bluuebunny/crossref_metadata_2025 huggingface dataset:
PD59 Review Of The International Epidemiology Of Long COVID
Authors: Norris Michelle , Comaskey Fearghal , Mc Loughlin Carol , Merriman Niamh , Tyner Barrie , O’Mahony Aislinn , Carrigan Marie , Harrington Patricia , Ryan Máirín , Neill Michelle O’
Published: January 2025

Introduction

Approximately 65 million people worldwide have Long COVID. Long COVID is a complex condition with more than 200 symptoms, which can substantially affect the lives of individuals. The evidence base for Long COVID is evolving rapidly and, therefore, an up-to-date understanding of the prevalence and risk factors of Long COVID is necessary to inform service delivery and allocation of healthcare resources.

Methods

A systematic literature review was conducted. Long COVID epidemiological literature published after October 2021 was identified in the MEDLINE, Embase, and Cochrane Library databases. Data extraction and quality appraisal were completed by one reviewer and checked for accuracy and omissions by a second reviewer. The following subgroups of interest were identified: general population; children and older adults; individuals who are medically vulnerable; and individuals with a history of severe COVID-19. Narrative synthesis of the prevalence and symptoms of Long COVID and of risk factors associated with the development of Long COVID was conducted.

Results

Over 3,000 documents were identified, of which 51 primary research studies met the inclusion criteria and were deemed of fair or good quality. Long COVID prevalence estimates ranged from 1.8 to 53.1 percent in the general population; 0.1 to 65.7 percent in children; 5.6 to 80.8 percent in older adults; 12.4 to 29.7 percent in medically vulnerable individuals; and 9.8 to 94.6 percent in individuals with a history of severe COVID-19. A wide range of symptoms were identified, with fatigue and neurological and respiratory symptoms being commonly reported. Female sex and increased age were identified as risk factors for developing Long COVID.

Conclusions

Long COVID is a complex condition involving a wide range of symptoms, which may result in significant reductions in quality of life and functioning in some individuals, a substantial burden on healthcare systems, and broader economic impacts. In planning healthcare delivery for this population, a focus on multidisciplinary holistic care will be necessary.
PD71 Survival Outcomes And Adherence To Defined Daily Doses Of Imiglucerase: A 16-Year Brazilian Cohort Study In Gaucher Disease
Authors: Borin Marcus Carvalho , de Assis Acurcio Francisco , Alvares-Teodoro Juliana , Guerra Augusto
Published: January 2025

Introduction

Gaucher disease is characterized by a deficiency of the enzyme glucocerebrosidase and requires lifelong enzyme replacement therapy. Imiglucerase is the standard treatment, which improves patient survival and quality of life. While defined daily doses (DDD) offer a standardized metric, the relative efficacy of adhering strictly to these guidelines, compared with tailored lower doses, has not been fully explored.

Methods

A retrospective cohort study was conducted on 1,234 patients to investigate the survival outcomes associated with various levels of adherence to DDDs of imiglucerase, factoring in demographic diversity and comorbidity profiles, and to evaluate the feasibility of a more personalized dosing approach in the management of Gaucher disease. DDD adherence was categorized as equal to DDD, higher than DDD, or lower than DDD. Kaplan-Meier survival analysis, log-rank tests, and Cox proportional hazards models were used to assess survival probabilities over 16 years. Data on age, sex, comorbidities, and other demographic factors were collected to adjust for potential confounders.

Results

Over the 16-year period, our Kaplan-Meier survival analysis revealed distinct survival probabilities across the three groups based on their adherence to DDD of imiglucerase. Patients who received doses lower than DDD (n=880) had a survival probability of 91.8 percent. In contrast, those receiving doses equal to the DDD (n=15) had a 100 percent survival probability, since no events were observed in this group. The greater than DDD group (n=339) exhibited a survival probability of 81 percent. A log-rank test indicated a borderline statistical significance (p=0.058) in the survival distributions among the various DDD adherence levels, with a favorable trend in the lower dose group.

Conclusions

Our research indicates that lower than usual doses of imiglucerase may improve survival rates in patients with Gaucher disease. This finding suggests that reduced dosages could lead to better clinical outcomes with fewer side effects, highlighting the potential benefits of personalized dosing strategies. Further studies are needed to confirm these preliminary results and optimize dosing protocols.
PD75 Using The Quality-Adjusted Life-Year For Economic Evaluations Of Public Health Interventions: Benefits And Criticisms
Authors: Atika Nur
Published: January 2025

Introduction

The number of economic evaluations of public health intervention is gradually increasing, which corresponds to the increasing interest of policymakers in public health interventions. However, there are some methodological challenges and debates regarding economic evaluations of public health interventions due to the nature and complexity of public health programs. One of the challenges is related to the outcome measure used.

Methods

This narrative review explored the advantages and disadvantages of using the quality-adjusted life-year (QALY) as an outcome measure in economic evaluations of public health interventions.

Results

The QALY is a preferred outcome measure in cost-utility analyses because of its simplicity, clarity, face validity, and ease of application. The QALY provides a measure of overall health and allows for comparability across different cases. However, there are some criticisms of using the QALY in economic evaluations of public health interventions. Many public health programs aim to affect not only health outcomes, but also other aspects such as participation and empowerment. In addition, public health programs might have positive externalities. The QALY is unable to detect minor changes resulting from community-based health interventions and does not capture equity aspects of public health interventions.

Conclusions

It is necessary to establish a common framework for a transparent and consistent decision-making process that accounts for the multidimensional and complex outcomes of public health interventions.
PD101 Evaluating The Budget Impact Of Introducing RefluxStop™ As A Novel Treatment Option For Gastroesophageal Reflux Disease In Italy
Authors: Harper Sam , Kartha Muralikrishnan , Mealing Stuart , Pavanello Maurizio , Bonavina Luigi
Published: January 2025

Introduction

In Italy, the first-line treatment for gastroesophageal reflux disease (GERD) is proton pump inhibitors (PPIs). Other options considered after PPI failure include Nissen fundoplication and magnetic sphincter augmentation. RefluxStop is a novel device for treating GERD. The aim of this study was to evaluate the budget impact of introducing RefluxStop into the Italian National Health Service (SSN).

Methods

The analysis, which used a five-year time horizon, one-year cycle length, and Italian payer perspective, was developed in line with ISPOR recommendations. Estimates for the Italian population and growth projections, GERD prevalence and incidence rates, and rates of anti-reflux surgery were obtained from relevant literature sources. The current market share of those requiring surgery was based on market research by Implantica (Zug, Switzerland). The cost of treatment was based on an adaptation of an economic model from the UK applied to the Italian setting. Unit costs were derived from available literature and diagnosis-related groups averaged across five Italian regions. Extensive sensitivity analyses involving key model inputs were also conducted.

Results

The overall one-year, three-year, and five-year financial impacts of introducing RefluxStop were EUR 242,641, EUR 710,651, and EUR 1,004,946 per year, respectively, corresponding to 0.063 percent, 0.197 percent, and 0.316 percent annual increases in overall Italian SSN expenditure for GERD. Use of more optimistic and pessimistic market uptake and surgery rates (i.e., doubled and halved) for RefluxStop led to one-year increases in Italian SSN expenditure of 0.126 percent and 0.032 percent and five-year increases of 0.636 percent and 0.155 percent, respectively. In our study, introducing RefluxStop avoided 95 surgical failures, 11 reoperations, and 64 endoscopic esophageal dilatations over five years.

Conclusions

The introduction of RefluxStop is likely to provide substantial benefits for patients with GERD at the cost of a marginal budget impact on the Italian healthcare system. Though Italian health care is organized at a regional level, this study is an example of a health technology assessment using budget impact analysis at a national level.
PD104 Percutaneous Ethanol Injection In Thyroid Nodular Pathology And Metastatic Cervical Adenopathies: A Systematic Review, Meta-Analysis, And Economic Evaluation
Authors: León-salas Beatriz , Hernández-Yumar Aránzazu , Infante-Ventura Diego , De Armas-Castellano Aythami , González-Hernández Yadira , Linertová Renata , Téllez-Santana Teresa , de Pablos-Velasco Pedro , Trujillo-Martín Mar
Published: January 2025

Introduction

Percutaneous ethanol injection (PEI) is a valuable treatment for several health conditions. However, its beneficial and harmful effects in patients with thyroid nodular pathology and metastatic cervical adenopathies have not been assessed in a systematic review.

Methods

A systematic review of available scientific literature on the safety, effectiveness, and cost effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies was performed according to Cochrane Collaboration methods and reported in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation [RFA]), the model compared the costs of the alternatives with a horizon of six months from the perspective of the Spanish National Health System.

Results

Three randomized controlled trials (n=157) evaluating PEI and RFA in patients diagnosed with benign thyroid nodules, 96 with predominantly cystic nodules and 61 with solid nodules, were identified. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in proportion of volume reduction, symptom score, cosmetic score, therapeutic success, or major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure to be EUR326, compared with EUR4,781 for RFA, with an incremental difference of −EUR4,455.

Conclusions

There are no differences between PEI and RFA in terms of safety and effectiveness, but the economic evaluation determined that the former option is cheaper.
PD111 A Health Technology Management Approach To Dupilumab Reimbursement In Ireland – Data From Year One
Authors: Barrett Rosealeen , Gorry Claire , Smith Amelia , Barry Michael , McCullagh Laura
Published: January 2025

Introduction

Following a health technology assessment, the Health Service Executive (HSE) supported reimbursement of dupilumab subject to a managed access protocol (MAP) being implemented. Reimbursement is restricted to a subgroup of the fully licensed indication, that is, moderate-to-severe refractory atopic dermatitis (AD) in adults and adolescents 12 years and older. This study provides an overview of the first year of the MAP.

Methods

All reimbursement applications submitted to the HSE Medicines Management Programme between 1 April 2021 and 31 March 2022 were reviewed. Key demographic and clinical characteristics of the approved population were analyzed. Reimbursement claims data within the specified period were extracted from the HSE Primary Care Reimbursement Services national pharmacy claims database. All data were compiled and analyzed using SPSS Statistics 27. Expenditure estimates were based on wholesale prices and were exclusive of value-added tax, fees, and confidential rebates.

Results

During the study period, 382 applications were submitted, 96 percent (n=365) of which were approved. Among approved patients, the mean age was 35 years (range 12 to 79 years), the mean number of years between AD diagnosis and approval was 22.65 years (range 1 to 78 years), and 65 percent (n=238) were men. The mean Eczema Area and Severity Index score was 28.72 and the mean (Children’s) Dermatology Life Quality Index score was 19.72. Approved patients who had unsuccessfully tried other systemic immunosuppressants had trialed up to five different medicines (mean=1.6). Year one expenditure was EUR2.4million, with 70 percent of approved patients accessing treatment.

Conclusions

Most applications submitted through the MAP were approved. These patients met the predefined evidence-based eligibility criteria for treatment. Patient numbers were higher than estimated, suggesting that the MAP did not hinder access. Utilizing health technology management by way of a MAP has facilitated access to expensive medicines for patients with the greatest need, while controlling expenditure for the payer.
PD112 Calcitonin Gene-Related Peptide Monoclonal Antibodies Reimbursed Under A Managed Access Protocol In Ireland
Authors: Finnigan Karen , Smith Amelia , Gorry Claire , Clarke Sarah , Barry Michael
Published: January 2025

Introduction

The calcitonin gene-related peptide monoclonal antibodies (CGRP MABs) erenumab, fremanezumab, and galcanezumab are reimbursed in Ireland under the High Tech Arrangement, subject to a managed access protocol (MAP), for the prophylaxis of chronic migraine in adults in whom three or more prophylactic treatments have failed. This study provides an overview of submitted reimbursement applications and the utilization of CGRP MABs.

Methods

The MAP for CGRP MABs was introduced on 1 September 2021 and is operated by the Health Service Executive (HSE) Medicines Management Programme. Individual patient reimbursement applications for CGRP MABs submitted through an online reimbursement application system between 1 September 2021 and 30 April 2023 were reviewed. Utilization data from 1 September 2021 to 30 April 2023 were extracted from the HSE Primary Care Reimbursement Service national pharmacy reimbursement claims database for the High Tech Arrangement. Analysis was performed using SAS® 9.4 software.

Results

A total of 1,517 reimbursement applications were submitted in the study period. Reimbursement was approved for 96.1 percent (n=1,458) of the applications. A total of 1,399 individual patients (mean age 45 years) were dispensed a CGRP MAB under the High Tech Arrangement between September 2021 and April 2023, the majority of whom were women (n=1,141). Almost 90 percent of patients were considered treatment adherent. In April 2023, the market share of the individual CGRP MABs on the High Tech Arrangement was 56 percent (n=599) for fremanezumab, 38.3 percent (n=409) for erenumab, and 5.7 percent (n=61) for galcanezumab.

Conclusions

MAPs are part of the health technology management approach to drug reimbursement in the Irish healthcare setting, ensuring that reimbursement is in line with approved subgroups of the licensed indication. Used in conjunction with health technology assessment, MAPs enable access to high-cost drug treatments for patients with the greatest unmet need, while providing budgetary oversight and certainty for the payer.
PD135 Real-World Evidence On The Effects Of Robotic Prostatectomy In Poland
Authors: Dzik Maciej , Płusa Aneta , Zaleska Monika
Published: January 2025

Introduction

Robot-assisted radical prostatectomy (RARP) was incorporated into the public healthcare system in Poland in April 2022. RARP quickly gained popularity among healthcare providers, constituting nearly 25 percent of all publicly financed prostatectomies by the end of 2022. The aim of this study was to evaluate the effects of RARP using early real-world data from the public reporting system.

Methods

The sample included 7,177 patients who had either RARP or conventional radical prostatectomy (CRP) between 27 March and 31 December 2022. CRP was performed as either an open or a laparoscopic procedure. Due to reporting limitations, a comparison with laparoscopic radical prostatectomy (LRP) only was carried out on a subset of 2,306 patients who had prostatectomy after 20 September 2022. Data analyzed included length of hospitalization, the percentage of patients who received transfusions of blood products or who were hospitalized within 30 days of discharge, and number of deaths.

Results

In total 2,190 patients had RARP. Compared with both CRP and LRP, RARP was associated with a reduction in hospital stay by 1.13 days (95% confidence interval [CI]: −1.27, −0.99; p<0.0001) and 0.83 days (95% CI: −1.02, −0.64; p<0.0001), respectively, and a lower risk of needing a transfusion of blood products, with odds ratios of 0.39 (95% CI: 0.31, 0.49; p<0.0001) and 0.53 (95% CI: 0.39, 0.77; p=0.0008), respectively. There were no statistically significant differences in rates of rehospitalization. Only three hospitalizations ended due to death. By 31 December 2022 only seven patients in the RARP group and 19 in the CRP group had died.

Conclusions

The findings of this study suggest that there is a marginal, though statistically significant, benefit with RARP, compared with CRP and LRP, that may be factored into economic evaluations of RARP.
PD144 Uncertainty In Precision Medicine: The Value Of Research To Support The Value Of Personalized Intervention Policies
Authors: Rothery Claire , Escudero Fernando Alarid , Kunst Natalia , Manca Andrea
Published: January 2025

Introduction

One-size-fits-all policies are not always optimal. Stratified decision-making is only possible when the characteristics used to define subgroups can be identified for stratum-specific predictions of outcomes. Conditioning decisions on characteristics that are not readily known may require information (diagnostic, prognostic, predictive) to be derived, the value of which needs to be assessed to support personalized strategies.

Methods

A general framework was developed to show how personalized policies can be accountably informed by characterizing uncertainty, heterogeneity, and bias in evidence. In the framework, observed heterogeneity was disentangled from random variability by conditioning the value of the model input parameters on a set of prognostic or predictive variables, while unobserved heterogeneity was quantified as the systematic variability that cannot be explained given current information. Value of information analysis was used to quantify the value of additional information for resolving decision uncertainty in model input parameters and to identify individual- or subgroup-level attributes that contribute to the degree of heterogeneity.

Results

Decision-making based on average cost effectiveness fails to account for the role that sources of outcome variability play in guiding nuanced decision-making. Conditioning on a set of known covariates to reflect observable heterogeneity may be extended to conditioning on the latent random variable for unobservable covariates to quantify unobservable heterogeneity. Quantifying the potential value of research to inform subgroup- or individual-level attributes may be used to direct further research toward the attributes expected to be of most interest because they drive the value of individualized decisions—the expected value of sample information for attributes.

Conclusions

Two distinct, but interrelated concepts for assessing the value of stratified decision-making are important: (i) the value of heterogeneity; and (ii) the value of further research to inform both heterogeneous factors and to reduce decision uncertainty in precision medicine. Assessing the value of unexplained heterogeneity and bias can be central to supporting the value of personalized intervention strategies in health technology assessment.
PD146 Can We Properly Evaluate Genetic And Genomic Applications? A Systematic Review Of Health Technology Assessment Reports
Authors: Migliara Giuseppe , Sciurti Antonio , Mussetto Ilaria , De Blasiis Maria Roberta , Di Lorenzo Giuseppe , Pierri Dr Francesco , Leone Immacolata , Marzuillo Carolina , Villari Paolo , Baccolini Valentina
Published: January 2025

Introduction

The last decade has witnessed a steady adoption of personalized medicine. However, the evaluation of genetic and genomic tests is not straightforward. The purpose of this systematic review was to identify health technology assessment (HTA) reports assessing genetic and genomic tests to summarize the methodologies used, the maturity level of the evidence included, and the highlighted research gaps.

Methods

The PubMed, Scopus, and Web of Science databases were searched for HTA reports of genetic or genomic tests. The main national and international HTA report repositories (e.g., the international HTA database) were also searched. HTA reports that were specifically created to assess genetic or genomic technologies and included at least three core evaluation components (analytic validity, clinical validity, clinical utility, economic evaluation, organizational aspects, or ethical, legal, and social implications) were included. This study was supported by the European Commission and the Ministry for Universities and Research under the National Recovery and Resilience Plan (M4C2-I1.3 Project PE_00000019 “HEAL ITALIA”).

Results

Overall, 27,331 unique records were retrieved, 55 of which were included in the systematic review. The reports were mainly from Australia (29%), Canada (27%), and the UK (25%); focused on pharmacogenomics (36%) and oncology (35%); and investigated test use for treatment guidance (42%) or diagnosis (29%). The most reported evaluation components were economic evaluation (87%), clinical utility (76%), and clinical validity (67%). On the other hand, personal utility (7%), patients’ perspectives (27%), and ethical (15%), legal (11%), and social (24%) implications were poorly represented. Analytical validity, safety, and organizational aspects were included in about half of the reports.

Conclusions

Although these are only preliminary results, the substantial lack of a shared standard in the evaluation of genetic and genomic applications is clear given the heterogeneity of the dimensions addressed among the reports. Theres is a need to strengthen evaluation of the neglected dimensions, which are often of primary importance in defining the value and risks of personalized medicine.
PD150 How Is Genetic Testing Evaluated? An Updated Systematic Review Of Assessment Frameworks
Authors: Baccolini Valentina , Migliara Giuseppe , Sciurti Antonio , Pitini Erica , Kaminska Anna Ewa , Soccodato Valentina , Iera Jessica , Leone Immacolata , Marzuillo Carolina , Villari Paolo
Published: January 2025

Introduction

Assessment of the risks and benefits of genetic and genomic tests has long been addressed using ad hoc evaluation methods. They are mostly ACCE-based, focus on technical aspects, and often overlook economic and organizational considerations. The few health technology assessment (HTA) based approaches, though more comprehensive, lack validation and implementation. This review’s purpose was to identify evaluation frameworks for genetic and genomic tests and to synthesize their key aspects.

Methods

PubMed, Scopus, Web of Science, Google Scholar, and Google Search were used to identify records describing any assessment framework for genetic or genomic tests. As this was an update of a previous systematic review, the search was restricted to records published from 1 October 2020. Inclusion criteria were documents describing evaluation frameworks for genetic or genomic tests that were original, specifically created, and covered at least three evaluation components (analytic validity, clinical validity, clinical utility, economic aspects, or ethical, legal, and social implications). This study was supported by the European Commission and the Ministry for Universities and Research under the National Recovery and Resilience Plan (M4C2-I1.3 Project PE_00000019 “HEAL ITALIA”).

Results

Overall, 22,862 records were retrieved and 12,546 unique records were screened, of which 67 documents were assessed for eligibility. However, none of these met the inclusion criteria and no additional framework was found. In contrast, a total of 37 studies reporting 30 different frameworks were included from the previous systematic review. The analysis of these frameworks revealed that they were published between 2000 and 2019 and were mostly based on the ACCE model (n=13), on the HTA process (n=6), or both (n=3). Others referred to the Wilson and Jungner screening criteria (n=3) or to a mixture of different criteria (n=5).

Conclusions

A pressing need exists for a universally accepted evaluation framework for genetic and genomic tests. A shift from ad hoc assessments to a general HTA methodology, potentially based on the EUnetHTA Core Model®, is needed. By integrating solid theoretical and methodological principles, a validated, comprehensive, and widely shared tool for evaluating genetic tests can be realized, promoting consistency across Europe and beyond.
PD166 Artificial Intelligence, Healthcare System Budget Cuts, And Flow of New Evidence: Moving To Living Health Technology Assessment Reform
Authors: Sarri Grammati , Abogunrin Seye
Published: January 2025

Introduction

Health technology assessment (HTA) agencies struggle with how to ensure timely assessment of promising technologies, especially considering the volume of rapidly produced evidence using complex analytical methodologies and applications, such as artificial intelligence (AI). Furthermore, healthcare systems that are already overburdened are now dealing with issues related to sustainability and increasing budgetary constraints resulting from several public health emergencies, such as the COVID-19 pandemic.

Methods

A targeted literature review of primary publications in English published during the last five years was conducted to answer the following research question: Would AI integration into health outcomes research and health economics encourage automation in the HTA process, allowing for a living model—a real-time, dynamic approach using explicit methods to determine the value of a technology at different points in its lifecycle—to be implemented? We selected publications presenting information on the following concepts: automation in evidence generation; health economics in the decision-making context; cost efficiencies from the integration of automation; and separation of concepts such as lifecycle and living HTA. A narrative synthesis was conducted.

Results

The publications selected explored four different aspects of the living concept in decision-making: living clinical guidelines, living evidence reviews and economic evaluations, and living HTA. Automation in systematic reviews (screening and data extraction), including time efficiencies, was the most frequently reported living aspect. The value of open-source economic models was increasingly recognized. Few references were found for methods such as living meta-analyses or network meta-analyses. Adaptive HTA was another related key term. A few publications outlined how a living HTA model could be implemented in real decision-making and its operational challenges.

Conclusions

So far, HTA bodies have been slow in adopting AI and automation innovation in their practices. Pressures to evolve with the increasingly complex treatment and evidence landscape necessitate a reform in HTA methods. A living HTA model may overcome these barriers and ensure faster patient access for new, promising technologies. A set of “living” standards is needed to gain HTA trust.
PD177 The Effect Of COVID-19 On Cancer Screening In Brazil, Canada, And The USA: A Cross-National Study
Authors: Kockaya Guvenc , Erkut Yaren , Okcun Selin , Ozdemir Ekin Begum , Kurnaz Mustafa , Tibet Birol
Published: January 2025

Introduction

The COVID-19 pandemic strained hospital systems and diverted resources, prompting a reorientation of healthcare priorities. This shift disrupted patient access to preventive cancer screenings and curtailed interactions between medical professionals and patients. This study aimed to examine changes in cancer screening during the COVID-19 pandemic period (2019 to 2021) in Brazil, Canada, and the USA.

Methods

The study included a literature review of academic articles, health reports, and government data that focused on the impact of the pandemic on cancer screening. Official health data in Brazil, Canada, and the USA were collected from medical records, national health databases, and screening statistics. A comparative analysis was conducted to unveil the changes in access to screening services for colorectal cancer (CRC), breast cancer, hepatocellular carcinoma (HCC), and cervical cancer.

Results

During the COVID-19 period, significant declines in cancer screening were observed globally. In Canada, CRC diagnoses dropped by 55 percent and remained 20 percent lower than averages from previous years, with an estimated 467 cases undiagnosed by August 2020. In the USA, HCC screenings were reduced by 44 percent, while cervical cancer screenings for women aged 21 to 29 years plummeted by 78 percent. Additionally, mammography screenings fell drastically from 180,724 in March to May 2019 to just 1,681 in the same period of 2020, leading to fewer breast cancers detected and a surge in symptomatic, aggressive tumors. Similarly, Brazil saw a 39 percent drop in breast cancer screenings.

Conclusions

The COVID-19 pandemic significantly disrupted cancer screening programs across Brazil, Canada, and the USA, resulting in marked declines in the number of diagnoses of various cancers. This reduction highlights the extensive impact of the pandemic on preventive health care, necessitating strategies to address the backlog and ensure timely cancer detection and treatment in the post-pandemic
era.
PD186 Treat-To-Target In Gout: Are Private General Practitioners In Malaysia Riding The Evidence-Based Wave?
Authors: binti Mohtar Siti Mariam , Ismail Maslinor , Anhar ‘Aziezah Norul , Mohamed Ghazali Izzuna Mudla
Published: January 2025

Introduction

Gout is an inflammatory disease that can cause severe pain and permanent joint destruction if it is not treated appropriately. Despite readily available treatments, the management of gout in primary care is suboptimal. Hence, this study aimed to investigate gout knowledge and compliance with evidence-based clinical practice guidelines (CPGs) among private general practitioners (GPs) in Malaysia.

Methods

A cross-sectional study using stratified random sampling was conducted among private GPs in Selangor, Putrajaya, and Kuala Lumpur from October to December 2023. The survey consisted of four parts: inclusion and exclusion criteria, sociodemographic data, knowledge, and practice domain. A total of 15 questions were posed in the knowledge domain and nine questions in the practice domain. Statistical analysis was performed using R software (version 4.3.2). Descriptive statistics were used for initial analyses. Proportions were calculated for categorical data, which were tested using a chi-square test. A p-value of less than 0.05 was considered statistically significant.

Results

The preliminary results from 203 private GPs showed that 64 percent had moderate knowledge of the management of gout. About two-thirds of the GPs were aware of local evidence-based CPGs on gout, but only 20 percent had good knowledge of gout. In the practice domain, only 65.5 percent of private GPs were aiming for a serum urate level of less than six milligrams per deciliter when starting urate-lowering therapy for gout.

Conclusions

Although most private GPs had moderate or good knowledge of gout, clinical practice was not fully concordant with the recommendations of local evidence-based CPGs. Our findings provide a foundation for local CPG developers and professional societies to enhance their strategies for implementing evidence-based CPGs and encouraging GPs in Malaysia to incorporate evidence-based practices into their clinical decisions.
PD194 The Scenario Of Hospital-Based Health Technology Assessment In Brazil, Italy, And Poland
Authors: Di Bidino Rossella , Lipska Iga , Kukla Monika , de Almeida Cardoso Marilia Mastrocolla
Published: January 2025

Introduction

Hospital-based health technology assessment (HB-HTA) is evolving constantly. In 2023, a survey was conducted by the HB-HTA Interest Group of Health Technology Assessment International with the aim of collecting data on HB-HTA activities, including perceptions of the role of, potential for, and barriers to HB-HTA. Overall, 87 responses were collected: 41 from hospitals performing health technology assessment (HTA), 18 from hospitals not conducting HTA, and 28 from policymakers.

Methods

The survey collected data from 28 countries. Italy, Poland, Brazil provided the highest number of responses. We conducted a descriptive comparative analysis focusing on these three countries to investigate whether and how the policies for HB-HTA, the activities of HB-HTA, and the perceptions of HB-HTA differed among policymakers and hospitals not performing HTA.

Results

Overall, 19 responses were collected from Italy and 10 each were collected from Brazil and Poland. While Italy (n=10) and Brazil (n=8) had a high number of responses from hospitals performing HB-HTA, most of the responses from Poland (n=9) were from hospitals not performing HTA. There was a lack of policies for HB-HTA in all three countries. HTA was performed in big hospitals (≥500 beds) in Italy and Brazil. HB-HTA covered all kinds of technologies, including digital health. In Poland, hospitals not conducting HTA recognized the ability of HB-HTA to promote cost containment. Policymakers were open to including HB-HTA in their activities.

Conclusions

Interpreting the diffusion of HB-HTA, its integration with other HTA processes, and the perceptions of its pros and cons should be both country specific and be conducted from an international perspective. The analysis demonstrated the need for specific policies and for better dissemination and promotion of HB-HTA activities and collaborations with HTA agencies.
PD197 Improving The Impact Of Health Technology Assessment Reports: Experience Of The Synthesis In Catalonia
Authors: Lleixà Berta Mestre , Vivanco-Hidalgo Rosa Maria
Published: January 2025

Introduction

To enhance the impact of health technology assessment (HTA) on Catalonia’s health system, a summary product called “synthesis” was developed. It presents the key information from HTA reports. After initial development and pilot testing, we developed a final version. Our aim was to evaluate its impact on decision-making at different levels.

Methods

We prepared an eight-question survey to assess the impact of the 15 syntheses that were published on the Agency for Health Quality and Assessment of Catalonia (AQuAS) website in 2023. We asked about the role of the healthcare professionals answering the questions, why they used the information of the syntheses, and whether they read the associated HTA report later and recommend it. We invited the professionals of the Catalan health system, providers, and payers to answer the survey by email. The survey also was published on the AQuAS website.

Results

We obtained 31 responses. The roles of the professionals who answered the questions were mainly directors and managers of the institutions of the Catalan health system (45.2%), healthcare professionals (32.3%), and care managers (12.9%). Most of them consulted the synthesis to update their knowledge about a specific topic (71.0%), obtain reliable data (35.5%), or support a strategic or professional decision (29.0%). The HTA report related to each synthesis was only consulted in some cases (38.7%) but was recommended in almost all cases (93.5%).

Conclusions

Summarizing the most important information of an HTA report in a new product can be a useful tool for improving the impact of the HTA on the Catalan health system. Professionals who answered the survey agreed that the syntheses helped them in making decisions related to the health technologies.
PD199 Global Collaboration Post-Brexit: Do Project Orbis And The Access Consortium Improve Access In The UK Compared With Europe?
Authors: Gassanova Aigun , Leong Katherine , Macaulay Richard
Published: January 2025

Introduction

As the newly independent regulator for medicines in the UK post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has entered international regulatory collaborations, notably Project Orbis (PO) and the Access Consortium (AC), to help expedite marketing authorizations. This research compared regulatory and reimbursement outcomes for medicines approved in Great Britain through PO and the AC with corresponding outcomes from the EU4Health Programme.

Methods

Products approved by the MHRA through PO and the AC were identified from the PO and New Active Substance Work Sharing Initiative websites, respectively. Marketing authorization dates and reimbursement outcomes were obtained from the respective regulatory and health technology assessment body websites on 20 November 2023.

Results

A total of 21 products have been authorized by the MHRA through either PO (17/21) or the AC (4/21); 17 of 21 have been authorized in Europe. Approval by the MHRA was 54 days earlier on average than for the European Medicines Agency. The results for various countries were as follows:

•

England: 14 of 21 (67%) products assessed (9/14 [64%] recommended);

•

Scotland: 14 of 21 (67%) products assessed (11/14 [79%] recommended);

•

France: 14 of 21 (67%) products assessed (2/14 [14%] received Amélioration du Service Médical Rendu level I to III);

•

Germany: 14 of 21 (67%) products assessed (5/14 [36%] achieved additional benefit);

•

Italy: 10 of 21 (48%) products assessed (9/10 [90%] reimbursed); and

•

Spain: 10 of 21 (48%) products assessed (7/10 [70%] reimbursed).

Days from regulatory approval to HTA were 306 (Scotland), 308 (France), 310 (UK), 330 (Germany), 398 (Spain), and 404 (Italy).

Conclusions

Compared with the EU4Health Programme, PO and the AC have enabled earlier marketing authorizations for medicines in the UK by an average of seven weeks. However, the proportion of therapies reimbursed and the delay from marketing authorization to reimbursement were comparable or more favorable for UK health technology assessment bodies. Thus, the UK may become a first-to-launch European market for certain therapies through PO and the AC.
PD203 Comparison Of Health Technology Assessment Methodologies Across Australia, Canada, New Zealand And The United Kingdom: Implications For Future Collaboration
Authors: Henderson Nadine , Theakston Claud , Brassel Simon , Garau Martina , Allen Rachel , Largeron Nathalie , Malottki Kinga , Patel Yuti , Garces Kirsten , Coombes Megan , Xavier Vanessa
Published: January 2025

Introduction

In 2022, a group of health technology assessment (HTA) bodies from Australia, Canada, and the UK announced a collaboration to identify solutions to common challenges. This collaboration was later expanded to include agencies from New Zealand and Quebec, Canada. Since one possible activity of the consortium is joint assessments, we compared the methodologies of the agencies on 11 topics to assess the feasibility of this.

Methods

We reviewed the methodological guidelines of the Canadian Agency for Drugs and Technologies in Health (CADTH), L’Institut national d’excellence en santé et services sociaux (INESSS), the National Institute for Health and Care Excellence (NICE), the Pharmaceutical Benefits Advisory Committee (PBAC), the Pharmaceutical Management Agency (Pharmac), and the Scottish Medicines Consortium (SMC). The topics considered were real-world evidence, consideration of health effects, economic reference case, survival analysis, surrogate endpoints, patient involvement, uncertainty, orphan pathways, clinical evidence requirements, carer perspective, and decision modifiers. We analyzed the level of alignment across the collaborating agencies using information from the guidelines, supplemented by published literature where necessary.

Results

Three topics exhibited high alignment: consideration of health effects, clinical evidence requirements and surrogate endpoints. The topics of orphan pathways and carer perspective had low alignment. The remaining topics had moderate alignment. Regarding orphan pathways, NICE and the SMC had separate processes for ultra-orphan drugs, CADTH and INESSS implicitly consider rarity, and PBAC and Pharmac do not appear to consider rarity. Since carer perspective is not commonly accepted in HTA, NICE was the only agency with relevant guidance on this topic. INESSS required the societal perspective as standard, while the PBAC and Pharmac explicitly excluded it. CADTH may consider carer perspective in some circumstances, whereas the SMC guidance was ambiguous.

Conclusions

While there is good alignment on most topics, there are several areas where agencies would need to resolve divergences in preferred methodology if joint assessments are going to be carried out in the future. All relevant stakeholders should be part of this process, including patient groups and industry.
PD206 Health Technology Assessment And Decision-Making During The COVID-19 Pandemic: Analysis Of Processes And Results From 25 Health Ministries
Authors: Hasdeu Santiago , Alvarez Jorgelina , Beliera Anabel , Viamonte Julian Sanchez
Published: January 2025

Introduction

The decision-making process in public administration can be analyzed from different perspectives. Evidence-based policies are not the only support for public policy design. High variability was observed regarding the health technologies used during pandemics. The processes and results of decision-making on health technologies in 25 health ministries in Argentina during the COVID-19 pandemic were analyzed.

Methods

This retrospective study utilized triangulation of quantitative and qualitative methods. Information was retrieved for the years 2020 to 2021 through document review of official web pages, surveys, and interviews with decision-makers and advisors of the national ministry of health and 24 Argentinian provinces. Recommendations and reimbursement policies for seven health technologies were considered as tracers. Official health technology assessment (HTA) reports, laws, judicial rulings, journalistic news, and civil society actions on social networks and the internet regarding these technologies were analyzed. The ruling political party in each province was mapped, with the aim of exploring the political influences and intervening actors.

Results

Contrary to World Health Organization (WHO) recommendations, ivermectin, inhaled ibuprofen, convalescent plasma, and equine serum were widely recommended and reimbursed outside a clinical trial context by most of the Argentinian ministries of health, leading to risks for patients and a huge opportunity cost. Health ministries with institutionalized HTA units had significantly higher adherence to WHO recommendations than other health ministries. Legislative and judicial powers influenced the use of health technologies through laws and judicial rulings. Researchers and civil society also influenced decision-makers. Partisan political issues did not fully explain the heterogeneity of the decisions made by the health ministries during the pandemic.

Conclusions

The impact of HTA organizations and their technical reports was limited. Health Ministries with institutionalized HTA units were more likely to adhere to WHO recommendations. The influence of different technical and political criteria, power relations within and outside the administrations, the pharmaceutical industry and academics, the media, social pressure, judicial and legislative powers, and the political context strongly influenced decision-making.
PD210 Sustainable Innovation In UK Care Homes: Acoustic Monitoring Systems In A “Living Lab” Setting - Technology Assessment Example
Authors: Nguyen Quang A , Wark Petra A , McCabe Louise , Zheng Dingchang , Jing Yanguo , Collinson Mark , Nomura Toshio , Rayner Vic , Russell Ed , Szczepura Ala
Published: January 2025

Introduction

Successful development of technologies to support older people in care homes remains challenging. The strategic establishment of a group of residential settings providing 24-7 living labs plus an innovation hub is described. Acoustic monitoring (AM) for continuous nighttime checking of residents was selected for assessment. A pilot study in 2016 identified potential cost savings, reduced nighttime falls, and improved daytime well-being.

Methods

The AM system was systematically assessed in four WCS Care Group Ltd care homes following demonstration and testing in an innovation hub. The first author undertook a mixed-methods study (2019 to 2023) to assess the technology in terms of falls prevention, practical implementation, and future benefits of enhanced sound classification using artificial intelligence (AI). In 2020, a network of care providers, the National Care Forum (NCF), was funded by National Health Service Digital to develop three similar innovation hubs across England. The NCF undertook a national survey to identify priorities in terms of implementing new technologies in care homes.

Results

Structured interviews with care workers and observational assessment in four care homes confirmed that the AM system has the potential to identify active residents and reduce the risk of falls, although it cannot offer fall prediction or prevention functionality. Two new functions were proposed. Eight machine learning models for sound classification and demonstration tests in three simulated settings supported feasibility and adoption. A post-demonstration survey (n=39) identified a high probability of adoption for these additional functions. The NCF survey found that the top four new technologies of interest to care homes were medication management systems, electronic care planning, wearable GPS trackers, and AM systems.

Conclusions

Care homes report interest in procuring AM systems, which could reduce the risk of falls. In addition, new AI-supported functions are acceptable to care providers. The UK government has proposed that 20 percent of care homes introduce AM by March 2024. Guidelines for future assessment of sustainable care technologies in living lab settings now need to be developed.