International Journal of Technology Assessment in Health Care最新文献

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PP152 Evaluation Of Reimbursement Periods In The Turkish Biosimilar Product Market (1995-2022) PP152 土耳其生物仿制药市场报销期限评估(1995-2022 年)
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323002544
Sena Unluler Deger, Elif Hilal Vural
{"title":"PP152 Evaluation Of Reimbursement Periods In The Turkish Biosimilar Product Market (1995-2022)","authors":"Sena Unluler Deger, Elif Hilal Vural","doi":"10.1017/s0266462323002544","DOIUrl":"https://doi.org/10.1017/s0266462323002544","url":null,"abstract":"<span>Introduction</span><p>Biosimilar products that would enhance the patient’s access to treatments have emerged as a product group that is becoming more widespread globally. Since Turkiye is an emerging market in the pharmaceutical area in the Middle East and North Africa region, and being a reference country in pricing processes for some countries, the number of products in the market and reimbursement decisions are important. The aim of this study is to evaluate duration of inclusion of biosimilars into reimbursement lists after registration in Turkiye.</p><span>Methods</span><p>This study used website-based information (Turkish Medicine and Medical Devices Agency Registered Products List and Detailed Pharmaceutical Price List, Social Security Institution Reimbursed Product List) to analyze the reimbursement approval duration for registered biosimilars in Turkiye after receiving registration approval. A study has been conducted on the launch period of biosimilar products to patients access with reimbursement and the evaluation period of reimbursement applications after registration approval. Even though they might not be active on the reimbursement list right now, products that have previously been approved for payment have been included.</p><span>Results</span><p>Between 1995-2022, biosimilars of 13 active substances in total were registered by the Ministry of Health in Turkiye. Thirty-three different brands and 105 biosimilars with all pharmaceutical forms are registered. As of November 2022, 72 biosimilars were in the reimbursement list. Twenty-two of reimbursed biosimilars were deactivated or excluded from reimbursement. It is calculated that the average evaluation and approval timeline for reimbursement of biosimilars between 2009 and 2022 is 9 months. When biosimilars in the European Medicines Agency (EMA) and Turkiye are compared, 13 biosimilar active substances are licensed in Turkiye compared to 19 for the EMA. When the total number of brands is compared, it has been observed that while 33 brands are registered in Turkiye, this number is 73 for the EMA.</p><span>Conclusions</span><p>This study, in which reimbursement approval dates for registered biosimilars in Turkiye have been compared based on years and access timelines of biotechnological products, shows that biosimilars have been launched to patients access with reimbursement much faster than biotechnological products.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP69 Health Technology Assessment And University Health Center Affiliation Agreement: Current Situation And Potential Developments In Quebec PP69 卫生技术评估与大学卫生中心附属协议:魁北克的现状与潜在发展
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323002052
Marc Rhainds, Gisèle Mbemba, Daniel La Roche, Marie-Pierre Gagnon
{"title":"PP69 Health Technology Assessment And University Health Center Affiliation Agreement: Current Situation And Potential Developments In Quebec","authors":"Marc Rhainds, Gisèle Mbemba, Daniel La Roche, Marie-Pierre Gagnon","doi":"10.1017/s0266462323002052","DOIUrl":"https://doi.org/10.1017/s0266462323002052","url":null,"abstract":"<span>Introduction</span><p>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.</p><span>Methods</span><p>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.</p><span>Results</span><p>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.</p><span>Conclusions</span><p>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP146 Seeing Eye-To-Eye on Real-World Evidence: Are Guidance from Japan and China Consistent with Recommendations from REALISE in Asia? PP146 在现实世界的证据上看齐:日本和中国的指导与亚洲 REALISE 的建议是否一致?
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323002507
Yan Ran Wee, Natsumi Fujita, Jennifer S Evans
{"title":"PP146 Seeing Eye-To-Eye on Real-World Evidence: Are Guidance from Japan and China Consistent with Recommendations from REALISE in Asia?","authors":"Yan Ran Wee, Natsumi Fujita, Jennifer S Evans","doi":"10.1017/s0266462323002507","DOIUrl":"https://doi.org/10.1017/s0266462323002507","url":null,"abstract":"<span>Introduction</span><p>The REAL World Data (RWD) In Asia for Health Technology Assessment (HTA) guidance was developed by a regional working group to facilitate the increasing acceptance of real-world evidence (RWE) in Asia. We compared the consistency of REALISE against guidance from Japan and China.</p><span>Methods</span><p>Country-specific guidance for RWE/RWD use in pharmaceutical development were identified in May 2022 through governmental websites, with validation searches via Google. Sections from local guidance were mapped onto REALISE and categorized as “agree”, “mixed”, “disagree” or “missing” based on coverage and consistency.</p><span>Results</span><p>Five Japanese and three Chinese documents were mapped. Most sections in Chinese guidance (77%) and 36 percent of sections in Japanese guidance were tagged “agree” or “mixed”, with general alignment on definitions and good practice considerations (study design, accountability); however, 63 percent of Japanese sections were tagged “missing” from REALISE. As local documents took the regulatory perspective, they lacked REALISE’s discussion of translating RWD to RWE for HTA/economic evaluations specifically. Local guidance focused on practicalities of RWD collection in local contexts, including descriptions of specific actions (e.g., evaluating RWD sources, ensuring data security) rather than overarching principles described in REALISE; specifically, Japanese guidance described how to access and analyze databases/registries, reflecting Japan’s landscape of robust sources of national healthcare data, but lacked discussion of other RWE study types, data sources and specialized analytical methods. While Chinese guidance had a broader view of RWD types (more similar to REALISE), they also contained discussions on pharmacovigilance and omics data, communication with regulatory bodies, and incorporation of RWE into the approval pathway for traditional Chinese medicines.</p><span>Conclusions</span><p>Despite differing purposes (with no RWE guidance from local HTA bodies), local and regional guidance align on general principles/good practice in generating/using RWE, providing common ground for increasing usage of RWE in HTA in Asia.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP149 Reengineering Of Processes For The Elaboration Of Health Technology Assessment Reports In Catalonia PP149 加泰罗尼亚健康技术评估报告编制流程再造
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323002520
Maria-Dolors Estrada, Jessica Ruiz-Baena, Roland Pastells-Peiró, Edurne Gallastegui-Calvache, Anna Godo, Laura Llinàs-Mallol, Pablo Martinez-Diaz, Berta Mestre-Lleixà, Carolina Moltó-Puigmartí, Daniel Pérez-Troncoso, Laia Ramos-Masdeu, Joan Segur-Ferrer, Gerard Solís-Díez, Rosa Maria Vivanco-Hidalgo
{"title":"PP149 Reengineering Of Processes For The Elaboration Of Health Technology Assessment Reports In Catalonia","authors":"Maria-Dolors Estrada, Jessica Ruiz-Baena, Roland Pastells-Peiró, Edurne Gallastegui-Calvache, Anna Godo, Laura Llinàs-Mallol, Pablo Martinez-Diaz, Berta Mestre-Lleixà, Carolina Moltó-Puigmartí, Daniel Pérez-Troncoso, Laia Ramos-Masdeu, Joan Segur-Ferrer, Gerard Solís-Díez, Rosa Maria Vivanco-Hidalgo","doi":"10.1017/s0266462323002520","DOIUrl":"https://doi.org/10.1017/s0266462323002520","url":null,"abstract":"<span>Introduction</span><p>In order to increase the value of its services and activities, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has incorporated in its strategic plan the commitment to improve the processes, quality and people, while ensuring transparency, independence, rigor and efficiency following the guidelines of the European Foundation for Quality Management. We aim to present the standardization processes to improve the efficiency in elaborating health technology assessment (HTA) reports at AQuAS.</p><span>Methods</span><p>Process standardization has been developed in seven stages: (i) definition of scope, objectives and creation of working groups; (ii) mapping and analysis of all ongoing processes to determine whether they needed improvement or were already optimal; (iii) creation of new processes by evaluating the inclusion of automatic tools and their possible digitization; (iv) creation of the process map; (v) communication to the team for its implementation after training; (vi) dissemination on corporate website; (vii) monitoring and evaluation of their impact.</p><span>Results</span><p>The creation of AQuAS’ HTA report development process map has involved 14 people over the past two years. After an initial two-day workshop, the team was organized in working groups of two to three people, with regular monitoring and the creation of a specific knowledge management unit led by the AQuAS’ evaluation manager. The process map was configured based on three axes. The strategic axis contains legal frameworks, ethical principles, good practices and methodological frameworks (29 specific for HTA reports). The key axis presents in an integrated way the process and methodology followed from the request of the HTA report to the final product’s dissemination. The support axis includes, among other, the management of 31 requests, information specialist processes (37 searches), training (51 courses) and 6 internal procedures with their corresponding 26 templates and 27 tools.</p><span>Conclusions</span><p>With a process reengineering approach, HTA reporting has become more efficient. We believe this approach can help other agencies improve their internal processes and subsequently improve team and customer satisfaction.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP131 Health Technology Assessment Agencies’ Expectations Regarding Patient Experience Data in Europe PP131 欧洲医疗技术评估机构对患者体验数据的期望
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s026646232300243x
Juergen Zschocke, Carolina Alonzo, Ding Ding, Jiat-Ling Poon, Lillbrith Vonarx, Arianna Avitabile, Shane Myrick, Jennifer Hill, Alberto Molero, Nancy Perez, Laure Delbecque
{"title":"PP131 Health Technology Assessment Agencies’ Expectations Regarding Patient Experience Data in Europe","authors":"Juergen Zschocke, Carolina Alonzo, Ding Ding, Jiat-Ling Poon, Lillbrith Vonarx, Arianna Avitabile, Shane Myrick, Jennifer Hill, Alberto Molero, Nancy Perez, Laure Delbecque","doi":"10.1017/s026646232300243x","DOIUrl":"https://doi.org/10.1017/s026646232300243x","url":null,"abstract":"<span>Introduction</span><p>Health technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to describe the European Network for HTA (EUnetHTA) and HTA agencies expectations regarding PED to support reimbursement in France, Germany, Italy, Spain and the UK.</p><span>Methods</span><p>Published HTA guidance documents were reviewed to identify recommendations related to clinical outcomes assessment (COA) (including disease-specificity, validation, analyses, endpoints and interpretation) and other forms of PED (e.g., patient preference information) in HTA decision-making. Insights from guidance documents were supplemented with a review of literature and published HTA cases and interviews with key opinion leaders (KOLs) focused on current and future states.</p><span>Results</span><p>The German and French guidance documents include PED recommendations focused on relevant COA and health-related quality of life data, without detailing preferred COA measures. However, key differences were noted between these two countries in the methodological approaches regarding responder definitions, acceptable missing data threshold and multiplicity analyses. These differences were reinforced by the case studies and the KOLs. UK’s sources also focused on COA, in general proposing specific use of the EQ-5D to derive utility values for modelling, but included limited details on other PED-related elements. The Italian and Spanish guidance documents do not detail COA or other PED expectations, but the Italian KOL described that COA is considered if submitted. The currently developed EUnetHTA21 guidelines include PED-related information that bear the signature of certain individual HTA bodies. Globally, there is limited interest in PED beyond COA across the agencies.</p><span>Conclusions</span><p>The level of expectations with regards to PED varies across EUnetHTA and several European HTA agencies. Interest in PED derived from non-COA sources is limited across the countries. Knowing each agency’s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development. Global harmonization would help advancing PED measurement standards.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP90 Artificial Intelligence To Detect Ischemic Heart Disease In Non-traumatic Chest Pain At The Emergency Department – SmartHeart Study 利用 PP90 人工智能检测急诊科非创伤性胸痛中的缺血性心脏病 - SmartHeart 研究
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323002180
Eunate Arana-arri, Aitor García de Vicuña, Silvia Carbajo, Sara de Benito Sobrado, Magdalena Carreras, Irma Arrieta, Juan Carlos Bayon-Yusta
{"title":"PP90 Artificial Intelligence To Detect Ischemic Heart Disease In Non-traumatic Chest Pain At The Emergency Department – SmartHeart Study","authors":"Eunate Arana-arri, Aitor García de Vicuña, Silvia Carbajo, Sara de Benito Sobrado, Magdalena Carreras, Irma Arrieta, Juan Carlos Bayon-Yusta","doi":"10.1017/s0266462323002180","DOIUrl":"https://doi.org/10.1017/s0266462323002180","url":null,"abstract":"<span>Introduction</span><p>An estimated 17.9 million people died from cardiovascular diseases (CVDs) in 2019, which is 32 percent of all global deaths and 85 percent were due to heart attack and stroke. Chest pain is one of the most common reasons for presenting to the emergency department (ED). It is increasingly recognized that artificial intelligence (AI) will have a significant impact on the practice of medicine in the near future and may help with diagnosis and risk stratification. We aim to estimate a diagnostic prediction of acute myocardial infarction by the development and validation of an AI model.</p><span>Methods</span><p>Data on 134 variables of 3,986 consecutive patients who presented to the ED with non-traumatic chest pain were included in the analysis. Using AI tools, a neural network model was developed to establish the risk of acute myocardial infarction (AMI) to achieve n=150 patients over 18 years of age attending the ED.</p><span>Results</span><p>The mean age was 65.5 (±13.7) years and 63.6 percent were male. Most (60.1%) patients were admitted to hospital, with only 20.3 percent diagnosed at hospital discharge with ischemic heart disease (IHD). All patients were followed up for two months, and 6.3 percent were readmitted to the ED, but none presented with an episode of IHD. In the data analysis of the entire sample we obtained a probability of diagnosing IHD by the SmartHeart model (S=93.1%, E=47.3%, PPV=31.0%, and NPV=96.4%). When we analyzed the sample of patients with no history of IHD (n=104), the diagnosis accuracy was as follows (S=100%, E=77.5%, PPV=42.8%, and NPV=100%).</p><span>Conclusions</span><p>Our AI model provides information to predict patients who are suffering from acute IHD. AI has been reported to outperform emergency physicians and current risk stratification tools to diagnose IHD, but has rarely been integrated into practice. This study highlights the diagnostic applicability and accuracy of this type of tool and that is why studies should be implemented to see its effectiveness in routine practice in EDs.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PP01 Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach PP01 颈椎人工椎间盘置换术的卫生技术评估:强调国际统一方法的必要性
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323001678
Enti Zhang, Elena Annoni, Liesl Strachan
{"title":"PP01 Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach","authors":"Enti Zhang, Elena Annoni, Liesl Strachan","doi":"10.1017/s0266462323001678","DOIUrl":"https://doi.org/10.1017/s0266462323001678","url":null,"abstract":"IntroductionCervical 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.MethodsA 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.ResultsTwenty 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.ConclusionsC-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.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
OP152 Use of Real-world Evidence By The Brazilian Health Technology Assessment Committee (Conitec) For Monitoring Of Health Technologies OP152 巴西卫生技术评估委员会(Conitec)利用现实世界的证据监测卫生技术
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323001514
Amanda Oliveira Lyrio, Tacila Pires Mega, Ana Carolina de Freitas Lopes, Felipe Ferré, Antônio Marcos Santana Barreira, Clarice Moreira Portugal, Samara Helena de Carvalho, Laís Lessa Neiva Pantuzza, Luciene Fontes Schluckebier Bonan, Vania Cristina Canuto Santos
{"title":"OP152 Use of Real-world Evidence By The Brazilian Health Technology Assessment Committee (Conitec) For Monitoring Of Health Technologies","authors":"Amanda Oliveira Lyrio, Tacila Pires Mega, Ana Carolina de Freitas Lopes, Felipe Ferré, Antônio Marcos Santana Barreira, Clarice Moreira Portugal, Samara Helena de Carvalho, Laís Lessa Neiva Pantuzza, Luciene Fontes Schluckebier Bonan, Vania Cristina Canuto Santos","doi":"10.1017/s0266462323001514","DOIUrl":"https://doi.org/10.1017/s0266462323001514","url":null,"abstract":"IntroductionIn Brazil, the incorporation or disinvestment of health technologies into the Unified Health System (SUS) are advised by the National Committee for Health Technology Incorporation (Conitec). Despite the thorough evaluation carried out by Conitec, the results measured after implementation do not always reflect the economic and clinical impact expected from the incorporation. Thus, real-world evidence (RWE) is essential for monitoring health technologies. The aim of this study was to report how Brazil is using the RWE to obtain additional information about the incorporated technologies.MethodsActions related to the use of RWE for monitoring of technologies incorporated into the SUS were described. The period evaluated was between 2012 and 2022.ResultsThe first Conitec recommendation in which the use of real-life data in the decision-making process was evidenced occurred in 2016. Administrative data from a cohort of patients identified that beta-interferons for Multiple Sclerosis were less effective than the other drugs used in the Brazilian public system. A further eight reports have been published assessing the performance of technologies using administrative data.Another strategy for RWE generation was through the funding of primary studies, highlighting a study with 21 rare diseases and another one to evaluate Zolgensma gene therapy, acquired through court for Spinal Muscular Atrophy. Both studies are ongoing and aim to evaluate the effectiveness, safety, adherence, and cost of medications in the evaluated diseases. Conitec is also following studies in RWE financed by pharmaceutical companies to evaluate effectiveness for incorporated technologies subject to reassessment. Additionally, managed access arrangements have been promoted for generating RWE when there is uncertainty about outcomes.ConclusionsReal-world evidence from administrative data and clinical research allows monitoring after the implementation of technologies in the Unified Health System in Brazil. This makes it possible to reallocate resources in health and contribute for the system sustainability, in addition to generating data that reduce the uncertainties assumed at the time of incorporation.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
OP62 Development Of The Oral Health Risk Adjustment Model To Predict The Outpatient Dental Expenditure In Children With Autism OP62 开发口腔健康风险调整模型以预测自闭症儿童的门诊牙科支出
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323000910
Mei-chi Lai, Ruei-Yi Chang, Li-Ying (Grace) Huang, Shu-Mei Hsu, Ying-Li Chen, Perng-Haur Wang
{"title":"OP62 Development Of The Oral Health Risk Adjustment Model To Predict The Outpatient Dental Expenditure In Children With Autism","authors":"Mei-chi Lai, Ruei-Yi Chang, Li-Ying (Grace) Huang, Shu-Mei Hsu, Ying-Li Chen, Perng-Haur Wang","doi":"10.1017/s0266462323000910","DOIUrl":"https://doi.org/10.1017/s0266462323000910","url":null,"abstract":"IntroductionNational health insurance (NHI) Taiwan has provided additional markups on dental service fees for people with specific disabilities, and the expenditure has increased significantly from TWD473 million (USD15 million) in 2016 to TWD722 million (USD24 million) in 2022. The purpose of this study was to determine oral health risk and to develop a risk assessment model for capitation outpatient dental payments in children with Autism.MethodsBased on the literature and expert opinion, we developed a level of oral health risk model from the claim records of 2019. The model uses oral outpatient claim data to analyze: (i) the degree of caries disease; (ii) the level of dental fear or cooperation; and (iii) the level of tooth structure. Each factor was given a score from zero to four and a total score was calculated. Low-, medium-, and high-risk groups were formed based on the total points. The oral health risk capitation models are estimated by ordinary least squares using an individual’s annual outpatient dental expenditure in 2019 as the dependent variable. For subgroups based on age group and level of disability, expenditures predicted by the models are compared with actual outpatient dental expenditures. Predictive R-squared and predictive ratios were used to evaluate the model’s predictability.ResultsThe demographic variables, level of oral health risk, preventive dental care, and the type of dental health care predicted 30 percent of subsequent outpatient dental expenditure in children with autism. For subgroups (age group and disability level) of high-risk patients, the model substantially overpredicted the expenditure, whereas underprediction occurred in the low-risk group.ConclusionsThe risk-adjusted model based on principal oral health was more accurate in predicting an individual’s future expenditure than the relevant study in Taiwan. The finding provides insight into the important risk factor in the outpatient dental expenditure of children with autism and the fund planning of dental services for people with specific disabilities.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
OP150 An Inventory Of Policy Levers For Influencing Appropriate Care OP150 影响适当护理的政策杠杆盘点
IF 3.2 4区 医学
International Journal of Technology Assessment in Health Care Pub Date : 2023-12-14 DOI: 10.1017/s0266462323001496
Lindsey Warkentin, Lisa Tjosvold, Ken Bond
{"title":"OP150 An Inventory Of Policy Levers For Influencing Appropriate Care","authors":"Lindsey Warkentin, Lisa Tjosvold, Ken Bond","doi":"10.1017/s0266462323001496","DOIUrl":"https://doi.org/10.1017/s0266462323001496","url":null,"abstract":"IntroductionHealthcare reform through appropriate care is a current focus for many jurisdictions. A variety of policy options, or “levers,” are available to decision makers to influence appropriate care. However, these levers are not always identified in advance of developing policy recommendations, and few direct, empirical analyses are available to support their selection. An appropriate care policy lever inventory was developed for health technology assessment (HTA) users in Alberta, Canada, to support HTA scoping and policy development.MethodsRelevant information was identified by a single reviewer through a scoping search of MEDLINE, forward and backward searching, and targeted gray literature searches. An Excel-based inventory was populated with a list of policy levers and their descriptions, policy effectiveness, and implementation considerations. Filters were developed to identify levers based on key characteristics. The inventory was iteratively refined through presentations to and feedback from key user groups.ResultsThe inventory contained 53 policy levers aiming to influence service provision, clinician behavior, fiscal policies, populations or organizations, and patient behavior. The levers varied in how they restrict decision-making. Few levers were considered high impact (&gt;5% change to behavior, utilization, or cost) or well-supported (&gt;10 studies reporting effectiveness). Stakeholders found the inventory information useful, particularly for considering potential levers not frequently utilized within their respective programs. A user guide and case examples were also developed to help users learn to navigate the inventory.ConclusionsAn inventory of policy levers, which can be tailored to specific clinical areas and topics, can be of assistance to healthcare decision makers developing and utilizing HTAs to improve appropriateness of care. With limited indication-specific evidence, policy makers must utilize the broader evidence base on appropriate care policy levers to select and implement strategies that are applicable and transferable to their context. Challenges remain in systematically identifying all relevant literature given the inventory’s breadth, and in updating the inventory to reflect new evidence.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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