Evaluating frequency, diagnostic quality, and cost of Lyme borreliosis testing in Germany: a retrospective model analysis

Abstract

Background: Data on the economic impact of Lyme borreliosis (LB) on European health care systems is scarce. This project focused on the epidemiology and costs for laboratory testing in LB patients in Germany.

Materials and methods: We performed a sentinel analysis of epidemiological and medicoeconomic data for 2007 and 2008. Data was provided by a German statutory health insurance (DAK) company covering approx. 6.04 million members. In addition, the quality of diagnostic testing for LB in Germany was studied.

Results: In 2007 and 2008, the incident diagnosis LB was coded on average for 15,742 out of 6.04 million insured members (0.26%). 20,986 EIAs and 12,558 immunoblots were ordered annually for these patients. For all insured members in the outpatient sector, a total of 174,820 EIAs and 52,280 immunoblots were reimbursed annually to health care providers (cost: 2,600,850€). For Germany, the overall expected cost is estimated at 51,215,105€. However, proficiency testing data questioned test quality and standardization of diagnostic assays used.

Conclusion: Findings from this study suggest ongoing issues related to care for LB and may help to improve future LB disease management.

Figure 1

Average number of participants and mean pass rates (%) with standard deviations (bars) for different assay systems as observed between 2006 and 2008 in the German LB proficiency testing program.

Figure 2

Youden‘s plot of different quantitative IgG-EIA results (U/mL) as obtained in two samples (no. 32 and 61) used for LB proficiency testing in 2008. For clinical information of samples, see Table 1. (ER, BW, DO, MK, VR, VT, others: anonymized abbreviations of different commercial EIA manufacturers).

Figure 3

Recovery of LB-specific IgM- (a) and IgG- (b) immunoblot banding patterns (reported borrelial antigen bands: p83/100, p58, p43, p41, p39, OspA, OspC, p17/18, VlsE) as obtained from the participating laboratories for one sample (no. 32/2008) used for LB proficiency testing in 2008. Absolute frequency of participants reporting positive results for each antigen are depicted by bars. Relative frequency of positive reports for the different manufacturers are shown by colored boxes within the bars. (ER, MK, VM, VT, others: anonymized abbreviations of different commercial blot manufacturers). For clinical information of samples, see Table 1.

Figure 4

Average number of participants and average pass rates (%) with standard deviations (bars) for IgG- (a) and IgM- (b) EIAs of different manufacturers as observed between 2006 and 2008 in the German LB proficiency testing program (ER, BW, DO, MK, VR, VT, others: anonymized abbreviations of different commercial EIA manufacturers).

Figure 5

Average epidemiological annual distribution of coded incident and prevalent diagnoses of LB (incident DAK, prevalent DAK) as observed in the retrospective claims' data analysis depicted together with the average annual distribution of cases as reported by mandatory reporting (incident RKI) in the six new German states for 2007 to 2008. Q1–Q4: quarter of year.