Details
| Translated title of the contribution | Health Technology Assessment (HTA) for medical devices - Do the same rules apply? |
|---|---|
| Original language | German |
| Pages (from-to) | 144-155 |
| Number of pages | 12 |
| Journal | Gesundheitsokonomie und Qualitatsmanagement |
| Volume | 14 |
| Issue number | 3 |
| Early online date | 25 Sept 2008 |
| Publication status | Published - Jun 2009 |
Abstract
Aim of this paper is to analyze whether medical devices can and should be assessed (as drugs) via a health technology assessment (HTA) approach meaning a methodologically standardized e. g. clinical and economic assessment. The discussion of specific issues relevant for the very heterogeneous field of medical devices compared to drugs results in the finding that there remain questions for the setting of the German health care system. For a large proportion of medical device products a formalized HTA approach aiming at giving health policy guidance on reimbursement decisions seems not feasible or not needed as other regulations or structures seem to work more efficient or are more adequate. Nevertheless, for some product groups HTA seems to offer valuable information, but the methodology of conducting such studies should be modified, as e. g. for some products randomized, controlled, double blinded trials are not possible due to methodological reasons. Hence, it should be further analyzed how existing and well established HTA methods could be modified in order to reflect specific product characteristics of some product groups. The main outcomes out of the theoretical analysis were transformed into a decision tree. With the help of that tree decision makers may analyse if for a specific product or product group a formal HTA makes sense. The latter term refers to whether a HTA is necessary from a clinical perspective, efficient from an economic perspective, and also if it is possible taking specific characteristics of the respective product into account. The decision tree was constructed to especially reflect the specific decision situation within the German health care system.
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In: Gesundheitsokonomie und Qualitatsmanagement, Vol. 14, No. 3, 06.2009, p. 144-155.
Research output: Contribution to journal › Review article › Research › peer review
}
TY - JOUR
T1 - Health Technology Assessment (HTA) im Bereich der Medizinprodukte
T2 - gleiches Spiel mit gleichen Regeln?
AU - Graf Von Der Schulenburg, J. Mathias
AU - Mittendorf, Thomas
AU - Kulp, W.
AU - Greiner, W.
PY - 2009/6
Y1 - 2009/6
N2 - Aim of this paper is to analyze whether medical devices can and should be assessed (as drugs) via a health technology assessment (HTA) approach meaning a methodologically standardized e. g. clinical and economic assessment. The discussion of specific issues relevant for the very heterogeneous field of medical devices compared to drugs results in the finding that there remain questions for the setting of the German health care system. For a large proportion of medical device products a formalized HTA approach aiming at giving health policy guidance on reimbursement decisions seems not feasible or not needed as other regulations or structures seem to work more efficient or are more adequate. Nevertheless, for some product groups HTA seems to offer valuable information, but the methodology of conducting such studies should be modified, as e. g. for some products randomized, controlled, double blinded trials are not possible due to methodological reasons. Hence, it should be further analyzed how existing and well established HTA methods could be modified in order to reflect specific product characteristics of some product groups. The main outcomes out of the theoretical analysis were transformed into a decision tree. With the help of that tree decision makers may analyse if for a specific product or product group a formal HTA makes sense. The latter term refers to whether a HTA is necessary from a clinical perspective, efficient from an economic perspective, and also if it is possible taking specific characteristics of the respective product into account. The decision tree was constructed to especially reflect the specific decision situation within the German health care system.
AB - Aim of this paper is to analyze whether medical devices can and should be assessed (as drugs) via a health technology assessment (HTA) approach meaning a methodologically standardized e. g. clinical and economic assessment. The discussion of specific issues relevant for the very heterogeneous field of medical devices compared to drugs results in the finding that there remain questions for the setting of the German health care system. For a large proportion of medical device products a formalized HTA approach aiming at giving health policy guidance on reimbursement decisions seems not feasible or not needed as other regulations or structures seem to work more efficient or are more adequate. Nevertheless, for some product groups HTA seems to offer valuable information, but the methodology of conducting such studies should be modified, as e. g. for some products randomized, controlled, double blinded trials are not possible due to methodological reasons. Hence, it should be further analyzed how existing and well established HTA methods could be modified in order to reflect specific product characteristics of some product groups. The main outcomes out of the theoretical analysis were transformed into a decision tree. With the help of that tree decision makers may analyse if for a specific product or product group a formal HTA makes sense. The latter term refers to whether a HTA is necessary from a clinical perspective, efficient from an economic perspective, and also if it is possible taking specific characteristics of the respective product into account. The decision tree was constructed to especially reflect the specific decision situation within the German health care system.
KW - Germany
KW - Health technology assessment
KW - Medical devices
UR - http://www.scopus.com/inward/record.url?scp=67649592503&partnerID=8YFLogxK
U2 - 10.1055/s-2008-1027813
DO - 10.1055/s-2008-1027813
M3 - Übersichtsarbeit
AN - SCOPUS:67649592503
VL - 14
SP - 144
EP - 155
JO - Gesundheitsokonomie und Qualitatsmanagement
JF - Gesundheitsokonomie und Qualitatsmanagement
SN - 1432-2625
IS - 3
ER -