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.
Highlights
Clostridium difficile infection (CDI) is a debilitating condition associated with mortality, substantial morbidity, and hospitalization [1, 2]
This study evaluates the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the firstline treatment of patient subgroups with CDI at increased risk of recurrence
Despite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup and cost-effective in the other subgroups, with incremental cost-effectiveness ratios (ICERs; incremental cost per quality-adjusted life year (QALY) gained) vs. vancomycin ranging from €26,900 to €44,500 [29] (Table 2)
Summary
Clostridium difficile infection (CDI) is a debilitating condition associated with mortality, substantial morbidity, and hospitalization [1, 2]. Treatment options for CDI patients have been vancomycin and metronidazole for a number of years. Recurrent CDI places a heavy burden on patients, including prolonged symptoms, repeated courses of antibiotics, and the attendant risk of side-effects and rehospitalization [5]. Certain subgroups of patients are more susceptible to recurrence, e.g., those with severe CDI, cancer or renal impairment, those with a previous recurrence, those aged ≥65 years, and those receiving concomitant antibiotics [6,7,8,9]. With impaired renal function or receiving concomitant antibiotics have been associated with lower cure rates and longer time to resolution of diarrhea [7, 12, 13]
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