Health Technology Assessment

Health Technology Assessment (HTA ) and medical technology assessment refers to a process for the systematic evaluation of medical technology, procedures, and tools, but also organizational structures in which medical services are provided. Examines this criteria such as efficacy, safety and cost, respectively, taking into account social, legal and ethical aspects. The result of an HTA study is usually published as an HTA report. This is primarily intended as a decision aid in health policy issues. This includes the adoption of innovations in the catalog of the statutory health insurance by the Federal Joint Committee (G -BA).

  • 3.1 Health policy 3.1.1 Relevant laws in Germany
  • 4.1 EUnetHTA
  • 4.2 HTA in the UK
  • 4.3 HTA in France
  • 4.4 HTA in Austria
  • 4.5 HTA in Canada
  • 4.6 HTA in the U.S.
  • 5.1 HTA is too slow as a management tool, too expensive and not goal-oriented.
  • 5.2 studies as a basis for HTA
  • 5.3 evidence is not evenly distributed ( orphan diseases ).
  • 5.4 No default for HTA organizations
  • 5.5 Social and ethical aspects of HTA

History and development

The term Technology Assessment ( Technology Assessment ) is mentioned in the U.S. Congress for the first time in 1965 and includes transportation, transport, energy, food, defense and aerospace. Always new medical developments bring with it a need to extend this reflection and analysis on the health sector, in particular because the financial resources are increasingly limited. Between 1970 and 1980 produced his first concepts for the evaluation of health technologies, especially by means of case studies.

The first committee that dealt specifically with technology assessment in health care, was the Office of Technology Assessment (OTA ), which is formed in 1972 in the United States. Its mission is the collection of relevant data and information for the politicians. First in Sweden (1987 ) and the Netherlands (1988 ), somewhat later in France (1990 ) and Great Britain (1991 ) - From the mid- 1980s, European governments also perform such national programs a. ( The U.S. Congressional Office of Technology Assessment was closed in 1995 by the then U.S. government. )

In the following years a steady internationalization and networking of HTA bodies takes place. In 1985, the International Society of Technology Assessment in Health Care ( ISTAHC ) is established as the principal forum for HTA questions. Since 2003, this specialist company is called after a start-up Health Technology Assessment International, The International Network of Agencies for Health Technology Assessment promotes since 1993, international cooperation and information exchange such devices. Since then, a systematic standardization and development of methods for example, by book series with HTA reports and bibliographies large as that of the Cochrane Collaboration.

In Germany, the policy encourages the HTA development considerably. In 1994, the Office of Technology Assessment at the German Bundestag was established. As part of a funding initiative of the Federal Ministry of Health an HTA Programme was set up in 1995. 2000 took over the German Institute for Documentation and Information ( DIMDI, the BMG downstream of ) the German HTA program, which has been enshrined in the SGB V. To this end, the German Agency for Health Technology Assessment of DIMDI ( DAHTA @ DIMDI) was founded. As the newest equipment with respect to HTA developed the Institute for Quality and Efficiency in Health Care ( IQWiG) since 2004 opinion on health policy issues and reviews of evidence-based guidelines. Since 2000, a German professional association for HTA, the Association for the Advancement of Technology Assessment in Health Care ( Health Technology Assessment ) exists eV.

Procedure in Germany

Objective

" The data contained in an HTA report information on possible effects of technologies and structures on the health and health care are ultimately used for the optimization of health care. The information on medical, economic and other aspects to support particular health policy decisions and identify actions and decisions required. "

HTA processes

In the implementation of HTA participate a variety of stakeholders in the health care and health policy. In Germany there are two main institutions dealing with HTA reports. The German Institute for Documentation and Information ( DIMDI), here specifically the German Agency for Health Technology Assessment (DAHTA @ DIMDI), commissioned comprehensive reports on HTA. The Institute for Quality and Efficiency in Health Care ( IQWiG) published in the Federal Joint Committee G -BA reports which, although not specifically designated as HTA reports, however, aspects of the Health Technology Assessment are covered here.

Procedure for DAHTA @ DIMDI

" The DAHTA initiated, supported and published HTA reports in collaboration with the public ( suggested topics ), the Board of Trustees HTA ( topic selection ) and the authors ( themes editing). This is done in a transparent and standardized process, which closely follows internationally accepted developments in the HTA methodology inspired. "

A HTA cycle always starts with finding a topic. Anyone interested can suggest topics for potential HTA reports in DAHTA @ DIMDI that are stored in a dedicated database. The topics submitted by different groups of people such as doctors, pharmacists, nurses, administrative staff or patients. They come from different areas that affect medical treatment, therapy, rehabilitation, nursing and other disciplines in the healthcare sector.

The proposals will be collected ( representatives from the decision-making bodies of health care: G -BA, physicians' associations, health insurance, insurance, etc. ) twice a year by the Board of Trustees for DAHTA @ DIMDI HTA prepared and proposed for prioritization. So-called feasibility analyzes are carried out previously. These consist of introduction of a medical text to give appropriate background knowledge; thereafter a literature search in major medical databases is done according to established methods and strict documentation to see if there are enough publications on the subject. In addition, it is checked whether the question was taken in enough detail. The subjects are then (special statistical evaluation procedures ) prioritized using the Delphi method, in which the members of the board of trustees are repeatedly questioned writing. For the final determination issues they meet in person. As a result of this process, the topics have been chosen from the database, for then indeed an HTA report is created.

This DAHTA @ DIMDI commissioned qualified scientists. The creation of an HTA report follows Standard Operating Procedures ( SOP). A high quality, transparency and verifiability of the individual steps is guaranteed. Scientists evaluate the technology after experimental effectiveness ( engl. " efficacy "), effectiveness under everyday conditions ( engl. " effectiveness ") and cost ( engl. " efficiency ") with respect to social, legal and ethical aspects. In addition, HTA reports are subjected to internal and external peer -review process. Completed HTA reports are available free of charge. Once an HTA report may, on application at any time an update done.

Procedure for IQWiG

The contract for a IQWiG report made ​​by the G -BA or the Federal Ministry of Health. The job is concretized in consultation with the client. This coarse objective criteria are defined and optionally included with expert opinions. In order to determine patient-related outcome measures recommended to regularly affected, patient advocacy and / or consumer organizations to be consulted and involved during the process.

In the next step, a report plan is created. It includes, for example, the definition and determination of the precise research question, including the objective criteria, inclusion and exclusion criteria for the benefit assessment information to be used or a statement of the project-specific methodology of collecting and assessing this information. In addition, a schedule will be maintained for the publication of the final report.

In this preparation, external experts may be consulted. If the report plan is completed it will be submitted to the Steering Committee for an internal review. He will then be forwarded and published the principal and the board of trustees.

Within the next four weeks written comments to be obtained on the report plan. This process is called hearing. Here, information on the inclusion and exclusion criteria are particularly important. If the hearing consider changes after themselves, they will be recorded and published in a Amendment. Only when these steps are performed, the information procurement and scientific assessments of the technology begins.

The results are recorded in the preliminary report. Also external experts can develop parts of the preliminary report. The preliminary report is again presented to the Steering Committee for internal review and forwarded to external experts, the principal and the board of trustees. In addition, this will also be published on the Internet.

Similar to the report plan also here a hearing shall be conducted on the preliminary report. Here existing Amendments are also taken into account may already be.

, The subsequent final report based on the preliminary report and includes the " assessment of the scientific evidence and taking into account the results of the written hearing ". It represents the end of the order processing and is also the control panel for internal review submitted.

Should new unrecognized studies are identified that meet the inclusion criteria, they can be evaluated and under circumstances, an update ( new commission by the contracting authority ) may be initiated.

HTA reports

Since 1999, the G -BA publishes the results found in the process as a "Summary Documentation ". Here it support the Institute's Director. External HTA reports play in Germany only a minor role, but may be the subject of the G -BA- advisory procedure. In general, possess the " Summary Documentation " following structure:

  • Summary / Abstract
  • Legal / public health background
  • Scientific Introduction
  • Research questions
  • Methodology of the evaluation process
  • Results
  • Discussion
  • Conclusion and recommendation for a resolution / Conclusions / Outlook
  • Attachments

Importance and benefits of HTA

Health policy

The aim of the policy was to provide a scientific basis for policy and legislative decisions in building an HTA report database. Depending on the time frame specified HTA reports may be initially commissioned to then serve as a basis for decision. Due to the lengthy preparation process, it is difficult to provide HTA reports available if the political decision has to be made in a narrow time frame. Unless a corresponding report is already available in the database.

In Denmark, where already long time HTA reports are carried out, the importance of the benefits and the potential misuse of HTA was discussed at a public meeting of the Health Committee of the Parliament. From this impression could win: HTA can be seen as a viable means for setting priorities, but you can not expect a clear answer on every question. In addition, politicians called partially still additional and objective advice.

Relevant laws in Germany

Providers

HTA can serve as a kind of decision support or assistance to the development of procedures for the treatment of patients to providers like health policy. However, HTA reports are often created under economic aspects. Sequence can be under certain circumstances to remove a "technology" from the catalog of health insurance. This limits the range of treatment methods for the health care provider. Since each patient is an individual, there are cases which respond well to treatment, although these are classified as not effective and not cost effective. HTA (and EBM) lead to better planning and cost estimation, but abstract from single individuals. Service providers are increasingly becoming agents of checklists.

Internationally

Over the past two decades, most industrialized countries have been increasingly concerned about the rapid pace of technological development and the escalation of costs for the provision of healthcare services. This fact led to an increasing interest in the application of the HTA method for assessing the medical technologies. Today, HTA reports are written almost in all industrialized countries and used for the above purpose. The impact of these reports on the political decisions in health care varies from country to country, but the necessity of this approach was recognized everywhere. Of the G -7 countries Canada, United Kingdom and France appear to be those countries where the production of HTA reports is best organized (see). In the UK, a large number of HTA agencies exists that are available to decision makers and the medical staff for advice. In France, the HTA agency landscape is rather homogeneous. The few institutions responsible for HTA, however, seem to have a large influence on political decisions.

EUnetHTA

Since 2006, the EU project EUnetHTA (European network for Health Technology Assessment ) coordinates the HTA process in 27 European countries. The objective of this research is the networking of regional and national HTA institutions, research institutions and health ministries to facilitate an effective exchange of information and support.

HTA in the UK

The aim of the HTA program of the National Institute for Health Research UK ( NIHR ) is to develop independent studies on the efficacy of different treatments in healthcare. Each year, approximately 50 new studies are published in peer-reviewed journals.

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

  • External institutions and organizations that do not work directly with the NIHR may submit suggestions for topics. There exist in this " arrangements".
  • Every citizen may propose topics about an "open channel" on the Internet.
  • Proposals of the " National Specialist Commissioning Advisory Group ", "National Service Frameworks" and the " National Institute for Health" and " Clinical Excellence ".

The topics are evaluated by a committee of three times a year. He may in this case lead to further expert. The result is a " panel paper", a plan of how to proceed. A list of these reports is available on the homepage of the NIHR.

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 topics
  • The NIHR Methodology Panel

HTA in France

To increase the quality of care, a number of different institutions were established in France since 1990, although they have to take the Ministry of Health reports, but are responsible for your customer.

The most important institution is the HAS, Haute Autorité de Santé, which from ANAES (Agence Nationale d' Accreditation et d' Evaluation en Santé ) has emerged. It is not a government agency, but an independent public institution with financial autonomy. The purpose of this authority is to optimize the quality and safety through evaluation in the area of clinical practice and population health. To this end it uses also the instrument of HTA reports. Furthermore, published HTA reports also from the Institut National de la Santé.

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

Within the framework of cooperation in the database area with Germany provides INSERM - Institut National de la Santé et de la Recherche médicale - DIMDI the French translation of MeSH available.

HTA in Austria

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

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 ), the national HTA agencies in Canada. In addition, since the late 1980s, there are several HTA institutions in the provinces (for example: AETMIS - Agence d' Évaluation of Technologies et des Modes d'Intervention en Santé, MAS - Medical Advisory Secretariat ) and in individual institutions ( hospitals, universities ) of the whole country. These agencies have their regional restriction often only influence the political decision makers in the province or the institute. The topics of the reports will be proposed by various groups of people. For one of the representatives of the Canadian Ministry of Health in the agencies, on the other hand by policy makers or by the public.

HTA in the U.S.

In the U.S., the implementation of health technology assessments in the context of health care is supported by the "United States Department of Health and Human Services." Sprung the Technology Assessment in Health Care is through the introduction of the introduced in Congress Office of Technology Assessment.

HTA in the U.S. reports are carried out by a plurality of organizations. These include, inter alia, the supervisory authorities of the individual states, clients from government and the private sector, hospital groups and networks in health care, academic health centers, etc.

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

  • AHRQ Agency for Healthcare Research and Quality
  • CMS Centers for Medicare & Medicaid Services
  • NIH National Institute of Health (The Nation 's Medical Research Agency)

Detailed information about the needs of HTA in the U.S. are on deemed the NIH

  • National Library of Medicine or the
  • National Information Center on Health Services Research and Health Care Technology ( NICHSR ) refer to.

Criticisms and limitations

HTA is too slow as a management tool, too expensive and not goal-oriented.

HTA takes too long and there are usually only rated technologies that are already used. Future technologies are not evaluated. Here it comes, however, have a break and there are so-called short - HTA reports prepared, evaluate what new technologies. There are also considerations to integrate HTA in the development of innovations to so early estimate their potential.

Studies as a basis for HTA

Where studies of the basis for HTA, the knowledge gained is dependent on the object of investigation, such as a scientific hypothesis, a scientific question, and the quality of the study design. Another point is that studies are generally not performed for the purpose of decision-making, but have a scientific background. For this reason, it is not always easy to use the results of HTA. In addition, the results obtained mostly from studies with selected patient clientele and are performed under standardized clinical conditions, which is a generalization of the results is not always possible because the everyday situation and the health care setting are inadequately represented and taken into account.

Evidence is not evenly distributed ( orphan diseases ).

HTA reports arise among others from research reports, which in turn in different areas such as cancer research, diabetes research, etc. As in many research fields, such as malaria and yellow fever, little research effort is being made, there are only a few technology reviews so that no HTA reports can be produced.

No standard for HTA organizations

Each organization can make HTA reports according to their own criteria and publish. This allows different organizations to come on a subject to completely different results.

Social and ethical aspects of HTA

In practice, often dominates the medical and economic evaluation of medicines and non-drug diagnostic and therapeutic methods. Social and ethical aspects, but also the effectiveness under everyday conditions are often ignored. This is however also that in many cases the time of admission or introduction of a technology assessment by Health Technology Assessment is difficult because of data availability. At this time often are only data for Efficacy, so the efficacy under study conditions, before.

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