bluuebunny/crossref_metadata_2025 huggingface dataset:
OP129 A Cost-Utility Analysis Of Denosumab (Prolia®) For Treating Osteoporosis In Postmenopausal Women: A Swiss Healthcare Payer Perspective
Authors: Stringer Danielle , Moshi Magdalena Ruth , Nicolopoulos Konstance , Jenal Mathias , Vreugdenburg Thomas , Ma Ning
Published: December 2023

Introduction

Osteoporosis is characterized by decreased bone mass and density, increasing skeletal fragility, and the risk of fragility fracture. Fragility fractures are associated with a high economic burden. Denosumab (Prolia®) is a pharmacological therapy used to treat osteoporosis and reduce the risk of fragility fracture. This study aimed to assess the cost effectiveness of denosumab, compared with other pharmacological therapies (oral bisphosphonates, intravenous [IV] ibandronate, zoledronate, raloxifene, and bazedoxifene) and no treatment, for treating postmenopausal women with osteoporosis.

Methods

A discrete event simulation model was developed using a lifetime time horizon. A Swiss healthcare payer perspective was adopted. Time-to-fracture distributions were derived from Swiss-specific Fracture Risk Assessment Tool (FRAX®) probabilities. Reductions in the risk of vertebral and nonvertebral fractures due to treatment were informed by a Bayesian network meta-analysis. Cost-effectiveness frontier analysis was utilized. Pairwise incremental cost-effectiveness ratios (ICERs) between denosumab and each comparator were also estimated. Sensitivity analyses were conducted to identify key drivers and explore the overall certainty of findings.

Results

At a hypothetical willingness-to-pay (WTP) threshold of CHF100,000 (EUR101,630), IV ibandronate was the most cost-effective therapy in women aged 60 years who had a very high risk of fracture, and in women aged 70 or 80 years of any risk level. In women aged 60 years with a lower risk level, zoledronate was the most cost-effective option. Nevertheless, ICERs from pairwise comparisons between denosumab and some comparators (no treatment, bazedoxifene, raloxifene, and/or zoledronate depending on the cohort’s age and risk profile) were below the hypothetical WTP threshold. Higher intervention costs, smaller reductions in the risk of hip fracture, and shorter duration of residual benefit associated with denosumab contributed to the high ICER values seen in pairwise comparisons with oral bisphosphonates (as a class) and IV ibandronate.

Conclusions

The present evaluation supported the cost effectiveness of denosumab against some, but not all, comparators. Nevertheless, these results should be interpreted cautiously in light of uncertainty in the true effect of treatments on fracture risk.
OP133 COVIDIAGNOSTIX: Health Technology Assessment For COVID-19 Serological Tests As Companion Diagnostics To Vaccination
Authors: Tomaiuolo Rossella , Resta Chiara Di , Derrico Pietro , Ritrovato Matteo , Banfi Giuseppe
Published: December 2023

Introduction

In scenarios of vaccine scarcity or the context of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine in compliance with the criteria of equity and efficiency of health resources. The COVIDIAGNOSTIX project, based on health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of strategies for vaccine administration. To guarantee evidence support for health policy choices, two different strategies were analyzed: one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy).

Methods

An Italian multidisciplinary team conducted a decision-oriented HTA using a combination of the EUnetHTA Core Model and the multicriteria decision analysis model based on the Analytic Hierarchy Process.

Moreover, the Department of HTA method was integrated with the Susceptible-Exposed-Infectious-Recovered model, appropriate modelling techniques, simulation, and quantification of uncertainty that considered the ability to reduce deaths and to contain the pandemic. After identifying the evaluation elements and the decision-making structure, the weights of the evaluation areas and key performance indicators were calculated. This is a constituent part of the mathematical model of data processing, as the Analytic Hierarchy Process was based on a structured questionnaire that compared the relative importance of the two elements on a qualitative scale (1=equal importance; 9=more important).

Results

The processing of the scores attributed to the key performance indicators concerning all the evaluation domains resulted in a performance of 94 percent for the TEST&VACCINE strategy and 84 percent for the VACCINE strategy. The TEST&VACCINE strategy was the most advantageous in various scenarios due to the greater speed of response from an operational and economic point of view.

Conclusions

The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies, intended use, and settings), which highlight the characteristics that differentiate the tests from each other and guarantee a timely and appropriate evaluation, can be adapted to respond to similar health policy management situations.
OP134 Mapping The Health Of The Nation Outcomes Scale To The EQ-5D Using The Pharmacotherapy Monitoring And Outcome Survey
Authors: Kleijburg Anne , Wijnen Ben , Hollander Wouter Den , Evers Silvia , investigators PHAMOUS , Kroon Hans , Lokkerbol Joran
Published: December 2023

Introduction

In clinical practice, health outcomes relevant for economic evaluations, such as health-related quality of life (i.e., utilities), are not always available. However, algorithms can be developed to map available outcome measures to utilities. In the Netherlands, the Health of the Nations Outcomes Scores (HoNOS) is a physician-reported, disease-specific outcome measure frequently used for patients with severe mental illness for which no mapping algorithms for utilities currently exist. The aim of this study was to develop an algorithm to map responses on the HoNOS to EQ-5D utilities for use in economic evaluations.

Methods

A dataset was obtained from the Pharmacotherapy Monitoring and Outcome Survey cohort study containing data from patients with psychotic disorders. The dataset contains EQ-5D-3L domain and HoNOS scores, the age and sex of patients, and additional demographics. Correlation between the EQ-5D-3L and HoNOS was evaluated. To derive mapping functions, least absolute shrinkage and selection operator (LASSO) regression and random forest algorithms were applied with various predictor variables using a machine learning approach, whereby data were split into separate training and test sets. Cross-validation was then used to compare the performance of different models using R-squared and the root mean square error (RMSE).

Results

A total of 2,111 patients were included in the study. Spearman’s correlation coefficients indicated a weak to moderate negative correlation of -0.31. Based on model performance metrics, LASSO models outperformed random forest models on the training set, where the model including all individual HoNOS items and the age and sex of patients showed the best overall performance with an RMSE of 0.237 and an R-squared of 0.218. When applied to the test set, this resulted in an R-squared of 0.233 and a mean absolute error of 0.177.

Conclusions

The HoNOS can be mapped onto EQ-5D-3L utilities with moderate predictive accuracy. The reported mapping algorithm may be sufficient to predict overall population utility scores for use in health economic evaluations but lacks accuracy for individual patient predictions.
OP135 Machine Learning And Cancer Registry: Evaluation Of The Effectiveness Of Case Coding
Authors: Viscosi Carmelo Ettore , Di Prima Alessia Anna , Torrisi Antonina , Torrisi Antonietta Alfia , Ferrante Margherita , Ragusa Rosalia
Published: December 2023

Introduction

Machine learning (ML) algorithms are computational procedures that use pattern recognition and inference by learning from previously categorized documents to predict the category to which a new document belongs. The role of machine learning within cancer registries remains unclear given the lack of in-depth testing and guidance from health technology assessment (HTA) agencies. We evaluated the effectiveness of coding new cases through machine learning at the Integrated Cancer Registry.

Methods

The Integrated Cancer Registry covers the eastern area of Sicily in Italy, which has an annual average incidence of about 10,000 cases of malignant neoplasm. Potential new cancer cases were retrieved from pathology services and processed by pathologists who confirmed the neoplastic nature of supposed cases and specified the morphological type and location of the tumors. The current method involves identification by reading the free-text report when International Classification Diseases for Oncology information was not provided. We used the new Microsoft ML.Net Library, a framework developed in response to the challenge of facilitating machine learning pipeline utilization in large software applications. A total of 1,050,952 free-text pathology reports published from 2003 to 2018 were selected separately from all Sicilian pathology services and uploaded to machine learning software that explored eight binary classification algorithms.

Results

We evaluated each algorithm’s performance by calculating metrics (the number of true positives, true negatives, false positives, and false negatives) from the classification procedure applied to the test dataset. The metrics used were accuracy, F1 score, and area under the receiver operating characteristic curve. With a test set of around 210,000 text diagnoses, each algorithm reached an F1 score of up to 95 percent.

Conclusions

Machine learning algorithms capture relevant information about tumors from free-text pathology reports, optimizing the process and reducing waste. With the help of machine learning systems, cancer registries can provide more timely data for research and evaluation of all types of new cancer technologies (drugs, devices, radiology and radiotherapy equipment, diagnostic devices, robotic surgery, and vaccines).
OP137 A Qualitative Exploration Of The National Institute For Health And Care Excellence’s Impact On International Health Technology Assessment
Authors: Henderson Nadine , Brassel Simon , Oliver Edward , Gibbons Ilana , Allen Rachel , Largeron Nathalie , Garau Martina
Published: December 2023

Introduction

The National Institute For Health And Care Excellence (NICE) is widely acknowledged as a seminal health technology assessment (HTA) body, known for its transparent and accountable approach to decision-making. This research aimed to investigate the impact of NICE methodology and decisions on international HTA bodies. We sought to identify direct and indirect factors that may influence an international HTA body’s methods or outcomes. To the best of our knowledge, this is the first research to use a qualitative approach to understand the influence of NICE on other HTA bodies.

Methods

We conducted 13 semi-structured qualitative interviews with HTA and market access experts from industry and academia from nine countries (Brazil, Israel, Italy, Japan, Poland, Saudi Arabia, South Korea, Sweden, and the United Arab Emirates). The interview script was organized into three main sections: comparing NICE methods and processes with other HTA bodies; the impact of specific NICE decisions; and Likert scale questions (to allow for comparability of opinions).

Results

Most interviewees believed their local HTA body would consider NICE’s decision when evaluating a medicine. However, the way and extent to which NICE influences HTA varied across countries. The most common means of considering a NICE decision was as background information or context for an HTA evaluation. Generally, interviewees suggested that negative NICE decisions had more impact on local decision-making than positive decisions. Nine of the 13 interviewees agreed or strongly agreed that their country’s HTA body considers the decisions of other HTA bodies in their decision-making process. Eleven of the 13 interviewees agreed or strongly agreed that the development of their country’s HTA body methods and processes was influenced by NICE.

Conclusions

NICE is perceived to be a seminal HTA body, with continued influence on HTA agencies in other countries. However, the mechanisms and extent of this influence varies considerably between countries. We suggest that implicit factors are likely to contribute more to NICE’s influence than individual decisions. Nevertheless, further research is needed to reveal these factors and increase efficiency in international HTA decision-making processes.
OP142 Progression Analysis Versus Traditional Methods To Quantify Slowing Of Disease Progression In Alzheimer’s Disease
Authors: Jönsson Linus , Ivkovic Milana , Handels Ron , Gustavsson Anders , León Teresa , Hahn-Pedersen Julie Hviid , Raket Lars Lau
Published: December 2023

Introduction

New statistical methodology, known as progression models for repeated measures (PMRM), can estimate the slowing of progression (percentage slowing or time delay) of Alzheimer’s disease from trial data on disease-modifying therapies. We compared the PMRM methodology with mixed models for repeated measures (MMRM) and Cox time-to-event analysis on simulated trial data with respect to their power and interpretability of estimates.

Methods

Two novel models were included: PMRM (estimating slowing of progression and allowing different rates across visits) and proportional-slowing PMRM. Clinical Dementia Rating (CDR) Sum of Boxes score and progression to dementia as assessed by CDR global score were the primary outcomes for MMRM/PMRM and the Cox model, respectively. Subject-level placebo arm trajectories were jointly simulated based on estimated CDR mean trajectories and joint temporal correlation structure of 538 amyloid-positive patients with mild cognitive impairment who met typical disease-modifying trial inclusion criteria from the Alzheimer’s Disease Neuroimaging Initiative study. Active arm trajectories were simulated to show an average 20 percent slowing of disease progression, compared with placebo, at each visit. We conducted 1,000 simulations across multiple scenarios, varying the number of patients per arm (200 to 700) and clinical trial duration (18 to 36 months).

Results

The power of PMRM models was greater than that of MMRM, and much greater than that of the Cox model whose power never exceeded 45 percent. PMRM models accurately estimated the underlying treatment effect (median 20% slowed progression, which translated to a delay in progression of 5 and 7 months at trial durations of 24 and 36 months, respectively), unlike quantifications of the MMRM (median estimated 25% reduction in decline), and the Cox model (median estimated hazard ratio of 0.9).

Conclusions

For disease-modifying therapies, PMRM estimates may have a more intuitive clinical interpretation in terms of delayed progression than MMRM or Cox models and enable a description of the amount of time spent in less severe disease stages. Among all the methods studied, PMRM offered the best combination of interpretability and power.
OP144 Impact Of A Training Program For The General Population On Knowledge Of Aortic Valve Stenosis
Authors: Fernández-Barceló Carla , Vidal Bàrbara , Abbas Ismail , Gonzalez Paloma , Trilla Marc , Carreño Marta Sitges , Sampietro-Colom Laura
Published: December 2023

Introduction

Limited knowledge of the symptomatology of aortic stenosis (AS) among the general population may delay diagnosis and have a major impact on morbidity and resource use. Training programs have often been advocated by the scientific community. The present study reported the results of an assessment of a training program for the general population.

Methods

Patients who attended healthcare centers were asked to answer a questionnaire on their level of knowledge around AS. A cohort of patients without training (n=681) answered the questionnaire and a second cohort answered the questionnaire via phone 24 hours after training (n=197). Propensity score matching by sex and age was used to obtain a balanced sample between the two cohorts, giving a total study sample of 394 individuals (197 without training and 197 with training). A descriptive analysis was performed to compare differences in the level of knowledge between the two cohorts. Predictors of AS symptomatology were identified using multivariate logistic regression.

Results

The trained cohort was more aware of AS disease than the untrained cohort (79% versus 31%, 95% confidence interval [CI]: 0.39, 0.56; p<0.001). They were also better at distinguishing the symptoms associated with AS (80% versus 43%, 95% CI: 0.28, 0.48, p<0.001) and were more aware of its severity (36% versus 12%; 95% CI: 0.16, 0.32, p<0.001). Moreover, the trained cohort were better at identifying symptoms that should make them consider visiting a doctor (76% versus 65%; 95% CI 0.02, 0.20, p<0.02). No differences were observed in level of concern regarding AS (8% versus 4%; 95% CI: -0.0046, 0.09, p=0.08).

The trained people who were aware of AS (p=0.04) correctly classified AS as a valvular disease (p=0.025), would seek medical consultation when AS symptoms occurred (p=0.04), and were more likely to correctly detect AS symptoms.

Conclusions

The training program significantly improved the knowledge and awareness of AS in the general population. This can improve the timeliness of AS diagnosis, reducing the health and economic burden of AS for the healthcare system.
OP153 Access To Real-World Data For Use In Health Technology Assessment – Still Work To Be Done
Authors: Ritz Christian , Kim Hansoo
Published: December 2023

Introduction

Real-world data (RWD) is an important source of evidence for health technology assessment (HTA). It is widely used to fill clinical trial data gaps and to inform risk-sharing agreements. HTA is mandatory in many jurisdictions as it is used for price negotiation between a manufacturer and a payer. HTA practitioners have so far had limited involvement in the debate surrounding access to RWD as regulators have primarily focused on scientific research and market authorization. This study examined the challenges of obtaining RWD for HTA decision-making that is beneficial at the population level when data sources are restricted to maintain the data integrity and rights of the public.

Methods

Types of RWD and processes for obtaining data were assessed for two jurisdictions (Australia and Denmark). Types of data considered were national registries, ongoing or completed cohorts, surveys at various universities, archived historical data, and medical claims data. The assessment was performed by analyzing a series of cases.

Results

There were similarities and differences between the two jurisdictions. In both jurisdictions the process for obtaining data included an ethics application as well as data handling fees. Patients and clinicians had little to no say in what their data are used for. It can take up to six months to obtain data. Person identification numbers enable linking of different datasets. Population wide data are accessible in Denmark only through secure servers, whereas full data sets, such as prescription data, can be released for research in Australia. Public hospital data, such as electronic health records, are not easily obtained in Denmark. In Australia, public hospitals are run by individual states and, therefore, additional effort is required to access nationwide data.

Conclusions

Access to RWD for HTA is challenging in both Australia and Denmark. Improvements in the process of applying for data and linking different data sources for HTA purposes are still needed.
OP167 An Analysis Of Medication Exclusion Reports In The Health Technology Assessment Process For The Brazilian Unified Health System
Authors: da Costa Nathalia , Borges Stefani , Pires Wolney , Rodrigues Fernanda , Louly Priscila , Prado Clementina , Santos Vania
Published: December 2023

Introduction

The National Committee for Health Technology Incorporation of the Brazilian Public Health System (Conitec), which was created in 2011 by federal law, defines the criteria for incorporating and excluding health technologies in the Brazilian health system. For technology evaluation proposals a recommendation report is carried out, which finds the best scientific evidence about the efficacy, accuracy, effectiveness, and safety of the technology being analyzed. The report also provides a comparative economic evaluation of the technologies already in the health system to promote and protect public health, achieve the best allocation of resources, and reduce regional inequalities.

Methods

This exploratory, descriptive, and retrospective study aimed to identify the criteria considered for the exclusion of medicines within the Brazilian health system from 2012 to November 2022. Data were extracted from Conitec’s website into a specific extraction form and analyzed using descriptive statistics.

Results

During the evaluation period, 763 technology recommendations by Conitec were identified, of which 75 (10%) related to the exclusion of medicines. Several criteria were identified among the exclusion recommendations, including protocol updates, expiry or lack of registration in the National Health Surveillance Agency, and drugs whose clinical indication was not included in the list of drugs registered for treatments in the health system.

Conclusions

Although there is no standardization of criteria in Conitec for recommendations on the exclusion of health technologies, this study contributes to a better understanding of these technologies. Disinvestment of technologies positively impacted the population because it resulted in better allocation of resources in the health system, and some of the excluded technologies presented a greater risk of interactions and undesirable adverse reactions.
OP173 Estimating The Marginal Productivity Of Health Technology Adoption
Authors: Yan Charles , Mohamed Jemal , Saini Manik , Bacigalupo Robert , Bayat Selva , Round Jeff
Published: December 2023

Introduction

Decisions to adopt health technologies rely, in part, on judgements about cost effectiveness. Cost effectiveness is commonly assessed against a willingness-to-pay threshold for health gains. Building an evidence base on the marginal productivity of health spending to inform the value of the threshold is increasingly of interest for resource allocation decision-making and technology implementation. We report on an in-progress analysis to inform a threshold for policy purposes in British Columbia, Canada.

Methods

We developed a ten-year panel-data model with instrumental variables, which lessens the degree of time-invariant confounding and addresses biased causal inferences caused by unobserved factors, to provide estimates of the marginal cost per health unit measured using quality-adjusted life-years (QALYs). We use the Johns Hopkins Adjusted Clinical Group (ACG) system and a British Columbia Health System Matrix to classify patients into six resource use bands (RUBs) ranging from ‘healthy’ to ‘very high morbidity’. Patients are also classified by chronic conditions and types of services. Place of residence and geographical region of health authorities are considered. Variables included age, gender, mortality and comorbidity rates, costs of hospitalizations, emergency department and physician visits, residential and home care, laboratory services, diagnosis and medications, and quality of life. Instrumental variables included sociodemographic characteristics as reported in the Canadian census.

Results

The largest RUB was ‘moderate’ morbidity (39.3%), while the smallest was ‘healthy’ (1.5%). The youngest was the ‘low’ morbidity (mean 31, standard deviation [SD] 21) and the oldest was ‘very high’ (mean 69, SD 17). The healthy group had the smallest mean costs (CND563, SD CND4,121; equivalent to USD421, SD USD3,083). In contrast, the ‘very high’ group had the largest (CND20,398, SD CND36,188; equivalent to USD15,258, SD USD27,069). Age and gender standardized comorbidity index scores ranged from 0.05 to 6.41 (median 0.98). Additional analyses (e.g., costs per QALY) are ongoing and the results will be reported at the conference.

Conclusions

Our empirical approach is robust and flexible, allowing estimates of marginal productivity according to factors such as disease, geographical region, service type, and care sector. This work has applications at the provincial and national levels and adds to methodological literature in the field.
OP176 Integrating Real-world Compliance In The Assessment Of Left Atrial Appendage Closure Versus Anticoagulation Therapy In Non-valvular Atrial Fibrillation
Authors: Pyne Sebastian , Tilden Dominic , Calcino Gordon , Mudge Mia
Published: December 2023

Introduction

In patients with non-valvular atrial fibrillation (NVAF), left atrial appendage closure (LAAC) has demonstrated non-inferior efficacy and safety relative to life-long oral anticoagulation therapy (OAT) in a four-year randomized controlled trial (RCT) (PRAGUE-17). Sub-optimal compliance to OAT in the real-world setting (Simmons 2016) has been associated with increased risk of stroke (Ozaki 2020) and may alter efficacy estimates derived from RCTs in which compliance is generally higher. The study aims to model disease outcomes in NVAF patients treated with LAAC versus lifelong OAT when applying trial versus real world compliance to OAT.

Methods

Real-world compliance to OAT in the Australian setting was investigated in a 10 percent Pharmaceutical Benefits Schedule (PBS) sample scripts analysis which measured treatment adherence and persistence to new oral anticoagulants (NOACs) and warfarin. Design of the 10 percent PBS analysis was informed by the compliance to medicine working group report and included the longest follow-up of any OAT compliance study identified in the literature. A Markov cohort model was developed to estimate the expected numbers of strokes and major bleeding events in NVAF patients.

Results

Rates of NOAC discontinuation in PRAGUE-17 was higher at 20 months median follow-up (6.5%) versus compliance in the Australian setting (35.4% and 30.0% according to 3 and 6 month ceasing rules at 20 months follow-up). Applying sub-optimal compliance to lifelong OAT demonstrated in the Australian setting resulted in higher numbers of strokes over a life time modelled time horizon compared with LAAC.

Conclusions

Real world compliance to medicines should be a consideration in economic analysis comparing lifelong medications to one-off surgical interventions.
PP07 Vaccine Decision-making In Canada: Processes And Guidelines For Using Economic Evidence
Authors: Sander Beate , Krahn Murray , Bryan Stirling , Brouwer Werner , Jit Mark , Lee Karen , Naus Monika , Ozawa Sachiko , Prosser Lisa , Lathia Nina , Yeung Man Wah , Nam Austin , Tuite Ashleigh , House Althea , Tunis Matthew
Published: December 2023

Introduction

Canada’s National Advisory Committee on Immunization (NACI) makes recommendations on the use of human vaccines. Provinces and territories subsequently use the advice to make decisions on public funding and program implementation. Traditionally, NACI reviewed vaccine characteristics and burden of illness.

With its recent expanded mandate, NACI now considers cost-effectiveness via economic evaluations, among other decision determinants. As such, new processes and guidelines were needed to formalize the incorporation of economic evidence into federal vaccine decision-making.

Methods

Two task groups were convened respectively to develop NACI’s “Economic Process” and “Guidelines for the Economic Evaluation of Vaccination Programs in Canada”. The groups conducted environmental scans to inform their work, as well as engaged with government partners, decision-makers, academics, national immunization technical advisory groups from other countries, health technology assessment agencies, industry, patient groups, among others.

Results

The Economic Process outlines when and how NACI incorporates economic evidence for vaccine recommendation. For instance, it describes how policy questions are prioritized given institutional capacity constraints for generating economic evidence. It also describes how policy questions are assessed to determine the appropriate type of economic evidence required (i.e., systematic review, economic evaluation, multi-model comparison of external models).

The Economic Guidelines provide recommendations in 15 chapters on how to conduct economic evaluations (i.e., from defining the decision problem to reporting). Unlike other health technologies, vaccines have the potential to affect both vaccinated and unvaccinated individuals. Hence, the Guidelines consider population-level impacts such as externalities (e.g., herd immunity, age-shifting of disease) and spillover effects. They also discuss equity considerations and non-health impacts of vaccines such as to productivity, consumption and education.

Conclusions

The Economic Process and Economic Guidelines promote the generation and use of credible and standardized economic evidence. They advocate for transparency, allowing evidence to be used across jurisdictions beyond Canada. Next steps include documentation of user feedback, incorporation of Indigenous considerations, and formal evaluations.
PP09 Capturing Broader Effects Of Influenza Vaccination Program In Economic Evaluation: Systematic Literature Review
Authors: Choi Seulki , Byrnes Joshua , Kim Hansoo
Published: December 2023

Introduction

Decision-making for vaccination programs requires additional consideration on broader effects. The cost-effectiveness guidelines published by the Professional Society for Health Economics and Outcomes Research (ISPOR) working group recommends considering broader effects such as herd protection. Whilst difficulty to produce robust data for such factors might hinder quicker decisions, they are important features of vaccination programs and some of them were the narratives that dominated over the COVID-19 pandemic. In this systematic literature review, the perspectives taken and inclusion of broader effects were investigated for recent influenza vaccine economic evaluations.

Methods

The search strategy based on the terms influenza vaccination and cost-effectiveness was carried out on Embase and PubMed. Considering the publication date of the ISPOR guidelines, articles since 2019 were searched. The review focus was the perspectives taken and inclusion of broader benefits in the analysis. A link between perspective and inclusion of broader effects was tested with a Chi-square
test.

Results

The total number of full cost-effectiveness articles screened was 48. Of those, the number of articles performed from both the perspectives was 18 (37.5%), and 13 articles (27.1%) considered the perspective of payer only. For those that had both perspectives considered, the ICER reported from the societal perspective was consistently lower than that from the payer perspective. Thirty-one articles (65%) included any of the broader effects. However, broader effects considered were limited to indirect protection (17 articles, 35.4%) and productivity loss (22 articles, 45.8%). The relation between perspective and inclusion of broader effects was significant (p=0.04).

Conclusions

This review highlights that studies performed using both payer and societal perspectives as recommended by the ISPOR research guidelines are not many, while more favorable outcomes were presented when the societal perspective was adapted. Broader effects included are productivity loss and indirect protection.

For other broader effects specified in the research guidelines, there are not many attempts to include those in economic evaluations.
PP10 Preventing The Winter Quadruple Threat: The Value Of Hospital Bed Capacity Freed Up By Vaccination
Authors: Neri Margherita , Brassel Simon , Schirrmacher Hannah , Mendes Diana , Vyse Andrew , Steuten Lotte , Hamson Elizabeth
Published: December 2023

Introduction

Hospitals in England experience extremely high levels of bed occupancy in the winter. In these circumstances, vaccine-preventable hospitalizations due to seasonal respiratory infections, have a high cost because of the missed opportunity to treat other patients on the waiting list.

This study sought to generate evidence on the hospitalizations that vaccines for older adults against seasonal influenza (flu), pneumococcal disease (PD), respiratory syncytial virus (RSV) and COVID-19 may prevent during the winter season (October-March) in England. The monetary value of the vaccine-preventable hospitalizations was estimated using a conventional reference costing method and a novel opportunity costing approach.

Methods

Based on retrospective analysis of Hospital Episode Statistics data on hospitalizations in England, and efficacy and observed coverage rates per vaccination program, we estimated the number of bed-days that current vaccines against flu, PD and COVID-19, and a hypothetical RSV vaccine, could free up by preventing hospitalizations in the winter among older adults. We valued the freed-up bed-days (1) as the cost of prevented hospitalizations (reference cost); (2) as the Net Monetary Benefit (NMB) generated by alternative uses of the freed-up bed-days. The opportunity cost of vaccines-preventable hospitalizations is (2) when they would be an optimal use of beds or (1)+(2) when they would be a suboptimal use.

Results

In the winter months, vaccination programs targeting flu, PD and RSV for older adults could collectively prevent 72,813 bed days and save over £45million (USD56 million) in hospitalization costs. The COVID-19 vaccine could prevent over 2 billion bed days and save GBP1.3 billion. Importantly, the value of hospital beds freed up by vaccination is likely to be 1.1–2 times larger (£48–£93 million [USD60-116 million] for flu, PD and RSV; £1.4–£2.8 billion [USD1.8-3.5 billion] for COVID-19) when quantified in opportunity cost terms. Scenario analysis replacing the current vaccine used in the adult PD program with the newly licensed pneumococcal conjugate 20-valent vaccine (PCV20), would increase the impact of each modelled outcome for this program by approximately 38 times.

Conclusions

Vaccines for flu, PD, RSV and COVID-19 could prevent a significant number of hospitalizations in the winter. The value of the associated freed-up bed capacity is likely to be underestimated by conventional reference costing methods.
PP19 Health Technology Assessment Reports In Brazilian Unified Health System: Number Of Potential Beneficiaries in 2022
Authors: Borges Stefani , Rodrigues Fernanda , Pires Wolney , da Costa Nathalia , Maldonado Thatiara , Louly Priscila , Prado Clementina , Santos Vania
Published: December 2023

Introduction

Universal access to health public services was established in Brazil 32 years ago. However, health technology assessment (HTA) as a requirement for the decision-making process in the Unified Health System (SUS) was defined only in 2011 with the National Committee for Health Technology Incorporation of the SUS (Conitec), which advises the Ministry of Health on the decision to incorporate health technologies into the SUS. All of Conitec’s recommendations are based on the best available scientific evidence regarding efficacy, effectiveness, and safety of a technology, but also include economic evaluation studies of these technologies, developed from the perspective of the SUS. Considering this an estimate of the population eligible for use of the technology under evaluation, if it is incorporated into the SUS, it is considered in the decision-making process.

Methods

This descriptive study, based on open access data from Conitec’s website, aimed at identifying the estimated number of patients potentially benefitting by the recommendations published in 2022, from January to November. Since each report includes an estimate for the first five years of incorporation of the technologies, all data were collected to check whether population growth was considered.

Results

Finally, 38 recommendation reports were identified, with 28 reports on incorporation and 10 reports for expansion of technology use. Among them, they related to 31 medicines and seven procedures or products. In the first year after incorporating the listed technologies, a total of 7,767,321 potential beneficiary patients were estimated, while over five years the total number would increase to approximately 7,967,874 patients. There were recommended drugs for rare diseases whose benefited population did not exceed the estimate of 10 patients per year; as an example is cerliponase alfa for treating neuronal ceroid lipofuscinosis. In another example, an estimate of 4,494,539 women would benefit by incorporated contraceptives into the SUS.

Conclusions

This study describes how accessible public health is becoming, meeting more health policies, showing potential to benefit more patients every day and showing what trends can be expected in the future.
PP20 Vaccines market access pathways in Asia-Pacific (APAC) – analysis and recommendations for improvement
Authors: Best Alex , Lim KyungHwa , Adam Aisha , Taurel Anne-Frieda , Feng Jun
Published: December 2023

Introduction

Immunization is one of the most effective public health interventions, saving millions of lives annually. However, complex and heterogenous market access pathways can impact timely and equitable population access to vaccines. Focusing on five Asia-Pacific (APAC) countries, this study described the current vaccine market access landscape and analyzed the success factors for National Immunization Program (NIP) inclusion.

Methods

The study was conducted in two phases (i) pragmatic literature review to map current regulatory and funding pathways and identify information gaps in China, Japan, Korea, Taiwan and Australia (ii) targeted interviews with market access and policy experts in each market to identify drivers and barriers to NIP inclusion.

Results

Regulatory approval, driven by safety and efficacy data, followed by introduction in the private market was commonly observed in all markets. However, pathways to NIP inclusion varied within and between markets. In all markets expert panels such as National Immunization Technical Advisory Groups (NITAG) were identified to play a crucial role in providing advice to governments on NIP inclusion. Health technology assessment was increasingly used to inform decision making. However, the assessment frameworks utilized were typically designed for medicines, rather than the unique features of vaccines.

Japan, Korea and Australia provided relatively consistent coverage via national programs, despite the different processes employed to review, recommend and reimburse vaccines. In some cases, the reimbursement timeframe varied significantly for different vaccines within the same market. China and Taiwan provided coverage at the regional level, which required engagement with multiple local authorities to enable access. The key barriers to patient access were budget limitations, long reimbursement timeframes and a lack of coverage consistency. Early stakeholder engagement, local epidemiology and cost-effectiveness evidence were the main success factors for NIP inclusion.

Conclusions

Funding pathways for vaccines in APAC are heterogenous. Adopting the Asia-Pacific Economic Cooperation (APEC) Action Plan on Vaccination Across the Life Course could increase vaccine coverage through alignment, collaboration, and improvement of reimbursement pathways in APAC.
PP23 A Health Technology Assessment Of Computerized Clinical Decision Support Systems: Challenges And Lessons Learnt
Authors: Moltó-Puigmartí Carolina , Gallastegui-Calvache Edurne , Cirillo Davide , Vivanco-Hidalgo Rosa Maria
Published: December 2023

Introduction

Computerized Clinical Decision Support Systems (cCDSS) are promising digital health tools whose development and use are increasing. The Agency for Health Quality and Assessment of Catalonia (AQuAS) received a request from the Spanish Ministry of Health, through the Spanish Network of Health Technology Assessment (HTA) Agencies (RedETS), to perform an HTA of cCDSS for cancer. We present the challenges that arose during the evaluation process.

Methods

We evaluated the safety, effectiveness and cost-effectiveness through a systematic literature review. We involved two clinicians and a technology expert to gain insight into the pathology and technology, respectively. To identify cCDSS used in Spain, we consulted with the Spanish regulatory agency (AEMPS) and the Spanish Federation of Healthcare Technology Companies (FENIN), plus did a survey among Spanish hospitals. To understand applicable regulations, we reviewed the European regulation (MDR) and consulted the Medical Device Coordination Group from the European Commission, AEMPS, and a regional regulatory expert.

Results

The scientific literature revealed large heterogeneity in the definition of cCDSS (e.g., from simple online prognostic calculators to complex commercial software using machine learning), making the literature search and screening arduous. Many articles dealt with cCDSS that do not qualify as medical devices, are not in the market anymore, are currently used as newer versions or are developed in-house. Next, we faced the difficulty to attain a comprehensive overview of the tools in use in the country. In terms of legislation, we observed that similar tools might receive different classifications in different jurisdictions, and the complexity of the MDR might lead to the need for a case-by-case discussion at a National level.

Conclusions

We identified many challenges in the HTA of cCDSS. The first step for proper assessment is a clear definition of the device and version to be evaluated. Multiple stakeholders must be involved, and alignment between regulatory and HTA agencies is key. We expect that the European Database on Medical Devices (EUDAMED) will help in the identification of existing cCDSS and hence ease their assessment.
PP27 The Private Healthcare Responses Against COVID-19 Emergencies In Brazil
Authors: Kelles Silvana , Pereira Camila , Martins Carina , Reis Daniel , Azevedo Ernesto , Ribeiro Geraldo , Zocrato Karina , Carvalho Lélia , Freitas Marcela , Horta Maria , Barbosa Mariana , Talim Mariza , Borin Marcus
Published: December 2023

Introduction

The Corona Virus Disease 2019 (COVID-19) pandemic is the biggest public health crisis of all time. Private health care plays a major role in health globally. We conducted a study to document the engagement of a Brazilian private health care organization to influence decisions to private and public health emergencies of COVID-19.

Methods

This retrospective study evaluated the outputs of the health technology assessment (HTA) group of Unimed-BH, a private Health Maintenance Organization (HMO) with 1.5 million participants in Belo Horizonte, Minas Gerais state. The study evaluated the impacts on the overview of health local decisions in the municipality and the national supplementary health agency (ANS) during the period from March 2020 to December 2022.

Results

During the pandemic, Unimed-BH made all its sanitary decisions based on scientific research, such as the use of masks and appropriate medications. Even though some medicines, such as regdanvimab, were authorized for emergency use by the Brazilian Health Regulatory Agency (ANVISA), Unimed-BH did not recommend their use due to uncertain evidence, and months later, ANVISA withdrew the registration.

Unimed-BH also conducted a systematic review of ivermectin for COVID-19 treatment, which showed no effect, and therefore did not recommend its use. Additionally, Unimed-BH provided weekly updates on COVID-19 data, including suspected and confirmed cases, hospitalizations, and deaths in their customer portfolio. The organization also actively supported the decisions made by ANS and municipal managers using evidence and statistics on the pandemic. The Unimed-BH HTA group produced a total of 167 reports from March 2020 to December 2022.

Conclusions

Belo Horizonte had the lowest in-hospital mortality rates with COVID-19 in Brazil. Unimed-BH’s HTA reports provided evidence-based assessments for decision-making, proposed partnership with policymakers, fomented information transparency, and strict follow-up on pandemic numbers, which may have contributed to the lower fatality rate in our city. These findings underscore the importance of private healthcare organizations in responding to COVID-19 emergencies, and their potential to support evidence-based decision-making and minimize the impact of the pandemic.
PP36 Immersion In Water During Childbirth
Authors: Reviriego-Rodrigo Eva , Ibargoyen-Roteta Nora , Carreguí-Vilar Soledad , Mediavilla-Serrano Luis , Uceira-Rey Sonia , Iglesias-Casás Susana , Martín-Casado Ana María , Toledo-Chávarri Ana , Ares-Mateos Gonzalo , Montero-Carcaboso Sonia , Castelló-Zamora Belén , Burgos-Alonso Natalia , Moreno-Rodríguez Anai , Hernández-Tejada Naiara , Koetsenruyter Carmen , Gutiérrez-Ibarluzea Iñaki
Published: December 2023

Introduction

Immersion in water is a non-pharmacological method for pain relief during childbirth. The aim was to describe the experiences, values and preferences of women regarding water immersion during childbirth identified in the evidence.

Methods

A systematic review and thematic synthesis of qualitative evidence was conducted. Databases were searched from 2009 to 2022 and screened for inclusion using pre-determined criteria. Studies that used qualitative methods for data collection and analysis to investigate the opinions of women or health professionals in hospital settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. The Critical Appraisal Skills Programme Qualitative Research Checklist was used to assess study quality and findings were synthesized using thematic synthesis, as described by Thomas and Harden.

The final report was reviewed by several categories of health professionals that care for mothers and infants, as well women.

Results

Thirteen studies met inclusion criteria and were included in this review. Nine studies have been identified that reflect the experience of women in relation to immersion in water during childbirth, a study exploring the factors that determine the use of immersion during childbirth according to the point of view of both women and midwives, and three more studies on midwives’ experience with water immersion during childbirth. In the qualitative studies the following key themes emerged: Reasons identified by the women/professionals for choosing a water birth, benefits experienced in water births and barriers and facilitators of immersion in water during childbirth.

Conclusions

The evidence from qualitative studies indicates that women associated water birth with a sense of autonomy and control over labor, and a lower level of associated pain. Further, a water birth was considered a positive experience. From the point of view of midwives, to make water births safe, there is a need for adequate resources, as well as rigorous standardized protocols.