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1.
Health Econ ; 31 Suppl 1: 1-9, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36068719

RESUMEN

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project.


Asunto(s)
Atención a la Salud , Evaluación de la Tecnología Biomédica , Economía Médica , Europa (Continente) , Unión Europea , Humanos , Evaluación de la Tecnología Biomédica/métodos
2.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 3281-3284, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36086143

RESUMEN

The Undergraduate Program in Biomedical Engineering ITB, Indonesia, introduce the Health Technology Assessment and Management as an elective course in 2021. This course is implemented to support the World Health Assembly that urges the member states to establish national strategies in health technology assessment and management, particularly medical devices. Furthermore, it is designed to give biomedical engineering students a broader insight into their career opportunities. Therefore, this course is delivered by the practitioner and guided by the main lecturer. The course syllabus is developed from the WHO Medical Devices Technical Series and European Network for Health Technology Assessment. It tries to implement HTA Core Model for Rapid Relative Effectiveness Assessments. A questionnaire is used to measure the students' perception of the course implementation. Moreover, it is used to obtain the students' comments and feedback. The course that is delivered by the practitioner not only gives the course content but also the context. After attending the course, students have a broader insight into the career opportunities as biomedical engineers in Indonesia.


Asunto(s)
Ingeniería Biomédica , Evaluación de la Tecnología Biomédica , Bioingeniería , Ingeniería Biomédica/educación , Curriculum , Humanos , Estudiantes
3.
J Manag Care Spec Pharm ; 28(10): 1190-1196, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36125060

RESUMEN

BACKGROUND: Recent attention to value frameworks has highlighted limitations of current conventional value and health technology assessment (V/HTA) methods (eg, cost-effectiveness). Multicriteria decision analysis (MCDA) has potential as a supplemental tool to incorporate additional value criteria into conventional value assessment. OBJECTIVE: To conduct a pilot study to illustrate the impact of an MCDA approach on the value perceptions of hypothetical treatment profiles from a multistakeholder panel. METHODS: Participants voted on value perceptions of 2 hypothetical treatments with similar cost-effectiveness evidence: Treatment A for aggressive B-cell non-Hodgkin lymphoma in adults and treatment B for episodic migraine in adults. Participants voted treatments A and B as low, intermediate, or high value before and after a weighting exercise on prespecified, additional value criteria. Weights from participants were used to calculate treatment-specific MCDA scores from 0 (least favorable) to 100 (most favorable) and were presented to participants for a second value-perception vote. Analyses compared changes in value perceptions within treatments A and B post-MCDA exercise. RESULTS: Before considering MCDA scores for treatment A, 0% of participants considered it to be low, 52% intermediate, and 48% high value. After considering MCDA scores for treatment A, 4% considered it low, 29% intermediate, and 67% high value. Both before and after considering MCDA scores for treatment B, 13%, considered it low, 57% intermediate, and 30% high value. Mean MCDA scores for treatments A and B were 67 and 63, respectively. Of all stakeholders, 41% altered their perception of value for treatment A (9% negatively and 32% positively) and, separately, 45% for treatment B (23% both negatively and positively) after considering MCDA scores. CONCLUSIONS: With nearly half of participants altering their perception of value after consideration of additional value criteria, findings support the need for a more inclusive and flexible value assessment process. DISCLOSURES: This study was funded by The National Pharmaceutical Council. Dr Perfetto was employed by the National Health Council (NHC) at the time this work was completed, and all honoraria and consulting and travel fees were paid to the NHC. The NHC is a not-for-profit, membership organization. It is supported through membership dues and sponsorship funds. The complete list of members and sponsors is located on the NHC's website at www.nationalhealthcouncil.org. She is also an advisor for the Brain Injury Association of America, Dan Lewis Foundation, and Canter for Medical Technology Policy.


Asunto(s)
Técnicas de Apoyo para la Decisión , Evaluación de la Tecnología Biomédica , Adulto , Femenino , Humanos , Percepción , Preparaciones Farmacéuticas , Proyectos Piloto , Evaluación de la Tecnología Biomédica/métodos , Estados Unidos
4.
Value Health ; 25(9): 1463-1468, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36049796

RESUMEN

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward.


Asunto(s)
Opinión Pública , Evaluación de la Tecnología Biomédica , Humanos , Medición de Resultados Informados por el Paciente
5.
Health Econ ; 31 Suppl 1: 10-24, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35989520

RESUMEN

Health technology assessment (HTA) of medical devices (MDs) increasingly rely on real-world evidence (RWE). The aim of this study was to evaluate the type and the quality of the evidence used to assess the (cost-)effectiveness of high risk MDs (Class III) by HTA agencies in Europe (four European HTA agencies and EUnetHTA), with particular focus on RWE. Data were extracted from HTA reports on the type of evidence demonstrating (cost-)effectiveness, and the quality of observational studies of comparative effectiveness using the Good Research for Comparative Effectiveness principles. 25 HTA reports were included that incorporated 28 observational studies of comparative effectiveness. Half of the studies (46%) took important confounding and/or effect modifying variables into account in the design and/or analyses. The most common way of including confounders and/or effect modifiers was through multivariable regression analysis. Other methods, such as propensity score matching, were rarely employed. Furthermore, meaningful analyses to test key assumptions were largely omitted. Resulting recommendations from HTA agencies on MDs is therefore (partially) based on evidence which is riddled with uncertainty. Considering the increasing importance of RWE it is important that the quality of observational studies of comparative effectiveness are systematically assessed when used in decision-making.


Asunto(s)
Evaluación de la Tecnología Biomédica , Análisis Costo-Beneficio , Europa (Continente) , Humanos , Evaluación de la Tecnología Biomédica/métodos
6.
Curr Oncol ; 29(8): 5774-5791, 2022 08 16.
Artículo en Inglés | MEDLINE | ID: mdl-36005193

RESUMEN

BACKGROUND: Advances in cancer medicines have resulted in tangible health impacts, but the magnitude of benefits of approved cancer medicines could vary greatly. Health Technology Assessment (HTA) is a multidisciplinary process used to inform resource allocation through a systematic value assessment of health technology. This paper reviews the challenges in conducting HTA for cancer medicines arising from oncology trial designs and uncertainties of safety-efficacy data. METHODS: Multiple databases (PubMed, Scopus and Google Scholar) and grey literature (public health agencies and governmental reports) were searched to inform this policy narrative review. RESULTS: A lack of robust efficacy-safety data from clinical trials and other relevant sources of evidence has made HTA for cancer medicines challenging. The approval of cancer medicines through expedited pathways has increased in recent years, in which surrogate endpoints or biomarkers for patient selection have been widely used. Using these surrogate endpoints has created uncertainties in translating surrogate measures into patient-centric clinically (survival and quality of life) and economically (cost-effectiveness and budget impact) meaningful outcomes, with potential effects on diverting scarce health resources to low-value or detrimental interventions. Potential solutions include policy harmonization between regulatory and HTA authorities, commitment to generating robust post-marketing efficacy-safety data, managing uncertainties through risk-sharing agreements, and using value frameworks. CONCLUSION: A lack of robust efficacy-safety data is a central problem for conducting HTA of cancer medicines, potentially resulting in misinformed resource allocation.


Asunto(s)
Neoplasias , Evaluación de la Tecnología Biomédica , Biomarcadores , Análisis Costo-Beneficio , Humanos , Neoplasias/tratamiento farmacológico , Calidad de Vida , Evaluación de la Tecnología Biomédica/métodos
7.
Int J Technol Assess Health Care ; 38(1): e71, 2022 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-36016516

RESUMEN

OBJECTIVE: The aim of this scoping review is to map the available evidence about the use of health technology assessment (HTA) in the assessment of whole genome sequencing (WGS). METHODS: A scoping review methodology was adopted. The population, concept, and context framework was used to build up the research question and to establish the eligibility criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was adopted to implement a comprehensive search strategy. Evidence was retrieved from scientific databases and HTA organizations Web sites. Reports were classified as full HTA, mini-HTA, rapid reviews or other. RESULTS: The search strategy identified seven reports. Five HTA organizations from five countries elaborated the reports: one full HTA, four rapid reviews, and two classified as others. The reports were mainly focused on the evaluation of the clinical utility and cost-effectiveness of genome-wide sequencing as well as informing policy questions by providing analyses of organizational and ethical considerations. CONCLUSIONS: Few HTA organizations are drafting reports for WGS. It is essential to stimulate a critical reflection during the elaboration of HTA reports for WGS to steer choices of decision makers in the establishment of priorities for research and policy and reimbursement rates.


Asunto(s)
Evaluación de la Tecnología Biomédica , Análisis Costo-Beneficio , Secuenciación Completa del Genoma
8.
Am J Manag Care ; 28(6 Suppl): S104-S111, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35997774

RESUMEN

BACKGROUND: The FINE-CKD model was developed to estimate the cost-effectiveness of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). OBJECTIVE: To perform internal and external validation by comparing the model estimates with trial results and outcomes from other models. METHODS: Incidence rates from trials were compared with the model predictions. Statistical tests were then performed to assess whether modeled event rates aligned with trial observations. A cross-validation was also performed using the online version of the SHARP CKD-Cardiovascular Disease (SHARP CKD-CVD) model, with population characteristics from the finerenone trials analyzed. Where no finerenone data were available, the default SHARP CKD-CVD values were used. Comparison of the results considered the ranges from both models. RESULTS: The outcomes of the FINE-CKD model reflect the event rates observed in the trials. Based on the results of the statistical tests, the hypothesis of no difference between observed and modeled events cannot be rejected for any of the outcomes. The results of the FINE-CKD model are within the ranges from the SHARP CKD-CVD model. Disease progressions align across the models; however, incident kidney failure events in the SHARP CKD-CVD model were higher. This can be explained by simulation of more severely affected patients in the SHARP CKD-CVD model. CONCLUSIONS: This study demonstrates that the FINE-CKD model adequately reflects the clinical data and provides reliable extrapolation relative to the existing predictive tools while also being conservative in its approach.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Insuficiencia Renal Crónica , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Progresión de la Enfermedad , Humanos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/tratamiento farmacológico , Insuficiencia Renal Crónica/epidemiología , Evaluación de la Tecnología Biomédica
9.
Front Public Health ; 10: 932093, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36033790

RESUMEN

In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications.


Asunto(s)
Medicina Estatal , Evaluación de la Tecnología Biomédica , Atención a la Salud , Genómica , Italia
10.
Int J Technol Assess Health Care ; 38(1): e68, 2022 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-35983625

RESUMEN

OBJECTIVES: There has been a lack of health technology assessment (HTA) methods for novel digital health technologies (DHTs) such as mHealth, artificial intelligence, and robotics in Finland. The Digi-HTA method has been developed for this purpose. The aim of this study is to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of DHT products, this study assesses the suitability of using the Digi-HTA framework to perform HTAs for their products. METHODS: Feedback about Digi-HTA recommendations was collected from healthcare professionals. DHT companies provided input about the Digi-HTA framework. Data were collected via a web-based survey and were analyzed using qualitative methods. RESULTS: Of the twenty-four healthcare professional respondents, twenty said that the Digi-HTA recommendations contained all the necessary information, and twenty-one found them useful for their work. Respondents hoped that the Digi-HTA recommendations would be better integrated into the decision-making processes and healthcare professionals would be more informed about this new HTA process. The questions of the Digi-HTA framework were applicable for different DHT products based on the responses from DHT companies (n = 8). CONCLUSIONS: According to the study participants, although the Digi-HTA recommendations include clear and beneficial information, their integration into healthcare decision-making processes should be improved. Responses from DHT companies indicate that the Digi-HTA framework would be an appropriate tool for performing assessments for their products. To generalize the findings of this study, more comprehensive studies will be needed.


Asunto(s)
Inteligencia Artificial , Evaluación de la Tecnología Biomédica , Tecnología Biomédica , Toma de Decisiones , Finlandia , Humanos , Proyectos de Investigación , Evaluación de la Tecnología Biomédica/métodos
11.
BMC Med Res Methodol ; 22(1): 217, 2022 08 08.
Artículo en Inglés | MEDLINE | ID: mdl-35941551

RESUMEN

BACKGROUND: Anchored covariate-adjusted indirect comparisons inform reimbursement decisions where there are no head-to-head trials between the treatments of interest, there is a common comparator arm shared by the studies, and there are patient-level data limitations. Matching-adjusted indirect comparison (MAIC), based on propensity score weighting, is the most widely used covariate-adjusted indirect comparison method in health technology assessment. MAIC has poor precision and is inefficient when the effective sample size after weighting is small. METHODS: A modular extension to MAIC, termed two-stage matching-adjusted indirect comparison (2SMAIC), is proposed. This uses two parametric models. One estimates the treatment assignment mechanism in the study with individual patient data (IPD), the other estimates the trial assignment mechanism. The first model produces inverse probability weights that are combined with the odds weights produced by the second model. The resulting weights seek to balance covariates between treatment arms and across studies. A simulation study provides proof-of-principle in an indirect comparison performed across two randomized trials. Nevertheless, 2SMAIC can be applied in situations where the IPD trial is observational, by including potential confounders in the treatment assignment model. The simulation study also explores the use of weight truncation in combination with MAIC for the first time. RESULTS: Despite enforcing randomization and knowing the true treatment assignment mechanism in the IPD trial, 2SMAIC yields improved precision and efficiency with respect to MAIC in all scenarios, while maintaining similarly low levels of bias. The two-stage approach is effective when sample sizes in the IPD trial are low, as it controls for chance imbalances in prognostic baseline covariates between study arms. It is not as effective when overlap between the trials' target populations is poor and the extremity of the weights is high. In these scenarios, truncation leads to substantial precision and efficiency gains but induces considerable bias. The combination of a two-stage approach with truncation produces the highest precision and efficiency improvements. CONCLUSIONS: Two-stage approaches to MAIC can increase precision and efficiency with respect to the standard approach by adjusting for empirical imbalances in prognostic covariates in the IPD trial. Further modules could be incorporated for additional variance reduction or to account for missingness and non-compliance in the IPD trial.


Asunto(s)
Modelos Estadísticos , Evaluación de la Tecnología Biomédica , Sesgo , Simulación por Computador , Humanos , Modelos Teóricos
12.
Front Public Health ; 10: 921226, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35910914

RESUMEN

The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse-from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified as data related, methodological, technological, regulatory and policy related, and human factor related. Some of the barriers are quite similar, especially concerning the technologies. Studies focusing on the AI usage for HTA decision making are scarce. AI and augmented decision making tools are a novel science, and we are in the process of adapting it to existing needs. HTA as a process requires multiple steps, multiple evaluations which rely on heterogenous data. Therefore, the observed range of barriers come as a no surprise, and experts in the field need to give their opinion on the most important barriers in order to develop recommendations to overcome them and to disseminate the practical application of these tools.


Asunto(s)
Inteligencia Artificial , Evaluación de la Tecnología Biomédica , Niño , Humanos , Evaluación de la Tecnología Biomédica/métodos
13.
Int J Technol Assess Health Care ; 38(1): e53, 2022 Jun 23.
Artículo en Inglés | MEDLINE | ID: mdl-35950525

RESUMEN

The unique task and contribution of health technology assessment (HTA) is to help identify those health technologies and their uses that are most likely to preserve and restore a population's health in a way that is consonant with its values, including, for example, equity and access to high-quality care (1). Such a task is challenging for at least two reasons. First, because of the vast and constantly evolving number and diversity of health technologies and their applications. Second, because of the usual wide variety of competing views within communities and their stakeholders regarding what strategies are likely to be conducive to the goal of preserving and restoring population health. Although perhaps tempting, it would be a grave mistake to hold that the controversies that result from such competing views can be resolved by taking recourse to the facts only. For such controversies are usually fueled by different notions of health and disease and different specifications of values such as equity and individual and collective responsibility for health. For this reason, they cannot be resolved in a satisfactory way without also addressing those normative issues and their interplay with empirical analysis.


Asunto(s)
Tecnología Biomédica , Evaluación de la Tecnología Biomédica
14.
Front Public Health ; 10: 922708, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35968493

RESUMEN

Patients' perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies. Patient and public involvement in health technology assessment (HTA) is essential in understanding and assessing wider implications of coverage and reimbursement decisions for patients, their relatives, caregivers, and the general population. There are two approaches to incorporating the patients' voice in HTA, preferably used in a mix. In the first one, patients, caregivers and/or their representatives directly participate at discussions in different stages of the HTA process, often at the same table with other stakeholders. Secondly, patient involvement activities can be supported by evidence on patient value and experience collected directly from patients, caregivers and/or their representatives often by patient groups Patient involvement practices, however, are limited in Central and Eastern European (CEE) countries without clear methodology or regulatory mechanisms to guide patient involvement in the HTA process. This poses the question of transferability of practices used in other countries, and might call for the development of new CEE-specific guidelines and methods. In this study we aim to map potential barriers of patient involvement in HTA in countries of the CEE region.


Asunto(s)
Participación del Paciente , Evaluación de la Tecnología Biomédica , Europa (Continente) , Humanos , Evaluación de la Tecnología Biomédica/métodos
15.
Artículo en Inglés | MEDLINE | ID: mdl-36011499

RESUMEN

Frail chronic patients consume the largest share of resources in advanced healthcare systems, with more hospitals waiting to receive them in the acute phase (awaiting paradigm) than there are effective public health interventions to keep them out of hospitals as much as possible. Effective chronic care management (CCM) requires organizational research as much as biomedical research (and, in some cases, perhaps more). Otherwise, excellent clinical care is wasted by poor coordination among professionals and institutions, with frail patients and their families paying the most expensive price. Comprehensive health technology assessment (HTA) procedures include organizational, social, and ethical dimensions to precisely capture the environmental factors that make medical interventions effective, accessible, and sustainable. Clinical outcomes and financial data are used extensively to evaluate care pathways from the providers' perspective, but much remains to be done to capture equally important indicators from the perspective of patients and society. The authors hypothesize that the ordinary use of patient-reported experience measurement (PREMs) in HTA can help reduce gaps and inequalities by identifying frail patients on time, curbing the risks of isolation and the burden on care givers, preventing complications and inappropriate emergency care use, improving adherence, health communication and behavior, supporting risk assessment, and relieving the frequency of the healthcare environment.


Asunto(s)
Salud Pública , Evaluación de la Tecnología Biomédica , Vías Clínicas , Atención a la Salud , Humanos , Cuidados a Largo Plazo
16.
Value Health ; 25(8): 1257-1267, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35931428

RESUMEN

Health technology assessment (HTA) has been growing in use over the past 40 years, especially in its impact on decisions regarding the reimbursement, adoption, and use of new drugs, devices, and procedures. In countries or jurisdictions with "pluralistic" healthcare systems, there are multiple payers or sectors, each of which could potentially benefit from HTA. Nevertheless, a single HTA, conducted centrally, may not meet the needs of these different actors, who may have different budgets, current standards of care, populations to serve, or decision-making processes. This article reports on the research conducted by an ISPOR Health Technology Assessment Council Working Group established to examine the specific challenges of conducting and using HTA in countries with pluralistic healthcare systems. The Group used its own knowledge and expertise, supplemented by a narrative literature review and survey of US payers, to identify existing challenges and any initiatives taken to address them. We recommend that countries with pluralistic healthcare systems establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA. These efforts can be enhanced by the development of good practice guidance from ISPOR or similar groups and increased training to facilitate local use of HTA.


Asunto(s)
Presupuestos , Evaluación de la Tecnología Biomédica , Atención a la Salud , Humanos , Evaluación de la Tecnología Biomédica/métodos
17.
Int J Technol Assess Health Care ; 38(1): e52, 2022 Jun 23.
Artículo en Inglés | MEDLINE | ID: mdl-35959563

RESUMEN

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O'Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology's value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union's program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project's website www.validatehta.eu.


Asunto(s)
Tecnología Biomédica , Evaluación de la Tecnología Biomédica , Europa (Continente) , Evaluación de la Tecnología Biomédica/métodos
18.
J Manag Care Spec Pharm ; 28(9): 1053-1058, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36001106

RESUMEN

BACKGROUND: Health plans guide enrollees' access to specialty drugs through coverage policies. Practice guidelines recommend that the evidence supporting drug coverage policies should be comprehensive and routinely updated to reflect evidence-based medicine. OBJECTIVE: To examine the frequency with which health plans update their coverage criteria and supporting evidence and to determine the pattern with which plans cited relevant literature in their coverage policies. METHODS: Coverage policies from 17 large US commercial health plans were retrieved from the Tufts Medical Center Specialty Drug Evidence and Coverage database for August 2017 and August 2019. We identified drug-indication pairs (eg, infliximab for rheumatoid arthritis) for which plans had issued coverage policies in August 2017 and August 2019. We examined the frequency with which plans reissued these policies (ie, issued a new coverage document) between these 2 time points and the frequency with which plans altered coverage criteria or updated the cited evidence. A random sample of 20 drug-indication pairs was chosen to determine the comprehensiveness of cited evidence from the Specialty Drug Evidence and Coverage database. For each pair, a systematic literature search was conducted to identify relevant clinical and economic studies. A comparison of the systematic literature search with the evidence cited in each drug-indication pair's coverage policy was conducted to determine the comprehensive nature of each coverage policy's evidence. RESULTS: We identified 4,597 instances of plans issuing a coverage policy for the same drug-indication pair in both August 2017 and August 2019. Of those 4,597 instances, plans reissued an updated coverage document in 4,468 (97%). Fifteen percent of reissued policies revised both their coverage criteria and the evidence cited, 2% only their coverage criteria, 69% only the cited evidence, and 14% made no change. A total of 2,760 literature documents were identified relevant to at least one of the 20 drug-indication pairs, of which at least one plan cited 146 of these documents at least once (5.3%). Plans cited health technology assessments, randomized controlled trials (RCTs), systematic reviews/meta-analyses, and clinical guidelines most comprehensively. CONCLUSIONS: Health plans reissued most of their specialty drug coverage policies over a 2-year period. When plans revised their drug coverage criteria, they also tended to revise the evidence cited in their coverage polices. Of all the evidence found in our systematic review, plans more comprehensively cite health technology assessments, RCTs, and systematic reviews/meta-analyses. DISCLOSURES: This study was funded by the National Pharmaceutical Council.


Asunto(s)
Artritis Reumatoide , Farmacia , Medicina Basada en la Evidencia , Humanos , Cobertura del Seguro , Evaluación de la Tecnología Biomédica
19.
Int J Cardiol ; 365: 61-68, 2022 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-35905826

RESUMEN

Regulatory approvals of, and subsequent access to, innovative cardiovascular medications have declined. How much of this decline relates to the final step of gaining reimbursement for new treatments is unknown. Payers and health technology assessment (HTA) bodies look beyond efficacy and safety to assess whether a new drug improves patient outcomes, quality of life, or satisfaction at a cost that is affordable compared to existing treatments. HTA bodies work within a limited healthcare budget, and this is one of the reasons why only half of newly approved drugs are accepted for reimbursement, or receive restricted or "optimised" recommendations from HTA bodies. All stakeholders have the common goal of facilitating access to safe, effective, and affordable treatments to appropriate patients. An important strategy to expedite this is providing optimal data. This is demonstrably facilitated by early (and ongoing) discussions between all stakeholders. Many countries have formal programmes to provide collaborative regulatory and HTA advice to developers. Other strategies include aligning regulatory and HTA processes, increasing use of real-world evidence, formally defining the decision-making process, and educating stakeholders on the criteria for positive decision making. Industry should focus on developing treatments for unmet medical needs, seek early engagement with HTA and regulatory bodies, improve methodologies for optimal price setting, develop internal systems to collaborate with national and international stakeholders, and conduct post-approval studies. Patient involvement in all stages of development, including HTA, is critical to capture the lived experience and priorities of those whose lives will be impacted by new treatment approvals.


Asunto(s)
Calidad de Vida , Evaluación de la Tecnología Biomédica , Humanos
20.
Artículo en Inglés | MEDLINE | ID: mdl-35886720

RESUMEN

Hospital-based health technology assessment (HB-HTA) is a scientific approach to inform decisions on investments in health technologies across multiple medical specialties at a hospital level. HB-HTA is not currently practiced in Poland. This study aimed to assess the need for HTA in Polish hospitals, including perceived benefits and challenges of adoption of HB-HTA in Poland, expected demand for training in HB-HTA, and perception of incentives to foster HB-HTA adoption. Study data were gathered using the computer-assisted telephone interview (CATI) technique. Between June and August 2021, 50 interviews were conducted: 52% of respondents had over 10 years of experience, and 40% comprised the highest degree reference hospitals. A high or moderate need for HB-HTA was reported by 86% of managers. The ability to indicate valuable and affordable medical technologies was the main reported benefit of HB-HTA (90%). The main obstacle to the adoption of HB-HTA was the shortage of competent staff (84%). The most important incentives to adopt HB-HTA were free training and premium financing from the National Health Fund. There is a clear need for HB-HTA in Polish hospitals despite some important obstacles.


Asunto(s)
Hospitales , Evaluación de la Tecnología Biomédica , Personal de Salud , Humanos , Polonia , Encuestas y Cuestionarios
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