determinants, such as model specifications, data used, or different exogenous
factors. Therefore, the ICER can be seen as a point-estimate stemming from a
cost-effectiveness analysis, while the results of the sensitivity analysis comprise a
confidence interval surrounding that point estimate.
3 Economic Evaluations of Companion Diagnostics
Faulkner et al. ( 2012 ) define personalized medicine in terms of the use of genetic or
other biomarker information to improve the safety, effectiveness, and health out-
comes of patients via more efficiently targeted risk stratification, prevention, and
tailored medication and treatment-management approaches. Companion diagnos-
tics are an important element of this genetic or biomarker stratification. While
diagnostics can refer to any type of test and measurement for evaluating a patient’s
condition (such as laboratory, pathology, or physiological tests), companion diag-
nostic technology’s primary purpose is to identify patients who will achieve the best
health outcome using the particular therapy under consideration.^22 Several com-
panion genetic tests are already widely used, mainly in oncology and also in other
areas.^23 The definition and different aspects of companion diagnostics and the
codevelopment of pharmacogenomic biomarkers in the context of drug develop-
ment are currently being formally discussed also at the level of regulatory agencies
in different jurisdictions, as analyzed by Shimazawa and Ikeda ( 2013 ).
A companion diagnostic technology may be suitable for economic evaluation in
the context of an appraisal of a new drug that it accompanies. In other cases,
companion diagnostic technologies may be suitable for evaluation independently,
for instance, when new companion diagnostics are developed for already existing
drugs. In the UK, NICE has acknowledged the potential complexity of the evalu-
ation of companion and other diagnostics by the introduction of specialized guide-
lines for the appraisal process, the Diagnostics Assessment Programme (DAP),
which provides guidelines for conducting assessments of diagnostic technologies
(diagnostics generally, not exclusively companion diagnostic technologies).^24
According to the UK Department of Health ( 2014 ), the purpose of introducing
specialized guidelines in this area is to value complex technologies and ensure that
the health care system in the UK is able to adopt clinically and cost-effective
technologies rapidly and consistently, hence promoting the rapid adoption of
clinically innovative and cost-effective diagnostic technologies.^25 Next to the
(^22) Byron et al. ( 2014 ), pp. 1469–1476.
(^23) For further details, we refer the reader to Kazi et al. ( 2014 ), pp. 221–232, and also the FDA
website:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/
ucm301431.htm.
(^24) Document available athttp://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guid
ance/NICE-diagnostics-guidance/Diagnostics-assessment-programme-manual.pdf.
(^25) The UK Department of Health Policy paper available athttps://www.gov.uk/government/
publications/personalised-health-and-care-2020/using-data-and-technology-to-transform-out
comes-for-patients-and-citizens.
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