Health Technology Assessment

from Wikipedia, the free encyclopedia

Health Technology Assessment ( HTA ) or medical technology impact assessment refers to a process based on scientific evidence for the systematic evaluation of health technologies, procedures and aids, but also organizational structures in which medical services are provided. The evaluation itself has no temporal or dynamic aspects, but only comprises a description of time-invariant characteristics. The focus of the HTA is in particular the therapeutic added value that a health technology offers in comparison to other new or existing health technologies.

Criteria such as effectiveness, safety and costs are examined, taking into account social, legal and ethical aspects. The result of an HTA study is usually published as an HTA report. This should primarily serve as a decision-making aid for health policy issues. This includes, among other things, the adoption of innovations in the catalog of services of the statutory health insurance by the Federal Joint Committee (G-BA) .

History and development

The term technology assessment was first mentioned in the US Congress in 1965 and encompasses transportation, traffic, energy, nutrition, armaments and space travel. New medical developments always bring with them the need to extend these considerations and analyzes to the health sector, especially because financial resources are increasingly limited. Between 1970 and 1980, the first concepts for the evaluation of technologies in the healthcare sector emerged, mainly through case studies.

The first body that specifically dealt with technology assessments in health care was the Office of Technology Assessment (OTA), which was formed in the USA in 1972. Its task is to collect relevant data and to inform politicians. From the mid-1980s onwards, European governments also introduced such national programs - first in Sweden (1987) and the Netherlands (1988), and a little later in France (1990) and Great Britain (1991). (The US Congressional Office for Technology Assessment was closed by the then US government in 1995.)

In the years that followed, there was constant internationalization and networking of the HTA institutions. In 1985 the International Society of Technology Assessment in Health Care (ISTAHC) was founded as the most important forum for HTA questions. Since 2003, this specialist society has been called Health Technology Assessment International (HTAi) after it was founded. The International Network of Agencies for Health Technology Assessment (INAHTA) has been promoting international cooperation and the exchange of information between such institutions since 1993. Since then there has been a systematic standardization and further development of the methods, for example through book series with HTA reports and large bibliographies such as that of the Cochrane Collaboration .

In Germany, politics is significantly promoting HTA development. In 1994 the Office for Technology Assessment was founded at the German Bundestag . An HTA program was set up in 1995 as part of a funding initiative by the Federal Ministry of Health . In 2000, the German Institute for Documentation and Information (DIMDI, subordinate to the BMG) took over the German HTA program, which has also been anchored in SGB ​​V. The German Agency for Health Technology Assessment of DIMDI (DAHTA @ DIMDI) was founded for this purpose. As the newest institution related to HTA, the Institute for Quality and Efficiency in Health Care (IQWiG) has been developing reports on health policy problems and evaluations of evidence-based guidelines since 2004. Since the year 2000 there has also been a German professional association for HTA, the Association for the Promotion of Technology Assessment in Health Care (Health Technology Assessment)

Procedure in Germany

Goal setting

"The information provided in an HTA report about the possible effects of technologies and structures on health or health care ultimately serves to optimize the health system. The information about medical, economic and other aspects is intended to support health policy decisions in particular and indicate the need for action and decision-making. "

HTA processes

Various interest groups from the health sector and health policy participate in the implementation of HTA. In Germany there are or were essentially two institutions dealing with HTA reports. The German Institute for Medical Documentation and Information ( DIMDI ), here specifically the German Agency for Health Technology Assessment (DAHTA @ DIMDI), commissioned comprehensive reports on HTA until 2016. On the one hand, the Institute for Quality and Efficiency in Health Care (IQWiG) publishes reports on behalf of the Federal Joint Committee that cover individual aspects of health technology assessment. On the other hand, the legislator has given IQWiG 2015 in the Statutory Health Insurance Supply Strengthening Act (GKV-VSG) the task of developing a public proposal process for HTA topics, commissioning and publishing corresponding HTA reports. This has been happening since 2016 under the name "Topic Check Medicine".

Procedure for the DAHTA @ DIMDI

DIMDI diagram

"The DAHTA initiates, accompanies and publishes HTA reports in cooperation with the public (topic suggestions), the HTA Board of Trustees (topic selection) and the authors (topic processing). This takes place in a transparent and standardized process that closely follows internationally accepted developments in the HTA methodology is based. "

Anyone interested could suggest topics for potential HTA reports at DAHTA @ DIMDI, which were stored in a database provided for this purpose. The topics were submitted by different groups of people such as doctors, pharmacists, nursing staff, administrative staff or patients. They came from areas that concerned medical treatment, therapy, rehabilitation, nursing and other disciplines in the health sector.

The collected suggestions were prepared twice a year by DAHTA @ DIMDI for the HTA Board of Trustees (representatives from the decision-making bodies of the health system: G-BA, associations of statutory health insurance physicians, health insurance companies, insurance companies, etc.) and proposed for prioritization. For this purpose, so-called feasibility studies were carried out beforehand. These consisted of an introductory medical text in order to provide background knowledge; this was followed by a literature search in the most important medical databases according to established methods and with strict documentation to see whether there were enough publications on the topic. It was also checked whether the question was formulated in sufficient detail. The topics were then prioritized using the Delphi method , a statistical evaluation process for which the members of the Board of Trustees were interviewed several times in writing. They met in person to finally determine the topics from the database for which an HTA report should actually be created.

Then DAHTA @ DIMDI commissioned qualified scientists. The creation of an HTA report followed Standard Operating Procedures (SOP) in order to ensure high quality, transparency and verifiability of the individual work steps. The scientists assessed the technology after experimental effectiveness (Engl. "Efficacy" ) effectiveness under everyday conditions (Engl. "Effectiveness" ) and cost (Engl. "Efficiency" ) social, legal and ethical aspects in compliance. In addition, the HTA reports were subjected to an internal and external peer review process. The completed HTA reports are available free of charge. After completing an HTA report, an update could be made at any time upon request.

Procedure at IQWiG

Procedure "Topic Check Medicine" at IQWiG

IQWiG has been carrying out benefit assessments on behalf of the G-BA, and occasionally the Federal Ministry of Health, since 2004. Depending on the legal basis, question, development time and scope, a distinction is made between so-called reports, rapid reports, dossier assessments, cost-benefit assessments, potential assessments, etc. These reports cover fundamental aspects of health technology assessment (essentially medical benefits and harm at patient level), but are not so-called full HTA and are not presented in more detail below.

Since 2016, the follow-up project to DAHTA @ DIMDI with a new focus under the name “Topic Check Medicine” has been located at IQWiG. The legal basis is § 139b SGB ​​V, Paragraph 5, in which it was laid down in 2015 in the course of the Statutory Health Insurance Care Strengthening Act: “Insured persons and other interested individuals can suggest evaluations [...] of medical procedures and technologies at the institute. The institute is to select and process the proposals that are particularly important for patient care. "

Due to the criticism of the lack of practical relevance or the low effectiveness of earlier HTA processes, the procedure was designed in such a way that not only experts are able to submit topic proposals. The Medicine TopicCheck is specifically aimed at all citizens. You can use a suggestion form on the Internet to ask questions about various aspects of health care - such as preventive or rehabilitation measures, early detection, diagnostics or medical treatments. The institute then specifies the question in consultation with the proposer to such an extent that it can be answered with an HTA report.

All topics on which a scientific question can be formulated are included in the public list of topics. The legislator has excluded questions about the benefits of drugs for which there are other assessment methods, such as the early benefit assessment . The annual selection of topics for the HTA reports takes place in two stages. First of all, a selection committee, in which the citizen and patient perspective as well as the scientific perspective are represented, names a maximum of 15 of all topics proposed by a deadline, which it believes are suitable for the preparation of an HTA report. The so-called extended advisory board, in which the BMG and the organizations that make up the foundation board of the Foundation for Quality and Efficiency are represented, then discuss this preselection. IQWiG finally selects up to five of the topics.

Unlike the IQWiG assessments, the reports are not drawn up in the institute. Rather, after a public invitation to tender, it commissions external teams of scientists as authors, organizes a commenting procedure, acts as editor and writes a comment on the so-called basic report. In order to ensure the methodological quality, the authors orientate themselves on the IQWiG methodology

The HTA reports of the Thematic Check Medicine deal with an assessment of the benefit as well as health economic, ethical, social, legal and organizational aspects of the technology to be examined.

First of all, the authors set out the methodological procedure in a report. Relevant information is then searched for and the preliminary results are recorded in a so-called preliminary basic report, which goes into a public commenting process. Taking into account the arguments put forward, the authors write the final basic report. Together with an editor's comment, in which IQWiG classifies the work results from its point of view, this forms the HTA report. In addition, a generally understandable version ("HTA compact") will be created.

All documents are published on the website of the TopicCheck Medicine and sent to bodies and institutions of the health system.

Importance and benefits of HTA

Health policy

The aim of politics was to provide a scientific basis for political and legal decisions when setting up an HTA reporting database. Depending on the time frame, certain HTA reports can first be commissioned in order to then serve as a basis for decision-making. Due to the lengthy creation process, it becomes difficult to provide HTA reports if the political decision has to be made in a tight time frame. Unless a corresponding report is already available in the database.

In Denmark, where HTA reports have been carried out for a long time, the importance, benefits and possible abuse of HTA was discussed in a public meeting of the Parliament's Health Committee. Some impressions could be gained from this: HTA can be seen as a useful means of setting priorities, but one cannot expect a clear answer to every question. In addition, some politicians still demanded additional and objective advice.

Relevant laws in Germany

Statutory Health Insurance Reform Act 2000 - Art. 19: Law on an information system for evaluating medical technologies
This article transfers "the German Institute for Medical Documentation and Information (DIMDI) in Cologne the establishment and operation of a database-supported information system for the evaluation of the effectiveness and the costs of medical procedures and technologies".
§ 35a SGB ​​V - Evaluation of the benefit of drugs with new active ingredients
Section 35b SGB ​​V - Evaluation of the benefits and costs of drugs
This article deals with the commissioning of IQWiG to assess drugs according to their benefit and cost-benefit ratio and thus to provide the G-BA with a recommendation.
§ 137c SGB ​​V - Evaluation of examination and treatment methods in hospitals
This article enables examination and treatment methods in hospitals to be assessed by the G-BA from the point of view of whether this method is necessary for sufficient, appropriate and economical care for the insured. If this is not the case, a corresponding guideline can be issued so that the health insurance companies no longer have to finance this method.
§ 139a SGB ​​V - Institute for Quality and Efficiency in Health Care
This article describes the establishment and the tasks of the Institute for Quality and Efficiency in Health Care.
§ 139b SGB ​​V - Task execution
The basic steps involved in carrying out a task, from awarding to the result, are described.
Section 56a Rules of Procedure for the Bundestag - analysis of the consequences of technology
Describes the right of the Committee for Research, Technology and Technology Assessment to commission a technology impact analysis.

Service provider

Like health policy, HTA can serve as a kind of decision support or aid for the development of procedures for treating patients. However, HTA reports are often prepared under economic aspects. The consequence may be the deletion of a "technology" from the health insurance companies' catalog of services. This limits the range of treatment methods available to the service provider. Since every patient is an individual, there are certainly cases that respond positively to treatments, even though they are classified as ineffective and not cost-effective. HTA (and also EBM) lead to better planning and cost estimation, but abstract from individual individuals. Service providers are increasingly turning to checklists.

International

Over the past two decades, most industrialized countries have been increasingly concerned about rapid technological developments and escalating costs for the provision of health services. This fact also led to increased interest in the use of the HTA method for the assessment of medical technologies. Nowadays, HTA reports are written in almost all industrialized countries and used for the above purpose. The impact of these reports on health policy decisions varies from country to country, but the need for it has been widely recognized. Of the G7 countries, Canada, the United Kingdom and France appear to be the most organized countries in which HTA reporting is organized. There are a large number of HTA agencies in the UK available to provide advice to decision-makers and medical staff. In France, the HTA agency landscape is rather homogeneous. The few institutions responsible for HTA seem to have a major influence on political decisions.

EUnetHTA

Since 2006 the EU project EUnetHTA (European network for Health Technology Assessment) has been coordinating the HTA process in 27 European countries. The aim of this facility is to network regional and national HTA institutions, research facilities and health ministries in order to facilitate an effective exchange of information and support.

HTA in the UK

The National Institute for Health Research UK's (NIHR) HTA program aims to develop independent studies of the effectiveness of various healthcare treatments. Every year around 50 new studies are published in renowned specialist journals.

New topics for the HTA program are identified or suggested as follows:

  • External institutes and organizations that do not work directly with the NIHR can submit topic proposals. There are “arrangements” in this regard.
  • Every citizen can propose topics via an "open channel" on the Internet.
  • Proposals from the “National Specialist Commissioning Advisory Group”, “National Service Frameworks” and the “National Institute for Health” as well as “Clinical Excellence”.

The topics are evaluated three times a year by a committee. He can consult other experts for this. The result is a “panel paper”, a plan of how to proceed. A list of these reports is available on the NIHR website.

According to the "panel papers", research projects are initiated by the following committees:

  • The HTA Commissioning Board (HTACB)
  • The HTA Clinical Trials Assessment Board (HTACTAB)
  • HTA assessment boards for specific subject areas
  • The NIHR Methodology Panel

HTA in France

In order to improve the quality of the healthcare system, a number of different institutions have been set up in France since 1990, which, although they have to submit reports to the Ministry of Health, are responsible for their customers themselves.

The most important institution is HAS, Haute Autorité de Santé, which emerged from ANAES (Agence Nationale d'Accreditation et d'Evaluation en Santé). It is not a state authority, but an independent public institution with financial sovereignty. The aim of this agency is to optimize quality and safety by evaluating clinical practice and public health. The HTA reports are used for this purpose. HTA reports are also published by the Institut National de la Santé.

On the side of the private institutions, there are the following: Comité d'Évaluation et de Diffusion des Innovations Technologiques (CEDIT) of the hospitals in Paris, Société Française pour l'Évaluation des Soins et des Technologies Médicales (SOFESTEC).

As part of the cooperation in the database area with Germany, INSERM - Institut nationale de la Santé et de la Recherche médicale- dem DIMDI provides the French translation of the MeSH.

HTA in Austria

Building on the preliminary work of an HTA working group at the Institute for Technology Assessment of the Austrian Academy of Sciences in Vienna, the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) was founded in April 2006. The LBI-HTA has established itself as an independent instance of scientific decision support in the Austrian healthcare system.

HTA in Canada

The Canadian Agency for Drugs and Technologies in Health (CADTH), formerly the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), and the Institute of Health Economics (IHE) are the national HTA agencies in Canada. In addition, there have been several HTA institutions in the provinces since the late 1980s (for example: AETMIS - Agence d'Évaluation des Technologies et des Modes d'Intervention en Santé, MAS - Medical Advisory Secretariat) and in individual institutes (hospitals, universities ) across the country. Due to their regional restrictions, these agencies often only have an influence on the political decision-makers of the respective province or the institute. The topics of the reports are suggested by different groups of people. On the one hand by the representatives of the Canadian Ministry of Health in the agencies, on the other hand by political decision-makers or by the public.

HTA in the USA

In the USA, the United States Department of Health and Human Services oversees the implementation of health technology assessments in the context of the healthcare system . The Technology Assessment in the healthcare sector arose from the introduction of the Office of Technology Assessment introduced in the Congress.

In the United States, HTA reports are conducted by a wide variety of organizations. These include the supervisory authorities of the individual states, government and private sector clients, hospital associations and networks in the healthcare sector, academic health centers and much more

The following institutes of the American health authority "United States Department of Health and Human Services" are significantly involved in the initiation of HTA investigations:

Detailed information on the interests of the HTA in the USA is available from the NIH subordinate

Criticism and limits

HTA is too slow, too expensive and not goal-oriented as a control instrument.

HTA takes too long, and only technologies that are already in use are usually evaluated. Future technologies are not evaluated. However, there is already a change here and so-called short HTA reports are being prepared that evaluate new technologies. There are also considerations to integrate HTA in the development of innovations in order to be able to assess their potential at an early stage.

Studies as a basis for HTA

The results obtained mostly come from studies with selected patient groups and are carried out under standardized clinical conditions, which means that it is not always possible to generalize the results, as the everyday situation and the care context are insufficiently mapped and taken into account. In general, the knowledge gained from studies depends on the subject of the investigation, such as the scientific question and the quality of the study design. Another point is that the studies carried out are usually not carried out for the purpose of HTA, but aim to gain general scientific knowledge or to assess the risk-benefit ratio for approval . Because of this, it is not always easy to use the results for HTA.

Evidence is not evenly distributed (orphan diseases).

HTA reports arise from research reports, among other things, these in turn in various areas such as cancer research, diabetes research, etc. Since little research is carried out in some research areas, such as malaria and yellow fever, there are only a few technology assessments, so none HTA reports can be prepared.

Not a standard for HTA organizations

Each organization can prepare and publish HTA reports according to their own criteria. This means that different organizations can come to completely different results on a given topic.

Social and ethical aspects of HTA

In practice, the medical and economic evaluation of drugs and non-drug diagnostic and therapeutic methods often dominates. Social and ethical aspects, but also the effectiveness under everyday conditions, are often neglected. However, this is also due to the fact that in many cases at the time a technology is approved or introduced, an assessment using health technology assessment is difficult due to the data situation. At this point in time, data are often only available on efficacy , i.e. on effectiveness under study conditions.

See also

literature

  • U. Siebert, N. Mühlberger, C. Behrend et al: PSA screening in prostate cancer. Systematic health economic review. Development and application of a set of instruments for the systematic evaluation of health economic studies. 1st edition. NOMOS Verlagsgesellschaft, 2001, ISBN 3-7890-7165-X .
  • R. Leidl, JM Schulenburg, J. Wasem: Approaches and methods of economic evaluation . Nomos, 1999, ISBN 3-7890-6355-X .
  • M. Perleth: Evidence-Based Decision Support in Healthcare. Concepts and methods of the systematic evaluation of medical technologies (Health Technology Assessment) in Germany . WiKu-Verlag, Berlin 2003.
  • R. Busse et al: Best practice in undertaking and reporting HTA. In: Int J Technol Assess Health Care. 18 (2), 2002, pp. 321-422.
  • M. Perleth et al: Health Technology Assessment. Concepts, methods, practice for science and decision making. 2nd Edition. Medical Scientific Publishing Company, Berlin 2014, ISBN 978-3-941468-71-9 .

Journals

Web links

Individual evidence

  1. ↑  ( Page no longer available , search in web archives )  Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. (PDF).@1@ 2Template: Toter Link / www.versorgungsforschung.nrw.de  
  2. ↑ Development of Medical Technology: Opportunities for Assessment .
  3. ↑ tatup-journal.de .
  4. ↑ HTAi .
  5. ↑ INAHTA .
  6. ↑ a b egms.de .
  7. ↑ See https://www.dimdi.de/dynamic/de/weiter-fachdienste/health-technology-assessment/ and https://www.egms.de/dynamic/de/journals/hta/index.htm .
  8. ↑ a b Institute for Quality and Efficiency in Health Care, "Methods", Version 5.0, as of April 26, 2019
  9. ↑ Ulrich Siering, Sarah Thys, Lutz Altenhofen: The Topic Check Medicine: Citizens' orientation when collecting topics and selecting topics for HTA reports . In: Healthcare . 2018, ISSN  0941-3790 . doi : 10.1055 / a-0640-3183 .
  10. ↑ H. Sigmund, FB Kristensen: Does HTA help the health system and health policy? Experience from an established HTA institution - the Danish Center for Evaluation and HTA. In: Federal Health Gazette . 44, 9-2001, pp. 855-856.
  11. ↑ Federal Law Gazette
  12. ^ W. Stöber (DIMDI): Health Technology Assessment as a basis for evidence-based decision-making in health policy. In: Federal Health Gazette. 44, 9-2001, pp. 855-856.
  13. ^ K. Kargus, C. Roehrig: Health Technology Assessment in Canada and the G-7 Countries: A comparative analysis of the role of HTA agancies in the decision-making process. November 2003, p. 46. medicine.mcgill.ca (PDF)
  14. ↑ eunethta.eu .
  15. ^ The Principles Underlying the Work of the National Coordinating Center for Health Technology Assessment. ( Memento of December 11, 2007 in the Internet Archive ; PDF) ()
  16. ↑ has-sante.fr
  17. ^ K. Kargus, C. Roehrig: Health Technology Assessment in Canada and the G-7 Countries: A comparative analysis of the role of HTA agancies in the decision-making process.
  18. ↑ hta.lbg.ac.at .
  19. ↑ cadth, approx .
  20. ↑ ihe.ca .
  21. ↑  ( page no longer available , search in web archives ).@1@ 2Template: Dead Link / www.aetmis.gouv.qc.ca
  22. ^ Medical Advisory Secretariat. ( Memento from January 31, 2009 in the Internet Archive ) on: health.gov.on.ca
  23. ^ Service Through Research. ( Memento of January 12, 2008 in the Internet Archive ) bcbs.com
  24. ↑ hhs.gov .
  25. ^ Clifford S. Goodman: HTA 101: Introduction to Health Technology Assessment. January 2004. ( nlm.nih.gov ( memento of March 23, 2009 in the Internet Archive ))
  26. ↑ M. Perleth, D. Lühmann: Benefit and profitability assessment of biomedical technology Federal Health Gazette Health Research Health Protection . 53 (8), Aug 2010, pp. 825-830.
  27. ↑ An instrument makes no decisions! ( Memento from January 15, 2008 in the Internet Archive ). Criticism from Marcus Müllner, Head of AGES PharmMed
  28. ↑ J. Bamford et al .: Current practice, accuracy, effectiveness and cost-effectiveness of the school entry hearing screen . In: Health Technol Assess. 11 (32), Aug 2007, pp. 1-168, iii-iv, PMID 17683682 .
  29. ↑ A. Mason et al .: A systematic review of the effectiveness and cost-effectiveness of different models of community-based respite care for frail older people and their carers . In: Health Technol Assess. 11 (15), Apr 2007, pp. 1-157, iii, PMID 17459263 .