Cost-Effectiveness of Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI) in Sweden

Abstract

Objectives: Untreated hepatitis C virus (HCV) infection results in chronic liver disease. The prevalence in The Netherlands is estimated at 0.1-0.4% with 50% of patients having HCV genotype 1 (GT1). Sofosbuvir (SOF), a novel Direct Antiviral Agent (DAA), reached high rates of sustained virological response (SVR) when given with pegylated interferon-α and ribavirin (PegIFN-α /RBV) in chronic HCV (all genotypes). This study compares the costs per successfully treated patient with sofosbuvir compared to current standard of care (SoC) in the Netherlands in treatment-naïve GT1 patients. MethOds: A Markov transition cost-utility model was used, reflecting efficacy and safety data from published RCTs with SOF+PegIFNα /RBV, PegIFN-α /RBV, telaprevir (TVR) +PegIFN-α /RBV and boceprevir (BOC) +PegIFN-α /RBV. Medical resource use is based on clinical guidelines and expert opinion. Costs include treatment costs, monitoring costs, costs for treatment of complications and adverse events. The model has a lifetime horizon and costs are discounted with 4% and outcomes with 1.5%. Successfully treated patients are defined as having an SVR. Results are presented for a treatment-naïve GT1 population. Results: The SVR rate for SOF ranged from 91.7% in non-cirrhotic patients to 80.1% in cirrhotic patients. This was 43.6% and 23.6% for PegIFN-α , 75.4% and 61.9% in TVR and 64.1% and 55% for BOC. Total treatment costs ranged from € 55,376 to € 70,336 for SOF (non-cirrhotic and cirrhotic), € 22,240 and € 44,751 for PegIFN-α , € 42,593 to € 60,071 for TVR and € 39,634 to € 57,647 for BOC. The costs per SVR varied from € 60.388 to € 87,050 for SOF (non-cirrhotic and cirrhotic), € 51,009 to € 189,623 for PegIFN-α , € 56,489 to € 97,045 for TVR and € 61,832 to € 104,813 for BOC. cOnclusiOns: The costs per successfully treated patient with sofosbuvir are comparable to current standard of care in GT1 treatment naive patients without cirrhosis and are lower than SoC in cirrhotic patients in The Netherlands.

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.…”

“…The most common treatment comparison was between fidaxomicin and vancomycin only, reported in 14 EEs [ 26 – 28 , 36 , 39 , 40 , 42 , 43 , 50 , 56 , 58 , 60 , 64 ]. Five EEs [ 37 , 47 , 49 , 57 , 62 ] compared fidaxomicin with vancomycin and metronidazole.…”

“…A Markov model was used in ten EEs [ 26 , 27 , 47 , 48 , 50 , 56 , 58 , 60 , 62 , 64 ], and a decision-tree model was used in 11 EEs [ 28 , 36 , 37 , 40 , 43 , 46 , 51 , 54 , 55 , 65 ]. Four EEs [ 39 , 44 , 49 , 59 ] used a decision-analytic model, but no further details were provided in the publications.…”

“…Five of the EEs comparing fidaxomicin and vancomycin [ 26 , 47 , 58 , 62 , 64 ] were based on country adaptations of the same model (see the ESM, Supplementary Fig. 2).…”