scholarly journals The Impact of Digital Therapeutics on Current Health Technology Assessment Frameworks

2021 ◽  
Vol 3 ◽  
Author(s):  
Kevin Yan ◽  
Chakrapani Balijepalli ◽  
Eric Druyts
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Health Technologies ◽  
Current Health ◽  
Recent Emergence ◽  
Economic Analyses ◽  
The Impact

Historically healthcare has been delivered offline (e.g., physician consultations, mental health counseling services). It is widely understood that healthcare lags behind other industries (e.g., financial, transportation) whom have already incorporated digital technologies in their workflow. However, this is changing with the recent emergence of digital therapeutics (DTx) helping to bring healthcare services online. To promote adoption, healthcare providers need to be educated regarding the digital therapy to allow for proper prescribing. But of equal importance is affordability and many countries rely on reimbursement support from the government and insurance agencies. Here we briefly explore how national reimbursement agencies or non-profits across six countries (Canada, United States of America, United Kingdom, Germany, France, Australia) handle DTx submissions and describe the potential impact of digital therapeutics on current health technology assessment (HTA) frameworks. A targeted review to identify HTA submissions and guidelines from national reimbursement agencies or non-profits was conducted. We reviewed guidelines from the Institute for Clinical and Economic Review (ICER) in the USA, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK), the Institute for Quality and Efficiency in Health Care (IQWIG) in Germany, Haute Autorité de Santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia. Our review identified one set of guidelines developed by NICE in the UK. The guidelines by NICE outlined an evidence standards framework for digital health technologies (DHT). Depending on the organizational impact, financial commitment, and economic risk for the payer, different economic analyses are required. Economic analyses levels are separated into 3 categories, basic, low financial commitment, and high financial commitment. All economic analyses levels require a budget impact analysis. A cost-utility analysis is recommended for DHTs categorized in the high financial commitment category. Whereas, for DHTs that are in the low financial commitment category, a cost-consequence analysis is typically recommended. No HTA guidelines for DTx submissions were identified for the remaining countries (Canada, USA, Germany, France, and Australia)

Application of a health technology assessment framework to digital health technologies that manage chronic disease: a systematic review

2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Amy von Huben ◽  
Martin Howell ◽  
Joseph Carrello ◽  
Sarah Norris ◽  
Sally Wortley ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Health Services ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Investment Decisions ◽  
Health Technology ◽  
Cochrane Library ◽  
Primary Research ◽  
Health Technologies

Abstract Background As health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown. Objectives To summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA. Methods Medline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed. Results A total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains. Conclusions Although DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.

Perspectives on the National Institute for Health and Clinical Excellence's recommendations to use health technologies only in research

2009 ◽  
Vol 25 (03) ◽  
pp. 272-280 ◽  
Author(s):  
Irfan A. Dhalla ◽  
Sarah Garner ◽  
Kalipso Chalkidou ◽  
Peter Littlejohns
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Workshop ◽  
Health Technology ◽  
The United States ◽  
Computer Assisted ◽  
Semistructured Interview ◽  
Ongoing Research ◽  
Health Technologies

Background:The concept of using public funds to pay for healthcare interventions only when provided in the context of ongoing research is receiving increasing attention worldwide. Nevertheless, these decisions are often controversial and implementation can be problematic.Objectives:The aim of this study was to investigate the views of United Kingdom stakeholders on the current arrangements for implementing “only in research” (OIR) decisions and to investigate how improvements might be made.Methods:After an internal review of previous OIR decisions issued by the National Institute for Health and Clinical Excellence (NICE), deliberations by NICE's Citizens Council, and an international workshop convened by NICE and the United States Agency for Healthcare Research and Quality, thirteen key stakeholders and experts from academia, industry, government, and the National Health Service (NHS) were interviewed using a semistructured interview guide. Interview transcripts were subjected to a framework-based analysis using computer-assisted qualitative data analysis software.Results:All interviewees endorsed the use of the OIR option. There was a high degree of consensus for several suggestions regarding how the use of the OIR option might be improved. For example, there was universal agreement that a formal process should be established to prioritize research needs arising from OIR decisions and that funds for publicly funded research projects should be channeled in a manner that would better motivate healthcare providers to participate in OIR-related research.Conclusions:The findings of this study suggest several potential modifications of the OIR pathway in the United Kingdom and may also be helpful to health technology assessment agencies in other countries that already use or are considering using an OIR-like option to reduce the uncertainty inherent in health technology assessment.

Integration of health technology assessment recommendations into organizational and clinical practice: A case study in Catalonia

2006 ◽  
Vol 22 (2) ◽  
pp. 169-176 ◽  
Author(s):  
Marie-Pierre Gagnon ◽  
Emília Sánchez ◽  
Joan M. V. Pons
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Complex Dynamics ◽  
Scientific Evidence ◽  
Health Technology ◽  
Health Technologies ◽  
The Impact ◽  
Support Decision Making

Objectives:Evaluating the impact of recommendations based upon health technology assessment (HTA) represents a challenge for both HTA agencies and healthcare policy makers. This research sought to understand factors affecting the uptake of HTA recommendations to support decision making with respect to the introduction of three health technologies.Methods:Using a multidimensional framework, based upon a combination of theoretical models, a case study was conducted. A total of twenty-eight semistructured interviews were done with physicians from fifteen hospitals and other stakeholders in Catalonia. Interview content was analyzed iteratively and classified according to theoretical dimensions and contextual factors.Results:At the sociopolitical level, factors related to the organization and financing of the health system were found to affect the utilization of HTA recommendations. At the healthcare organization level, existing collaborations between the hospital and the HTA agency favored the integration of recommendations into practices. Formalism in the organization also influenced the utilization of HTA recommendations. At the professional level, the high degree of autonomy of specialists, the importance of peers and collegial control, and the definition of professional roles and responsibilities influenced physicians' willingness to integrate HTA recommendations into their practice.Conclusions:This study offers a comprehensive framework to understand the complex dynamics that affect adoption of health technologies in organizational and professional practices. The findings suggest some avenues to promote the integration of HTA recommendations into practices and, thus, increase the utilization of scientific evidence to support decision making in health care.

OP314 What Happened Next? Assessing Health Technology Assessment Impact In Scotland

2021 ◽  
Vol 37 (S1) ◽  
pp. 12-12
Author(s):  
Jess Kandulu
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Major Influence ◽  
International Network ◽  
Health Technologies ◽  
Four Levels ◽  
The Impact

IntroductionThe Scottish Health Technologies Group (SHTG) set out to assess the impact of HTA products. Two questions were posed: Does advice from SHTG have influence? How is SHTG advice used?MethodsSHTG adapted a tool developed by the International Network of Agencies for Health Technology Assessment (INAHTA). The INAHTA framework investigates indications of impact and categorizes outputs into levels of impact. Over three years, potential users of SHTG advice were contacted six to twelve months after advice was published and asked how the advice had been used. HTA outputs were categorized into the four levels of influence they achieved: ‘major influence’, ‘some influence’, ‘some consideration’ and ‘no known influence’.ResultsHTA products were found to have been used in four main ways: ‘informed discussion’, ‘referenced’, ‘informed policy’ or ‘directly informed practice’. Levels of influence had steadily increased over the three years assessed. The findings were well received by internal audiences, with particular interest in the various ways HTA recommendations had been used. There was also feedback about ‘marking our own homework’. These results have informed a new SHTG strategy and supported clear messaging around the value of HTA.ConclusionsSHTG has found a pragmatic, resource-light way to explore the impact of HTA outputs, which has proved valuable for driving strategy and messaging.

Health Technology Assessment: Current Issues Impacting on the Regulatory and Legal Framework

2021 ◽  
pp. 158-176
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Legal Framework ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Based Medicine ◽  
Significant Milestone

6This chapter reviews how new or innovative pharmaceuticals, medical devices, diagnostics, and digital health technologies are appraised for their clinical and cost effectiveness by the National Institute for Health and Care Excellence. It gives context on the processes and considerations in following the regulation of medical devices and medicines. It also refers to the Health Technology Assessment (HTA) as a branch of policy that aims at examining and rationally optimising the value of measures to improve healthcare and prevent ill health. The chapter defines the HTA as a systematic evaluation of the properties and effects of a health technology. It recounts the beginnings of health technology that go back to the dawn of evidence-based medicine, in which the randomised comparative experiments of naval surgeon James Lind on scurvy in the eighteenth century were a significant milestone.

PP135 Setting The Scope For Assessing e-Health Technologies In Hungary

2019 ◽  
Vol 35 (S1) ◽  
pp. 63-63
Author(s):  
Bence Takács ◽  
Gergő Merész
Keyword(s):  
Literature Review ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Digital Health ◽  
Public Funding ◽  
Health Technology ◽  
Current Status ◽  
Health Technologies ◽  
Assessment Approach

IntroductionE-health and m-health are emerging health technology fields that could possibly give a new scope to health technology assessment (HTA). The Division for Health Technology Assessment (DfHTA) is currently assessing medicines and non-drug technologies (medical devices intended for patient use or for use in hospitals). The experience assessing medical devices for use in hospitals yielded difficulties which could also arise from the critical appraisal of e-health or m-health technologies. The objective of this study was to explore the foundations for HTA guidance on e-health or m-health technologies.MethodsA targeted literature review was conducted to map the current status of technology assessment practices for e-health and m-health technologies and to assess its concordance with current reimbursement processes in countries belonging to the Organisation for Economic Co-operation and Development. Experiences from past evaluations of other medical devices that could not be evaluated under the current guidance guided the literature search. The findings of this research were used to create a recommendation to amend the current Hungarian Guideline for Health Economic Analyses.ResultsThe resulting articles of the targeted literature review provided an insight into current practices on of assessing e-health and m-health products, particularly with respect to the domains of safety, quality, and impact. Recommendations suggested including a list of requirements for companies to submit for critical evaluations of e-health and m-health technologies, in support of a self-assessment approach.ConclusionsAs for other HTA bodies, there is an urgent need for the DfHTA to increase its capacity to assess digital health technologies for entry into the healthcare system, with a focus on the relevant clinical domains. The reimbursement process for these technologies remains a challenge for public funding bodies.

PP020 Decision-Making Beyond Evidence Alone – Topic Prioritization For Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 77-78
Author(s):  
Hong Ju ◽  
Kwong Ng ◽  
Elaine Teo ◽  
Daphne Khoo
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Budget Impact ◽  
Policy Decision ◽  
Health Technology ◽  
Left Ventricular ◽  
Health Technologies ◽  
Potential Impact ◽  
The Impact

INTRODUCTION:The number of health technologies needing evaluation far outweighs available resources, and most Health Technology Assessment (HTA) agencies use criteria-based frameworks for topic prioritization (1,2). Despite variability, most frameworks include clinical, economic and budget impact. Some limitations of current frameworks lack mentioning of any explicit political/ethical deliberation and an evaluation on the potential impact of the HTAs (1).METHODS:During a topic prioritization for HTA, Left Ventricular Assist Device (LVAD) as destination therapy for adults with end-stage heart failure was submitted. The prioritization criteria used were largely in line with those described above. We also included criteria on ethical/equity consideration and the potential impact of an HTA on decision making. A literature search was conducted to gather clinical and economic evidence on LVAD for the target population, supplemented by local data on potential need for and budget impact of providing a LVAD service.RESULTS:LVAD was scored high on clinical, economic and budget impact with a moderately high need, which would generally subject it to an HTA in order to inform a policy decision. However LVAD was also considered as a technology with a high impact on ethical and political grounds, given that it is a technology offering survival and quality-of-life benefits for a small group of patients for whom effective treatment is otherwise lacking. Through deliberation, the prioritization panel concluded that the impact of an HTA would be low, as a policy decision on whether a LVAD program should be funded would go beyond evidence. Therefore an HTA was not recommended for LVAD.CONCLUSIONS:To inform decision making, an evaluation on the potential impact of the HTA itself taking into account of the ethical/political consideration of funding a technology is of equal importance as the evidence alone. Subsequently, limited HTA resources can be reserved for technologies where an HTA can truly make a difference.

Development of a health technology assessment module for evaluating mobile medical applications

2020 ◽  
Vol 36 (3) ◽  
pp. 252-261
Author(s):  
Magdalena Ruth Moshi ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Medical Applications ◽  
Medical Practitioners ◽  
Software Updates ◽  
Evaluation Module ◽  
Application Developers ◽  
The Impact

ObjectiveThe aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes.MethodsIn-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs.ResultsStakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians.ConclusionAn MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.

scholarly journals Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Surrogate Endpoint ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
Patient Centered ◽  
Statistical Validation ◽  
Level Of Evidence ◽  
The Impact

Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.

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