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Objectives: COVID 19 and increasing unmet needs of health technology had accelerated an adoption of digital health globally and the major categories are mobile-health, health information technology, telemedicine. Digital health interventions have various benefit on clinical efficacy, quality of care and reducing healthcare costs. The objective of the study is to identify new reimbursement policy trend of digital health medical devices in South Korea. Method(s): Official announcements published in national bodies and supplementary secondary research were used to capture policies, frameworks and currently approved products since 2019. Result(s): With policy development, several digital health devices and AI software have been introduced as non-reimbursement by utilizing new Health Technology Assessment (nHTA) pathway including grace period of nHTA and innovative medical devices integrated assessment pathway. AI based cardiac arrest risk management software (DeepCARS) and electroceutical device for major depressive disorders (MINDD STIM) have been approved as non-reimbursement use for about 3 years. Two digital therapeutics for insomnia and AI software for diagnosis of cerebral infarction were approved as the first innovative medical devices under new integrated assessment system, and they could be treated in the market. In addition, there is remote patient monitoring (RPM) reimbursement service fee. Continuous glucose monitoring devices have been reimbursed for type 1 diabetes patients by the National Health Insurance Service (NHIS) since January 2019. Homecare RPM service for peritoneal dialysis patients with cloud platform (Sharesource) has been reimbursed since December 2019, and long-term continuous ECG monitoring service fee for wearable ECG monitoring devices (ATpatch, MEMO) became reimbursement since January 2022. Conclusion(s): Although Korean government has been developed guidelines for digital health actively, only few products had been reimbursed. To introduce new technologies for improved patient centric treatment, novel value-based assessment and new pricing guideline of digital health medical devices are quite required.Copyright © 2023
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Objectives: To better understand the constantly evolving global perspectives on health economics and outcomes research (HEOR), ISPOR conducts surveys among its members and global leaders to capture key methodological and policy HEOR trends expected to significantly impact on health care decision-making. To summarise these trends over time and capture the potential impact of health technology assessment (HTA) processes, we conducted a review of ISPOR's HEOR trends and where we are to-date. Method(s): We systematically searched for trends published by ISPOR between 2018 and 2022 and extracted key information to understand the consistency of trends over time and the evolution of themes. This search was supplemented by identifying key HTA developments and related methodological movements in decision-making in the same period that may have impacted the ranking of trends across years. Results were synthesized qualitatively using infographics. Result(s): Overall, across the last 5 years, 11 different trends were identified. Real-world evidence appeared as the third most influential trend in 2019 and became the number one trend since 2020, whereas drug and healthcare pricing dropped from a key trend in 2018 to 6th position in 2022. Some trends (e.g., biosimilars) only appeared once, due to potentially limited interest or lack of new related methods, whereas other topics (e.g., health equity) regained attention during recent years. Latest research initiatives such as the GetReal Initiative in Europe, HTA collaborations with real-world data organisations (Flatiron), the rise of advanced methodologies (e.g., value-based frameworks) and the recent COVID-19 pandemic may have influenced the appearance, upgrade, or disruption of some of these trends, reflecting changes occurring in HEOR landscape and decision-making. Conclusion(s): Capturing HEOR trends through a representative organisation such as ISPOR is key to understanding past and potential future developments in methods and processes of health policy, considering the wider interplay of contextual and methodological advances.Copyright © 2022
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Background: Despite important discoveries/advances in treating multiple sclerosis (MS), people with MS (pwMS) can experience delays in accessing new treatments if decision-makers lack robust health economic evidence including health-related quality-of-life (HRQoL) benefits of the intervention. Health state utilities (HSU) are a HRQoL input for cost-utility analysis. Objective(s): Several multi-attribute utility instruments (MAUIs) are available from which HSUs can be derived, but the most appropriate MAUI for use in MS has not been identified. We aimed to determine the preferentially sensitive MAUI(s) that capture the full impact of MS on HRQoL. Method(s): Participants in this study came from a comprehensive HRQoL survey (mid-2020) of the Australian MS Longitudinal Study. The survey included six MAUIs (EQ-5D-5L/ EQ-5D5LPsychosocial, SF-6D versions 1 and 2, AQoL-8D and PropR), and sociodemographic, Covid19-related and subjective wellbeing data. HSUs were generated from Australian value sets. Ceiling and floor effects were investigated. Bland-Altman plots and Shannon's Indices were examined. Minimal important differences and population norms were sourced from the literature. Result(s): N=1,683 pwMS completed the survey (67% response). HSUs were derived for >97% of respondents. Mean age 58.6 years, 80% female, 19% reported severe disease and 63% had relapsing-remitting MS. Mean (SD) HSUs ranged from 0.45+/-0.29 (SF-6Dv1) to 0.63+/-0.22 (AQoL-8D). EQ-5D-5L revealed the highest ceiling (HSU=1.0;n=157,10%) and floor (HSU<=0;n=113,7%) effects. PwMS with EQ-5D-5L HSU<=0/HSU=1 reported mean HSUs of 0.37/0.91, 0.35/0.90, and 0.08/0.85 for the AQoL-8D, EQ-5D5LPsychosocial and SF-6D, respectively. Conclusion(s): While the EQ-5D is the most commonly cited MAUI (in 85% of health technology assessment guidelines), our preliminary comparison results suggest the EQ-5D-5L is not preferentially sensitive in assessing the complex HRQoL domains for pwMS.
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Introduction. The transition from the budget model of the healthcare system to compulsory social health insurance has created a competitive environment among hospitals in Kazakhstan. Managers are interested in introducing the most effective new technologies. Implementation of the health technology assessment (HTA) process in Kazakhstan began in 2010 but few managers have created a structure for HTA development in their hospitals. Our aim was to identify issues in the implementation of new health technologies in hospitals. Methods. Structured interviews were held with hospital managers and physicians in June 2020, and September 2021. In the first stage, the needs of hospitals in the implementation of new technologies were considered. In the second stage, the impact of COVID-19 on the introduction of new technologies in the hospital was addressed. Interviews were held on-line by mobile phone or zoom and lasted 25-30 minutes. Results. The first interviews involved 8 managers and 14 physicians from 5 hospitals. The needs of HTA for physicians was noted by respondents of both groups. Only a few physicians had been trained in HTA. Hospital staff lacked time and experience in preparing applications for new technologies by a national assessment unit and could not meet deadlines. Managers were interested in use of HTA for hospitals' technologies in short-term timeframes within existing policies. However, physicians believed that long-term performance of technologies over 5 years or more should also be considered in hospital management. Physicians were aware of the importance of ethical considerations in the HTA of new health technologies. Managers did not consider ethical issues. At the second stage of the project, 5 managers and 8 physicians were interviewed. COVID-19 had shown the importance and necessity of developing the scientific potential of doctors, and of introducing HTA and training medical personnel in its use. Conclusions. Positive outcomes from the interviews were the interest of respondents in increasing their knowledge of the HTA process and acceptance of its importance at the hospital level.
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Introduction. The use of telemedicine services has increased worldwide during recent years because of national strategies for digitalization of health care and the coronavirus disease 2019 (COVID-19) pandemic. However, healthcare professionals often express uncertainty regarding the effectiveness of telemedicine interventions. The TELEMED database (https://telemedicine.cimt.dk/) was introduced by the Centre for Innovative Medical Technology (CIMT) at Odense University Hospital to ensure that hospital managers, healthcare professionals, and other stakeholders have access to scientific studies of telemedicine interventions. Methods. The database constitutes a structured literature search in PubMed for randomized and non-randomized controlled trials on the use of telemedicine for treating somatic diseases in the hospital setting. The search was conducted by staff members in the health technology assessment unit at CIMT. Identified studies were sorted by first screening titles and s and then by reading full-text versions. The data extracted from the studies included setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. The value of each study was also assessed with respect to effectiveness. Results. A total of 510 articles were selected for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the criteria of medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as an information platform for clinical departments who wish to implement telemedicine services. It has great potential for supporting digital transformation during COVID- 19 by providing accessible evidence-based information on patient groups and relevant technologies and their effects. More than 95 percent of the studies in the database that compared telemedicine with a control group showed either statistically significant improvements in clinical outcomes with telemedicine or no statistically significant difference between the two groups. Conclusions. The TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time.
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Introduction. Health Technology Assessment (HTA) Process assists decision-making in health policies. The COVID-19 pandemic caused a high demand on protocol or guideline updates and incorporation of new drugs or therapies, overwhelming local agencies. A recent study reported that major HTA bodies in England, Scotland, Germany, and Canada reduced their number of drug recommendations in 2020, due to reprioritization of resources and COVID-related challenges. The present study aimed to evaluate the impact of the COVID-19 pandemic at the Brazilian National Committee for Health Technology Incorporation (Conitec) recommendation process. Methods. This descriptive study evaluated all official recommendation reports available on the Government website in 2020 and 2021, extracting the data of disease category, technology type, the aim of the report, Public Involvement, and final result for the recommendation. The results were presented in tabular and graphical form using the machine learning, through the software R studio and excel. Results. A total of 168 documents were evaluated, including guidelines and recommendation reports, with no reduction in the number of evaluations considering 2019. In 2020, there was a more significant evaluation of guidelines, and in 2021, a report on the nonincorporation of technologies. There were four specific documents about COVID 19, including vaccines and hospital care guidelines. The most incorporated and non-incorporated technologies were medication, targeting rare and highly prevalent diseases in balance. The Brazilian government was the main proposer. These results are part of the study A Survey about the core methods of the recommendation reports for Brazilian Ministry of Health carried out by Brazilian Health Technology Assessment Centers, which will characterize and analyze the core methods of the recommendation reports conducted by the Brazilian HTA Centers. Conclusions. The pandemic had a low impact on demands in the routine of the Conitec. Establish indicators and technological norms applicable to health services, contribute to the identification of possible new practices, methods or criteria.
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Introduction. Health technology assessment (HTA) reports are complex technical documents that address multiple aspects of the incorporation of a technology into the health care system applying complicated methodologies coming from different disciplines. The purpose of HTA is to support decision-makers and these should have an adequate level of training to fully understand these assessments. However, most HTA education programs and courses are intended for HTA doers and there is a lack of practical guidance training aimed at preparing health managers or policy makers in HTA. The objective is to describe an HTA training program developed for decisionmakers of the three levels (health care administration, hospital management and clinical practice). Methods. Rolling Collaborative Review (RCR) 01 of convalescent plasma was identified and selected because it complied with our Population Intervention Comparator Outcome Design Question. The EUnetHTA HTA adaptation Toolkit was used to check the relevance (about research question);reliability (quality of the report) and transferability (application of information to the target setting). Additional considerations regarding the local context were examined. A panel of four professionals and one patient was formed to rate the importance of the outcomes and to carry out the external review Results. According to the toolkit, information on RCR01 Convalescent Plasma could be adopted for the safety and effectiveness domains. The technical characteristics and current use domains were adapted and extended. It was considered of interest to include the domains of organization and ethics. The organizational aspects were answered through the information retrieved in a search for systematic reviews and guides, and with the collaboration of experts. The ethics domain was answered through a specific literature search on ethical issues related to COVID-19 and transfusions. Conclusions. The use of the EUnetHTA Toolkit has been helpful in supporting the adaptation process. The adoption of the effectiveness and safety domains from already developed HTA assessments is an efficient way to provide useful information for the decision-making process. However, contextual elements should be included in the adaptation process to ensure a complete framework for the decision.
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Introduction. The outbreak of the COVID-19 global pandemic in 2020 has been a major challenge for the world's population and governments. The lack of vaccines, the saturation of health systems, and its rapid spread forced governments to take non-pharmacological interventions (NPI) that had a high impact on the population. Assessing the efficacy of these measures is a challenge for health technology assessment bodies. Methods. The main NPIs for which assessment was required were: mobility restrictions, social distancing, cancellation of events or reduction of seating capacity, closure or reduction of seating capacity in non-essential businesses, closure or limitation of seating capacity in educational establishments, and promotion of teleworking in potential jobs. The implementation of these measures at a global level provides a large population for the study of the impact of these measures. However, the challenges for their evaluation are numerous: * The joint implementation of these measures makes it difficult to evaluate them in an isolated manner. * The heterogeneity between countries and regions of the pandemic situation at the time when these measures are initiated and terminated. * The different accuracy in the application of the measures. * Heterogeneity in the quality and accessibility of public health services for citizens. Results. Outcome variables to assess the effectiveness of these measures should include parameters related to: * Incidence variables: the number of new or accumulated cases in a given time range, the variation in the number of cases in a given time range and the proportion of positive tests. * Transmission variables: the basic reproductive number (R0) and the effective reproductive number (Rt). * Severity and mortality variables: the number or variation of hospitalizations, the number or variation of intensive care unit (ICU) hospitalizations and the number or variation of deaths. Conclusions. The large number of available data, the heterogeneity of the measures, the differences between populations, the numerous outcome variables and the possible inclusion of mathematical modelling studies, are a methodological challenge for the HTA bodies.
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Introduction. Apatient/person-reported outcome measure (PROM) is a questionnaire that measures patient's health self-assessment (PROs), such as pain/wellbeing. HTx is a Horizon 2020 project supported by the European Union lasting for 5 years from January 2019. The main aim of HTx is to create a framework for the Next Generation Health Technology Assessment (HTA) to support patient-centred, societally oriented, real-time decision-making on access to and reimbursement for health technologies (HTs) throughout Europe. Individual values, needs, and preferences should be taken into account when appraising HTs and in clinical decision-making. Better guidance is needed about how to develop and select generic and/or more specific outcome measures that are relevant to patients and fit-for-purpose. Our goal is to provide that guidance via the PROM toolbox and enable users to select PROMs by using this. The HTx project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement Ndegree 825162. Methods. A framework for the assessment of PROMs was discussed with experts, tested for a subset of PROMs (Linnean menu) and resulted in the PROM-cycle. Multiple literature studies were performed on PROMs, their properties, and characteristics. The general population was studied as well as cancer, diabetes, multiple sclerosis, myelodysplastic syndrome, and (long-lasting) COVID-19. This resulted in an Excel database (PROM-overview) made available via a user-friendly web-application helping users to select PROMs: the PROM select app via https://www.prom-select.eu/proms. Results. Multiple tools were developed and are available in the PROM toolbox starting with the PROM-guide, Literature review on the use of PROMs, PROM-cycle accompanied by the Linnean menu. In addition, PROM-links, The making of the PROM-overview & PROM-select app, PROM-overview, PROM-select app, its usability test report and PROM toolbox presentation can be found on https://www.zorginzicht.nl/ondersteuning/prom-toolboxsummary- in-english#what-is-the-prom-cycle. Conclusions. The PROM toolbox guides users and helps them to select PROMs and trustworthy information and finding relevant scientific articles.
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Introduction. In areas where public confidence is low and there is a lack of understanding around behaviors, such as COVID-19 vaccine hesitancy, there is a need to explore novel sources of evidence. When leveraged using artificial intelligence (AI) techniques, social media data may offer rich insights into public concerns around vaccination. Currently, sources of 'soft-intelligence' are underutilized by policy makers, health technology assessment (HTA) and other public health research agencies. In this work, we used an AI platform to rapidly detect and analyze key barriers to vaccine uptake from a sample of geo-located tweets. Methods. An AI-based tool was deployed using a robust search strategy to capture tweets associated with COVID-19 vaccination, posted from users in London, United Kingdom. The tool's algorithm automatically clustered tweets based on key topics of discussion and sentiment. Tweets contained within the 12 most populated topics with negative sentiment were extracted. The extracted tweets were mapped to one of six pre-determined themes (safety, mistrust, underrepresentation, complacency, ineffectiveness, and access) informed using the World Health Organization's 3Cs vaccine hesitancy model. All collated tweets were anonymized. Results. We identified 91,473 tweets posted between 30 November 2020 and 15 August 2021.Asample of 913 tweets were extracted from the twelve negative topic clusters. Of these, 302 tweets were coded to a vaccine hesitancy theme. 'Safety' (29%) and 'mistrust' (23%) were the most commonly coded themes;the least commonly coded was 'under-representation' (3%). Within the main themes, adverse reactions, inadequate assessment, and rushed development of the vaccines as key findings. Our analysis also revealed widespread sharing of misinformation. Conclusions. Using an AI-based text analytics tool, we were able to rapidly assess public confidence in COVID-19 vaccination and identify key barriers to uptake from a corpus of geo-located tweets. Our findings support a growing body of evidence and confidence surrounding the use of AI tools to efficiently analyze early sources of soft-intelligence evidence in public health research.
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Introduction. Multi-criteria decision analysis (MCDA) is a useful tool in complex decision-making situations and has been used in medical fields to evaluate treatment options and drug selection. We aimed to provide valuable insights on the use ofMCDAin health care through examining the research focus of existing studies, major fields, major applications, most productive authors and countries, and most common journals in the domain using a scientometric and bibliometric analysis. Methods. Publications related to MCDA in health care were identified by searching the Web of Science Core Collection on 14 July 2021. Three bibliometric software programs (VOSviewer, Bibliometrix, and CiteSpace) were used to conduct the analysis. Results. A total of 410 publications were identified from 196 academic journals (average yearly growth rate of 32% from 1999 to 2021), with 23,637 co-cited references by 871 institutions from 70 countries or regions. The USA was the most productive country (n=80), while the Universiti Pendidikan Sultan Idris (n=16), Universite de Montreal (n= 13), and Syreon Research Institute (n=12) were the most productive institutions. The biggest nodes in every cluster of author networks were Aos Alaa Zaidan, Mireille Goetghebeur, and Zoltan Kalo. The top journals in terms of number of articles (n=17) and citations (n=1,673) were Value in Health and the Journal of Medical Systems, respectively. The research hotspots mainly included the analytic hierarchy process (AHP), decision-making, health technology assessment, and healthcare waste management. In the recent literature there was more emphasis on coronavirus disease 2019 (COVID-19) and fuzzy Technique for Order Preference by Similarities to Ideal Solution (TOPSIS). Big data, telemedicine, TOPSIS, and the fuzzy AHP, which are well-developed and important themes, may be the trends in future research. Conclusions. This study provides a holistic picture of the MCDArelated literature published in health care. MCDA has a broad application in different topic areas and would be helpful for practitioners, researchers, and decision makers working in health care when faced with complex decisions. It can be argued that the door is still open for improving the role ofMCDAin health care, both in its technologies and its application.
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Introduction. The aim of this EUnetHTA (European Network for Health Technology Assessment) Rolling Collaborative Review on high dose vitamin D for the treatment of COVID-19 was to inform health policy at an early stage in the life cycle of therapies and to monitor ongoing studies in the format of a Living Document. Methods. The systematic literature search was conducted in Medline, Pubmed, medRxiv, bioRxiv, arXivso, Cochrane COVID-19 Study Register, ClinicalTrials.gov, ISRCTN Registry, EU Clinical Trials Register. The first search was done in January 2021, and the last in November 2021. English and German randomized controlled studies (RCTs) investigating treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected individuals with high dose vitamin D2, D3 or their metabolites were included if examining mortality, length of hospital stay, viral burden, clinical progression, hospitalization rates, intensive care unit (ICU) admission, mechanical ventilation, quality of life or adverse events. Two reviewers independently screened search results and assessed risk of bias and certainty of evidence. One reviewer extracted study data, checked by another. Results. Of the nine RCTs published to date, two investigate calcifediol, one calcitriol and six vitamin D3. All used different dosing regimens. Disease severity and proportion of vitamin D deficiency varied between studies. Calcifediol treated patients in one study required significantly less ICU admissions than untreated patients. Vitamin D3 in another study led to significantly more SARS-CoV-2 PCR-negative patients before day 21 than placebo. There were no other significant differences between groups. Twenty-five RCTs are ongoing, five of them with over 1,000 patients. Conclusions. The current evidence is heterogenous regarding form and dosage of vitamin D, baseline disease severity and baseline vitamin D deficiency. There is currently no standardized/recommended level of what constitutes a (beneficial) high dose. Most results did not show significant differences between vitaminDtreated groups and no vitamin D / placebo groups. Many of the studies are very small and certainty of evidence is predominantly low or very low.
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Objectives: To research HTA procedures used to assess COVID-19 technologies in US, Canada, and EU5;to assess whether HTA procedures for COVID-19 technologies differ from established HTA procedures for that country and which COVID-19 monoclonal antibodies (mAb) have been assessed. Method(s): Information relating to HTA procedures, mAbs, and outcomes (if available) were identified and extracted from each agency's website and qualitatively assessed. Result(s): Two countries with decentralized HTA procedures (Italy, Spain) were excluded from analysis. Five countries have HTA agencies assessing COVID-19 technologies. Adapted HTA procedures are used by three (NICE, CADTH, ICER), and procedures are unclear for two (HAS, G-BA) it is unclear what procedures are used. Of nine mAbs available for treatment and prevention of COVID-19, four are the subject of HTA: * Casirivimab & Imdevimab: HAS (published;early access granted), CADTH (published;unable to make a decision), NICE (in progress), G-BA (in progress) * Lenzilumab: NICE (in progress) * Sotrovimab: HAS (published;opinion in favor of reimbursement), CADTH (published;no decision) NICE (in progress), G-BA (in progress) * Tocilizumab: NICE (in progress), CADTH (published;no decision) No HTAs were identified for the remaining five mAbs: bebtelovimab, bamlanivimab & etesevimab, regdanvimab, sarilumab, and tixagevimab & cilgavimab. Conclusion(s): Agencies are applying HTA procedures to COVID-19 technologies. Assessments, particularly for COVID-19 mAbs, will face challenges. Differing trial designs, definitions and outcomes, and a lack of standard-of-care treatments early in the pandemic may render estimates of comparative effectiveness invalid. Clinical and cost-effectiveness estimates will be affected by a number of other factors, including trial timing, prevalence of variants and their susceptibility to different mAbs, and the proportion of patients remaining vulnerable to severe disease after vaccine rollout. These variables may not be captured in traditional trial-based evidence, rendering HTA reliant on real-world evidence, and HTA decisions may lack longevity and will require frequent updates. Copyright © 2022
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Objectives: The European Health Data and Evidence Network (EHDEN.eu) is a large-scale federated network in development of real-world data from across Europe, standardised to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM). We demonstrate how EHDEN can facilitate the generation of real-world evidence (RWE) to support health technology assessment (HTA) in the context of cancer and COVID-19 use cases. Method(s): The cancer use case employs observational data from EHDEN partners to examine the real-world survival associated with common cancers (e.g., breast, lung) and one rarer cancer (head and neck). Using data from the UK Clinical Practice Research Datalink in the first instance, a user-friendly dashboard provides HTA agencies and researchers with a quick tool to view natural history data for the selected cancers and examine long-term survival projections using different parametric survival functions. The COVID-19 use case includes a multi-database network comparative cohort study, using observational EHDEN data, and explores how these data can be meta-analysed in combination with results from randomised trials. We focus on the effectiveness of tocilizumab and baricitinib in hospitalised patients. Result(s): This work will produce 2 key outputs. Firstly, an EHDEN Cancer Survival Dashboard that will allow HTA agencies to compare survival estimates received in evidence submissions with real-world survival data and projections. Secondly, novel insights into the comparison between 2 treatments for COVID-19, informed by the meta-analysis of non-randomised data from EHDEN and randomised data. Conclusion(s): Federated data networks like EHDEN could provide evidence-based healthcare decision makers with invaluable, rapid access to relevant RWE. The outputs from our use cases demonstrate potential opportunities. They also provide valuable tools to inform evidence gaps and reduce decision uncertainty in cancer and COVID-19 assessments, as exemplars. Copyright © 2022
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Objectives: Retractions related to COVID-19 publications has highlighted how prevalent retractions of primary research can be. Whilst there is a responsibility for authors of primary research to correct errors or remove fraudulent studies, the responsibility of correcting errors in downstream research is less clear. To further understand the situation we identifyed case studies where evidence synthesis has included retracted articles or articles with subsequently identified errors, how it has been handled and propose potential solutions. Method(s): Identified case studies from work the authors were undertaking where evidence synthesis ended up including primary studies with errors or retractions included. Result(s): Case studies with different responses to errors in primary articles were identified: A typographical error in a primary study was identified in evidence synthesis used to support a NICE health technology assessment;authors of the primary study acknowledged the error but did not correct the publication meaning the error remained in the publication and subsequent meta-analyses. Retracted COVID-19 publications were acknowledged by authors of one published meta-analysis;authors updated analysis to remove the offending research. A primary study was retracted whilst the evidence synthesis publication was under peer-review;following publication authors were notified of the retraction and opted to retract rather than revise their analysis. Conclusion(s): Prevailing errors in evidence synthesis, despite retraction or correction of a primary study, could negatively influence healthcare decision making. Living systematic reviews or meta-analyses are one solution but may not always be practicable. To minimise the risk of perpetuating errors, authors of secondary analyses could commit to ensure data included in their analyses is accurate for a defined period after the initial analysis has been conducted, e.g., 2 years, after which the analyses could be presumed to be outdated. The defined period could be influenced by several factors including rate of new studies being published in the indication. Copyright © 2022
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Objectives: Assess how transparency and independence in health technology assessment (HTA), pricing, reimbursement and access procedures influence drug availability and time to market. Method(s): Secondary research to analyze the independence and transparency of the Spanish, French, German and Italian national pricing, reimbursement and access processes (scale: high, medium, low) and how those impact drug availability and time to market. For each country, HTA, final decision and timing from European Commission (EC) approved medicines (January 2019-December 2021) were analyzed. Biosimilars, generics, hybrids, vaccines, and covid-19 medicines were excluded. Result(s): On the one hand, France and Germany are the most independent systems (medium), both driven by (1) separated clinical and economic evaluations, with some differences: (2) these are assessed by autonomous agencies in Germany and (3) France has different procedures for pricing and reimbursement. Spain and Italy achieved lower scores. On the other hand, the German system is the most transparent (high) as (1) drug added value is defined using objective scales, (2) publication of detailed decisions and (3) participation of external entities in the evaluation process. France and Italy obtained medium scores;Spain got a low score. Of 138 medicines EC approved, 135 (98%) accessed Germany, 81 (58%) France, 59 (42%) Italy and 37 (26%) Spain. The mean time from EC approval to national access was 9,9+/-5.9 months in Germany (HTA outcome), France 13+/-7.1 months, Italy 17.4+/-7.2 months and Spain 19+/-7.5 months. Excluding Germany (reimbursement is automatic), France is the country with the most rapid reimbursement decisions. Conclusion(s): Higher rates of independence/ transparency seem to lead to higher availability and faster drug access to the market, providing a stable framework for all stakeholders. Best practices for improving independence include the establishment of separate evaluations for clinical and economic. Additionally, include objective scales and the active participation of external stakeholders support transparency. Copyright © 2022
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Objectives: Due to the rapid development of the Internet and Internet of Things technology, as well as the catalysis of the COVID-19 epidemic and the favorable policy environment, China's online medical services has developed rapidly. But some serious problems also emerged, such as diseases diagnosis and treatment by artificial intelligence instead of by clinicians on some online medical service platforms, drugs prescribing before prescriptions, patient information leaking, etc. The assessment of drugs using health technology assessment (HTA) methods has been matured in recent years in China, but the assessment mechanism of online diagnosis and treatment behavior is still blank. This study plans to fill this gap. Method(s): Assessment mechanism of Chinese guide for medicine comprehensive evaluation and Guidance of Deliberative process for HTA were used as references. The framework was developed based on input-throughput-output model and was subjected to two rounds of consultation using Delphi method. Members with different backgrounds, perspectives and expertise relevant to online medical services were included to ensure the representativeness of the framework. Result(s): A framework for assessment mechanism of online diagnosis and treatment behavior was developed, which consists of the assess reasons, objects, organizations, time, participants and methods of all types of online diagnosis and treatment behaviors. Conclusion(s): This framework for assessment mechanism of online diagnosis and treatment behavior clarified the dimensions and indicators of online diagnosis and treatment behavior from the perspectives of medical security, network security, service quality, economy, and appropriateness, as well as the entire process of assessment operations. it is in line with Chinese policy requirements and will provide useful tool for the governments, medical institutions and research establishments. Copyright © 2022
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Objectives: Economic assessments of healthcare interventions for health technology assessments (HTAs) limit societal impact to productivity losses. Other societal impact has been highlighted by the Covid-19 pandemic that was associated with a severe impairment of the ability of the healthcare system to provide adequate and timely care to patients in many indications due to unprecedented increases in hospitalizations. The impact of healthcare interventions on health care system capacity and security has been identified as a priority value item for consideration by HTA recently. In imperfect markets with permanent excess demand, the accounting costs of resources underestimate their opportunity costs. Hence, reliance on accounting costs in economic evaluations of interventions that can avoid future demand for care leads to undervaluation of these interventions. Attempts have been made to evaluate the value of vaccines by accounting for their impact on health system capacity, through valuing bed-days used by patients with vaccine-preventable disease by their opportunity cost. Method(s): We apply theoretical methods for calculating opportunity costs of services proposed by Sandmann et al. to interventions in a chronic disease. An example is shown for chronic kidney disease that has high and increasing prevalence, and an associated surge in the demand for renal care services, coupled with supply shortages of dialysis equipment and adequate workforce, creating a situation of permanent overdemand on the market of renal care services. The quantitative magnitude of the undervaluation of delaying dialysis and renal transplant is demonstrated by accounting for opportunity costs of resource use as opposed to valuing used resources on accounting price. Its potential impact on results of economic evaluations of CKD therapies and HTA decisions is shown in a simple model on eGFR slope, and methods are assessed and compared. We generalize our findings to other chronic therapies. Copyright © 2022
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Objectives: Vaccination is paramount to reduce the health and economic impact of vaccine preventable diseases (VPDs), but are mainly focused on the immunization of children where COVID-19 demonstrated the importance of considering other age groups too. Providing healthcare decision makers with evidence-based assessments and recommendations is crucial but health technology assessments (HTAs) of older adult vaccination might be challenging. Method(s): Drawing upon the review of relevant literature and recent study cases, an expert panel elaborated on a list of HTA challenges and recommendations for older adult vaccination that could be instrumental to foster implementation of lifelong immunization. Result(s): Five challenges were identified for older adult vaccination: i) population characteristics, including immunosenescence, waning rates, comorbidities, changing functional status, and frailty;ii) limited surveillance data, causing a knowledge gap between population characteristics and vaccine effectiveness;iii) uncertainty in health economic value assessments - as a spill-over of the first two challenges;iv) prioritization of sub-groups might not align with health equity principles;and v) vaccination acceptance/hesitancy could prevent attaining optimal vaccination coverage and population benefits. Five concrete recommendations were issued in response to abovementioned challenges: i) introduce specific adult working groups within NITAGs as in the UK and US;ii) develop standardized/transferrable assessment methods adapted for older adults vaccination;iii) filling evidence gaps by the design of inclusive surveillance systems;iv) strengthen transparency of assessments to improve trust within healthcare and the society;and v) establish dedicated budget plans for prevention so that policy decisions - supported by adequate HTAs - can be implemented, inclusive older adults vaccination. Conclusion(s): Global interest in strengthening evidence-based policymaking for vaccination is increasing. It is therefore the right time to rethink how HTA could serve in fostering older adults' vaccination and to convey the message that implementing preventive measures and promoting lifelong immunization programs are instrumental to secure healthcare systems' sustainability. Copyright © 2022