The future of best investing in vaccines: The Health Technology Assessment approach

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作者：Giuseppe La Torre ; Chiara de Waure ; Giacomina Chiaradia ; Alice Mannocci ; Maria Lucia Specchia ; Nicola Nicolotti ; Walter Ricciardi
关键词：Health Technology Assessment ; Vaccines ; Decision-making process
刊名：Vaccine
出版年：2008
期刊代码：89_0264410x
类别：imm
出版时间：20 March 2008
卷：26
期：13
页码：1609-1610
文件大小：97 K

摘要

In the present paper legal aspects of Health Technology Assessment (HTA) reports will be discussed. German health care law and legal regulations constitute a framework for methods, assessment criteria and standards set by HTA. This HTA-specific legal framework comprises aspects of all legal fields in which HTA has been gaining importance. Among other things, these legal fields include the Social Code Book V, the guidelines of the Federal Joint Committee, regulations for health care providers, pharmaceutical and medical devices law, licensing of providers, criminal law and data protection regulations. Whether and when lawyers should be involved in an HTA project will in practice depend on the clarity and controversiality of the subject matter.

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European Journal of Cancer

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European Journal of Cancer, Volume 42, Issue 17, November 2006, Pages 2876-2880
Norman Waugh

Abstract

height:150%">Health technology assessment (HTA) poses three main questions: does it work? at what cost? is it worth it? Since funds for health care are always finite, it will not be possible to provide every form of care that may do some good for some people. Hard choices have to be made. HTA is a form of policy analysis that helps decide what to fund and what not to fund. Tensions arise mainly when a new intervention is clinically effective but not cost-effective, usually because the benefit is small and the cost high.

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Zeitschrift fur arztliche Fortbildung und Qualitat im G...

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g border=0 src="/scidirimg/jrn_nsub.gif" alt="You are not entitled to access the full text of this document" title="You are not entitled to access the full text of this document" width=12 height=14"> href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B8H18-4PGH831-1&_user=10&_coverDate=10%2F29%2F2007&_rdoc=1&_fmt=high&_orig=article&_cdi=42516&_sort=v&_docanchor=&view=c&_ct=1283&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=598c62f3c6eaffc458bdfe88e81fd8e9">Vom Nutzen der Nutzenbewertung: Die Prinzipien der evidenzbasierten Medizin und des Health Technology Assessments als Entscheidungsgrundlage des Gemeinsamen Bundesausschusses
Zeitschrift für ärztliche Fortbildung und Qualität im Gesundheitswesen - German Journal for Quality in Health Care, Volume 101, Issue 7, 29 October 2007, Pages 455-462
Hilke Bertelsmann, Dominik Roters, Dorothea Bronner

Abstract

height:150%"><h3 class="h3">Zusammenfassungh3>Mit der Einführung des NUB-Ausschusses im Jahre 1990 begann ein Paradigmenwechsel in der Arbeit des damaligen Bundesausschusses der Ärzte und Krankenkassen. Fortan stützte er und sein Nachfolgegremium Gemeinsamer Bundesausschuss (G-BA) sich nicht mehr (allein) auf den Sachverstand von Experten bei der Bewertung von neuen Untersuchungs- und Behandlungsmethoden, sondern begann sukzessive und systematisch die Methoden der evidenzbasierten Medizin als maßgebliche Grundlage für die Bewertung bei der Einführung von neuen Untersuchungs- und Behandlungsmethoden anzuwenden. Während zunächst nur Verfahren der ärztlichen – nicht-medikamentösen-Behandlung nach den Kriterien der evidenzbasierten Medizin (ebm) bewertet wurden, gilt dies inzwischen konsequent ebenso für die Bewertung neuer Heilmittel wie auch für psychotherapeutische Verfahren und Früherkennungsmaßnahmen, die als Leistung von der gesetzlichen Krankenversicherung erstattet werden sollen. Die vom G-BA angewandte Methodik entspricht dabei den internationalen Standards der ebm und des Health Technology Assessments (HTA) und ist in seiner Verfahrensordnung verbindlich niedergelegt. Es wird dargestellt, wie er im Einzelnen dabei vorgeht. Ein Blick über die Ländergrenzen macht deutlich, dass er mit dieser Arbeitsweise nicht allein steht.<h3 class="h3">Summaryh3>

In the former German Federal Committee of SHI (-accredited) Physicians and Health Insurance Funds (Bundesausschuss der Ärzte und Krankenkassen) a full paradigmatic change was initiated in 1990 by establishing the NUB Committee (NUB=New Methods of Diagnosis and Treatment).

The NUB committee and its successor, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA), extended the basis of their decision making process. In order to evaluate new methods of diagnosis and treatment, the methods of Evidence-based Medicine (EbM) were increasingly taken into account aiming to establish a readjusted set of criteria for the evaluation and introduction of new diagnostic and therapeutic methods.

In the beginning the criteria of Evidence-based Medicine (EBM) were applied to the methods of medical diagnosis and treatment only, but in the meantime have consistently been extended to also cover the evaluation of new physiotherapeutic therapies, psychotherapeutic treatments and measures of early diagnosis and screening, the costs of which are reimbursed by the statutory health insurance (SHI).

The methodology of the G-BA is in compliance with the international standards of EbM and Health Technology Assessment (HTA) and is the mandatory basis of its work, laid down in its code of procedure.

This article gives a detailed description of its mode of operation, reflecting in addition the work of similar institutions in other countries with often comparable modes of operation.

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The future of best investing in vaccines: The Health Technology Assessment approach

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