properly defined.^49 Analysis of the social value of innovative technologies will
enable proper assessment of social costs, answering the question of whether a
particular innovative activity is actually worth its social cost since not all innova-
tion is valuable or its social cost acceptable. This effort will likely prove crucial for
the further development of personalized medicine products, and economic evalua-
tions can be a great asset in demonstrating the social value and creating a frame-
work for adequate comparisons between social costs and benefits.
Finally, the value of companion diagnostics and better testing strategies will not
be adequately assessed by looking only at the size of the health gain (e.g., a QALY)
produced by an intervention, as is conventional in cases of pharmaceuticals. As
already discussed, companion diagnostic tests create benefits beyond health. But
also, companion diagnostics can identify cost-saving possibilities within health care
systems. If tests are able to identify patients who will not benefit from treatments,
this will primarily lead to cost offset (since valuable resources are not spent where
they cannot generate health improvement) and side-effects offset (since treatments,
especially chemotherapy for cancer, can have severe adverse side effects). The
search for the additional health benefit expressed as QALYs, however, is the
cornerstone of the traditional way of assessing the benefits generated by an inter-
vention within the framework of economic evaluations. In the example of
trastuzumab analyzed by Phillips et al. ( 2009 ), if the treatment is withheld from a
patient with HER2-positive breast cancer or if trastuzumab is given to a patient with
HER2-negative breast cancer, this will cause undesirable outcomes. In the former
situation, patients may not benefit from the substantial reduction in the risk of death
from breast cancer conferred by trastuzumab,^50 and in the latter situation, patients
who will not benefit from treatment will be exposed to an unnecessary risk of heart
failure, which only further increases the health care costs.^51 The benefits of personal
medicine products may hence cause significant cost offset or may contribute to
avoiding unwanted side effects and not necessarily cause the generation of direct
additional benefits in terms of more QALYs gained (but prevent QALY loss). As
also suggested by Annemans et al. ( 2013 ), this can be defined as “decremental” cost
per QALYs, and different decision criteria may be introduced to interpret such
results.
(^49) For further discussion, see Claxton et al. ( 2009 ), report by the Decision Support Unit available at
https://www.nice.org.uk/proxy/?sourceUrl¼http%3A%2 F%2Fwww.nice.org.uk%2Fmedia%
2FED8%2F7A%2FNICESubmissionAppendix.pdf.
(^50) As noted by other authors as well, such as Perez et al. ( 2007 ), p. 25.
(^51) As shown by Wolff et al. ( 2007 ), pp. 118–145.
130 A. Bobinac and M. Vehovec