Economic Evaluation of Fidaxomicin for the Treatment of Clostridium Difficile Infection (C. difficile-associated diarrhoea) in Ireland

Abstract

Background: Clostridium difficile is associated with 20–30% of cases of antibiotic-associated diarrhoea. The incidence of C. difficile infection (CDI) is higher in Ireland than in other countries in Europe, and it is associated with considerable morbidity. Previously recommended standard therapeutic options were vancomycin and metronidazole, but the macrocyclic antibiotic fidaxomicin has recently been recommended for use in adults with CDI in Ireland. Objectives: To perform a cost-utility analysis of fidaxomicin compared to oral metronidazole (used to treat initial non-severe disease and first non-severe recurrence) and oral vancomycin (used to treat severe disease and any non-severe recurrence beyond the first) for the treatment of CDI. Methods: A Markov model was used to determine the cost-utility of fidaxomicin in the treatment of all adult CDI patients (base case), patients with severe CDI and patients with initial CDI recurrences, respectively. Patients enter the model in the CDI health state and are treated either with fidaxomicin or current standard of care (oral metronidazole for non-severe CDI; vancomycin for severe CDI) for 10 days. The time horizon was 1 year. Deterministic and probabilistic sensitivity analyses were performed. Health state utilities were derived from the literature. The perspective was that of the Irish Health Service Executive (HSE). Results: In the base case, fidaxomicin was dominant to current standard-of-care therapy, with cost savings of €2,904 and incremental quality-adjusted life year (QALY) gain of 0.031. The main drivers of costeffectiveness were recurrence rates and cost of hospitalization. Fidaxomicin was also dominant for all patient subgroups. The probability of fidaxomicin being cost-effective in all patients with CDI at a willingness to pay threshold of €45,000 per QALY gained was 82%. Conclusion: Fidaxomicin was dominant to the current standard-of-care therapy for CDI. Based on this analysis, fidaxomicin has received reimbursement for CDI treatment under the High Tech Drug Scheme in Ireland.

A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection

“…Of the 13 EEs reported as full publications, six [ 26 , 27 , 46 , 58 , 62 , 65 ] had previously been presented at a conference [ 38 , 41 , 45 , 52 , 63 , 66 ] and posters were sourced for all except one [ 45 ]. For the remaining EEs, the data were reported in abstract ( n = 7) [ 36 , 39 , 49 , 53 , 54 , 56 , 57 , 59 ] or poster form ( n = 7) only [ 40 , 43 , 44 , 47 , 51 , 60 , 61 , 64 ].…”

“…Vancomycin was assessed in all 27 EEs, whereas fidaxomicin and metronidazole were investigated in 24 EEs [ 26 – 28 , 36 , 37 , 39 , 40 , 42 , 43 , 46 – 51 , 54 , 56 – 60 , 62 , 64 ] and 13 EEs [ 37 , 44 , 46 – 49 , 51 , 54 , 55 , 57 , 59 , 62 , 65 ], respectively. In two EEs [ 37 , 57 ], vancomycin and metronidazole were combined in a single treatment arm and the intervention used was based on CDI severity or C. difficile strain.…”

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

“…A US study from the third-party payer perspective found that fidaxomicin may be a more cost-effective option for the treatment of CDIs compared with vancomycin under most scenarios tested [ 34 ]. In addition, a recent cost-utility analysis from an Irish Health Service Executive perspective showed that fidaxomicin was dominant to vancomycin or metronidazole for the treatment of CDI [ 19 ]. Finally, a cost-utility study from the Spanish National Health Service perspective showed that the treatment of CDI with fidaxomicin would be cost-saving and lead to improved quality of life when compared with vancomycin in patients with cancer, renal impairment, or treated with concomitant antibiotics [ 35 ].…”

“…The following health state utility values [ 27 ] were used in the model: 0.33 per cycle for patients with CDI; 0.56 for patients treated successfully (first cycle, 10 days) after the end of treatment; 0.78 for successfully treated patients (second and subsequent cycles after the end of treatment); and 0.78 for patients without CDI. Due to a lack of available CDI-specific utility data, the data utility source used was not disease-specific; however, these utility data have been used in other published cost-effectiveness and cost-utility CDI models [ 18 , 19 ].…”

“…In two phase III trials, fidaxomicin was shown to be non-inferior to vancomycin in terms of clinical cure and produced significantly lower recurrence rates and significantly higher sustained cure rates [ 3 , 17 ]. In patients with severe CDI and those with a first CDI recurrence, recent studies in Scotland and Ireland, respectively, have shown that fidaxomicin was cost-effective compared with vancomycin [ 18 ] and less costly and more effective than vancomycin or metronidazole [ 19 ].…”