Biomedical Engineering Reference
In-Depth Information
prices; it may also lead to welfare losses in the short- and the long-run by reducing
incentives for research-based firms to invest in R&D to develop innovative prod-
ucts. RP and restrictive formularies negatively affect the uptake and diffusion of
innovative medicines. RP, especially affects diffusion of “on-patent” medicines, by
forcing down their prices, thereby diminishing the incentive for research-led firms
to invest in R&D. Although RP can achieve short-term savings for drug budgets
these savings are not sustained, and health expenditure may actually increase — as
many patients whose medicines are switched to lower-cost substitutes because of
RP may stop their treatment and experience worsening health outcomes.
HTA is being used more widely in developed countries to aid priority setting
and to inform reimbursement decisions for new drugs and technologies. However,
few studies have rigorously examined the effect of HTA on the uptake and dif-
fusion of innovations. Long delays during the assessment of new and innovative
drugs restrict or excessively delay access to them. As HTA is applied very early
in a product's lifecycle, before there is an opportunity to use the drug in the target
population, it inadequately captures the benefits offered by those medicines and
creates a disadvantage for innovations whose benefits are delayed. This demon-
strates the risks of partial understanding of the innovation process in the life sci-
ences, as HTA functions as a cost-containment tool, rather than as a mechanism
used to increase adoption and diffusion of effective technologies, reducing oppor-
tunities for innovations. A recent pan-European study comparing patient access to
cancer drugs concluded that delays in health technology assessments (such those
undertaken by NICE) negatively affected patient care by further delaying the avail-
ability of licensed new innovative medicines (Wilking and Jonsson, 2005). There
are concerns that the recently established Institute for Quality and Efficiency in
Medical Care in Germany (Institut für Qualität und Wirtschaftlichkeit im Gesund-
heitswesen (IQWiG)) may lower the incentives to introduce innovations into the
German market and may act as a barrier to uptake of innovative medicines Both
IQWiG and NICE require cost-effectiveness analysis before a new innovation is
made available to patients (Von der Schulenberg, 2006). This approach has several
weaknesses as far as the innovation process is concerned: (1) the true benefit of
new drugs is often not apparent until long after their introduction, (2) reliance on
limited data from clinical trials and economic models to assess likely cost effec-
tiveness may be misleading, (3) a major element of drug innovation results from
clinical experience following the launch of the prototype of a new drug class, which
can not be foreseen or predicted, (4) HTA has the potential to impact not only on
the diffusion of a particular medicine but also the innovation process and financial
mechanisms that generated it as well as potential future innovations that may result
from post launch clinical experience of its use. This approach to HTA appears to
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