and to improve the awareness and satisfaction of NIPT among pregnant women. Meanwhile, if it is affordable enough for NIPT services to be provided by the government, this mode should be promoted. In conjunction with the willingness to pay of pregnant women, NIPT payment methods should be developed appropriately.

Abstract Number: 352 Abstract Title: Systematic Review Of Clinical Effects Of Different Thermal Insulation Measures In Patients Undergoing Major Surgery Abstract Status: Accepted Poster Presentation Author Name: He Xu, Yijuan Lu, Xin Guan, Aixia Ma, Wenxi Tang ([email protected]) Introduction Hypothermia (core temperature <36°C) during major surgeries could result in a number of adverse events such as surgical site infection, bleeding, and prolonged hospital stay. The incidence of intraoperative hypothermia was 44.3 percent in China in 2015, with only 10.7 percent of patients receiving effective hypothermia prevention measures during major surgeries. By systematically examining the adverse risks for patients using different warming measures (active and passive), our study discussed the potential of bringing the most effective one(s) into clinical guidelines. Methods Articles, ongoing trials and grey literatures were retrieved from PubMed, The Cochrane Library and Clinical Trials till February 2019. Bair HuggerTM (BH) was determined to be the reference group and all randomized controlled trials including BH were included. In the control group, we kept all possible warming measures. Adverse effect indicators were decided using scoping reviews and then applied in literature screening. Type (open/endoscopic) and length of surgery were included in sub-group analysis. Results A total of forty-two studies were included, with twenty-seven of them passive insulation measures and fifteen active measures. Compared with passive measures, BH had significant advantages, such as in surgical site infection (risk ratio [RR]=0.13, 95% confidence interval [CI]: 0.05, 0.80), chills (RR=0.37, 95% CI: 0.25, 0.54) and hospitalization stay (mean difference [MD]=-1.27d, 95% CI: -2.05, -0.48). Compared with active insulation measures, BH had no significant advantages. Patients with open or longer surgeries (≥2 hours) experienced higher risks. Conclusions Generally, an active warming system is more effective in lowering risks (e.g., hypothermia, surgical site infection, chills, length of stay) than passive ones, especially for patients going through non-endoscopic or longer surgeries. Among the active warming systems, BH does the same job as other active insulation measures. Given that the practice of peri-operative hypothermia prevention using active warming systems is not popular in China, the use of BH and other active insulation measures during major surgeries are recommended to improve the safety and potentially reduce the cost of treating those clinical adverse events.

Abstract Number: 355 Abstract Title: Evolution Of Health Technology Assessment For Rare Diseases In Asia Abstract Status: Accepted Poster Presentation Author Name: Tarveen Jandoo ([email protected]), Baris Deniz, Shuo Yang Introduction We reviewed the health technology assessment (HTA) guidelines for therapies targeting orphan conditions in four countries/regions in Asia. Methods A pragmatic literature search was conducted to identify and review key documents outlining reimbursement, pricing, and coverage policies in China, Taiwan, Korea, and Japan. Results Therapies for rare diseases in Japan and those for ultra-rare diseases in Korea are exempt from cost- effectiveness evaluations. Taiwan provides full financial coverage for rare disease therapies. China has no special considerations for rare diseases. Drugs included in the medical insurance list are reimbursed at varying levels depending on the “class” of the listing. Unlike prior variations at provincial levels for coverage of off-the-list drugs, new national policy has introduced consistency in coverage. Conclusions Access and reimbursement processes vary between markets in Asia. New HTA guidelines in Japan allow for easier access to therapies targeting rare diseases by eliminating cost-effectiveness analysis for price determination. On the other hand, a value dossier including an economic evaluation is necessary for rare diseases in Korea. However, manufacturers can provide risk-sharing schemes for rare diseases. China has not yet introduced any specific evaluations or reimbursement criteria for therapies targeting rare diseases. Policies for rare diseases are evolving rapidly to improve access and affordability.

Abstract Number: 369 Abstract Title: Development Of A Dysmenorrhea Quality Of Life Scale Based On Traditional Chinese Medicine Theory: A Mixed-Methods Study Abstract Status: Accepted Poster Presentation Author Name: Gengliang Bai ([email protected]), Minghui Hu, Yue Liu, Yingxiong Wu, Kan Tian Introduction It is difficult to generalize health technology assessment in the field of traditional Chinese medicine (TCM). The lack of an outcomes evaluation system based on TCM theory is one of the important reasons. Studies conducted in menstruating women have shown that the prevalence of primary dysmenorrhea varies from 45 to 95 percent. As a debilitating condition for many women, dysmenorrhea is one of the leading causes of absenteeism from school or work, which has a negative effect on quality of life (QoL). TCM has obvious advantages in treating dysmenorrhea. This study aimed to develop a dysmenorrhea QoL scale based on TCM theory. Methods We conducted focus group discussions and in-depth interviews with TCM gynecologists and patients, and adapted items from previously published scales. We generated an initial pool of forty-one items with eight domains. The Delphi method was used for preliminary item selection. Then, we administered the items to a sample of adolescent girls (n=200). The distribution of survey items, discrete trend, factor analysis, correlation coefficient, and Cronbach's α coefficient were used to select items. Results After two rounds of expert consultation, a total of thirty items were included in the dysmenorrhea QoL scale. And after sample analysis, four items' frequency distribution was skewed, five items' standard deviation (SD) was <0.8, four items' factor loading was <0.4, five items' score correlation coefficient with a related domain was <0.4, and three items’ deletion would cause their domain's Cronbach's α coefficient increased. The items were deleted when they met more than two above standards. Conclusions A total of twenty items with eight domains were included in the dysmenorrhea QoL scale. The methods to select the dysmenorrhea QoL scale items based on TCM theory were preferable. Given the paucity of research in this area, this new dysmenorrhea QoL scale may provide opportunities for patient-reported outcome evaluation in the field of TCM.

Abstract Number: 374 Abstract Title: Low-Density Lipoprotein Cholesterol Management Among Atherosclerotic Cardiovascular Disease Patients In China: A Protocol Abstract Status: Accepted Poster Presentation Author Name: Zhu H ([email protected]), Li J, Yang X, Zhang R Low-density lipoprotein cholesterol (LDL-C) plays a key role in the development and progression of atherosclerotic cardiovascular disease (ASCVD). Decreasing LDL-C may reduce the risk of cardiovascular events and all-cause deaths in patients with acute coronary syndrome (ACS). As average blood lipid levels in the Chinese population has continued to increase in the last 30 years, we aimed to investigate management of LDL-C among ASCVD patients using large-scale real-world hospital data in China. Methods A retrospective study was conducted among ASCVD patients, including ACS, ischemic stroke, coronary heart disease (excluding ACS), and peripheral artery disease. Patients diagnosed with ASCVD between 1 January 2015 and 31 December 2017 were recruited from multi-centers, and followed up until 30 June 2018. Hospital electronic medical information data (e.g. electronic medical record, hospital information system, and laboratory information system) of the multi-centers were retrieved. Results LDL-C levels and control rates of LDL-C (<1.8 mmol/L) among the ASCVD population during their hospitalization, first-year after discharge, and second-year after discharge will be analyzed retrospectively. The study will also describe the characteristics of ASCVD patients (risk factors, risk factors include demographic characteristics, smoking status, blood pressure, BMI, HbA1c, TC, HDL-C, hypertension, diabetes mellitus, etc.). Conclusions Real-world data will observe risk factors of cardiovascular disease, as well as control rate of LDL-C in Chinese ASCVD patients.

Abstract Number: 382 Abstract Title: Research On The Second-Line Anti-Tuberculosis Drugs Supply Based On Stakeholder Theory Of China Abstract Status: Accepted Poster Presentation Author Name: Zhao Liu, Lijun Shen, Fan Zhang, Tiantian Du, Yuehua Liu ([email protected]) Introduction China is one of the twenty-seven countries with a high burden of Multidrug-resistant tuberculosis (MDR- TB) in the world. Of the new TB patients in China in 2017, about 63,000 are MDR-TB patients, accounting for one-third of the number of new MDR-TB patients worldwide. In the latest “China's 13th Five-Year Plan” national TB prevention and control plan promulgated in 2017, it is clearly emphasized that all regions should gradually incorporate TB into the payment catalogue of special outpatient medical insurance, according to local conditions. However, for this special group of MDR-TB patients, there is no specialized prevention and control policy at the national level, and there are also blind spots in the medical security policy. Responding to the drug needs of MDR-TB patients, it is necessary to provide patients with stable and affordable second-line anti-TB drugs. It is also necessary to understand the overall drug demand for second-line drugs nationwide to guide further policy formulation and budget research. Methods Through semi-structured group interviews and key informant interviews, five provinces and cities were investigated. Qualitative analysis was conducted based on stakeholder theory selected doctors and staff from Centers for Disease Control. Results Through investigations in this study, problems like low purchasing price, insufficient purchasing volume, low drug supply efficiency, and monopoly producers were found. Through the analysis of roles and relationships among the major stakeholders in the second-line drug supply system, together with the motivation and resistance factors, it was found that all stakeholders have the motivation to solve the problem and face their dilemmas and obstacles at the same time. Conclusions Patients with MDR-TB still have difficulties in obtaining medicines. The interests of various stakeholders need to be balanced to improve drug accessibility and affordability. It is recommended to take advantage of the country's centralized procurement, encourage the development and listing of new anti-tuberculosis drugs and generic drugs, and improve the supervision system to ensure the supply of drugs to benefit more patients with tuberculosis.

Abstract Number: 383 Abstract Title: Assessment Of The Implementation Effect Of Health Poverty Alleviation Policy: A Case Study Of Hebei Province, China. Abstract Status: Accepted Poster Presentation Author Name: Yuehua Liu ([email protected]), Chen Chen , Zhao Liu, Fan Zhang, Tiantian Du, Kun Zhao Introduction Since the 18th National Congress of the Communist Party of China (CPC), remarkable achievements have been made in poverty alleviation. Over the past five years, the population of people living in poverty had decreased by 68.53million, fallen from 98.99 million in 2012 to 30.46 million at the end of 2017. As an impoverished province, Hebei province has been implementing the CPC Central Committee’s guidance in the battle against poverty. In 2016, the government released the Implementation Scheme Plan for Improving the Level of Medical Security and Assistance. The plan introduces multi-layer medical security and assistance mechanisms which covers basic medical insurance, major disease insurance and medical assistance. In 2017, the government formulated the Implementation Plan for the Three-Batch Action Plan on the Health Care Program for Poverty Alleviation in Hebei Province, for people with major disease. Hebei Province has carried out many explorations on the health care program for poverty alleviation, and its effectiveness is a problem worthy of attention. Methods Based on data including basic medical insurance, major illness insurance, medical assistance, and other related information, we used descriptive statistics and quantitative methods to evaluate the overall expenditure of the poverty alleviation for Hebei province and the areas under its jurisdiction. Additionally, the expenditure of different levels of medical security system, the medical burden for people facing poverty and the distribution of disease in the population with assistance were evaluated. Results The out-of-pocket payment per capita has decreased year by year, and it has dropped to 3% of catastrophic medical expenditure and 20% below the poverty line by June 2018. An imbalanced situation occurred with the implementation, with the more impoverished areas having greater the pressure on medical care and poverty alleviation. For people with medical assistance, diseases with higher population and overall expenditure are cerebrovascular disease, malignant tumor, diabetes and some other chronic diseases. Conclusions The health policies for poverty alleviation in Hebei province has achieved a remarkable success, and the medical burden of the poor has been significantly reduced. However, the implementation of the policies in various cities has shown an imbalanced situation, and the poverty alleviation policies need to be further improved.

Abstract Number: 385 Abstract Title: Using Common Data Models And Data Networks For Evidence Generation In Health Technology Assessment Abstract Status: Accepted Poster Presentation Author Name: Seamus Kent ([email protected]), Jacoline Bouvy Introduction Differences between healthcare datasets in structure, content, and coding systems are widely recognized as significant barriers to generating robust evidence for regulatory and medical decision making. As a result, there is a growing interest in using common data models embedded within large data networks. By standardizing the structure, contents, and semantics of disparate healthcare databases, common data models like the Observational and Medical Outcomes Partnerships common data model (OMOP-CDM) enable multidatabase studies to be undertaken at speed and in a transparent way. To date, little attention has been given to their potential role in health technology assessment (HTA). Methods We identify the uses of observational data in generating evidence in HTA, some common analytical challenges faced in their estimation, and the infrastructural, technical, and data reusability constraints that limit its wider use. We discuss where and how the OMOP-CDM could overcome these barriers in relation to different types of evidence requirements. Results The OMOP-CDM increases the interoperability of otherwise disparate datasets, allowing reliable evidence to be generated from multidatabase studies at speed and transparently. The current analytical tools are best suited for clinical characterization and population-level effect estimation. Further developments to these tools are required to support analyses common in HTA like parametric survival modeling. Differences in costing methods as well as the structure of healthcare delivery between countries may limit the feasibility and value of standardization. Conclusions The OMOP-CDM has the potential to support reliable and timely evidence generation in HTA. The analytical tools should be further developed to support common HTA use cases.

Abstract Number: 387 Abstract Title: Budget Impact Analysis Of Adalimumab In The Treatment Of Ankylosing Spondylitis In China Abstract Status: Accepted Poster Presentation Author Name: Chengaxin Duan ([email protected]), Binyan Sui, Kun Zhao, Dandan Ai, Qian Xu Introduction Ankylosing spondylitis (AS) is a common disease that causes pain and affects productivity. Tumor necrosis factor-α (TNF-α) like adalimumab can bring better clinical efficacy and improve quality of life. Adalimumab is likely to be covered by health insurance. It is necessary to assess the impact of adalimumab for patients with AS on the medical insurance budget in China. Our research aims to give support evidence for policy-making. Methods From the perspective of medical insurance payers, a budget impact model was established to evaluate the impact of adalimumab for the treatment of adults with severe active AS that has responded inadequately to conventional therapy. The time horizon was 5 years (2020-2024). The cost of measurement included drug and treatment costs for adverse events. Scenario analysis was conducted to evaluate the results under different drug price reimbursement ratios and treatment ratios. Results Based on the current price of adalimumab (CNY 3,160 [USD 446]/unit), under the reimbursement ratio of 70 percent, adalimumab will increase medical insurance expenditure by CNY 162 [USD 22] million, CNY 152 [USD 21] million, CNY 114 [USD 16] million, CNY 100 [USD 14] million and CNY 88.11 [USD 12] million in the next 1-5 years, respectively. The increased medical insurance expenditure accounts for 0.091, 0.085, 0.064, 0.056, and 0.049 percent of the annual medical insurance expenditure in the next 1- 5 years, respectively, which is assumed to be equivalent to the expenditure in 2018 of CNY 1782.2 [USD 251] billion. Conclusions The budget impact of adalimumab for AS on medical insurance expenditure is limited, and including adalimumab in the medical insurance catalogue can reduce the burden on individuals, enrich treatment options, and satisfy clinical needs better.

Abstract Number: 391 Abstract Title: Economic Analysis Of Treatment For Spinal Muscular Atrophy: A Scoping Review Abstract Status: Accepted Poster Presentation Author Name: Chengaxin Duan ([email protected]), Binyan Sui, Kun Zhao, Dandan Ai, Qian Xu Introduction Spinal muscular atrophy (SMA) is a rare, life-threatening, and seriously debilitating neuromuscular disorder, which has a heavy burden on patients, caregivers and the health system. Technological advances have improved clinical effect, but have also increased the financial burden. There is limited information in the literature on the resource utilization and economic burden of SMA. Our research aims to summarize the current literature on resource use, cost and economic evaluations of treatments for SMA, to inform further research and policy decision making. Methods Databases, including PubMed, Embase, Cochrane Library and CRD Database, were searched from inception. Two reviewers undertook title and abstract screening followed by full-text screening, and any disagreement was resolved in consensus. Data extraction was conducted using a customized form. Included studies were summarized using narrative synthesis structured around general and economic characteristics. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were adhered to where applicable. Results We reviewed 552 abstracts and included twenty-six from 2015 to 2019. Four-fifths were published in the United States and Europe. Five full economic evaluations and one budget impact analysis compared nusinersen with AVXS-101 or best supportive care, and the remaining evaluated the economic burden of SMA. The most common outcomes were healthcare resource utilization and direct medical costs, only a few studies evaluated direct non-medical costs or indirect cost. Conclusions SMA patients have significant medical expenditures and high utilization of healthcare services, including nusinersen-treated patients. The results highlight the substantial burden of treatment for SMA, not only for patients but also for their caregivers. SMA represents a significant hidden cost that society should be made aware of, and that should be considered in the design, implementation and evaluation of support programs for people who suffer from this disease and their families, as well as in the economic evaluation of new treatments.

Abstract Number: 399 Abstract Title: Analysis Of Referral Patterns To Specialized Centers In Idiopathic Pulmonary Fibrosis To Define A New Regional Care Pathway Abstract Status: Accepted Poster Presentation Author Name: Rossella Di Bidino ([email protected]), Luca Richeldi, Paola Rogliani, Alfredo Sebastiani, Alberto Ricci, Francesco Varone, Americo Cicchetti Introduction Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease. Due to insufficient awareness of the disease, and the lack of specificity of clinical and physiological signs, the diagnosis of IPF is often delayed. In the Lazio Region (Italy) four reference centers manage patients with IPF. The objective of this analysis is to support the definition of a new regional care and therapeutic pathway (Percorso Diagnostico Terapeutico Assistenziale [PDTA]) for IPF to anticipate the moment of diagnosis by reference centers. The delayed referral to specialized centers has clinical consequences both in terms of survival and access to treatments. Methods A survey collected aggregated evidence on factors associated with referral patterns to specialized centers for IPF. Its content was defined on the basis of a literature search, the experience of involved clinicians, and hospital data sources. The survey considered patients diagnosed with IPF by the network of reference centers from 2014 to 2018. Aggregated data on the pre-diagnosis pathway and evidence on organizational features of each reference center were collected. Results Patients with a confirmed diagnosis of IPF increased from 2014 (n=81) to 2018 (n=344). A similar trend emerged considering only older patients. Incidence rates reached 11.33 cases per 100,000 residents in 2018. The majority of patients had a diagnosis in time to access to available treatments (87% in 2018). The number of specialists in multidisciplinary teams didn’t change in a significant way. GPs, pneumologists, and IPF centers emerged as the pillar of the de-facto PDTA. Conclusions A new regional care and therapeutic pathway has been proposed to improve treatment of IPF. The first goal is to improve interaction among GPs, pneumologists, and IPF centers along the natural course of the disease. Criteria for referral to IPF centers has been defined (i.e. high-resolution computed tomography) as well as for adoption of a hub-and-spoke approach based on telemedicine.

Abstract Number: 400 Abstract Title: Cost-Effectiveness Analysis Of Adding Bedaquiline To Drug Regimens For Multidrug- Resistant Tuberculosis Treatment In China Abstract Status: Accepted Poster Presentation Author Name: Fan Zhang ([email protected]), Yuehua Liu, Zhao Liu, Zining Guo, Junting Yang, Kun Zhao Introduction According to the World Health Organization, there were approximately 0.5 million new cases of rifampicin-resistant tuberculosis in 2018, of which 78 percent were multidrug-resistant tuberculosis (MDR-TB), and China has one of the largest shares of the global burden (14%). In recent years, the Chinese government has made progress in TB control and prevention, but for MDR-TB, treatment options are still limited and expensive, and novel drugs are not always available. This research aims to evaluate the cost-effectiveness of adding bedaquiline to a background regimen (BR) of drugs for MDR-TB treatment in China, and to provide evidence for government to improve public health policies. Methods A cohort-based Markov model was developed to evaluate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR alone in MDR-TB treatment, over a 10-year time horizon. Data were sourced from a phase II clinical trial, real-world data in China, published literature, and expert opinion. Outcomes were evaluated in quality-adjusted life years (QALYs) and life-years gained (LYG). The discount rate was 3.5%. Probabilistic and deterministic sensitivity analyses were conducted. Results The discounted costs per person for BBR was CNY 135,706 [USD 19,172], compared with CNY 92,465 [USD 13,063] for BR. The discounted utility per person for BBR was also higher than that for BR (3.943 QALYs versus 3.193 QALYs). The ICER of BBR was CNY 58,096 [USD 8,208]/QALY, which was lower than the willingness-to-pay threshold of CNY 212,676 [USD 30,046] (three-times the gross domestic product per capita). Therefore, BBR was considered to be cost-effective. The sensitivity analysis confirmed the robustness of the results. BBR remained cost-effective in the sensitivity analysis, with a 77.2 percent probability of being cost-effective versus BR. Conclusions In China, bedaquiline is not included in the National Reimbursement Medicine List, which results in a heavy financial burden for MDR-TB patients. From this study, BBR was cost-effective by significantly reducing time to sputum culture conversion and increasing QALYs and LYGs, which offset the higher drug costs.

Abstract Number: 404 Abstract Title: Effect Evaluation Of Two Family Doctor Contracting Service Models On Diabetic Patients: A Real-World Study In Chengdu, China Abstract Status: Accepted Poster Presentation Author Name: Li Zhou, Xingyue Zhu, Hongyuan Liu, Yanli Huang, Ming Hu ([email protected]) Introduction To strengthen the care capacity of primary facilities, China has vigorously promoted the construction of a hierarchical medical system and a family doctor care system. In July 2017, a family doctor care plan was launched in an urban district of Chengdu, Sichuan Province, and two family doctor contracting service models were adopted, one provided a basic-service package and the other a paid-service package. In order to evaluate the effect of different models on diabetic patients, this study conducted a real world study based on the district healthcare database. Methods Diabetic patients who contracted family doctor services January 2018 to January 2019 as reported in the database were enrolled in the paid- or basic-service group. Propensity score matching (PSM) was conducted to balance the distribution of covariances between the groups. The results of the first and last examination of glycosylated hemoglobin, low-density lipoprotein cholesterol (LDL-C), systolic and diastolic blood pressure in the groups were compared by independent sample t-test and chi-square test. Results Included were 4,871 patients in basic-service and 394 patients in paid-service. In both groups the total control rates of blood pressure, glycosylated hemoglobin and LDL-C at the last physical examination were 43.67, 79.28 and 51.11 percent, respectively, a significant increase from pre-test. The combined control rates of HbAlc, LDL-C and blood pressure in the basic- and paid-service group were 20.76% and 22.37%, respectively. After PSM, there was no significant difference between the groups. Conclusions Up to now, there is no significant difference between basic-service and paid-service family doctor contracting service models in improving the comprehensive control rate of diabetic patients. The possible reasons may be that the quality and content of paid-service is not as good as expected, the period of implementation is not long enough and the sample size of paid-service patients is limited.