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.

scholarly journals Digi-HTA: Health technology assessment framework for digital healthcare services

2019 ◽  
Vol 11 (4) ◽  
Author(s):  
Jari Haverinen ◽  
Niina Keränen ◽  
Petra Falkenbach ◽  
Anna Maijala ◽  
Timo Kolehmainen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
State Of The Art ◽  
Health Technology ◽  
Healthcare Services ◽  
The State ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Digital Healthcare ◽  
And Robotics

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified. The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare. In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.

scholarly journals Health technology assessment in Finland

2009 ◽  
Vol 25 (S1) ◽  
pp. 102-107 ◽  
Author(s):  
Marjukka Mäkelä ◽  
Risto P. Roine
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Evidence Based ◽  
Policy Makers ◽  
Health Technologies ◽  
Based Medicine ◽  
Special Responsibility ◽  
Made In

Since the 1990s, health policy makers in Finland have been supportive of evidence-based medicine and approaches to implement its results. The Finnish Office for Health Technology Assessment (Finohta) has grown from a small start in 1995 to a medium-sized health technology assessment (HTA) agency, with special responsibility in providing assessments to underpin national policies in screening. External evaluations enhanced the rapid growth. In the Finnish environment, decision making on health technologies is extremely decentralized, so Finohta has developed some practical tools for implementing HTA findings. The Managed Uptake of Medical Methods program links the hospital districts to agree on introduction of technologies. The Ohtanen database provides Finnish-language summaries of major assessments made in other countries.

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.

INTRODUCTION OF INNOVATIVE MEDICAL DEVICES AT FRENCH UNIVERSITY HOSPITALS: AN OVERVIEW OF HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT INITIATIVES

2015 ◽  
Vol 31 (1-2) ◽  
pp. 12-18 ◽  
Author(s):  
Nicolas Martelli ◽  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Judith Pineau ◽  
Patrice Prognon ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Local Health ◽  
University Hospitals ◽  
Health Technologies ◽  
Management Processes

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.

scholarly journals Health Technology Assessment of the Medical Devices: A Case Study from the Czech Republic

2021 ◽  
Vol 14 (2) ◽  
pp. 253-272
Author(s):  
Jana Rozmarinová ◽  
Barbora Říhová
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Systematic Evaluation ◽  
The Czech Republic ◽  
Slowing Down

Abstract Health technology assessment (HTA) has become the systematic evaluation of health technology’s properties and effects that inform decision-makers. The implementation and expansion of HTA can contribute to slowing down burgeoning healthcare costs. In the Czech Republic, elements of HTA are quite standardly used in pharmacoeconomics, but questions arise on the use of HTA of medical devices. The theoretical framework developed is followed by a case study of the Czech Republic to assess whether the use of HTA of medical devices in the Czech Republic is implemented. This study uses publicly available resources, mainly public health acts and public notices related to HTA. We examined the institutionalisation of HTA for medical devices (HTA applied only at a selected area of medical devices) in the Czech Republic and compared Czech’s HTA principles of medical devices to the HTA Core Model. It was found that the HTA process used for medical devices is very limited in the Czech Republic. Our data show that HTA was officially established, but in reality, the medical devices have not been assessed following HTA principles.

VP83 How To Identify Technologies Eligible For Health Technology Assessment: A Bottom-Up Approach

2017 ◽  
Vol 33 (S1) ◽  
pp. 187-187
Author(s):  
Susanna Maltoni ◽  
Maria Domenica Camerlingo ◽  
Antonella Negro ◽  
Luigi Palestini ◽  
Giovanni Ragazzi ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Local Level ◽  
Health Technology ◽  
Decision Makers ◽  
Bottom Up ◽  
Health Technologies ◽  
Emilia Romagna Region ◽  
User Friendly

INTRODUCTION:Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.METHODS:To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.RESULTS:The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.CONCLUSIONS:The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.

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)

scholarly journals Estimating an EQ-5D-3L Value Set for Romania Using Time Trade-Off

2021 ◽  
Vol 18 (14) ◽  
pp. 7415
Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Process ◽  
Computer Assisted ◽  
Health State ◽  
Health States ◽  
Value Set ◽  
Health Technologies ◽  
Related Quality

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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