In vitro diagnostic (IVD) investigations are indispensable for routine patient management.
Appropriate testing allows early-stage interventions, reducing late-stage healthcare expenditure
To investigate HCE on IVDs in two developed markets and to assess the perceived value of
IVDs on clinical decision-making. Physician-perceived HCE on IVD was evaluated, as well
as desired features of new diagnostic markers.
Past and current HCE on IVD was calculated for the US and Germany. A total of 79 US/German
oncologists and cardiologists were interviewed to assess the number of cases where:
physicians ask for IVDs; IVDs are used for initial diagnosis, treatment monitoring, or posttreatment;
and decision-making is based on an IVD test result. A sample of 201 US and
German oncologists and cardiologists was questioned regarding the proportion of HCE they believed to be attributable to IVD testing. After disclosing the actual IVD HCE, the physician’s
perception of the appropriateness of the amount was captured. Finally, the association
between physician-rated impact of IVD on decision-making and perceived contribution
of IVD expenditure on overall HCE was assessed.
IVD costs account for 2.3% and 1.4% of total HCE in the US and Germany. Most physicians
(81%) believed that the actual HCE on IVDs was >5%; 19% rated the spending correctly (0–4%, p<0.001). When informed of the actual amount, 64% of physicians rated this as
appropriate (p<0.0001); 66% of decision-making was based on IVD. Significantly, more
physicians asked for either additional clinical or combined clinical/health economic data
than for the product (test/platform) alone (p<0.0001).
Our results indicate a poor awareness of actual HCE on IVD, but a high attributable value of
diagnostic procedures for patient management. New markers should deliver actionable and
medically relevant information, to guide decision-making and foster improved patient
S1 Fig. Average (cardiologists, oncologists, USA, Germany) percentage of IVD subtype use
and average rated importance of IVD subtype use during initial patient workup.
S3 File. Stage 2 –Interview answers from oncologists and cardiologists.
S4 File. Stage 3 –SERMO questions.
S5 File. Stage 3 –Physician answers to SERMO questions.
S1 Table. IVD Total Spending and Percentage of HCE 1993–2013 for US and Germany.
S2 Table. IVD subtype usage and rated importance. A) Percentage of IVD subtype use during
initial patient workup according to specialty and country; B) Rated importance of IVD subtypes
for clinical practice and decision making during initial patient workup according to specialty and country (rating based on Likert scale, 1 = very low, 5 very high).