HTAi Annual Meeting Poster Presentation Abstract Book

Poster Abstracts THE ROAD TO POLICY AND CLINICAL INTEGRATION June 24-28,2023 htai2023.org #HTAi2023Adelaide

Poster Presentation Number: PP01 Abstract Title: Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach Author Names: Enti Zhang, Elena Annoni, Liesl Strachan ([email protected]) Introduction. Cervical artificial disc replacement (C-ADR) is not a new technology but one that has seen many technological advances in the past 10 years. Indeed, a recent review described total disc arthroplasty as the most innovative development in the history of spinal surgery. The primary goals of C-ADR are to reduce or eliminate pain, and restore normal segmental motion. The aim of this analysis was to identify, extract and examine key health outcomes and economic data from published health technology assessment (HTA) reports on C-ADR, with the aim of understanding how the evolution of this technology has influenced assessments internationally. Methods. A comprehensive search of over 90 HTA organization websites and the INAHTA HTA database using key terms for C-ADR surgical procedures was coupled with a literature search of recent systematic reviews. No language restrictions were applied. Results. Twenty HTA reports of C-ADR surgery published from 2005 to 2022 were included for review. Several HTAs (4/20) were updates or reassessments by the same agency and one was an update across agencies (Italy update of Belgian HTA). While many of the HTAs concluded C-ADR is as effective as standard care and superior in certain outcomes, there was no pattern or consistency in the conclusions or recommendations from these assessments, even as the evidence base expanded over time. Our analysis found this was largely due to variations in HTA approaches among agencies including: differences in research questions asked, PICO (Population, Intervention, Comparator, Outcomes) criteria and methods performed, such as: rapid versus full systematic reviews; inclusion of economic evaluations and/or budget impact analyses. Indeed, one of the only predictive factors for a positive HTA was a favorable cost-effectiveness analysis. Conclusions. C-ADR is an established technology with extensive HTA investigation internationally. The lack of a consistent approach taken by HTA bodies made prediction of successful HTA outcomes difficult. Future alignment of key evaluation processes and methods may help address current international variations and support consistent decision making on patient access.

Poster Presentation Number: PP03 Abstract Title: Neurosphere Digital Clinic Platform For Patients With Neurological Disorders: Is Clinical Implementation Aligned With Policymaker Objectives? Author Names: Bharat Phani Vaikuntam ([email protected]), Shebnem Erdol, John Gillespie, Arif Fahim Introduction. The burden of neurological disorders such as Parkinson’s Disease (PD) is increasing with the aging population in Australia and around the world. Around 82,000 (2018) and 1.6 million (2016) people are estimated to be living with PD and chronic pain in Australia respectively, with a substantial cost to the health care system. Neuromodulation therapies like Deep Brain Stimulation and Spinal Cord Simulation have been proven to be an effective long-term treatment for people with neurological disorders like PD and chronic pain. Maintaining the efficacy of neuromodulation therapies necessitates regular symptom monitoring with timely clinical reviews to optimize neurostimulator programming. However, patient access to care is limited by barriers such as distance, disability and geographical distribution of specialist neurologists. To overcome these barriers, clinical and policy integration is required to enable timely and funded access to health innovations. These access challenges in a country such as Australia where patients may need to travel large distances to see specialists, further exacerbated by COVID-19 environment, have led to an increasing demand for an integrated wireless remote-care platforms. Abbott’s personalized Digital clinic software, NeuroSphere™ can facilitate the clinician to remotely review and reprogram stimulation parameters of the patient through videoconferencing. Healthcare policy makers in Australia have recognized this patient need by implementing funding of remote patient review and neurostimulator reprogramming for patients with chronic neuropathic pain and PD. Methods. We aim to review the utilization of the remote programming procedures following the reimbursement coverage implementation from November 2022 to assess the timeliness of digital clinical adoption. Results. The Medicare Benefits Schedule (MBS) utilization statistics will be analyzed to determine the state-based breakdown of utilization trends including the uptake rate, growth rates and the proportion of face-to-face procedures shifted to remote follow-up enabled by a Digital Clinic. Conclusions. As an alternative to in-person consultations, remote programming platforms will enable patients with mobility disorders and chronic pain overcome their access barriers and achieve better clinical and cost-effective outcomes.

Poster Presentation Number: PP04 Abstract Title: Developing A Streamlined Health Technology Assessment Framework For Positron Emission Tomography/Computed Tomography For Uncommon Cancers Author Names: Ning Ma, Danielle Stringer ([email protected]), David Tivey Introduction. The current health technology assessment (HTA) project aims to streamline the public funding model of positron emission tomography/computed tomography (PET/CT) for the initial staging of uncommon and rare cancers in Australia. The project has completed its pilot stage, where the generic economic model (GEM) with the associated triaging criteria has gone through two validations and five case studies. Rare and uncommon cancer indications are firstly subject to a multi-criterion triaging process to which a GEM is suitable. Once eligible cancers are determined, they will be evaluated via the GEM for their cost-effectiveness. Methods. The GEM is a decision-tree model with a 12-month time horizon in the base case. The model is designed to capture key decisions during the initial staging process of any cancers. The model can also produce both cost- effectiveness and cost-utility analysis outcomes. The cost-effectiveness outcome focuses on the incremental cost per additional optimal treatment allocation, whereas the cost-utility analysis generates the incremental cost per quality-adjusted life-year gained. The two validations of the GEM were undertaken using breast cancer and pancreatic cancer, which were considered internal and external validations, respectively. Results. The results of the two validations by GEM had consistent results compared to the original model. The five case studies were undertaken using anal cancer, biliary cancer, Merkel cell carcinoma, Langerhans cell histiocytosis (LCH), and gastrointestinal stromal tumor (GIST). For the first three cancers, PET/CT was found likely to be cost-effective. For LCH and GIST, PET/CT was not found to be cost-effective for initial staging. Conclusions. The pilot stage of the PET/CT project has shown the value of using generic models to evaluate health economic outcomes. Also, it provides significant lessons to finalize the streamlining process further and provide a foundation to expand GEM to other oncological applications such as treatment response monitoring and restaging.

Poster Presentation Number: PP07 Abstract Title: Vaccine Decision-making In Canada: Processes And Guidelines For Using Economic Evidence Author Names: Beate Sander ([email protected]), Murray Krahn, Stirling Bryan, Werner Brouwer, Mark Jit, Karen Lee, Monika Naus, Sachiko Ozawa, Lisa Prosser, Nina Lathia, Man Wah Yeung, Austin Nam, Ashleigh Tuite, Althea House, Matthew Tunis Introduction. Canada’s National Advisory Committee on Immunization (NACI) makes recommendations on the use of human vaccines. Provinces and territories subsequently use the advice to make decisions on public funding and program implementation. Traditionally, NACI reviewed vaccine characteristics and burden of illness. With its recent expanded mandate, NACI now considers cost-effectiveness via economic evaluations, among other decision determinants. As such, new processes and guidelines were needed to formalize the incorporation of economic evidence into federal vaccine decision-making. Methods. Two task groups were convened respectively to develop NACI’s “Economic Process” and “Guidelines for the Economic Evaluation of Vaccination Programs in Canada”. The groups conducted environmental scans to inform their work, as well as engaged with government partners, decision-makers, academics, national immunization technical advisory groups from other countries, health technology assessment agencies, industry, patient groups, among others. Results. The Economic Process outlines when and how NACI incorporates economic evidence for vaccine recommendation. For instance, it describes how policy questions are prioritized given institutional capacity constraints for generating economic evidence. It also describes how policy questions are assessed to determine the appropriate type of economic evidence required (i.e., systematic review, economic evaluation, multi-model comparison of external models). The Economic Guidelines provide recommendations in 15 chapters on how to conduct economic evaluations (i.e., from defining the decision problem to reporting). Unlike other health technologies, vaccines have the potential to affect both vaccinated and unvaccinated individuals. Hence, the Guidelines consider population- level impacts such as externalities (e.g., herd immunity, age-shifting of disease) and spillover effects. They also discuss equity considerations and non-health impacts of vaccines such as to productivity, consumption and education. Conclusions. The Economic Process and Economic Guidelines promote the generation and use of credible and standardized economic evidence. They advocate for transparency, allowing evidence to be used across jurisdictions beyond

Canada. Next steps include documentation of user feedback, incorporation of Indigenous considerations, and formal evaluations.

Poster Presentation Number: PP09 Abstract Title: Capturing Broader Effects Of Influenza Vaccination Program In Economic Evaluation: Systematic Literature Review Author Names: Seulki Choi ([email protected]), Joshua Byrnes, Hansoo Kim Introduction. Decision-making for vaccination programs requires additional consideration on broader effects. The cost- effectiveness guidelines published by the Professional Society for Health Economics and Outcomes Research (ISPOR) working group recommends considering broader effects such as herd protection. Whilst difficulty to produce robust data for such factors might hinder quicker decisions, they are important features of vaccination programs and some of them were the narratives that dominated over the COVID-19 pandemic. In this systematic literature review, the perspectives taken and inclusion of broader effects were investigated for recent influenza vaccine economic evaluations. Methods. The search strategy based on the terms influenza vaccination and cost-effectiveness was carried out on Embase and PubMed. Considering the publication date of the ISPOR guidelines, articles since 2019 were searched. The review focus was the perspectives taken and inclusion of broader benefits in the analysis. A link between perspective and inclusion of broader effects was tested with a Chi-square test. Results. The total number of full cost-effectiveness articles screened was 48. Of those, the number of articles performed from both the perspectives was 18 (37.5%), and 13 articles (27.1%) considered the perspective of payer only. For those that had both perspectives considered, the ICER reported from the societal perspective was consistently lower than that from the payer perspective. Thirty-one articles (65%) included any of the broader effects. However, broader effects considered were limited to indirect protection (17 articles, 35.4%) and productivity loss (22 articles, 45.8%). The relation between perspective and inclusion of broader effects was significant (p=0.04). Conclusions. This review highlights that studies performed using both payer and societal perspectives as recommended by the ISPOR research guidelines are not many, while more favorable outcomes were presented when the societal perspective was adapted. Broader effects included are productivity loss and indirect protection. For other broader effects specified in the research guidelines, there are not many attempts to include those in economic evaluations.

Poster Presentation Number: PP10 Abstract Title: Preventing The Winter Quadruple Threat: The Value Of Hospital Bed Capacity Freed Up By Vaccination Author Names: Margherita Neri, Simon Brassel, Hannah Schirrmacher, Diana Mendes, Andrew Vyse, Lotte Steuten, Elizabeth Hamson ([email protected]) Introduction. Hospitals in England experience extremely high levels of bed occupancy in the winter. In these circumstances, vaccine-preventable hospitalizations due to seasonal respiratory infections, have a high cost because of the missed opportunity to treat other patients on the waiting list. This study sought to generate evidence on the hospitalizations that vaccines for older adults against seasonal influenza (flu), pneumococcal disease (PD), respiratory syncytial virus (RSV) and COVID-19 may prevent during the winter season (October-March) in England. The monetary value of the vaccine-preventable hospitalizations was estimated using a conventional reference costing method and a novel opportunity costing approach. Methods. Based on retrospective analysis of Hospital Episode Statistics data on hospitalizations in England, and efficacy and observed coverage rates per vaccination program, we estimated the number of bed-days that current vaccines against flu, PD and COVID-19, and a hypothetical RSV vaccine, could free up by preventing hospitalizations in the winter among older adults. We valued the freed-up bed-days (1) as the cost of prevented hospitalizations (reference cost); (2) as the Net Monetary Benefit (NMB) generated by alternative uses of the freed-up bed-days. The opportunity cost of vaccines-preventable hospitalizations is (2) when they would be an optimal use of beds or (1)+(2) when they would be a suboptimal use. Results. In the winter months, vaccination programs targeting flu, PD and RSV for older adults could collectively prevent 72,813 bed days and save over GBP45million (USD56 million) in hospitalization costs. The COVID-19 vaccine could prevent over 2 billion bed days and save £1.3 billion. Importantly, the value of hospital beds freed up by vaccination is likely to be 1.1–2 times larger (GBP48–GBP93 million [USD60-116 million] for flu, PD and RSV; GBP1.4–GBP2.8 billion [USD1.8-3.5 billion] for COVID-19) when quantified in opportunity cost terms. Scenario analysis replacing the current vaccine used in the adult PD program with the newly licensed pneumococcal conjugate 20-valent vaccine (PCV20), would increase the impact of each modelled outcome for this program by approximately 38 times. Conclusions.

Vaccines for flu, PD, RSV and COVID-19 could prevent a significant number of hospitalizations in the winter. The value of the associated freed-up bed capacity is likely to be underestimated by conventional reference costing methods.

Poster Presentation Number: PP11 Abstract Title: Patient Involvement In Drug Evaluations To Inform Funding Decisions: A Singapore Case Study Author Names: Ping-Tee Tan ([email protected]), Fiona Pearce, Shawn Quek, Sok Huang Teo Introduction. Patient involvement has become increasingly integral to health technology assessment (HTA) processes globally due to greater recognition of the important contribution patients make to address uncertainties in the scientific evidence base and interpret results for real-world implementation. To align with best practices and encourage meaningful patient input in HTAs in Singapore, patient involvement processes were established by the Agency for Care Effectiveness (ACE) in 2021. This presentation discusses how patient groups were identified in Singapore and describes the new patient involvement processes. Methods. In the absence of a centralized database, a stakeholder mapping exercise was undertaken in 2021 to identify all relevant patient and volunteer groups in Singapore. A comprehensive search of the Singapore Charity Portal, hospital websites, standard search engines and social media platforms was conducted. Identified groups were screened in line with specific inclusion criteria and contacted via email and cold calling to find out more about their remits. Plain English resources, targeted training materials and a process guide to encourage patient involvement in ACE’s work were co-developed with local patient organizations by drawing upon best practices from overseas HTA agencies contextualized to local patients’ needs. Supporting resources and processes were revised in 2022 based on ACE’s experience receiving inputs from patients and caregivers to inform drug HTAs. Results. One hundred and six patient groups covering 20 conditions were identified including registered organizations and informal support groups. In the first half of 2022, ACE received responses from 82 patients from ten patient organizations to inform seven drug HTAs for cancer, diabetes, HIV, and other conditions in line with the new patient involvement processes. Patient organizations viewed the opportunity to submit testimonials of their lived experience with different conditions as a meaningful and important activity for their members. Conclusions. Patient involvement processes have improved the legitimacy and acceptance of ACE’s work and will be continuously revised to ensure that they remain relevant and meet patients’ expectations and needs.

Poster Presentation Number: PP13 Abstract Title: Results Of An International Survey About Barriers In Patient Involvement In Health Technology Assessment Of Digital Health Technologies Author Names: Edurne Gallastegui-Calvache ([email protected]), Carolina Moltó-PuigmartíJoan Segur-Ferrer, Rosa Maria Vivanco-Hidalgo Introduction. In recent years, several efforts have been initiated by health technology assessment (HTA) agencies to increasingly incorporate patient involvement (PI) into their assessment processes. The rationale behind PI in HTA is that patients can give their perspective and experiences about health, illness and the use of health technologies, complementing clinical and healthcare system standpoints. A recent systematic review summarized current evidence on the barriers and facilitators of PI in HTA. Barriers and facilitators were classified according to the context in which they appear, as organizational, decision- making, political and community-related. Digital health technologies offer a singular opportunity to address some challenges faced by healthcare systems. However, we hypothesized that their intrinsic characteristics may have some implications for PI in digital HTA. We conducted a survey to gain knowledge about barriers in PI in digital HTA. Methods. The survey was elaborated using Microsoft Forms and consisted of 31 questions divided into four blocks (organizational, decision-making, political and community-related). It was sent to three Spanish, one Catalan and one International patient umbrella organizations. The results were analysed using Microsoft Excel. Results. A total of four responses were received from three Spanish and one Catalan patient umbrella organizations. Results showed high, partial, and low concordance among organizations in 65%, 19% and 16% of the answers received, respectively. According to the results, most of the barriers for PI seem to be the same for HTA of digital health technologies as for other types of health technologies. However, two or three of the four umbrella organizations consider that HTA of digital health technologies might pose greater challenges in terms of achieving significant patient participation, sufficient patient training and knowledge of HTA processes, proper preparation and tools of the HTA experts and logistics during the HTA process. Conclusions. Barriers in PI are mostly the same for digital or other types of health technologies. Few differences are related to patient training, tools, and logistics during HTA process.

Poster Presentation Number: PP14 Abstract Title: The Role Of Health Technology Assessment In The Public Hospitals Of The National Health Service Of Catalonia Author Names: Berta Mestre-Lleixà ([email protected]), Laura Llinàs-Mallol, Edurne Gallastegui- Calvache, Laia Ramos-Masdeu, Jessica Ruiz-Baena, Rosa Maria Vivanco-Hidalgo Introduction. Hospitals play an essential role to facilitate the appropriate introduction of health technologies into the National Health System. We aimed to analyze if the decision-making at the hospital level is based on health technology assessment (HTA). Methods. We developed a seventeen-question survey to assess the decision-making mechanisms for the introduction of health innovation into the public hospitals of the National Health Service (NHS) of Catalonia. All questions were related to the field of HTA and health innovation. We asked about the process of new health technology acquisition, the existence of HTA units, and the impact those units might have within the center. We invited the three main public healthcare providers (n= 68 centers). We performed a quantitative analysis grouping the results by type of healthcare provider. Results. Thirty-five different health providers (51.5%) remitted forty-two responses. We identified two differential mechanisms for the introduction of health innovation in those centers: 51.4 percent used a directive committee for decision-making, whereas 37.1 percent employed a technical commission. Some centers (8.6%) used both options. Both the directive committees and technical commissions predominantly considered the professional experience or scientific evidence provided by the healthcare professionals of the center (80%) or external HTA reports or clinical practice guidelines (65.7%) to guide their decision-making. Using HTA products developed within the center was less frequent (34.3%). Only 57.1 percent of the healthcare providers had an HTA unit, but 75 percent of them declared that HTA products had a direct and quantifiable impact on their decision-making regarding the introduction of innovation. Healthcare providers without HTA units manifested their willingness to adopt HTA practices into their decision-making processes. Conclusions. HTA at the hospital level is not a common practice when deciding to introduce innovative health technologies in the NHS of Catalonia. However, the main healthcare providers agreed that the introduction of HTA is necessary for improving their decision-making and that the HTA agency, Agency for Health Quality and Assessment of Catalonia (AQuAS) will play a key role (training, promoting, and assessing).

Poster Presentation Number: PP17 Abstract Title: Rare Diseases: An Analysis Of Assessments Carried Out By The National Committee For Health Technology Incorporation In Brazilian Public Health System (Conitec) Author Names: Fernanda Rodrigues, Stefani Borges ([email protected]), Wolney Pires, Nathalia da Costa, Priscila Louly, Clementina Prado, Vania Santos Introduction. The treatment of rare diseases has been a challenge for the Brazilian Unified Health System. In addition to the high costs of treatments, the characteristics inherent to this type of disease bring weaknesses to the scientific evidence of efficacy and safety. The National Committee for Health Technology Incorporation In Brazilian Public Health System (Conitec) is formed by a plenary of experts who monthly assess demands for incorporation into the public health system. Methods. This exploratory, descriptive, and retrospective study aims to gather qualitative and quantitative data on criteria considered by healthcare decision-makers from Conitec and analyzes which rare diseases were benefited by the commission recommendations. Data from June 2012 to November 2022 were collected from the Conitec website to a specific extraction form and analyzed using descriptive statistics. Results. A total of 763 technologies were evaluated from June 2012 to November 2022, with 158 being drugs for rare diseases. Among these, those with the highest number of diseases benefited were multiple sclerosis 13.3 percent (n=21), cystic fibrosis 6.3 percent (n=10) and pulmonary hypertension 5.7 percent (n=9). About 70 (44.3%) technologies were incorporated into the Unified Health System to treat rare diseases. In these incorporations, 25 technologies initially had an unfavorable recommendation, and only after the public consultation they were recommended for incorporation. Reasons that contributed to this change in recommendation were the new scientific evidence presented (64%), new negotiation of the drug price (28%), and new budgetary impact by revising the calculation of the target population (8%). Conclusions. The criteria for evaluating technologies for rare diseases are similar to those adopted for other clinical conditions. However, it is important to adopt specific criteria in analysis of drugs targeted at diseases considered rare for the population. Negotiating prices with industry is an important factor that was highlighted, potentially favoring access to new treatments that can modify the progress of these diseases.

Poster Presentation Number: PP18 Abstract Title: Unlocking The Potential Of Medical Device Reimbursement In India For Better Health Outcomes Author Names: Ashwin Goel, Stephen Sunderland, Shruti Srinivasan, Arif Fahim ([email protected]), Monika Pusha, Kirti Kataria Introduction. The Indian healthcare landscape has witnessed several promising changes including the introduction of a comprehensive medical technology inclusion process, Diagnosis-related group (DRG)-pilot and value-based incentives for hospital services under the national public health insurance scheme. Realizing the need for a more patient-centric stance towards improving healthcare outcomes as the way forward, we propose incremental changes including greater participation of public and private care-providers in topic prioritization and the appraisal committee. We also propose a unique evidence-driven approach using reimbursement as a lever for rewarding quality and innovation in medical technologies. Methods. We developed two discussion guides to capture the ideas around deeper involvement of care-providers and patient societies, and introduction of value-based reimbursement for incentivizing high-quality implantable medical devices in India. The guides were prepared using secondary research and key informant interviews. Over 25 key stakeholders representing payers, regulatory agencies, government authorities, clinical experts, and industry players selected through quota sampling participated in a roundtable meeting. Based on the meeting outcomes, key recommendations for leveraging medical device reimbursement for better health outcomes were developed. Results. This qualitative research was carried out with participation of key stakeholders across the medical device reimbursement process. The group proposed recommendations for bringing care-providers closer to the process through a structured and inclusive nomination approach involving therapy users and patient groups at various stages of evaluation. Complementing the existing value-based incentives framework for hospital services, we proposed a similar two-step pathway for incentivizing quality of implantable medical devices. The proposal includes the introduction of certification-based and outcome-based incentives built on a scientific and holistic evaluation criterion. Conclusions. Through this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care to poor patients. These strategies follow the principles of value-based care and will go a long way

in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd. (now Abbott).

Poster Presentation Number: PP19 Abstract Title: Health Technology Assessment Reports In Brazilian Unified Health System: Number Of Potential Beneficiaries in 2022 Author Names: Stefani Borges ([email protected]), Fernanda Rodrigues, Wolney Pires, Nathalia da Costa, Thatiara Maldonado, Priscila Louly, Clementina Prado, Vania Santos Introduction. Universal access to health public services was established in Brazil 32 years ago. However, health technology assessment (HTA) as a requirement for the decision-making process in the Unified Health System (SUS) was defined only in 2011 with the National Committee for Health Technology Incorporation of the SUS (Conitec), which advises the Ministry of Health on the decision to incorporate health technologies into the SUS. All of Conitec’s recommendations are based on the best available scientific evidence regarding efficacy, effectiveness, and safety of a technology, but also include economic evaluation studies of these technologies, developed from the perspective of the SUS. Considering this an estimate of the population eligible for use of the technology under evaluation, if it is incorporated into the SUS, it is considered in the decision-making process. Methods. This descriptive study, based on open access data from Conitec’s website, aimed at identifying the estimated number of patients potentially benefitting by the recommendations published in 2022, from January to November. Since each report includes an estimate for the first five years of incorporation of the technologies, all data were collected to check whether population growth was considered. Results. Finally, 38 recommendation reports were identified, with 28 reports on incorporation and 10 reports for expansion of technology use. Among them, they related to 31 medicines and seven procedures or products. In the first year after incorporating the listed technologies, a total of 7,767,321 potential beneficiary patients were estimated, while over five years the total number would increase to approximately 7,967,874 patients. There were recommended drugs for rare diseases whose benefited population did not exceed the estimate of 10 patients per year; as an example is cerliponase alfa for treating neuronal ceroid lipofuscinosis. In another example, an estimate of 4,494,539 women would benefit by incorporated contraceptives into the SUS. Conclusions. This study describes how accessible public health is becoming, meeting more health policies, showing potential to benefit more patients every day and showing what trends can be expected in the future.

Poster Presentation Number: PP20 Abstract Title: Vaccines market access pathways in Asia-Pacific (APAC) – analysis and recommendations for improvement Author Names: Alex Best ([email protected]), KyungHwa Lim, Aisha Adam, Anne-Frieda Taurel, Jun Feng Introduction. Immunization is one of the most effective public health interventions, saving millions of lives annually. However, complex and heterogenous market access pathways can impact timely and equitable population access to vaccines. Focusing on five Asia-Pacific (APAC) countries, this study described the current vaccine market access landscape and analyzed the success factors for National Immunization Program (NIP) inclusion. Methods. The study was conducted in two phases (i) pragmatic literature review to map current regulatory and funding pathways and identify information gaps in China, Japan, Korea, Taiwan and Australia (ii) targeted interviews with market access and policy experts in each market to identify drivers and barriers to NIP inclusion. Results. Regulatory approval, driven by safety and efficacy data, followed by introduction in the private market was commonly observed in all markets. However, pathways to NIP inclusion varied within and between markets. In all markets expert panels such as National Immunization Technical Advisory Groups (NITAG) were identified to play a crucial role in providing advice to governments on NIP inclusion. Health technology assessment was increasingly used to inform decision making. However, the assessment frameworks utilized were typically designed for medicines, rather than the unique features of vaccines. Japan, Korea and Australia provided relatively consistent coverage via national programs, despite the different processes employed to review, recommend and reimburse vaccines. In some cases, the reimbursement timeframe varied significantly for different vaccines within the same market. China and Taiwan provided coverage at the regional level, which required engagement with multiple local authorities to enable access. The key barriers to patient access were budget limitations, long reimbursement timeframes and a lack of coverage consistency. Early stakeholder engagement, local epidemiology and cost-effectiveness evidence were the main success factors for NIP inclusion. Conclusions. Funding pathways for vaccines in APAC are heterogenous. Adopting the Asia-Pacific Economic Cooperation (APEC) Action Plan on Vaccination Across the Life Course could increase vaccine coverage through alignment, collaboration, and improvement of reimbursement pathways in APAC.

Poster Presentation Number: PP21 Abstract Title: Are We Ready For It? Developing Criteria To Include Artificial Intelligence Medical Devices (AI- MDs) For Health Technology Assessment Author Names: Rachel See-Toh ([email protected]), Lydia Ooi, Zhen Long Ng, Swee Sung Soon, Hong Ju, Kwong Ng Introduction. The increasing pace at which artificial intelligence medical devices (AI-MDs) or digital health technologies (DHTs) have been introduced and integrated in healthcare has not been matched with appropriate selection criteria for health technology assessment (HTA) to inform funding decision-making. To align with international best practice and local regulatory guidance, the Agency for Care Effectiveness (ACE) developed criteria to include AI-MDs as part of its 2022 topic prioritization process for medical technologies. This abstract describes ACE’s approach to develop the inclusion criteria. Methods. To develop key principles for including AI-MDs in ACE’s topic prioritization process, relevant information from overseas HTA agencies, local regulatory guidelines, and ACE’s existing topic selection criteria were reviewed. A search of international HTA agency websites was conducted in September 2022 to identify relevant information on inclusion of AI-MDs in healthcare for reimbursement recommendations. Additionally, local regulatory guidelines for AI-MDs in healthcare were also identified. The inclusion criteria were then piloted with AI-MDs identified from ACE’s horizon scanning workstream to examine their feasibility for HTA topic selection. Results. One overseas framework on DHTs from the National Institute for Health and Care Excellence (NICE) and two local regulatory guidelines were identified. Based on the key finding that the purpose of AI-MD use in guiding clinical management and its associated risks were important considerations, the following criteria were developed: (i) full registration with the regulatory body;(ii) device characteristics should be interventional, have direct impact on patient safety, or support accurate diagnosis or treatment which is critical to avoid death and serious health deterioration; and (iii) the AI algorithm should be fixed as opposed to adaptable as per regulatory requirements. Using this inclusion criteria, eight AI-MDs surfaced from horizon scanning were screened with the above criteria and deemed suitable for HTA topic selection. Conclusions. As AI technologies are increasingly used to replace or supplement current clinical practice, continuous adaptation of HTA method is needed to ensure appropriate topic selection.

Poster Presentation Number: PP23 Abstract Title: A Health Technology Assessment Of Computerized Clinical Decision Support Systems: Challenges And Lessons Learnt Author Names: Carolina Moltó-Puigmartí ([email protected]), Edurne Gallastegui-Calvache, Davide Cirillo, Rosa Maria Vivanco-Hidalgo Introduction. Computerized Clinical Decision Support Systems (cCDSS) are promising digital health tools whose development and use are increasing. The Agency for Health Quality and Assessment of Catalonia (AQuAS) received a request from the Spanish Ministry of Health, through the Spanish Network of Health Technology Assessment (HTA) Agencies (RedETS), to perform an HTA of cCDSS for cancer. We present the challenges that arose during the evaluation process. Methods. We evaluated the safety, effectiveness and cost-effectiveness through a systematic literature review. We involved two clinicians and a technology expert to gain insight into the pathology and technology, respectively. To identify cCDSS used in Spain, we consulted with the Spanish regulatory agency (AEMPS) and the Spanish Federation of Healthcare Technology Companies (FENIN), plus did a survey among Spanish hospitals. To understand applicable regulations, we reviewed the European regulation (MDR) and consulted the Medical Device Coordination Group from the European Commission, AEMPS, and a regional regulatory expert. Results. The scientific literature revealed large heterogeneity in the definition of cCDSS (e.g. from simple online prognostic calculators to complex commercial software using machine learning), making the literature search and screening arduous. Many articles dealt with cCDSS that do not qualify as medical devices, are not in the market anymore, are currently used as newer versions or are developed in-house. Next, we faced the difficulty to attain a comprehensive overview of the tools in use in the country. In terms of legislation, we observed that similar tools might receive different classifications in different jurisdictions, and the complexity of the MDR might lead to the need for a case-by-case discussion at a National level. Conclusions. We identified many challenges in the HTA of cCDSS. The first step for proper assessment is a clear definition of the device and version to be evaluated. Multiple stakeholders must be involved, and alignment between regulatory and HTA agencies is key. We expect that the European Database on Medical Devices (EUDAMED) will help in the identification of existing cCDSS and hence ease their assessment.

Poster Presentation Number: PP24 Abstract Title: Methodological Frameworks And Assessment Domains For Digital Health Technology Assessment: Scoping Review And Thematic Analysis Author Names: Joan Segur-Ferrer ([email protected]), Carolina Moltó-Puigmartí, Roland Pastells-Peiró, Rosa Maria Vivanco-Hidalgo Introduction. Experts highlight the need to reconsider the frameworks used in health technology assessment (HTA) in order to cover the particularities of digital health technologies (DHT). However, there is a large heterogeneity in the literature about terminologies and definitions. Our objective was to identify the methodological frameworks used worldwide for HTA of DHT and generate a proposal of domains to consider in the assessment through a thematic analysis, a qualitative data analysis method that consists of identifying, analysing and reporting patterns across the data. Methods. Methodological frameworks were identified through a scoping review (ScR) in accordance with the PRISMA extension for ScR. We searched five different databases for peer-reviewed and grey literature published between 2011 and 2021. The retrieved references were screened using Rayyan by two authors in a single- blind manner. References included were analyzed thematically by three reviewers using ATLAS.ti. Results. The systematic search retrieved 3,061 references (2,238 unique), of which 26 were included. These, in turn, synthesized 102 frameworks designed for the assessment of DHT. The included documents contained a wide variety of items to consider in HTA of DHT and often used different wording to refer to similar concepts. Through the thematic analysis, we reduced this heterogeneity. Specifically, in the first analysis phase we established 176 provisional codes related to different assessment domains. In the second one, these codes were grouped in 86 descriptive themes that, in turn, were clustered in the third phase in 61 analytical themes. The latter were organized through a vertical hierarchy of three levels: level 1 (13 domains), level 2 (38 dimensions), and level 3 (11 sub-dimensions). Conclusions. There is a need to reconsider the frameworks and assessment domains used for HTA of DHT. Our thematic analysis of 26 references led to the definition of 13 domains, 38 dimensions and 11 sub-dimensions to consider in HTA of DHT. From our perspective, thematic analysis is the most appropriate method to identify assessment items for HTA of DHT from literature.

Poster Presentation Number: PP26 Abstract Title: Critical Review Of The Reimbursement Process For Software As A Medical Device And Challenges In South Korea Author Names: Soontack Kwon ([email protected]), Seung Jin Han, Kyung-Hoon Kim Introduction. The global artificial intelligence (AI) healthcare market is predicted to grow rapidly. Various technologies for AI-based Software as Medical Device (SaMD) have been developed, and demand for their health insurance reimbursement coverage is increasing. Reimbursement policies for new medical technologies need to be thoroughly examined, despite their role in stimulating the market. The reason is that health insurance finance can have significant impact on the entire country, including patients, providers, and industry. Methods. Based on guidelines for applying Korea’s innovative medical technologies, especially AI-based imaging medical technology, to health insurance, we examined outcome factors such as procedures and benefits. After the guidelines’ publication in 2019, we examined their impact on the medical device market through changes in the number of clinical trials and identified cases in which health insurance was listed. Results. The process of registering SaMD’s health insurance occurs in accordance with the existing medical technology evaluation system, and it can take up to 460 days from application to approval. If new technologies, including SaMDs demonstrate significant improvement in diagnostic capabilities and cost-effectiveness compared to existing practices, separate health insurance claims are available. Since the scheme’s announcement in 2019, items approved for SaMD clinical trials have increased (2018: ‘n=4; 2020: n=44; 2021: n=37). However, as of November 2022, only one was listed for health insurance benefits (VUNO Med-DeepBrain®), and one case was not listed on benefits but was recognized for its innovation and entered the market on the premise of suspending the health technology assessment process and accumulating real-world data (VUNO Med- DeepCARS®).™ DeepBrain® is a deep learning-based image reading technology costing about KRW80,000 (USD60) higher than conventional brain-magnetic resonance imaging and readings. Conclusions. The number of SaMDs attempting clinical trials is increasing, but there is a low number of cases of reimbursement because most technologies are often classified as existing technologies and do not receive additional compensation. Since SaMD continuously is developed by accumulating data and feedback, a flexible system that can reflect this is required.

Poster Presentation Number: PP27 Abstract Title: The Private Healthcare Responses Against COVID-19 Emergencies In Brazil Author Names: Silvana Kelles, Camila Pereira, Carina Martins, Daniel Reis, Ernesto Azevedo, Geraldo Ribeiro, Karina Zocrato, Lélia Carvalho, Marcela Freitas, Maria Horta, Mariana Barbosa, Mariza Talim, Marcus Borin ([email protected]) Introduction. The Corona Virus Disease 2019 (COVID-19) pandemic is the biggest public health crisis of all time. Private health care plays a major role in health globally. We conducted a study to document the engagement of a Brazilian private health care organization to influence decisions to private and public health emergencies of COVID-19. Methods. This retrospective study evaluated the outputs of the health technology assessment (HTA) group of Unimed- BH, a private Health Maintenance Organization (HMO) with 1.5 million participants in Belo Horizonte, Minas Gerais state. The study evaluated the impacts on the overview of health local decisions in the municipality and the national supplementary health agency (ANS) during the period from March 2020 to December 2022. Results. During the pandemic, Unimed-BH made all its sanitary decisions based on scientific research, such as the use of masks and appropriate medications. Even though some medicines, such as regdanvimab, were authorized for emergency use by the Brazilian Health Regulatory Agency (ANVISA), Unimed-BH did not recommend their use due to uncertain evidence, and months later, ANVISA withdrew the registration. Unimed-BH also conducted a systematic review of ivermectin for COVID-19 treatment, which showed no effect, and therefore did not recommend its use. Additionally, Unimed-BH provided weekly updates on COVID-19 data, including suspected and confirmed cases, hospitalizations, and deaths in their customer portfolio. The organization also actively supported the decisions made by ANS and municipal managers using evidence and statistics on the pandemic. The Unimed-BH HTA group produced a total of 167 reports from March 2020 to December 2022. Conclusions. Belo Horizonte had the lowest in-hospital mortality rates with COVID-19 in Brazil. Unimed-BH's HTA reports provided evidence-based assessments for decision-making, proposed partnership with policymakers, fomented information transparency, and strict follow-up on pandemic numbers, which may have contributed to the lower fatality rate in our city. These findings underscore the importance of private healthcare organizations in responding to COVID-19 emergencies, and their potential to support evidence-based decision- making and minimize the impact of the pandemic.

Poster Presentation Number: PP29 Abstract Title: Health Technology Assessment Contribution To The Health Care System During Challenging Times In Ukraine Author Names: Oresta Piniazhko, Marharyta Khmelovska ([email protected]), Mykhailo Babenko, Mykhailo Lobas, Valeriia Serediuk, Yuliia Malyshevska, Iryna Romanenko, Alona Masheiko, Kostiantyn Kosyachenko, Rabia Sucu Introduction. According to WHO’s Surveillance System for Attacks on Health Care, there have been 715 attacks on health care (health facilities, transport, personnel, patients, supplies and warehouses), resulting in 129 injuries and 100 deaths, reported in Ukraine between 24 February and 7 December 2022. These high indicators are a result of 287 days of Russia’s full-scale invasion of Ukraine. Nevertheless, the Ukrainian healthcare system has demonstrated the capacity and fortitude to continue the operations alongside rising to wartime needs. This research aims to explore the results of continuous health technology assessment (HTA) implementation in Ukraine under severe pressure caused by full-scale war. Methods. The recommendations of the Health Technology Assessment (HTA) Department of the State Expert Centre of the Ministry of Health (MoH) of Ukraine were analyzed for the period of more than 9 months of the Russian assault on Ukraine. Results. Since 24 February 2022 the HTA Department prepared 39 HTA conclusions. The majority of HTA conclusions concerned treatment of oncologic diseases (38.5%) and orphan diseases (35.9%). Other nosologies included anticoagulant therapy, hepatitis and cirrhosis, emergency care, infectious diseases (5.1% for each), and mental illness and diabetes mellitus (2.6% for each). Most of the requests aimed for inclusion on the National Essential Medicines List (NEML) (48.7%) and on the nomenclature (43.6%), while two were to either nomenclature or NEML (5.1%) and one to the NEML with further access through reimbursement under the “Affordable Medicines” reimbursement program (2.6%). Listing was recommended in 89.7 percent of cases; moreover 38.5 percent of medicines were recommended for the managed entry agreement (MEA) procedure, of which the MoH has already addressed applicants of 10 medicines with a proposal to negotiate a MEA. Conclusions. Recognizing the importance of promoting patient access to effective, safe and cost-effective medicines, the HTA Department continues its daily operations on assessments despite the Russian invasion of Ukraine.

Poster Presentation Number: PP30 Abstract Title: The Fast Track In Drug Registration By ANVISA – Brazil And Possible Consequences Author Names: Silvana Kelles, Camila Pereira, Carina Martins, Daniel Reis, Ernesto Azevedo, Geraldo Ribeiro, Karina Zocrato, Lélia Carvalho, Marcela Freitas, Maria Horta, Mariana Barbosa, Mariza Talim, Marcus Borin ([email protected]) Introduction. The fast track in drug registration by the Brazilian Health Regulatory Agency, ANVISA, began in 2017 and is intended to prioritize analysis related to drugs relevant to public health. This process is appropriate in situations where there are no therapeutic alternative available or for technologies show significant improvement in safety, efficacy, or adherence to treatment. Methods. The Brazilian public administration has a tool for accessing information called Transparency Portal. Thus, data on the number of drugs approved by fast track between 2018 and 2021 were requested through this tool and evaluated. Results. The data received by the Brazilian transparency portal shows that the number of requests for fast track had an increase from one in 2018 to 32 in 2021. There is an important increase of registrations, being drugs with phase II trials and with single-arm clinical trials. With registration based on a phase II trial, these patients are in fact receiving drugs in a context similar to clinical trials, but with funding from the healthcare system. Given that phase II studies are conducted in a limited population, there has been an increase in the registration of drugs with suboptimal efficacy and safety concerns. This scenario of uncertainty leads to non-adherence to treatment and a discrepancy in real-world outcomes in comparison to the clinical trial. About 70 percent of phase II trials, show no benefit, and only 30 percent proceed to later phases. It is noteworthy that about 50 percent of the studies that move on to later phases fail to show benefits. Nowadays the number of drugs approved by the fast track has increased, many probably with phase II studies and no comparator group. Conclusions. Given the uncertainties in the efficacy and safety of a drug registered via fast track, often based on phase II studies, implementing provisional registration with real-world evaluation of outcomes, and coupled with financing based on risk-sharing agreements, may be a sustainable alternative for health systems.

Poster Presentation Number: PP33 Abstract Title: The Cost-effectiveness Of Regorafenib In The Treatment Of Advanced Hepatocellular Carcinoma From A Canadian Perspective Author Names: Mohammad Salman Hussain ([email protected]), Ambrish Singh Introduction. Hepatocellular carcinoma (HCC) is the most common form of liver cancer and the fourth leading cause of cancer-related death globally. There are unmet needs for effective systematic therapy. The findings of the RESORCE trial highlighted the improvement in overall survival with regorafenib in advanced HCC patients progressing on sorafenib treatment. This study aimed to assess the cost-effectiveness of regorafenib compared with best supportive care (BSC) for advanced HCC from the Canadian healthcare system perspective. Methods. We developed a Markov model based on four health states: live with adverse events, live without adverse events, progression, and dead. Health outcomes were measured using life-years (LYs), and quality-adjusted life-years (QALYs), and costs were presented in Canadian dollars (CAD). Clinical inputs were derived from the RESORCE trial. A 1.5 percent discount rate was applied to costs and outcomes. One-way and probabilistic sensitivity analyses were performed to assess the uncertainty in findings due to variability in parameters. TreeAge Pro software was used for model implementation. Results. The use of regorafenib results in a gain of 0.38 LYs and 0.25 QALYs as compared to BSC with a high incremental cost of CAD26,954 (US$22,313). The ICER for regorafenib compared with BSC was CAD105,850/QALY (US$87,624/QALY) in the base-case analysis. Further, probabilistic sensitivity analyses revealed regorafenib not to be cost-effective at a willingness-to-pay threshold of CAD50,000/QALY. Conclusions. Regorafenib was not found to be cost-effective in the treatment of advanced HCC because of the lower health benefits and higher incremental costs. Lowering the official price of regorafenib or use for only selected patients who can achieve maximum benefits would enhance its cost-effectiveness and treatment preference value.

Poster Presentation Number: PP35 Abstract Title: MetaImpact: A Novel Tool To Enable Evidence Based Sample Sizes For Future Studies Author Names: Clareece Nevill ([email protected]), Terence Quinn, Nicola Cooper, Alex Sutton Introduction. There is a balance when determining the sample size of a new study: if too few participants, the study may not detect an effect; if too many, some participants may undergo inferior treatments unnecessarily. Both scenarios are wasteful and unethical. Furthermore, new studies are often designed in isolation, increasing the risk of duplication and wasted research. To better support decision-makers, who rely on reviews of evidence to assess new interventions, new studies should be designed with the current evidence base in mind. This project aimed to facilitate such designs. Methods. Previous work by Sutton et al describe how to estimate the sample size of a new trial such that it has impact on the current evidence base. This involves simulating a new trial using parameters from the current meta- analysis (thus accounting for heterogeneity in existing trials), adding it to the review, and then seeing how the results change. Repeating this multiple times estimates the power of the sample size – the proportion of simulations that give the desired effect. A free interactive web-app was created for researchers to easily utilize these methods themselves. Past reviews will be utilized to assess the benefit of the app by removing the most recent addition, adding a newly simulated trial to the review, and then comparing the results to the original. Results. The new innovative tool, MetaImpact (https://crsu.shinyapps.io/MetaImpact), was created using software ‘R’ and ‘shiny’ to estimate the power of a future study with a certain sample size having impact on a body of evidence. Educational features range from information boxes explaining different components, to plots illustrating how the estimation is calculated. Results from assessing the app utilizing past reviews will be presented at the conference. Conclusions. MetaImpact has potential to benefit patients and research by encouraging ethical sample sizes and reducing ‘wasteful’ trials. By advocating research groups designing new studies to consider past reviews of current evidence bases, MetaImpact encourages harmonization of research leading to more efficient HTA.

Poster Presentation Number: PP36 Abstract Title: Immersion In Water During Childbirth Eva Reviriego-Rodrigo ([email protected]), Nora Ibargoyen-Roteta, Soledad Carreguí-Vilar, Luis Mediavilla- Author Names: Serrano, Sonia Uceira-Rey, Susana Iglesias-Casás, Ana María Martín-Casado, Ana Toledo- Chávarri, Gonzalo Ares-Mateos, Sonia Montero-Carcaboso, Belén Castelló-Zamora, Natalia Burgos-Alonso, Anai Moreno-Rodríguez, Naiara Hernández-Tejada, Carmen Koetsenruyter, Iñaki Gutiérrez-Ibarluzea Introduction. Immersion in water is a non-pharmacological method for pain relief during childbirth. The aim was to describe the experiences, values and preferences of women regarding water immersion during childbirth identified in the evidence. Methods. A systematic review and thematic synthesis of qualitative evidence was conducted. Databases were searched from 2009 to 2022 and screened for inclusion using pre-determined criteria. Studies that used qualitative methods for data collection and analysis to investigate the opinions of women or health professionals in hospital settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. The Critical Appraisal Skills Programme Qualitative Research Checklist was used to assess study quality and findings were synthesized using thematic synthesis, as described by Thomas and Harden. The final report was reviewed by several categories of health professionals that care for mothers and infants, as well women. Results. Thirteen studies met inclusion criteria and were included in this review. Nine studies have been identified that reflect the experience of women in relation to immersion in water during childbirth, a study exploring the factors that determine the use of immersion during childbirth according to the point of view of both women and midwives, and three more studies on midwives' experience with water immersion during childbirth. In the qualitative studies the following key themes emerged: Reasons identified by the women/professionals for choosing a water birth, benefits experienced in water births and barriers and facilitators of immersion in water during childbirth. Conclusions. The evidence from qualitative studies indicates that women associated water birth with a sense of autonomy and control over labor, and a lower level of associated pain. Further, a water birth was considered a positive experience. From the point of view of midwives, to make water births safe, there is a need for adequate resources, as well as rigorous standardized protocols.

Poster Presentation Number: PP37 Abstract Title: Immersion in water during childbirth: A survey to the Spanish National Health System Author Names: Eva Reviriego-Rodrigo ([email protected]), Nora Ibargoyen-Roteta, Soledad Carreguí-Vilar, Luis Mediavilla-Serrano, Sonia Uceira-Rey, Susana Iglesias-Casás, Ana María Martín-Casado, Ana Toledo- Chávarri, Gonzalo Ares-Mateos, Sonia Montero-Carcaboso, Belén Castelló-Zamora, Natalia Burgos-Alonso, Anai Moreno-Rodríguez, Naiara Hernández-Tejada, Carmen Koetsenruyter, Iñaki Gutiérrez-Ibarluzea Introduction. Certain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities. Methods. A questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories. Results. Regarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth. Conclusions. The availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.

Poster Presentation Number: PP38 Abstract Title: Designing A Training And Capacity Building Pathway In Patient Involvement Author Names: Yolanda Triñanes ([email protected]), María J. Faraldo-Vallés, Patricia Gómez, Paula Cantero-Muñoz, María J. Vicente-Edo, Eva Reviriego-Rodrigo, Blanca Novella, Ana Toledo-Chávarri Introduction. The Patient Involvement (PI) Interest Group of the Spanish Network of Health Technology Assessment Agencies (RedETS) was set up in 2017 by a group of health technology assessment (HTA) researchers interested in PI. Since its inception, training and capacity-building to support PI and patient-based evidence in HTA processes has been one of its main aims. The objective of this work was to identify the needs and priorities related to training and capacity building activities to be developed within the framework of the PI Interest Group. Methods. The PI Interest Group met on November 14, 2022, for its Annual Meeting. The group discussed the needs, priorities and possibilities on training, and carried out a prioritization exercise. For this purpose, a self- reported and anonymous questionnaire was used, which included 16 training activities. Every item was scored with a Likert-type scale ranging from 0 to 10. Results. The questionnaire was answered by twenty participants. The most highly rated training activities (mean less thank or equal to 8) were: qualitative evidence synthesis (8.75); PI case studies (basic (8.65) and advanced (8.56) level); quality assessment tools for qualitative evidence (8.37); and qualitative research (8.11). Other proposals scoring above 7 points were: ethical aspects related to PI, evaluation of patient participation and impact, identification and recruitment procedures, and discrete choice experiments. The group agreed to organize bi-monthly webinars and three structured training activities for the whole RedETS network on: Qualitative Evidence Synthesis, Qualitative Research and PI Case Studies. Conclusions. The prioritization of training activities according to PI Interest Group members allowed planning a tailored capacity-building program adapted to the needs of RedETS.

Poster Presentation Number: PP40 Abstract Title: Structuring Unstructured Medical Device Reimbursement In India Author Names: Ashwin Goel, Arif Fahim ([email protected]), Monika Pusha, Kirti Kataria Introduction. As India makes rapid strides towards universal health coverage, focusing on medical device reimbursement is key to ensuring patient access to device-based technologies. The nascent medical device reimbursement process offers a promising opportunity for interventions driven by a diverse group of stakeholders. We conducted policy research to capture these diverse perspectives and highlight key elements to develop a structured framework for reimbursement. Methods. This research was a two-part process, including secondary research with expert interviews followed by policy research using focus group discussions (FGDs) through an online workshop with key stakeholders. We developed a white paper proposing changes to the reimbursement pathway, based on a benchmarking study of global markets and interviews with experts in the field. As a next step, key changes proposed in the white paper were deliberated upon by three focus groups (six to eight participants). Group participants were selected by quota sampling and represented key stakeholders in the reimbursement process. A discussion guide was used to capture participants’ opinions and an addendum to the white paper was released highlighting small, actionable, and impactful changes to the reimbursement process. Results. FGDs with key stakeholders highlighted the need to establish a more structured, inclusive, and transparent process. Accordingly, we proposed key recommendations to the medical device reimbursement process in India. A first change is the creation of an online submission portal allowing different healthcare stakeholders to submit new technologies for consideration through a streamlined pathway. Secondly, we proposed enhancing evaluation transparency by improving availability of publicly shared information on the evaluation process, metrics, and assessment timelines. We also suggested adoption of adaptive health technology assessments to leverage existing evidence for faster, efficient decision-making. Conclusions. Through this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care for poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd (now Abbott).

Poster Presentation Number: PP41 Abstract Title: Using Medicare Claims Data To Support Reimbursement Of A Novel Leadless Pacing System For The Management Of Bradycardia Author Names: Koji Makino ([email protected]), Mia Mudge, Chelsea Zaunmayr, Dom Tilden Introduction. The Micra Transcatheter Pacing System (Micra TPS) is a single-chamber transcatheter leadless pacemaker (LPM). LPMs do not require leads or a subcutaneous pocket, which represent the primary sources of device- related complications with conventional transvenous pacemakers (TVPMs). Complications such as infections and lead dislodgements cause significant patient burden, which have significant economic consequences. Running a randomized controlled trial (RCT) to estimate risk differences of infrequent events requires large sample sizes and long follow-up periods. Real-world observational data, while informative, requires an appropriate study design and statistical adjustments to control for potential biases. Methods. The Micra Coverage with Evidence Development (CED) study was a cohort study of LPM versus TVPM based on US Medicare claims data of 16,431 patients with 2-year follow up (LPM: n=6,219; TVPM: n=10,212). Propensity score matching (PSM) was applied to account for differences in baseline characteristics. As no RCT was identified in the literature, this study was presented to the Australian payer as the primary source of clinical evidence, upon which a cost-utility analysis was conducted. Results. After PSM, the CED study demonstrated significantly more complications with TVPM versus LPM with adjusted rates of 6.5 percent and 4.6 percent (p<0.001). Significant differences favoring LPM (p<0.01) were observed in device breakdown (1.4% vs 2.0%), dislodgment (0.4% vs 1.2%) and infection (<0.1% vs 0.6%). Based on these findings, a claim of superior safety was accepted by Medical Services Advisory Committee (MSAC) to support reimbursement. In making this decision, MSAC considered that the large sample size and propensity weighting overcame some of the potential biases and the magnitude of the benefit supported cost-effectiveness relative to TVPM. Conclusions. The lack of a sufficiently powered RCT with an extended follow-up period can mean the impact and benefits of new technologies that reduce clinically important adverse events of relative infrequency are not formally incorporated into payer decision making, particularly where RCTs are a requirement. A well-designed observational study can provide valuable, real-world evidence to support a HTA for reimbursement decisions.

Poster Presentation Number: PP42 Abstract Title: Insights Of Health Technology Assessment In Brazilian Health Unified System: Areas Of Interests In Health Author Names: Wolney Pires, Stefani Borges ([email protected]), Fernanda Rodrigues, Nathalia da Costa, Priscila Louly, Clementina Prado, Vania Santos Introduction. The National Committee for Health Technology Incorporation of the Brazilian Public Health System’ s (Conitec) principle is to advise the Ministry of Health (MS) in the tasks related to incorporation, exclusion or modification of any health technologies into the Unified Health System (SUS). Moreover, this also involves alteration of clinical protocols or therapeutic guidelines. All of the recommendations consider the international classification of diseases (CID) as a common language that allows health professionals and managers to understand standardized information, to identify trends and benefits of recommendations in each therapeutic area. Methods. This exploratory, descriptive and retrospective study aims to provide qualitative and quantitative data from the technologies evaluated by the Conitec in the period June 2012 to November 2022. Data were extracted in Conitec’s website. Results. The searches resulted in 763 recommendations in total. Among them, the most evaluated therapeutic area was Infectology with 126 technologies (16.5%). In this field the highlighted diseases and conditions were Hepatitis 42 (33.3%); HIV 23 (18.3%) and COVID-19 11 (8.7%). In Oncology, 113 recommended technologies (14.8%) were identified, in order of prominence for the diseases: Breast Cancer 21 (18.6%); Colorectal Cancer 11 (9.7%); Leukemias 17 (15.0%). In the Respiratory Diseases area, 89 technologies (11.7%) were recommended, among them: Chronic obstructive pulmonary disease (COPD) 17 (19.1%); Asthma 15 (16.9%) and COVID-19 11 (12.4%). These results clarify which diseases are most needing new technologies to be treated. Conclusions. The results show what conditions and fields in health needs to be prioritized for public policies and prevention measures. This study demonstrates how important is to make accessible the public health information, improving public knowledge and social actions in SUS.

Poster Presentation Number: PP44 Abstract Title: Time Is Now: Advancing Value Assessment Of Cancer Therapies To Help Eliminate Cancer As The Cause Of Death Author Name: James Ryan ([email protected] Introduction. Earlier cancer diagnosis and advances in science are resulting in improved patient and societal outcomes. However, payer frameworks and methods can find it difficult to keep pace with scientific progress, evolution of endpoints, and assess the wider value of these advances. Methods A multidisciplinary, international group of experts working in the cancer field was brought together to reach consensus on key principles of defining and assessing of cancer treatment value. A Delphi-based approach including surveys, virtual panels, interviews and structured online discussions was used to reach consensus. This work was initiated and funded by AstraZeneca. Results. Twenty-four experts from across the world (including patient advocates, oncologists, health economists, regulators, members of payer and health technology assessment (HTA) bodies) reached consensus on seven key principles across two themes, oncology relevant endpoints and dimensions of value. Three of the seven principles were found to be of particular relevance to HTA bodies and payers: assessing broad economic impact of new medicines (including socio-economic and caregiver impact), where early-stage cancer treatments can enhance patients’ ability to lead productive lives and contribute to economic activity; consider other value aspects of relevance to patients and society; use of Managed Entry Agreements (MEAs) supported by ongoing evidence collection to help address decision-maker evidence needs and address clinical uncertainty. Conclusions. Incentivizing access to early-stage treatments can promote cancer control, improved outcomes and generate long-term societal benefit. Furthermore, early diagnosis and treatment at earlier stages of cancer can be cost- effective, and sometimes cost-saving, as well as provide opportunities for cure. Expanding value components in therapy assessments to include, for example, insurance value, the value of choice, scientific spillovers, and wider societal perspectives, along with structured MEAs to manage clinical uncertainty and balance budgets will help realize the potential to eliminate cancer as the cause of death.

Poster Presentation Number: PP47 Abstract Title: Experience And Its Implication For Reassessment Of The Transcatheter Aortic Valve Implantation Using Real World Data Author Names: Jung Mi Park ([email protected]), Seung Jin Han, Kyoung Hoon Kim Introduction. South Korea has introduced conditionality to coverage decisions for certain difficult or high-risk procedures. The transcatheter aortic valve implantation (TAVI) was included in the coverage with evidence development (CED) in 2014. This study reviewed the results of reassessment for the TAVI using real world data (RWD) and suggested its implications. Methods. Healthcare providers authorized to use the promising technologies are required to collect the RWD for suitability evaluation, safety monitoring, and cost-effectiveness, differing from the general reassessment process. In 2021, 45 healthcare providers collected clinical information for TAVI patients. Their registries were linked with the national health insurance claims, which provided data on 19 items to assess safety and effectiveness such as overall mortality, reoperation rates, hospital readmission rates, and degree of functional improvement. Results. According to the Society of Thoracic Surgeons' predicted risk of mortality (STS), 988 TAVI patients were classified into three groups; high(STS >8 percent, n=347), intermediate (STS 4-8 percent, n=272),and low (STS <4 percent, n=369); We compared main outcomes and estimated survival probabilities between subgroups. Within 30 days, the overall mortality rates were 4.9 percent (high), 2.6 percent (intermediate), and 1.4 percent (low); major bleeding rates were 7.6 percent (high),6.2 percent (intermediate),and 1.4 percent (low); incidence of new atrial fibrillation were 6.8 percent (high), 4.2 percent (intermediate), and 3.2 percent (low). Based on the quantitative results using RWD and systematic review for the safety and effectiveness, TAVI is reported to have essential benefits for high-risk group and elderly patients (>80 years). Whereas, intermediate and low-risk groups have out-of-pocket payment rates of 50 percent and 80 percent, respectively. Conclusions. The reassessment system through RWD accumulation enabled the evidence-based evaluation for the TAVI. Based on the transition to CED for essential benefits, a systematic framework such as RWD collection from treatment commencement should be introduced to broaden RWD use for benefit management of medical technologies with uncertain levels of evidence. Therefore, this ensures overall quality of care and effective coverage in health.

Poster Presentation Number: PP48 Abstract Title: Cardiac Implantable Electronic Device (CIED) Infections In New South Wales, Australia: A Non- Interventional Study Utilizing Linked Secondary data Author Names: Shajedur Rahman Shawon, Oluwadamisola Sotade, Michelle Hill ([email protected]), Liesl Strachan, Gabrielle Challis, Kate King, Louisa Jorm Introduction. Cardiac Implantable Electronic Device (CIED) infection is a serious complication associated with morbidity, mortality and high healthcare costs. Internationally, the published rate of CIED infection ranges from 1.0 percent to 1.6 percent. There is a lack of data on CIED infection rates in Australia; the reported range is from less than 1% at 30 days to 7.0 percent over 5 years. Due to the variability within the limited number of studies there is a need for further analyses of CIED infection rates in Australia. Methods. This was a retrospective cohort study using secondary linked hospital (the NSW Admitted Patient Data Collection) and mortality data for patients who underwent CIED procedures between July 2017 and June 2020 in NSW. Overall and procedure- and patient-specific incidence of infection was calculated. Results. A total of 23,786 CIED procedures were performed among 22,404 patients and 422 CIED infections were identified, giving an overall infection rate of 1.77 percent. When infections were limited to those following a CIED procedure in the period July 2017-June 2020 (n=309), the procedure-specific CIED infection rate was 1.30 percent, ranging from 1.01 percent for permanent pacemaker (PPM) to 2.71 percent for cardiac resynchronization therapy-defibrillator (CRT-D). The proportion of patients undergoing CIED procedures in this period who had a subsequent CIED infection was 1.29 percent, ranging from 0.97 percent for permanent pacemaker (PPM) to 3.05 percent for cardiac resynchronization therapy defibrillator (CRT-D). Procedure- based infection rate in high-risk patients (generator replacement; system upgrade; revision; or CRT-D procedure) was 1.47 percent and patient-based infection rate was 1.68 percent. Infection rate was highest within the first month following the CIED procedure that dropped significantly over time. Conclusions. Rates of infection were highest among patients with cardiac resynchronization therapy (CRT) devices, and those who underwent revision or upgrade procedures. Ongoing monitoring of CIED infection rates and preventative measures are necessary, especially for high-risk patients. This study highlights the important role linked secondary data has in reducing uncertainty and removing the reliance on international estimates by providing targeted, local data for health technology assessment.

Poster Presentation Number: PP49 Abstract Title: Cost Of Cardiac Implantable Electronic Device (CIED) Infections In Australia: A Private And Public Sector Payer Perspective Author Names: Michelle Hill ([email protected]), Adam Gordois Introduction. In Australia, approximately 200,000 patients have a cardiac implantable electronic device (CIED), and in an aging population that number is rising. CIED-related infections are also increasing, causing considerable morbidity and mortality, and substantial healthcare costs. Internationally, the rate of CIED infection ranges from 1.0 percent to 1.6 percent, while in Australia, the reported range is from less than 1 percent to 7.0 percent. The average hospital cost to treat an infection in the US ranges between USD48,000–USD83,000. To date, few publications have estimated the cost of CIED infections in Australia. Critical appraisal of these studies has highlighted issues in their methodology, making them unreliable sources for use in economic evaluations. The purpose of this study was to utilize Australian routinely collected health data to robustly model costs of CIED infections to reduce uncertainty for future health technology assessment (HTA). Methods. The cost of treating a CIED infection was modeled for the public and private sector including cost of system removal and re-implantation procedures, hospital and intensive care unit (ICU) stay, and outpatient follow-up. Cost inputs were obtained from the Australian Prostheses List, Medicare Benefits Schedule, Australian Institute of Health and Welfare, and Private Hospital Data Bureau. Other inputs were obtained by surveying Australian clinicians, which were validated with published data. Phone interviews and online surveys were conducted with clinicians to elicit specific Australian practice pathways for patients with a CIED infection. Results. The majority of patients with a CIED have their device system removed (95-100%) and re-implanted (83%) once the infection has cleared. In the private sector, cost of infection ranged from AUD80,869 (USD54,384) for a single chamber pacemaker (PM), to AUD140,103 (USD94,248) for a dual chamber Implantable Cardioverter- defibrillator (ICD). Modeled costs of CIED infection were slightly lower in the public sector (AUD73,643- AUD88,446 (USD49,555 – USD59,516) for the same devices). Conclusions. The cost of a CIED infections to the healthcare system is high and differs by device type. Utilizing local real- world data to estimate costs will improve accuracy of economic evaluations and reduce uncertainty for decision makers.

Poster Presentation Number: PP50 Abstract Title: Early Diagnosis Effect Of Newborns With Critical Congenital Heart Disease Using National Health Insurance Data In South Korea Author Names: Miyoung Choi ([email protected]), Jimin Kim, Chanmi Park, Byung Min Choi, Gisu Ha,Hong Joo Shin, Sujin Kim, Jeonghee Shin, Eui Kyung Choi Introduction. Critical congenital heart disease (CCHD) refers to a group of heart defects that cause serious, life-threatening symptoms in the neonatal period and requires timely surgical or catheter interventions. We tried to explore current status of CCHD burden and the effect of early diagnosis of CCHD to mortality using the Korean national health insurance (NHI) data. Methods. We analyzed the national health insurance (NHI) data from 2014 to 2018. We identified CCHD patients using the diagnosis codes and intervention codes from the claim data and the prevalence, mortality and medical expenditure of CCHD were analyzed. We linked neonatal data with their mother’s medical claim data and developed retrospective cohort data set for analyzing the effect of early diagnosis to mortality and related outcomes of CCHD treatment. Results. The annual prevalence of neonatal CCHD in Korea was 0.144% percent. A total of 2,241 CCHD neonates, 1,546 (69.0%) underwent cardiac ultrasound within three days after birth, and mothers of 419 neonates had a record of prenatal fetal ultrasound (18.7%). In our comparison of neonates diagnosed with CCHD within three days of birth with those diagnosed with CCHD on or after day 4 of birth, the probability of early diagnosis increased for preterm infants and infants with low birth rate. Regarding mortality rate, most types of CCHD showed a significantly higher mortality rate in the early diagnosis group. Conclusions. The reason for the high mortality rate despite a high early diagnosis rate pertains to the high percentage of patients with severe conditions that induce a serious heart rate within three days of birth. More than half of the neonates with CCHD were found to have not undergone a prenatal fetal ultrasound, rendering this an important policy target.

Poster Presentation Number: PP52 Abstract Title: Will Joint European Health Technology Assessment Provide Additional Benefits Over Individual Country-wise Assessments? Author Names: Rhythm Arora ([email protected]), Ignacio Garcia Gonzalez, Caroline Delaitre-Bonnin Introduction. In December 2021 the European Union (EU) Health Technology Assessment (HTA) Regulation, a key pillar of the EU Pharmaceutical Strategy, was adopted by the Council and the European Parliament. The focus areas of Joint HTA Cooperation include Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), and joint early-stage horizon scanning. The European HTA regulation will be adopted in a stepwise approach and from 2030 onwards, all products (drugs, high-risk medical devices, and in vitro diagnostics) approved in all indications will be subjected to JCA in EU. Methods. A targeted literature research was performed for policies and the European Network for HTA (EUnetHTA) methodological guidelines describing the HTA methods including scoping process, comparators, endpoints, the applicability of evidence, and validity of clinical studies. Additionally, the anticipated opportunities and challenges were also summarized with respect to these methods. Results. EUnetHTA put forward a timeline for different activities over the next three years as part of the new EU HTA Regulation, including key deadlines for ongoing EUnetHTA consultations on the processes and methods. EUnetHTA will set up a new ecosystem across the EU as it aims to reduce duplication and time to access by supplementing multiple national clinical assessments with a joint central assessment. In any case, assessment of added value and pricing and reimbursement decisions will still occur at the national level. Additionally, EU HTA may promote harmonization of processes, standards, and evidence requirements, which will increase predictability and simplify evidence requirements. However, differences in clinical practice, standard of care, and national priorities may lead to assessments that are not generalizable to all Member States. Conclusions. The joint EU HTA cooperation will benefit countries which have less developed or do not have established HTA expertise or infrastructure. However, the JCA process could result in increased requirements for clinical evidence generation as relative effectiveness and relevance of outcomes to patients gain further importance for products to successfully gain access across countries.

Poster Presentation Number: PP53 Abstract Title: Increasing Emergence Of Novel Digital Health Technologies Identified Through Horizon Scanning Author Names: Zhen Long Ng ([email protected]), Hong Ju, Jaryl Ng, Kwong Ng Introduction. Recently, there have been calls for the development of new health technology assessment (HTA) methodologies to address the growing emergence of novel digital health technologies (DHTs). In particular, the lack of robust evidence base and technology-specific considerations of DHTs, such as software updates, present challenges for evaluation with conventional HTA methods. In Singapore, the Agency for Care Effectiveness (ACE) has established a horizon scanning (HS) system to provide the healthcare system with advance notice on emerging medical technologies (MedTechs) that may enter the Singapore market. This study aims to investigate the anticipated emergence of DHTs identified by ACE’s HS system and the potential implications on subsequent HTA methodology. Methods. Based on ACE’s HS methodology, which is in line with international best practices, new and emerging MedTechs that address the top five local disease burden (i.e., cardiovascular, cancer, mental, neurological and musculoskeletal disorders) were identified from various sources and monitored for its development. These MedTechs were further filtered to shortlist potential technologies for HS assessment based on its innovative nature and appropriate time horizon to local regulatory approval. For this exercise, the filtered MedTechs were classified into categories such as DHTs, comprising technologies involving software or artificial intelligence (AI), and non-DHTs. Results. Between 2021 and 2022, ACE has completed two topic filtration exercises. Based on 807 and 1,231 monitored MedTechs, 35 and 42 technologies remained after filtration, respectively. Among them, six out of 35 (17%) and 15 out of 42 (36%) filtered MedTechs were classified as DHTs, accounting for approximately two-fold increase in the number of DHTs shortlisted year-on-year. These DHTs include standalone AI software, software in a medical device, and digital therapeutics. Conclusions. There is a substantial increase in DHTs identified that are anticipated to enter the local healthcare system. Given their unique characteristics, this may call for the modification of current HTA method to enable meaningful evaluation of DHTs.

Poster Presentation Number: PP54 Abstract Title: Machine Learning For Accelerating Screening In Literature Reviews Author Names: Mary Chappell ([email protected]), Mary Edwards, Deborah Watkins, Christopher Marshall, Lavinia Ferrante di Ruffano, Anita Fitzgerald, Sara Graziadio Introduction. Systematic reviews are important for informing decision-making and primary research, but they can be time consuming and costly. With the advent of machine learning, there is an opportunity to accelerate the review process in study screening. We aimed to understand the literature to make decisions about the use of machine learning for screening in our review workflow. Methods. A pragmatic literature review of PubMed to obtain studies evaluating the accuracy of publicly available machine learning screening tools. A single reviewer used ‘snowballing’ searches to identify studies reporting accuracy data and extracted the sensitivity (ability to correctly identify included studies for a review) and specificity, or workload saved (ability to correctly exclude irrelevant studies). Results. Ten tools (AbstractR, ASReview Lab, Cochrane RCT classifier, Concept encoder, Dpedia, DistillerAI, Rayyan, Research Screener, Robot Analyst, SWIFT-active screener) were evaluated in a total of 16 studies. Fourteen studies were single arm where, although compared with a reference standard (predominantly single reviewer screening), there was no other comparator. Two studies were comparative, where tools were compared with other tools as well as a reference standard. All tools ranked records by probability of inclusion and either 1) applied a cut-point to exclude records or 2) were used to rank and re-rank records during screening iterations, with screening continuing until most relevant records were obtained. The accuracy of tools varied widely between different studies and review projects. When used in method 2), at 95% to 100% sensitivity, tools achieved workload savings of between 7% and 99%. It was unclear whether evaluations were conducted independent of tool developers. Conclusions. Evaluations suggest the potential for tools to correctly classify studies in screening. However, conclusions are limited since i) tool accuracy is generally not compared with dual reviewer screening and ii) the literature lacks comparative studies and, because of between-study heterogeneity, it is not possible to robustly determine the accuracy of tools compared with each other. Independent evaluations are needed.

Poster Presentation Number: PP61 Abstract Title: Cost-Effectiveness Analysis Of Trastuzumab Deruxtecan Versus Chemotherapy For Previously Treated HER2-Positive Gastric Cancer In Singapore Author Names: Ivan Koh ([email protected]), Ling Eng Tan, Mohamed Ismail Abdul Aziz, Liang Lin, Kwong Ng Introduction. The phase two DESTINY-Gastric-01 trial demonstrated that trastuzumab deruxtecan (T-DXd) improved overall survival in Asian patients with human epidermal growth factor receptor 2 (HER2)-positive, advanced gastric or gastroesophageal adenocarcinoma that had progressed following two or more treatments, compared with chemotherapy (irinotecan or paclitaxel monotherapy). Considering the high cost of T-DXd, we assessed the cost-effectiveness of T-DXd versus chemotherapy from the Singapore healthcare system’s perspective. Methods. A partitioned survival model with three health states (progression-free, progressed disease and death) was developed, with a five-year time horizon. Survival curves from DESTINY-Gastric-01 were extrapolated beyond the trial duration using parametric functions. Health state utilities were obtained from published literature and direct costs were sourced from public healthcare institutions in Singapore. Utility decrements for adverse events such as interstitial lung disease was incorporated into the model for the differences in safety profiles. A discount rate of three percent was applied to costs and outcomes. One-way deterministic sensitivity analyses (OWSA) and scenario analyses were conducted to assess parameter and model uncertainties. Results. Treatment with T-Dxd, compared to chemotherapy, had a high base case incremental cost-effectiveness ratio (ICER) of over SGD450,000 (USD334,900) per quality-adjusted life-year gained. The cost of T-DXd greatly influenced the results according to OWSA. Seventy-three percent of the total costs accrued in the T-DXd arm was due to the cost of the drug, compared to seven percent in the chemotherapy arm. The ICER was also sensitive to the assumptions around extrapolation of the survival curves, but when tested across all scenario analyses, the results remained unfavorable. Conclusions. At the current cost, T-DXd does not represent good value compared to chemotherapy for previously treated HER2-positive gastric cancer in Singapore. The findings from our cost-effectiveness analysis, alongside other considerations, will be useful to inform policy makers on funding decisions.

Poster Presentation Number: PP64 Abstract Title: Cost-Effectiveness Of Fractional Flow Reserve As Diagnostic Tool In Coronary Artery Disease Versus Angiogram Alone In Indian context Author Names: Monika Pusha, Arif Fahim ([email protected]), Kirti Kataria Introduction. Fractional Flow Reserve (FFR) is a diagnostic tool that aids decision-making in the treatment of coronary artery disease (CAD). FFR provides an objective measurement and is used as an adjunct to an angiogram. The clinical and cost-benefit of using FFR have been well established across published literature. This research was aimed at evaluating the economic impact of using FFR as an adjunct to angiogram versus an angiogram alone, in the Indian healthcare context. Methods. A study from a tertiary care public hospital in India estimated the impact of using FFR as an adjunct to angiogram in management of CAD. This study was used to create a mathematical simulation model to estimate cost-effectiveness and economic impact of using FFR over seven years’ time horizon, from the Indian health systems perspective. A targeted literature review was performed to collect the clinical inputs for the model, and the national public health insurance program data was referenced to obtain the cost inputs. Results. A hypothetical cohort of 100,000 patients in the model reported 30 percent reduction in unnecessary stenting. Moreover, 14,025 deaths were averted with the adoption of FFR. In addition, there was a cost-saving of INR46,986 (574USD) per death averted and INR5,169 (63USD) per patient treated over a seven-year time horizon. The analysis demonstrated that FFR inclusion in the current clinical practice saves INR2,651 (32USD) per patient in overall upfront cost and INR2,518 (31USD) per patient in overall follow-up cost over a seven year follow-up period owing to improved diagnosis and prognosis. Conclusions. In conclusion, FFR prevents unnecessary stenting, reduces overall mortality, and proves to be a cost-saving intervention in the long-term when used as a decision-making criterion in CAD patients in the Indian context.

Poster Presentation Number: PP65 Abstract Title: An Economic Evaluation of Day Care Surgery For Non-Acute Hernia Repair In Government Hospitals Of Sri Lanka Author Names: Anuji Gamage, Amala de Silva, Hideki Higashi, Deepika Attygalle, Sathasivam Sridharan, Lakshmen Senanayake, Ranjan Dias, D M C D Dissanayake, Hansoo Kim ([email protected]) Introduction. Early discharge of publicly funded non-acute hernia repair patients may save healthcare costs by reducing inpatient stays. This study reports a cost analysis of establishing day-care surgeries for publicly funded patients undergoing non-acute hernia repair in Sri Lanka. Methods. A decision tree model was developed to represent the pathway probabilities and costs. Cost data was taken from the Medical Supplies Division, relevant hospitals, and laboratories. Hospital costs per-day were calculated based on WHO-CHOICE model with inflation adjusted to 2022 value. The model assumed that 60 percent of the hernia patients presented to the outpatient department, 39 percent were referred from private clinics, and 1 percent of hernia repairs admitted as inward transfers or emergencies. Of the hernia repairs that were conducted, 95 percent were assumed to be uncomplicated hernias, and the most common post- operative compilation encountered was urine retention accounting for 95 percent of the complicated cases. Results. It was estimated that in the current situation for a cohort of 1,000 patients undergoing non-acute hernia repair, 2,055 overnight in-hospital days were utilized. If day surgery services can be performed with patients observed for less than 24 hours before being discharged the overnight stay can be reduced to 155 patients. In the current scenario the total cost for non-acute hernia repair at a state hospital was estimated LKR170.9M (≈USD529K) per 1000 patients while the same procedure done as a Day Care procedure cost estimate was LKR155.7M (≈USD482K) per 1000 patients. The savings from implementing day-care surgeries for non-acute hernia repair will amount to approximately LKR15M (≈USD40K) when caring for 1,000 patients. The results were sensitive to length of stay and proportion of complicated cases. Conclusions. Shifting uncomplicated non-acute hernia repair patients from an inward scenario to a day care scenario would lead to a considerable financial saving to the government. More evidence on the value of expanding day care services and observation services capacity should be explored as this would guide efficient and sustainable publicly funded healthcare system in Sri Lanka.

Poster Presentation Number: PP67 Abstract Title: What Patients Want – Optimizing Oncology Value Assessment To The Goals Of Patients Author Name: Richard Vines ([email protected]) Introduction. Cancer is now diagnosed and treated earlier, resulting in improved patient benefit and outcomes. While overall survival (OS) is crucial to patients, there are other value dimensions, such as quality of life (QoL) and reduction in severe side effects, that change patient lives while on treatment. Considering patient reported outcomes (PROs) in value assessments for decision-making can improve individual, population and societal outcomes. Methods. A multidisciplinary, international group of experts working in the cancer field was brought together to reach consensus on key principles of defining and assessing cancer treatment value. A Delphi-based approach including surveys, virtual panels, interviews and structured online discussions was used to reach consensus. This work was funded by AstraZeneca. Results. Use of PROs in oncology value assessment is important because it can lead to: improvements in caregiver/patient/physician communication; unmet problem and needs detection; disease and treatment tracking; and better cost effectiveness. While some health technology assessment (HTA) bodies are already accepting QoL data, such as the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany and US Centers for Medicare and Medicaid (CMS), many others do not. It is important that there is consistency in use of QoL data and other PROs, ensuring inclusion and a standardized and simple way of capture. In trials, tolerability data collected via PROs and QoL should be routinely and consistently incorporated and emphasized in HTA value assessments together with safety, efficacy and effectiveness. Data from PROs should be considered in decision-making to help build a better picture of health-related QoL, morbidity and adverse events from the patient perspective. Conclusions. We are calling on the cancer community to: continue to encourage the use of a broad set of oncology-relevant endpoints in clinical trials to further validate their relevance as endpoints either as predictors of clinical outcomes or endpoints with intrinsic value; collect complementary PRO data in clinical trials and as real-world evidence to better tailor treatment options to the outcomes that individual patients value most; involve patients in HTA processes.

Poster Presentation Number: PP68 Abstract Title: When Evidence Takes A Backseat To Politics - The Rise Of Robot Surgery In Australia Author Name: Paul Fennessy ([email protected]) Introduction. A 2018 health technology assessment (HTA) on robot-assisted surgery (RAS) led to a national committee recommendation, which some state Health Ministers adopted as policy, which stated: (i) no further public investment in RAS until subsequent HTAs demonstrate improved evidence; and (ii) clinical and patient outcomes from existing platforms should inform future decisions. This work also identified the Royal Australasian College of Surgeons (RACS) does not accredit any RAS training program for Australian surgeons, nor is there any nationally agreed or consistent credentialing mechanism, which creates ambiguity for hospitals (can this surgeon safely deliver?). Some state governments are ignoring its own policy and investing in RAS. At the same time, some public hospitals are ignoring the policy and procuring RAS through affiliated private hospitals. While market competition is expected to reduce price, governments responding to ‘squeaky wheels’ sets a dangerous precedent for high-cost technology procurement, especially if it needs to be replaced, and cost of delivery may not offset revenue generated. Methods. Australia’s states and territories can collaborate to commission HTAs. Since 2015, they have, jointly or independently, commissioned HTAs to monitor RAS evidence, which led to the 2018 HTA and policy. However, this policy is being ignored by hospitals and governments. Results. RACS is working with local agencies to develop accredited training programs for different RAS platforms, which should offer comfort to provider hospitals regarding surgeon credentialing. Surgeons and patients are increasingly vocal regarding RAS, resulting in some governments investing in RAS. Not consulting with all stakeholders has led to confusion and a questionable role for policy makers. Private hospitals operated by public hospitals are procuring RAS in contravention of the policy and with no consequences, creating further confusion. Conclusions. While accredited surgeon training will improve skills and outcomes, governments ignoring their own policy is resulting in unplanned technology introduction, which led to the need for HTA in the first place. Do we need to rethink the role of HTA, or should we accept that politics trumps evidence?

Poster Presentation Number: PP69 Abstract Title: Health Technology Assessment And University Health Center Affiliation Agreement: Current Situation And Potential Developments In Quebec Author Names: Marc Rhainds ([email protected]), Gisèle Mbemba, Daniel La Roche, Marie- Pierre Gagnon Introduction. According to the Quebec law on health and social services, health technology assessment (HTA) is part of university hospital centers’ mission, together with training, research and care. However, unlike these other functions, HTA is not covered in current affiliation agreements that bind a university with academic health institutions. Université Laval and its affiliated health institutions set up a consultation committee whose mandate is to propose the terms of an agreement to specify collaboration regarding HTA between the university and its affiliated institutions. This study investigates perceptions and needs of stakeholders from Université Laval and its affiliated health institutions with respect to the HTA mission. Methods. Semi-structured interviews were conducted with four types of participants, namely university faculty members, health professionals and managers from institutions with and without HTA units, as well as external partners. Interview guides were developed based on the integrated analysis framework of Greenhalgh et al., and adapted to each group of respondents. Most interviews were conducted in groups and were facilitated by a research associate and a senior investigator. Interviews were recorded and uploaded to NVivo 1.6.2 software for codification and analysis. Results. A total of 57 people were interviewed (nine group interviews and 35 individual interviews). Three main themes emerged, namely knowledge of HTA, factors related to the relevance of the HTA function, and organizational factors. Results showed that half of the respondents have a vague knowledge of HTA or have never heard of it. Most of the respondents agreed that the HTA function fits well with the mission of a health institution. They would accept getting involved with HTA activities at different levels if all conditions are met. Nevertheless, almost half of respondents believed that others strategies than including HTA into contracts of affiliation should be explored to regulate this function. Finally, organizational obstacles such as the lack of funding, shortage of staff and the lack of well-structured collaborations were highlighted by respondents. Conclusions. Despite recognition of the importance of the HTA function in university health centers, interventions will be required at different levels to support the development of local HTA capacity. In particular, popularization of the HTA function and collaboration networks through specific projects should be developed.

Poster Presentation Number: PP70 Abstract Title: Mapping Of Health Technology Assessment In China: A Comparative Study Between 2016 And 2021 Author Names: Shimeng Liu, Yu Xia ([email protected]), Yi Yang, Jian Ming, Hui Sun, Yan Wei, Yingyao Chen Introduction. This study aimed to compare changes in the level of health technology assessment (HTA) development from 2016 to 2021, and to inform policies and decisions to promote further development of HTA in China. Methods. We conducted a cross-sectional and anonymous web-based survey to relevant stakeholders in China in 2016 and 2021 respectively. The mapping of the HTA instrument was used to reflect the HTA development from eight domains. To reduce the influence of confounders and to compare the mapping outcomes between 2016 and 2021 groups, we performed 1:1 propensity score matching methodology in this study. Univariate analysis was performed to compare the differences in these two groups. We also compared the overall results with that of a mapping study that included ten countries. Results. A total of 212 and 255 respondents completed the survey in 2016 and 2021 respectively. After propensity score matching methodology, 183 cases from the 2016 group and 2021 group were matched. Overall, the mean score of 2021 in most of the domains was higher than in 2016 in China (p < 0.05), matching the level of HTA institutionalization and dissemination strategy, except for the assessment domain. Although China scored significantly lower among the three developed countries, the overall HTA development score for China was comparable among the ten countries. Conclusions. Our study suggested the level of HTA development in China has made great progress from 2016 to 2021. Prior to HTA activities, the researcher or policy makers should first formulate an explicit assessment goal and scope, and during the assessment process, more attention should be paid to the clinical effectiveness and cost- effectiveness indicator to ensure a higher quality of HTA evidence.

Poster Presentation Number: PP71 Abstract Title: Hospitalization Costs Associated With Advanced Non-Small Cell Lung Cancer In China: Real World Evidence From Jiangsu Author Names: Yu Xia ([email protected]), Yi Yang, Yingyao Chen Introduction. Non-small cell lung cancer (NSCLC) constitutes 85 percent of lung cancer diagnoses and poses an economic threat to the sustainability of healthcare services. This study was conducted to estimate hospitalization costs associated with advanced NSCLC without sensitizing EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) alterations in China and explore the potential predictors. Methods. Data linked with patients with advanced NSCLC (stage IIIB–IV) without sensitizing EGFR and ALK alterations were obtained from the electronic medical record system of one general hospital and one cancer hospital in Jiangsu province, China, ranging from January 2017 to December 2020. We excluded patients with lung metastases from tumors elsewhere in the body. The socio-demographic characteristics, disease-related characteristics, and hospitalization cost of eligible patients were extracted. We used the generalized linear model (GLM) to assess the potential influencing factors of hospitalization cost. Results. Patients with advanced NSCLC (n=7,260) were included in this study. The median hospitalization cost of advanced NSCLC was USD11,540.47. The median hospitalization examination and test costs were USD1,539.46, and the median hospitalization drug cost was USD6,351.47. GLM results showed that patients aged 60 or older (95% Confidence Interval [CI]: -1019.1,128.6), who had no gene driver (95%CI: -1,681.6,- 233.6) were more likely to have relatively lower hospitalization costs for advanced NSCLC. Patients treated in cancer hospital (95%CI: 1,329.1,2,620.0) and with non-squamous carcinoma (95%CI: 171.3, 1,235.4) may have higher hospitalization costs. Compared with Urban Employee Basic Medical Insurance, patients with free medical services (95%CI: 1,248.4,6,298.7) were associated with higher hospitalization costs. Patients with higher hospitalization frequency and longer length of hospital stay (p < 0.05) were linked to higher hospitalization costs. Conclusions. The hospitalization costs linked to advanced NSCLC is considerable for patients, with drug costs accounting for the largest. More efforts still need to be made to alleviate the direct medical burden.

Poster Presentation Number: PP75 Abstract Title: Using Real World Evidence To Support The Reimbursement Of Proton Therapy Across A Broad Range Of Rare Cancers Author Names: Nimita Arora ([email protected]), Dominic Tilden, Scott Penfold Introduction. The Australian Bragg Centre for Proton Therapy and Research in Adelaide will be Australia’s first center with the capacity to deliver proton beam therapy (PBT). PBT uses energy from protons to target cancer cells while minimizing damage to surrounding healthy tissue, including vital organs. Compared to X-ray (photon) radiation therapy (PRT), PBT reduces the risk of serious and long-term complications. To improve access to PBT, the South Australian Health and Medical Research Institute (SAHMRI) submitted an application to the Medical Services Advisory Committee (MSAC) including a cost utility analysis (CUA) comparing PBT with PRT to treat specific pediatric/adolescent and young adult (AYA) and rare adult tumors. Methods. A systematic review identified 28 comparative, mostly real-world studies to support the conclusion that PBT has superior safety and non-inferior efficacy to PRT in the requested indications. The key challenge for the CUA was to quantify the cost and quality of life implications of the superior safety profile across a wide range of indications with a limited comparative evidence base. A simple lifetime decision analytic model was developed which modeled the rates, costs and utilities associated with relevant toxicities. The complications of radiotherapy are often chronic and included secondary malignancies, visual impairments, endocrine dysfunction, dysphagia, hearing loss and intellectual disability. Some of these toxicities are only applicable to patients with cranial cancers. Therefore, the event rates applied in the evaluation were adjusted to account for the proportion of patients within each population estimated to have extracranial cancers. Results. When results in the adult and pediatric/AYA populations were weighted across the expected utilization of PBT (34% adults, 66% pediatric/AYA) in each population, PBT was dominant relative to PRT. Conclusions. In November 2020, MSAC recommended funding PBT in specific populations at high risk of long-term side effects from PRT. To address uncertainties around the evidence base, MSAC further requested the following: • All patients receive comparative photon/proton plans to determine eligibility • A national registry is established for patients treated with PBT.

Poster Presentation Number: PP76 Abstract Title: From Hospital-based Health Technology Assessment (HTA) To Treatment Decision: What Decisions Actually Result After HTA In A Resource Constrained Environment? Author Names: Anita Fitzgerald ([email protected]), James Le Fevre, Gina Morgan, Stephen Streat, Stephen Munn Introduction. The Northern Region Clinical Practice Committee (NRCPC) conducts hospital-based health technology assessments (HTA) to provide advice to hospital managers regarding both the implementation of new technologies and the configuration of existing services. To assist in the comparison of dissimilar health technologies applied across different disciplines and different hospitals, the NRCPC developed a prioritization tool. This abstract reports the use of the tool over the 17-year period that the committee has been in operation. Methods. The score given to each HTA depends on cost-utility, predicted health improvements and the quality of evidence. In addition to the scoring tool, editorial notes are provided to contextualize the agreed score and to explain the NRCPCs interpretation of the evidence. Results. Most of the time hospital managers have made decisions concordant with the recommendations of the NRCPC; submissions are recommended to be implemented, declined, or receive interim approval with data collection. The latter often occurs when there are uncertainties about efficacy, but no (or very few) safety concerns, or where there are uncertainties about whether the proposed costs are reproducible in the hospital setting. In these cases, management responses often require submitters to undertake a limited number of cases and collect data for audit over a one- to two-year period. Low-scoring submissions are often declined, whereas high-scoring submissions have not been declined to date. The interim approval (with data collection) strategy has had variable outcomes based on the willingness of the implementing clinicians to collect accurate data about both costs and outcomes. From 2005 to 2022, the NRCPC received 146 submissions. This poster reports graphical representations of the decisions made over the NRCPCs period of operation. Conclusions. The NRCPC scoring tool has been successful to date in providing a framework for decision makers to allow consistent, unbiased and objective assessments of dissimilar technologies. Prioritization tools in hospital- based HTA are beneficial to decision makers in hospital settings.