Given the increasing pressures on health care budgets, decision-makers are increasingly demanding evidence on the effectiveness and cost-effectiveness of medical technologies. Medical devices have considerable potential to deliver economic value for the health care sector, in increasing length and quality of life, producing savings in the use of other health care resources and facilitating changes in the organization of care. However, in a recent paper, Drummond et al outlined 6 reasons why the clinical and economic evaluation of medical devices posed greater challenges than the evaluation of drugs. First, some devices are diagnostic and the value of improved diagnosis cannot be separated from the value of the improvement, in patient outcome, resulting from the subsequent treatment. Secondly, it is more difficult to conduct randomized controlled trials of devices, because there are often product modifications and, for some devices, there is a ‘learning curve’ in their use. This links to the third reason why devices are different, in that the effectiveness of a device depends not only on the device itself, but how it is used. Thus, for a device used in surgery, the outcome can depend on the skill of the surgeon as much as the effectiveness of the device itself. Fourthly, the implementation of a new therapy involving a device can have wider economic implications, in training or in the provision of other facilities locally. Fifthly, the difficulties in obtaining equivalent clinical evidence may mean that there is a greater tendency to ‘generalize’ experience with similar devices, whereas there may be important differences between them, likely to affect outcome. Finally, whereas the prices of drugs tend to be set until they become generic, the prices of devices are more likely to change over time with the market entry of new products, or because of the way devices are procured in many healthcare systems. The purpose of this paper is to explore these issues further, calling for specific, innovative methodologies to assess medical devices, and using a case study of transcatheter aortic valve implantation (TAVI), a minimally invasive technique for the treatment of aortic stenosis, whereby an expandable prosthesis is inserted via a catheter and has been recently proven to be a highly effective and safe option for patients who would be otherwise inoperable. We will explore the implications for assessing medical devices based on the characteristics that differentiate devices from pharmaceuticals.

Challenges in the clinical and economic evaluation of medical devices: the case of transcathether aortic valve implantation

TARRICONE, ROSANNA;
2011

Abstract

Given the increasing pressures on health care budgets, decision-makers are increasingly demanding evidence on the effectiveness and cost-effectiveness of medical technologies. Medical devices have considerable potential to deliver economic value for the health care sector, in increasing length and quality of life, producing savings in the use of other health care resources and facilitating changes in the organization of care. However, in a recent paper, Drummond et al outlined 6 reasons why the clinical and economic evaluation of medical devices posed greater challenges than the evaluation of drugs. First, some devices are diagnostic and the value of improved diagnosis cannot be separated from the value of the improvement, in patient outcome, resulting from the subsequent treatment. Secondly, it is more difficult to conduct randomized controlled trials of devices, because there are often product modifications and, for some devices, there is a ‘learning curve’ in their use. This links to the third reason why devices are different, in that the effectiveness of a device depends not only on the device itself, but how it is used. Thus, for a device used in surgery, the outcome can depend on the skill of the surgeon as much as the effectiveness of the device itself. Fourthly, the implementation of a new therapy involving a device can have wider economic implications, in training or in the provision of other facilities locally. Fifthly, the difficulties in obtaining equivalent clinical evidence may mean that there is a greater tendency to ‘generalize’ experience with similar devices, whereas there may be important differences between them, likely to affect outcome. Finally, whereas the prices of drugs tend to be set until they become generic, the prices of devices are more likely to change over time with the market entry of new products, or because of the way devices are procured in many healthcare systems. The purpose of this paper is to explore these issues further, calling for specific, innovative methodologies to assess medical devices, and using a case study of transcatheter aortic valve implantation (TAVI), a minimally invasive technique for the treatment of aortic stenosis, whereby an expandable prosthesis is inserted via a catheter and has been recently proven to be a highly effective and safe option for patients who would be otherwise inoperable. We will explore the implications for assessing medical devices based on the characteristics that differentiate devices from pharmaceuticals.
2011
Tarricone, Rosanna; M., Drummond
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11565/3729011
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