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

Author(s):  
Amy von Huben ◽  
Martin Howell ◽  
Joseph Carrello ◽  
Sarah Norris ◽  
Sally Wortley ◽  
...  

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.

2000 ◽  
Vol 16 (2) ◽  
pp. 449-458 ◽  
Author(s):  
Frank Ahern ◽  
Nessa O'Doherty

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual “development funding” have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory group on HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.


2013 ◽  
Vol 23 (2) ◽  
Author(s):  
Brynjar Fure ◽  
Vigdis Lauvrak ◽  
Helene Arentz-Hansen ◽  
Åse Skår ◽  
Sari Susanna Ormstad ◽  
...  

I Norge har vi siden slutten av 1990-tallet utført metodevurderinger om effekt av tiltak i helsetjenesten som støtte til beslutningstakere. Metodevurderingene ble frem til 2004 utført ved Senter for medisinsk metodevurdering, og deretter ved Nasjonalt kunnskapssenter for helsetjenesten, som i dag er landets nasjonale metodevurderingsorganisasjon. Metodevurderinger kan i prinsippet brukes som beslutningsstøtte på alle nivåer i helsetjenesten, men i praksis benyttes metodevurderinger først og fremst som en del av et kunnskapsbasert beslutningsgrunnlag på overordnet politisk eller administrativt nivå. Hovedhensikten med metodevurderinger er å bidra til at gode og nyttige metoder kommer raskt ut til pasientene. Med metoder menes alle tiltak som er aktuelle i helsetjenesten, både legemidler, medisinsk utstyr, prosedyrerelatert diagnostikk og behandling, screening og organisatoriske tiltak. Metodevurderingene sammenfatter først og fremst kunnskapsgrunnlaget om klinisk effekt og sikkerhet, men ofte inngår også en helseøkonomisk evaluering. Her benyttes en strikt og etterprøvbar metodikk utarbeidet av anerkjente og veletablerte internasjonale metodevurderingsmiljøer. Avhengig av hva slags metode det er snakk om, vurderes også andre aspekter, som for eksempel etiske, sosiale, organisatoriske eller juridiske konsekvenser av å innføre metoden. For å sikre metodevurderingenes relevans i de kliniske miljøene, inviteres vanligvis kliniske spesialister til å delta i arbeidet. Metodevurderingsorganisasjoner samarbeider i økende grad med søsterorganisasjoner i andre land, ikke bare rundt forskning og utvikling av metodikken som benyttes i metodevurderinger, men også ved å dele resultater fra metodevurderinger, og dermed unngå dobbeltarbeid. En metodevurdering oppsummerer utelukkende forskningsresultatene om en metode, og inneholder ingen anbefaling om hvorvidt metoden bør innføres i helsetjenesten. Fure B, Lauvrak V, Arentz-Hansen H, Skår Å, Ormstad SS, Vang VS, Frønsdal KB. Health Technology Assessment: Knowledge-based decision support at the superior level in the health services. Nor J Epidemiol 2013; 23 (2): 165-169. ENGLISH SUMMARY In Norway, Health Technology Assessment (HTA) has existed since the late 1990s as support for decision makers in the health services. Until 2004, HTA was performed at the Norwegian Centre for Health Technology Assessment and later at the Norwegian Knowledge Centre for the Health Services which is, today, the national HTA-organization in Norway. HTA may be used as decision support at all levels in the health services. However, in practice, HTA is mainly used as part of evidence-based decisions by politicians or health leaders. The main purpose of HTA is to contribute to rapid introduction of useful health technologies, for the benefit of the patients. HTA may be used for all types of health technologies, including pharmaceuticals, medical devices, diagnostic and therapeutic procedures, screening and organizational measures. In HTA-reports, the evidence regarding effect and safety of a technology is summarized, and, in most cases, also include a health economic evaluation. A strict and transparent methodology, developed by well-established international HTA-agencies, is used. Other aspects such as ethical, social, organizational or legal consequences of the technology may be evaluated, depending on the technology. In order to make HTA clinically relevant, clinical experts are usually invited to participate in the work. HTA-organizations, increasingly, collaborate with HTA-organizations in other countries, not only in order to develop the methodology of HTA, but also to share the results of HTA-reports, and, thus, avoid double work. An HTA-report summarizes the research results on a technology, and gives no advice regarding the decision that should be made about the introduction of the new technology.


2000 ◽  
Vol 16 (2) ◽  
pp. 347-381 ◽  
Author(s):  
Torben Jørgensen ◽  
Anne Hvenegaard ◽  
Finn Børlum Kristensen

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, co-ordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.


2007 ◽  
Vol 23 (2) ◽  
pp. 155-161 ◽  
Author(s):  
Henry Z. Borowski ◽  
Jon Brehaut ◽  
David Hailey

Objectives: The objective of this study was to develop and implement a decision-making process for public funding of health services that links policy areas with health technology assessment and input from interested parties.Methods: Health authorities, assessment organizations, and healthcare professionals were consulted as a follow-up to recommendations of an expert panel established by the Alberta government. The methods involved formulation of an eight-stage, collaborative process that incorporates identification through the health ministry of health technologies requiring review, assessment of the technologies using expert groups in Alberta, and consultation and formulation of advice within the ministry to inform ministerial funding decisions.Results: All components of the decision process have been put in place and have collaborated to provide advice to inform policy on provincial health services. Of nineteen technologies selected for review, five have been completed and decisions made: laparoscopic adjustable gastric banding, fetal fibronectin assay for premature labor, newborn screening for cystic fibrosis, newborn screening for inborn errors of metabolism, and gastric electrical stimulation. A further six reviews are in progress, and reviews of the remaining technologies are planned for 2007.Conclusions: Bridging the evidence-to-policy gap is more likely to succeed when the policy community is actively engaged and an explicit model is used to put health technology assessment into practice.


2017 ◽  
Vol 33 (S1) ◽  
pp. 213-214
Author(s):  
Raysa Martins ◽  
Jorge Barreto ◽  
Flavia Elias

INTRODUCTION:This paper is based on a narrative review to identify and describe approaches to incorporate ethical aspects in Health Technology Assessment (HTA). On the first decade HTA was being established as a new area of research, the social and ethical dimensions seemed to play an essential role. This perspective, centered on the social impact of technology contrasts with the current definition, which focuses on the technical conditions of technology, especially properties and effects. Some authors have discussed the obstacles to include the ethical dimension into this area to a large extent. Those authors were motivated by the perception that there are few sections explicitly dedicated to these dimensions in the evaluation reports.METHODS:We searched these scientific databases: Pubmed, Cochrane Library, Centre for Review and Dissemination (CRD), PDQ - Evidence and Virtual Health Library (VHL), and selected studies that presented procedures and methodologies for the inclusion of ethical analysis in HTA.RESULTS:A total of 308 articles were retrieved, nine of them were included. The identified methods were classified into four groups according to the parameters and procedures: (i) normative-based evaluation, (ii) case comparison-based evaluation; (iii) predefined questionnaire application-based evaluation and iv) debate and deliberation-based evaluation.The result showed a great diversity of approaches (1 - 3) for the inclusion of the ethical dimension in the evaluation studies of health technologies, which can even be used together. It is suggested that its use considers the characteristics and needs of each different application contexts.CONCLUSIONS:This work presented as methodological base of approaches for the integration of the ethical dimension in the HTA field. Nonetheless, the proposed approaches to the incorporation of philosophical field of ethics into the systematization and objectivity field of the HTA reveal a considerable approach diversity that is applied productively. Since it has been agreed that technology evaluation is contextual, different approaches would help to meet the needs for possible adjustment.


2021 ◽  
Vol 3 ◽  
Author(s):  
Kevin Yan ◽  
Chakrapani Balijepalli ◽  
Eric Druyts

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)


2021 ◽  
pp. 158-176

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.


2019 ◽  
Vol 35 (S1) ◽  
pp. 63-63
Author(s):  
Bence Takács ◽  
Gergő Merész

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.


Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  

Objective: To provide health-related quality of life (HRQoL) data to support health technology assessment (HTA) and reimbursement decisions in Romania, by developing a country-specific value set for the EQ-5D-3L questionnaire. Methods: We used the cTTO method to elicit health state values using a computer-assisted personal interviewing approach. Interviews were standardized following the most recent version of the EQ-VT protocol developed by the EuroQoL Foundation. Thirty EQ-5D-3L health states were randomly assigned to respondents in blocks of three. Econometric modeling was used to estimate values for all 243 states described by the EQ-5D-3L. Results: Data from 1556 non-institutionalized adults aged 18 years and older, selected from a national representative sample, were used to build the value set. All tested models were logically consistent; the final model chosen to generate the value set was an interval regression model. The predicted EQ-5D-3L values ranged from 0.969 to 0.399, and the relative importance of EQ-5D-3L dimensions was in the following order: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. Conclusions: These results can support reimbursement decisions and allow regional cross-country comparisons between health technologies. This study lays a stepping stone in the development of a health technology assessment process more driven by locally relevant data in Romania.


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