Health Technology Assessment Tools Research Articles

Intangible assets innovation through Health Technology Assessment. The case of the Italian Healthcare Organisations

The use of Health Technology Assessment (HTA) for the evaluation of medical devices in healthcare organisations implies the creation of new knowledge to be combined with that stored in the human, relational, and structural dimensions of their Intellectual Capital (IC).Therefore, HTA can represent a trigger for innovating the IC and this process can be influenced by external factors that can be reconducted to the Institutional Theory (IT). However, to the best of our knowledge, there are no studies in the literature analysing these aspects. By using the case study methodology, this work explores how the innovation of the IC dimensions is triggered by the use of the HTA tools, considering also the moderating role of the IT pillars.

HTA35 Should Health Technology Assessment (HTA) Bodies Utilize Living HTA Tools? Validation of LiveSLR® and LiveNMA™ Tools Using ICER’S Class Review in Relapsed Refractory Multiple Myeloma (RRMM)

HTA35 Should Health Technology Assessment (HTA) Bodies Utilize Living HTA Tools? Validation of LiveSLR® and LiveNMA™ Tools Using ICER’S Class Review in Relapsed Refractory Multiple Myeloma (RRMM)

Application of DMAIC Cycle and Modeling as Tools for Health Technology Assessment in a University Hospital.

Background The Health Technology Assessment (HTA) is used to evaluate health services, manage healthcare processes more efficiently, and compare medical technologies. The aim of this paper is to carry out an HTA study that compares two pharmacological therapies and provides the clinicians with two models to predict the length of hospital stay (LOS) of patients undergoing oral cavity cancer surgery on the bone tissue. Methods The six Sigma method was used as a tool of HTA; it is a technique of quality management and process improvement that combines the use of statistics with a five-step procedure: “Define, Measure, Analyze, Improve, Control” referred to in the acronym DMAIC. Subsequently, multiple linear regression has been used to create two models. Two groups of patients were analyzed: 45 were treated with ceftriaxone while 48 were treated with the combination of cefazolin and clindamycin. Results A reduction of the overall mean LOS of patients undergoing oral cavity cancer surgery on bone was observed of 40.9% in the group treated with ceftriaxone. Its reduction was observed in all the variables of the ceftriaxone group. The best results are obtained in younger patients (−54.1%) and in patients with low oral hygiene (−52.4%) treated. The regression results showed that the best LOS predictors for cefazolin/clindamycin are ASA score and flap while for ceftriaxone, in addition to these two, oral hygiene and lymphadenectomy are the best predictors. In addition, the adjusted R squared showed that the variables considered explain most of the variance of LOS. Conclusion SS methodology, used as an HTA tool, allowed us to understand the performance of the antibiotics and provided variables that mostly influence postoperative LOS. The obtained models can improve the outcome of patients, reducing the postoperative LOS and the relative costs, consequently increasing patient safety, and improving the quality of care provided.

OP165 Health Technology Assessment And Public Health Priority Setting In China

IntroductionSince 2009, China has initiated a national program on free provision of essential public health services. The national program has expanded both in terms of service categories and funding, showing China's great commitment to universal health coverage. However, with slowdown of public input in the health sector, the government decided to prioritize interventions and optimize reimbursement packages. Researchers in the China National Health Development Research Center (CNHDRC)—the Chinese national health technology assessment (HTA) agency were asked to design the tools to facilitate the decision process.MethodsWith multi-criteria decision analysis (MCDA) method, the researchers analyzed value dimensions in public health issues, and built an evidence matrix for the priority-setting decisions. Supported by HTA tools, they appraised interventions and services through literature review and field studies, and projected budget impact of potential adjustment decisions based on cost analysis results. A deliberative process of key stakeholder groups was taken, and their views were counted in making the final recommendations.ResultsBased on evidence review and scores of stakeholders’ judgment, two public health service interventions were recommended for removal, and another two for adjustment (one for merger, one for optimizing care pathway). Cost estimation and potential budgetary impact were also analyzed to support financial decisions.ConclusionsHTA and MCDA are key tools for defining the value criteria, evidence framework, and deliberative process for the essential public health program. However, lack of cost-effectiveness evidence hinders fine-tuned decisions on resource allocation. Continual health economic evaluation needs to be conducted in the near future.

An Evidence Framework for Off-Patent Pharmaceutical Review for Health Technology Assessment in Emerging Markets

ObjectiveThis article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. MethodsA literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). ResultsThe IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. ConclusionsEmerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials.

Decision Making and Priority Setting: The Evolving Path Towards Universal Health Coverage.

Health technology assessment (HTA) is widely viewed as an essential component in good universal health coverage (UHC) decision-making in any country. Various HTA tools and metrics have been developed and refined over the years, including systematic literature reviews (Cochrane), economic modelling, and cost-effectiveness ratios and acceptability curves. However, while the cost-effectiveness ratio is faithfully reported in most full economic evaluations, it is viewed by many as an insufficient basis for reimbursement decisions. Emotional debates about the reimbursement of cancer drugs, orphan drugs, and end-of-life treatments have revealed fundamental disagreements about what should and should not be considered in reimbursement decisions. Part of this disagreement seems related to the equity-efficiency tradeoff, which reflects fundamental differences in priorities. All in all, it is clear that countries aiming to improve UHC policies will have to go beyond the capacity building needed to utilize the available HTA toolbox. Multi-criteria decision analysis (MCDA) offers a more comprehensive tool for reimbursement decisions where different weights of different factors/attributes can give policymakers important insights to consider. Sooner or later, every country will have to develop their own way to carefully combine the results of those tools with their own priorities. In the end, all policymaking is based on a mix of facts and values.

OP104 Health Technology Assessment's Ethical Evaluation: Understanding The Diversity Of Approaches

INTRODUCTION:The main difficulties encountered in the integration of ethics in Health Technology Assessment (HTA) were identified in our systematic review. In the process of analyzing these difficulties we then addressed the question of the diversity of ethical approaches (1) and the difficulties in their operationalization (2,3).METHODS:Nine ethical approaches were identified: principlism, casuistry, coherence analysis, wide reflexive equilibrium, axiology, socratic approach, triangular method, constructive technology assessment and social shaping of technology. Three criteria were used to clarify the nature of each of these approaches: 1.The characteristics of the ethical evaluation2.The disciplinary foundation of the ethical evaluation3.The operational process of the ethical evaluation in HTA analysis.RESULTS:In HTA, both norm-based ethics and value-based ethics are mobilized. This duality is fundamental since it proposes two different ethical evaluations: the first is based on the conformity to a norm, whereas the second rests on the actualization of values. The disciplinary foundation generates diversity as philosophy, sociology and theology propose different justifications for ethical evaluation. At the operational level, ethical evaluation's characteristics are applied to the case at stake by specific practical reasoning. In a norm-based practical reasoning, one must substantiate the facts that will be correlated to a moral norm for clearly identifying conformity or non-conformity. In value-based practical reasoning, one must identify the impacts of the object of assessment that will be subject to ethical evaluation. Two difficulties arise: how to apply values to facts and prioritize amongst conflicting ethical evaluations of the impacts?CONCLUSIONS:Applying these three criteria to ethical approaches in HTA helps understanding their complexity and the difficulty of operationalizing them in HTA tools. The choice of any ethical evaluations is never neutral; it must be justified by a moral point of view. Developing tools for ethics in HTA is operationalizing a specific practical reasoning in ethics.

PP023 Applying Oncology Patient Registries As A Health Technology Assessment Tool

INTRODUCTION:The limited healthcare resources have to be invested efficiently; Health Technology Assessment (HTA) is applied ever more often in many health care systems for “rational decision-making”. The oncology patient registries (OPR) track the eligibility of patients and the complete flow of treatments, guaranteeing appropriateness in use of pharmaceutical products, according to approved indications.METHODS:Normative legal acts and other regulatory documents in the field of oncology medical and pharmaceutical activity, include content and maintenance oncology registries. The system, process and information analysis, direct observation, comparative analysis, logical modelling, sociological methods (surveys and expert opinions) are applied.RESULTS:A temporary coverage/funding of oncology drugs often requires additional collection of data on safety, effectiveness, cost-effectiveness, and the appropriate use of the drug. Many of the oncology drugs show little or marginal effectiveness at time of approval and reimbursement agencies demand further data before deciding whether to cover the new drug. Pragmatic clinical trials, patient access schemes and standard data requirements on patient relevant outcomes in OPR are some of the approaches to generate further evidence and to fill the gap between knowledge on efficacy at time of approval and demanded knowledge on effectiveness for coverage decisions. For each monitored drug, patients eligible for treatment are registered in the specific therapeutic indication dynamic monitoring database to collect epidemiologic and clinical data, including data on the safety profile, and ex-post information missing at first evaluation stage.CONCLUSIONS:OPR provide a detailed view of the morbidity, mortality and resource utilization associated with an oncologies diseases entity. This data is of prime importance in coming to decisions on coverage of a drug or treatment. The collation of information is also quick and efficient owing to better methods of data management. OPR of Kazakhstan are equipped with sophisticated data processing software and technologies.

A systematic review of health technology assessment tools in sub-Saharan Africa: methodological issues and implications.

BackgroundHealth technology assessment (HTA) is mostly used in the context of high- and middle-income countries. Many “resource-poor” settings, which have the greatest need for critical assessment of health technology, have a limited basis for making evidence-based choices. This can lead to inappropriate use of technologies, a problem that could be addressed by HTA that enables the efficient use of resources, which is especially crucial in such settings. There is a lack of clarity about which HTA tools should be used in these settings. This research aims to provide an overview of proposed HTA tools for “resource-poor” settings with a specific focus on sub-Saharan Africa (SSA).MethodologyA systematic review was conducted using basic steps from the PRISMA guidelines. Studies that described HTA tools applicable for “resource-limited” settings were identified and critically appraised. Only papers published between 2003 and 2013 were included. The identified tools were assessed according to a checklist with methodological criteria.ResultsSix appropriate tools that are applicable in the SSA setting and cover methodological robustness and ease of use were included in the review. Several tools fulfil these criteria, such as the KNOW ESSENTIALS tool, Mini-HTA tool, and Multi-Criteria Decision Analysis but their application in the SSA context remains limited. The WHO CHOICE method is a standardized decision making tool for choosing interventions but is limited to their cost-effectiveness. Most evaluation of health technology in SSA focuses on priority setting. There is a lack of HTA tools that can be used for the systematic assessment of technology in the SSA context.ConclusionsAn appropriate HTA tool for “resource-constrained” settings, and especially SSA, should address all important criteria of decision making. By combining the two most promising tools, KNOW ESSENTIALS and Multi-Criteria Decision Analysis, appropriate analysis of evidence with a robust and flexible methodology could be applied for the SSA setting.

Integration of tablet technologies in the e-laboratory of cytology: a health technology assessment.

Although tablet systems are becoming a powerful technology, particularly useful in every application of medical imaging, to date no one has investigated the acceptance and performance of this technology in digital cytology. The specific aims of the work were (1) to design a health technology assessment (HTA) tool to assess, in terms of performance and acceptance, the introduction of tablet technologies (wearable, portable, and non portable) in the e-laboratories of cytology and (2) to test the tool in a first significant application of digital cytology. An HTA tool was proposed operating on a domain of five dimensions of investigation comprising the basic information of the product of digital cytology, the perceived subjective quality of images, the assessment of the virtual navigation on the e-slide, the assessment of the information and communication technologies features, and the diagnostic power. Six e-slides regarding studies of cervicovaginal cytology digitalized by means of an Aperio ( www.aperio.com ) scanner and uploaded onto the www.digitalslide.it Web site were used for testing the methodology on three different network connections. Three experts of cytology successfully tested the methodology on seven tablets found suitable for the study in their own standard configuration. Specific indexes furnished by the tool indicated both a high degree of performance and subjective acceptance of the investigated technology. The HTA tool thus could be useful to investigate new tablet technologies in digital cytology and furnish stakeholders with useful information that may help them make decisions involving the healthcare system. From a global point of view the study demonstrates the feasibility of using the tablet technology in digital cytology.

Early Assessment of Medical Technologies to Inform Product Development and Market Access

Worldwide, billions of dollars are invested in medical product development and there is an increasing pressure to maximize the revenues of these investments. That is, governments need to be informed about the benefits of spending public resources, companies need more information to manage their product development portfolios and even universities may need to direct their research programmes in order to maximize societal benefits. Assuming that all medical products need to be adopted by the heavily regulated healthcare market at one point in time, it is worthwhile to look at the logic behind healthcare decision making, specifically, decisions on the coverage of medical products and decisions on the use of these products under competing and uncertain conditions. With the growing tension between leveraging economic growth through R&D spending on the one hand and stricter control of healthcare budgets on the other, several attempts have been made to apply the health technology assessment (HTA) methodology to earlier stages of technology development and implementation. For instance, horizon scanning was introduced to systematically assess emerging technologies in order to inform health policy. Others have introduced iterative economic evaluation, e.g. economic evaluations in earlier stages of clinical research. However, most of these methods are primarily intended to support governments in making decisions regarding potentially expensive new medical products. They do not really inform biomedical product developers on the probability of return on investment, nor do they inform about the market needs and specific requirements of technologies in development. It is precisely this aspect that increasingly receives attention, i.e. is it possible to use HTA tools and methods to inform biomedical product development and to anticipate further development and market access. Several methods have been used in previous decades, but have never been compiled in a comprehensive review. The main objective of this article was to provide an overview of previous work and methods in the field of early HTA, and to put these approaches in perspective through a conceptual framework introduced in this paper. A particular goal of the review was to familiarize decision makers with available techniques that can be employed in early-stage decision making, and to identify opportunities for further methodological growth in this emerging field of HTA.

Health Technology Assessment, ricerca e sanità pubblica

The relationship between research, health technology assessment (HTA) and public health has been recognized as fundamental in recent years in Italy, both at the national and regional levels. Sometimes the HTA process could be seen as an opportunity to conduct primary research, and this process is well established in some Countries. Nevertheless, the research for HTA purposes several times suffers from lack of evidence in terms of availability of clinical trials, economic evaluations, legal, ethical and social assessments. The research as a HTA tool could be of great interest in the field of public health, not only for well established issues, such as vaccination, but also for alcohol, smoking and drug abuse, for dietary habits, home and traffic injuries, physical and psychiatric disability.

Bridging experience and evidence in mental health care reform

Bridging experience and evidence in mental health care reform