scholarly journals Characterizing the Validity and Real-World Utility of Health Technology Assessments in Healthcare: Future Directions Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modelling"

2019 ◽  
Author(s):  
Nadine K. Zawadzki ◽  
Joel W. Hay
Keyword(s):  
Health Economic ◽  
Real World ◽  
Reliability And Validity ◽  
Health Technology ◽  
Economic Modeling ◽  
Economic Evaluations ◽  
Economic Modelling ◽  
Complete Representation ◽  
Health Technologies ◽  
Wide Range

With their article, Grutters et al raise an important question: What do successful health technology assessments (HTAs) look like, and what is their real-world utility in decision-making? While many HTAs are published in peer-reviewed journals, many are considered proprietary and their attributes remain confidential, limiting researchers’ ability to answer these questions. Models for economic evaluations like cost-effectiveness analyses (CEAs) synthesize a wide range of evidence, are often statistically and mathematically sophisticated, and require untestable assumptions. As such, there is nearly universal agreement among researchers that enhancing transparency is an important issue in health economic modeling. However, the definition of transparency and guidelines for its implementation vary. Model registration combined with a linked database of model-based economic evaluations has been proposed as a solution, whereby registered models and their accompanying technical and nontechnical documentation are sourced into a single publicly-available repository, ideally in a standardized format to ensure consistent and complete representation of features, code, data sources, results, validation exercises, and policy recommendations. When such a repository is ultimately created, modelers will not have to reinvent the wheel for every new drug launched or new treatment pathway. These more open and transparent approaches will have substantial implications for model accuracy, reliability, and validity, improving trust and acceptance by healthcare decision-makers.

OP07 Real World Evidence: How Can It Improve Health Technology Assessment?

2018 ◽  
Vol 34 (S1) ◽  
pp. 2-3
Author(s):  
John Gillespie ◽  
Sebnem Erdol ◽  
Chris Foteff ◽  
Liesl Strachan
Keyword(s):  
Health Economic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
New Technologies ◽  
Eligible Patient ◽  
Cost Effective ◽  
Health Technology ◽  
Economic Evaluations ◽  
Patient Pathways

Introduction:Health Technology Assessment (HTA) considers the question of whether evaluated technologies are cost-effective in real world settings. As observed in HTA conducted by the Australian Medical Services Advisory Committee (MSAC), questions regarding the validity of data inputs to economic analyses that reflect real-world practice is a common reason for uncertainty on the cost effectiveness of new technologies. In addition to resource use and costs, there may be other uncertainties regarding the eligible patient population, patient management pathways and comparator selection. Our objective in this study was to present case studies from Australia where real world linked datasets could be better utilized to inform HTA conducted by the MSAC.Methods:For selected therapy areas, assessment reports and public summary documents of HTA conducted by the MSAC published between January 2015 and November 2017 were reviewed. Our analysis identified HTAs where uncertainties around the inputs for health economic evaluations, as well as uncertainties in defining eligible patient numbers or current patient pathways of care were shown to exist. We then explored whether these uncertainties could have been addressed through real world linked datasets.Results:Our preliminary investigations identified two assessments: MSAC assessment of capsule endoscopy and transcatheter aortic valve implantation - where availability of real world linked data could have addressed uncertainties around the inputs required for the health economic evaluations.Conclusions:Australia has a range of real world datasets with the potential to be used to inform HTA conducted by the MSAC. This can only be achieved if the datasets could be better linked and accessible for use by key stakeholders in the MSAC HTA process (e.g. industry, clinician, patient societies). Use of these data sets in HTA will enable timelier patient access to cost-effective technologies and more effective implementation and review of technologies after adoption into clinical practice.

scholarly journals Early Health Economic Modelling – Optimizing Development for Medical Device Developers? Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling"

2019 ◽  
Author(s):  
Conor Teljeur ◽  
Máirín Ryan
Keyword(s):  
Health Economic ◽  
Early Stage ◽  
Data Gathering ◽  
Economic Modeling ◽  
Economic Modelling ◽  
Negative Consequences ◽  
Health Technologies ◽  
Stage Of Development ◽  
Early Health

Abstract This commentary considers the positive and negative consequences of early economic modelling and explores potential future directions. Early economic modelling offers device manufacturers an opportunity to assess the potential value of an innovation at an early stage of development. Early modelling can direct resources into potentially viable technologies and reduce investment in technologies with limited prospect of value. However, it is unclear whether early modelling is sufficiently specific to identify innovations with low value. It may be that early modelling is more useful for directing data gathering to reduce decision uncertainty. Early modelling is of primary benefit to the manufacturer and may have both positive and negative consequences for reimbursement processes that should be considered

scholarly journals The Potential for Early Health Economic Modelling in Health Technology Assessment and Reimbursement DecisionMaking Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling"

2020 ◽  
Author(s):  
Hansoo Kim ◽  
Stephen Goodall ◽  
Danny Liew
Keyword(s):  
Health Economic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Economic Modelling ◽  
Broad Perspective ◽  
Health Technologies ◽  
Early Health ◽  
Health Economic Modelling

Grutters et al recently investigated the role of early health economic modelling of health technologies by undertaking a secondary analysis of health economic modelling assessments performed by their group. Our commentary offers a broad perspective on the potential utility of early health economic modelling to inform health technology assessment (HTA) and decision-making around reimbursement of new health technologies. Further we provide several examples to compliment Grutters and colleagues’ observations.

scholarly journals Imaginary Worlds: The European Network for Health Technology Assessment (EUnetHTA) Recommendations for Health Economic Evaluations

2016 ◽  
Vol 7 (3) ◽  
Author(s):  
Paul C Langley
Keyword(s):  
Health Economic ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Relative Effectiveness ◽  
Health Technology ◽  
Economic Evaluations ◽  
Normal Science ◽  
European Network ◽  
Health Technologies

The European Network for Health Technology Assessment (EUnetHTA) guidelines for health economic evaluations represent a consolidated view of non-binding recommendations for assessments of the relative effectiveness of pharmaceuticals or other health technologies. EUnetHTA views itself as the scientific and technological backbone of the development of health technology assessment in the European Union and among its member states and other partners. Unfortunately, the standards for health technology assessment proposed by EUnetHTA do not meet the standards of normal science. They do not support credible claims for the clinical and comparative cost-effectiveness of pharmaceuticals. In rejecting the standards of normal science the guidelines put to one side the opportunity not only to re-assess and replicate clinical and cost-effectiveness claims but to provide meaningful feedback on claims assessment to health care decision makers. The purpose of this review is to make the case that, in failing to support standards for experimentation, EUnetHTA is advocating its partners support the creation of modeled or simulated imaginary or false worlds. While EUnetHTA is not alone in recommending the construction of imaginary worlds to support formulary decisions, there is still the opportunity to revisit these recommendations and decide whether or not to encourage a scientifically rigorous approach to health technology assessments - to abandon a commitment to intelligent design in favor of natural selection.  Conflict of Interest None   Type: Commentary  

scholarly journals Expanding the Role of Early Health Economic Modelling in Evaluation of Health Technologies Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling"

2020 ◽  
Author(s):  
Carlo Federic ◽  
Aleksandra Torbica
Keyword(s):  
Health Economic ◽  
Early Stage ◽  
Economic Modeling ◽  
Evaluation Framework ◽  
Economic Modelling ◽  
Health Technologies ◽  
Innovative Methods ◽  
Healthcare Decision Making ◽  
Early Health

In this commentary, we discuss early stage assessments of innovative medical technologies both in terms of methods applied as well as their use in healthcare decision-making. We argue that cost-effectiveness alone may be too reductive if taken as the only decision rule, and it would benefit from being used within a broader evaluation framework. We discuss innovative methods which may contribute to better estimate the potential costs and consequences of a technology in the absence of solid clinical data, as frequently the case in early assessments. Finally, we comment on the potential synergies which may take place should early economic models be used not only by technology developers alone but as a negotiating base during early dialogues with health technology assessment (HTA) bodies.

The Impact of Hypoglycemia on Productivity Loss and Utility in Type 2 Diabetes Patients Treated with Insulin in Real-World Canadian Practice: Protocol for a Prospective Study (Preprint)

2021 ◽  
Author(s):  
Veronique Lambert-Obry ◽  
Jean-Philippe Lafrance ◽  
Michelle Savoie ◽  
Jean Lachaine
Keyword(s):  
Type 2 Diabetes ◽  
Prospective Study ◽  
Real World ◽  
Productivity Loss ◽  
Economic Modeling ◽  
Economic Evaluations ◽  
Productivity Cost ◽  
Productivity Losses ◽  
The Impact

BACKGROUND Type 2 diabetes mellitus (T2DM) imposes a significant burden, with its increasing prevalence and life-threatening complications. In patients not achieving glycemic targets on oral antidiabetic drugs, initiation of insulin is recommended. However, a serious concern about insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and healthcare resource utilization. However, health economics and outcomes research (HEOR) data for economic modeling are limited, particularly in terms of utility values and productivity losses. OBJECTIVE The aim of this real-world prospective study is to assess the impact of hypoglycemia on productivity and utility in insulin-treated T2DM adults from Ontario and Quebec (Canada). METHODS This noninterventional, multicenter, 3-month prospective study will recruit patients from four medical clinics and two endocrinology/diabetes clinics. Patients will be identified using appointment lists, and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be ≥18 years of age, diagnosed with T2DM, and treated with insulin. Utility and productivity will be collected using the EQ-5D-5L questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ), respectively. Questionnaires will be completed at 4, 8 and 12 weeks after recruitment. Generalized estimating equations (GEE) models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure precision of HEOR estimates. RESULTS This study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for economic modeling in T2DM. CONCLUSIONS Insulin therapies are expensive, and hypoglycemia is a significant component of economic evaluations. Robust HEOR data may help health technology assessment (HTA) agencies in future reimbursement decision making.

scholarly journals It’s Not the Model, It’s the Way You Use It: Exploratory Early Health Economics Amid Complexity Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modelling"

2020 ◽  
Author(s):  
Andrew Partington ◽  
Jonathan Karnon
Keyword(s):  
Health Economic ◽  
Complex Interventions ◽  
Healthcare Services ◽  
Economic Modelling ◽  
Learning And Development ◽  
Health Technologies ◽  
Significant Disagreement ◽  
Early Health ◽  
Health Economic Modelling

In a review recently published in this journal, Grutters et al outline the scope and impact of their early health economic modelling of healthcare innovations. Their reflections shed light on ways that health economists can shift-away from traditional reimbursement decision-support, towards a broader role of facilitating the exploration of existing care pathways, and the design of options to implement or discontinue healthcare services. This is a crucial role in organisations that face constant pressure to react and adapt with changes to their existing service configurations, but where there may exist significant disagreement and uncertainty on the extent to which change is warranted. Such dynamics are known to create complex implementation environments, where changes risk being poorly implemented or fail to be sustained. In this commentary, we extend the discussion by Grutters et al on early health economic modelling, to the evaluation of complex interventions and systems. We highlight how early health economic modelling can contribute to a participatory approach for ongoing learning and development within healthcare organisations.

scholarly journals Modeling in Early Stages of Technology Development: Is an Iterative Approach Needed? Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling"

2019 ◽  
Author(s):  
Michael F. Drummond
Keyword(s):  
Health Economic ◽  
Technology Development ◽  
Integrated Approach ◽  
Economic Modeling ◽  
Future Research ◽  
Iterative Approach ◽  
Health Technologies ◽  
Early Health ◽  
The Cost

A recent paper by Grutters et al makes the case for early health economic modeling in the development of health technologies. A number of examples of the value of early modeling are given, with analyses being performed at different stages in the development of several non-drug health technologies. This commentary acknowledges the contribution of the paper by Grutters et al and argues for an iterative and integrated approach to early modeling, assessing the cost-effectiveness of the technology, the value of future research and the interaction with the manufacturer’s pricing and revenue expectations.

OP101 Do We Need To Extend Health Technology Assessment To Health Enhancement Assessment?

2017 ◽  
Vol 33 (S1) ◽  
pp. 46-46
Author(s):  
Bjørn Hofmann
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cognitive Abilities ◽  
Literature Search ◽  
Ethical Issues ◽  
Health Technology ◽  
Health Technologies ◽  
Health And Wellbeing ◽  
Wide Range

INTRODUCTION:Several health technologies used for therapy can also be used for health enhancement. Drugs stimulating cognitive abilities are but one example. Health Technology Assessment (HTA) has not been developed for assessing enhancements. This raises the question of how HTA should address the blurred distinction between therapy and enhancement. Should we (i) carve out a distinction between therapy and enhancement and limit HTA to therapy, (ii) use HTA for both therapy and enhancement (with some modifications), or (iii) should we develop a separate health enhancement assessment (HEA)?METHODS:A literature search of the medical, philosophical, and bioethical literature was conducted for debates, arguments, and suggested solutions to the issue of therapy versus enhancement.RESULTS:The same improvement in health may be therapeutic in one patient, but an enhancement in another. Moreover, both therapy and enhancement share the same goal: increased health and wellbeing. A wide range of arguments try to establish a difference between therapy and enhancement. They refer to naturalness, rehabilitation, normality, species-typical functioning/potential, disease, sustainability, and responsibility. On closer scrutiny few of these arguments do the job in bolstering the therapy-enhancement distinction. We already use a wide range of means to extend human abilities. Moreover, the therapy-enhancement distinction raises a wide range of ethical issues that are relevant for the assessment of a number of emerging health technologies.CONCLUSIONS:Existing HTA methodology can address a wide range of non-therapeutic health enhancements. However, a series of broader issues related to the goal of health care and responsibility for altering human evolution may not be addressed within traditional HTA frameworks. Specific HEAs may therefore be helpful.

HEALTH TECHNOLOGY ASSESSMENT IN PORTUGAL

2000 ◽  
Vol 16 (2) ◽  
pp. 520-531 ◽  
Author(s):  
Manuela Mota Pinto ◽  
Francisco Ramos ◽  
João Pereira
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Universal Coverage ◽  
Health Technology ◽  
Pharmaceutical Products ◽  
Economic Evaluations ◽  
National Agency ◽  
Wide Range ◽  
Hospital Stays ◽  
National Tax

The Portuguese healthcare system is often portrayed as a National Health Service (NHS) model, characterized by universal coverage, comprehensive benefits, nearly free services, national tax financing, and public ownership or control of the factors of production. However, in reality the system fails to accomplish these features in a complete way. There coexist a number of occupation-related health insurance schemes that were originally intended to be integrated into the NHS. In addition, in key areas the NHS does not provide the wide range of services it promises. The public sector has a predominant role in the provision of hospital stays and general practitioner consultations, but the private sector provides a major portion of specialist consultations, dental consultations, and diagnostic services. Major problems in the system led to health reforms in the 1990s. New reform proposals include some specific steps concerning health technology, including standards for medical equipment based on quality, geographic distribution, sustainability, and cost-effectiveness. A new National Plan of Health Equipment was completed in 1998, aimed at improving the distribution of equipment. Despite reforms, healthcare expenditures continue to rise. There is general agreement that gains in efficiency could be made. This situation is beginning to encourage interest in health technology assessment (HTA) in Portugal, although these activities are not yet very developed. Recently, legislation requiring presentation of economic evaluations for new pharmaceutical products was enacted. Present plans also call for the creation in the future of a national agency for HTA.

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