A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with Clostridium difficile infection (CDI) in Germany

Abstract

PurposeClostridium difficile infection (CDI) represents a significant economic healthcare burden, especially the cost of recurrent disease. Fidaxomicin produced significantly lower recurrence rates and higher sustained cure rates in clinical trials. We evaluated the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the first-line treatment of patient subgroups with CDI at increased risk of recurrence.MethodsA semi-Markov model was used to compare the cost-effectiveness and budget impact of fidaxomicin vs. vancomycin from a payer perspective in Germany. The model cycle length was 10 days. The time horizon was 1 year. Model inputs were probability of clinical cure, 30-day probability of recurrence, and 30-day attributable mortality based on evidence from two randomized controlled trials comparing fidaxomicin and vancomycin in patients with CDI. Cost-effectiveness outcomes were cost per quality-adjusted life year gained, cost per bed-day saved, and cost per recurrence avoided.ResultsDespite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup (less costly and more effective) and cost-effective in the other subgroups, with incremental cost-effectiveness ratios vs. vancomycin ranging from €26,900 to €44,500. Hospitalization costs of the first-line treatment of CDI with fidaxomicin vs. vancomycin were lower in every patient subgroup, resulting in budget impacts ranging from −€1325 (in patients ≥65 years) to −€2438 (in cancer patients). Reductions in the cost of treating recurrence with fidaxomicin ranged from −€574.32 per patient in those receiving concomitant antibiotics to −€1500.68 per patient in renally impaired patients.ConclusionsIn patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer.Electronic supplementary materialThe online version of this article (doi:10.1007/s15010-016-0894-y) contains supplementary material, which is available to authorized users.

Cost-Effectiveness of Competing Treatment Strategies for Clostridium difficile Infection: A Systematic Review

“…13,15,30,31 These rates were, however, lower than that of fidaxomicin, except for severe CDI (NAP1/BI/027 strain) or patients with renal impairment. 17,27 For recurrent CDI, Varier et al used a vancomycin cure rate of 0.69, 16 which was lower than the 0.889–0.926 range used in other studies. 13,17,29 Furthermore, 2 studies assumed that vancomycin and fidaxomicin were similarly effective, 25,29 and in 1 study, both drugs had much lower cure rates for C. difficile –induced colitis.…”

“…17,27 For recurrent CDI, Varier et al used a vancomycin cure rate of 0.69, 16 which was lower than the 0.889–0.926 range used in other studies. 13,17,29 Furthermore, 2 studies assumed that vancomycin and fidaxomicin were similarly effective, 25,29 and in 1 study, both drugs had much lower cure rates for C. difficile –induced colitis. 28 The fidaxomicin cure rates for the NAP1/BI/027 strain were considerably different in 2 studies, 12,27 whereas the cure rate of FMT was high (0.910–0.945) when delivered via colonoscopy but not other modes.…”

“…14 Comorbidities (eg, cancer, concomitant antibiotics, renal impairment) were accounted for in 3 studies. 17,24,27 …”

“…Utility weights generally varied substantially across studies; for example, utility for CDI was between 0.319 and 0.880. 14,17,24–27 …”

Control of Clostridium difficile Infection by Defined Microbial Communities

“…Whereas a course of metronidazole or vancomycin can be relatively inexpensive ($35 - $700 respectively), fidaxomicin can cost $3,360 for a 10 day course (122). This has led to some reluctance to prescribe fidaxomicin, however, it has been argued that compared to the expense (financial and to the health of the patient) associated with rCDI, fidaxomicin is the superior first line treatment option (123). Despite the increased efficacy of fidaxomicin, >10% of patients will develop recalcitrant rCDI (124).…”