Веб-сайт Ассоциации LRC

Framework for describing and classifying decision-making systems using
technology assessment to determine the reimbursement of health technologies
(fourth hurdle systems)

International Journal of Technology Assessment in Health Care > Vol. 22
Issue 01 (Free full-text )
----------------------------------------------------------------------------

John Hutton , Clare McGrath , Jean-Marc Frybourg , Mike Tremblay
, Edward Bramley-Harker and Christopher Henshall

Abstract
http://journals.cambridge.org/action/displayIssue?jid=THC&volumeId=22&issueId=01#

Objectives: Australia, Canada, and many European countries now use various
forms of health technology assessment (HTA) in decision making regarding the
reimbursement of drugs and other health technologies. To achieve a better
understanding of the potential for use of HTA in this context, an analytical
framework was developed to describe and classify existing fourth hurdle
systems.

Methods: Based on a review of published literature, and official
documentation, the key aspects of a fourth hurdle system were identified at
two levels: policy implementation and individual technology decision.
Characteristics of the systems were grouped under four main headings:
constitution and governance, objectives, use of evidence and decision
processes, and accountability. The comprehensiveness and relevance of this
framework was assessed by an independent group of experts in HTA. A pilot
study was undertaken, using only published sources, to test the feasibility
of obtaining the information needed to complete the framework.

Results: The framework was found to be sufficiently broad to encompass all
the issues of interest regarding the systems, but the proportion of
information available from published sources was variable between sections
of the framework and between countries, with average availability of 45
percent.

Conclusions: The analytical framework will help researchers and
policy-makers in individual countries to understand their own systems and
will allow some preliminary sharing of experience between countries. More
experience of its application is needed to judge whether it will provide the
basis for more formal comparison of systems and whether it will determine
the appropriateness for particular decision contexts.

"The requirement to justify the reimbursement of pharmaceuticals by health
systems has been labeled “the fourth hurdle”, as it is perceived by
manufacturers to be an additional barrier to market access, after
demonstration of product quality, efficacy, and safety to obtain a product
license. Requirements for the licensing of other health technologies, such
as devices and surgical procedures, differ from those for drugs, so the term
“fourth hurdle” may not be strictly accurate in this context. However, it
has become an internationally recognized descriptive term, understood by all
stakeholders in the HTA field, so we shall apply it to all such systems in
the remainder of the study."