Table 2.
Cost inputs
| Base case value | Sensitivity low | Sensitivity high | Sources | |
|---|---|---|---|---|
| Drug acquisition costa | ||||
| Cost per unit (2022 USD) | ||||
| FMBL | $9000 | $6750 | $11,250 | Redbook [18] |
| SOC | $0 | N/A | N/A | Assumption |
| Subsequent antibiotic useb | ||||
| Vancomycin | $26.85 | $20.14 | $33.56 | Redbook [19] |
| Fidaxomicin | $194.14 | $145.61 | $242.68 | Redbook [19] |
| Strength per unit | ||||
| FMBL | 150 ml | N/A | N/A | PUNCH CD3 [6] |
| SOC | N/A | N/A | N/A | |
| Subsequent antibiotic useb | ||||
| Vancomycin | 125 mg | N/A | N/A | Redbook [19] |
| Fidaxomicin | 200 mg | N/A | N/A | Redbook [19] |
| Total units required per regimen | ||||
| FMBL | 1 | N/A | N/A | PUNCH CD3 [6] |
| SOC | N/A | N/A | N/A | Assumption |
| Subsequent antibiotic useb | ||||
| Vancomycin taper-pulse | 83 | N/A | N/A | IDSA 2021 guidelines [2] |
| Fidaxomicin | 20 | N/A | N/A | IDSA 2021 guidelines [2] |
| Treatment distribution among subsequent antibiotic users | ||||
| Vancomycin | 93.1% | N/A | N/A | PUNCH CD3 [6] |
| Fidaxomicin | 6.9% | N/A | N/A | PUNCH CD3 [6] |
| Total drug acquisition cost per regimen (2022 USD) | ||||
| FMBL | $9000 | $6750 | $11,250 | Calculation |
| SOC | $0 | N/A | N/A | |
| Subsequent antibiotic useb | $2342.36 | N/A | N/A | |
| Drug administration cost | ||||
| Unit cost per admin or pharmacy dispensing (2022 USD) | ||||
| FMBL | $113.85 | $85.39 | $142.31 | CMS physician fee schedule [20] |
| SOC | $0 | N/A | N/A | Assumption |
| rCDI-related medical cost | ||||
| Unit cost (2022 USD) | ||||
| Hospitalization per day | $2039.06 | $1529.30 | $2548.83 | HCUPnet [21] |
| ICU per day | $5232.00 | $3924.00 | $6540.00 | Halpern 2016 [22] |
| ED per visit | $1003.73 | $752.80 | $1254.66 | Nelson 2021 [23] |
| Post-acute care per day | $562.12 | $421.59 | $702.65 | Nelson 2021 [23] |
| Outpatient per visit | $208.67 | $156.50 | $260.84 | Optum360 National Fee Analyzer [24] |
| Stool test | $58.35 | $43.76 | $72.94 | Rodrigues 2017 [25] |
| Resource use per year | ||||
| Hospitalization stays | 1.60 | 1.20 | 2.00 | Rodrigues 2017 [25] |
| LOS per hospitalization | 15.80 days | N/A | N/A | Rodrigues 2017 [25] |
| ICU days | 0.18 | 0.14 | 0.23 | Rodrigues 2017 [25] |
| ED visits | 0.12 | 0.09 | 0.15 | Rodrigues 2017 [25] |
| Post-acute care days | 21.08 | 15.81 | 26.36 | Rodrigues 2017 [25]; Nelson 2021 [23] |
| Outpatient visits | 2.20 | 1.65 | 2.75 | Rodrigues 2017 [25] |
| Stool tests | 4.40 | 3.30 | 5.50 | Rodrigues 2017 [25] |
| Total rCDI-related medical costs (excluding colectomy-related cost and terminal care cost) | ||||
| Medical cost per year | $64,810.39 | N/A | N/A | Calculation |
| Medical cost per 8 weeksc | $9970.83 | N/A | N/A | Calculation |
| Colectomy-related costs | ||||
| Cost per event (2022 USD) | ||||
| Colectomy | $54,421.37 | $40,816.03 | $68,026.71 | Rodrigues 2017 [25] |
| Ileostomy reversal | $46,297.54 | $34,726.16 | $57,871.93 | Wilson 2013 [26] |
| Terminal care costs | ||||
| One-time cost (2022 USD) | ||||
| Terminal care | $53,332.75 | 39,999.56 | 66,665.94 | Byhoff 2017 [27] |
Cost parameters were varied by ± 25% in the sensitivity analysis
CMS Centers for Medicare & Medicaid Services, ED emergency department, FMBL fecal microbiota, live-jslm, HCUP Healthcare Cost and Utilization Project, ICU intensive care unit, LOS length of stay, N/A not applicable, rCDI recurrent C. difficile infection, SOC standard of care, USD United States dollar
aThe dosing schedules for subsequent antibiotics were based on IDSA 2021 guidelines (vancomycin taper-pulse over 6 weeks, fidaxomicin 10 days)
bDrug costs of subsequent antibiotics were estimated on the basis of the average wholesale acquisition cost of oral forms (tablet or solution) of vancomycin and fidaxomicin taken from Redbook
cThe total annual rCDI-related medical costs were calculated as the sum of the resource use per year multiplied by the unit cost across care settings and then were converted to cost per 8-week cycle (8 out of 52 weeks of the annual cost) and applied to patients that stayed in the rCDI health state per model cycle