Table 1.
Clinical and utility inputs
| Base case value | Sensitivity low | Sensitivity high | Sources | Original value as reporteda | |
|---|---|---|---|---|---|
| Clinical inputs | |||||
| FMBL-specific | |||||
| Among patients with ≥ 1 rCDI | |||||
| Treatment success (%) 8 weeks | 70.6% | 63.7% | 76.8% | PUNCH CD3 [6] | 70.6% |
| Sustained response per 8 weeks (%) between 8 weeks and 6 monthsb | 96.4% | N/A | N/A |
PUNCH CD3 (8 weeks and 6 months) [6] PUNCH CD Open Label (12 and 24 months) [10] |
92.1% |
| Sustained response per 8 weeks (%) between 6 and 12 monthsb | 98.5% | N/A | N/A | 95.3% | |
| Sustained response per 8 weeks (%) between 12 and 24 monthsb | 98.4% | N/A | N/A | 90.0% | |
| Among patients at first recurrence | |||||
| Treatment success (%) 8 weeks | 81.0% | N/A | N/A | PUNCH CD3 [6] | 81.0% |
| Sustained response per 8 weeks (%) between 8 weeks and 6 monthsb | 95.6% | N/A | N/A |
PUNCH CD3 (8 weeks and 6 months) [6] Assumption |
90.5% |
| Sustained response per 8 weeks (%) between 6 and 12 monthsb | 98.5% | N/A | N/A | 95.3% | |
| Sustained response per 8 weeks (%) between 12 and 24 monthsb | 98.4% | N/A | N/A | 90.0% | |
| SOC-specific | |||||
| Among patients with ≥ 1 rCDI | |||||
| Treatment success (%) 8 weeks | 57.5% | 48.4% | 68.2% | PUNCH CD3 [6] | 57.5% |
| Sustained response per 8 weeks (%) between 8 weeks and 6 monthsb | 95.7% | N/A | N/A |
PUNCH CD3 (8 weeks and 6 months) [6] PUNCH CD Open Label (12 and 24 months) [10] |
90.6% |
| Sustained response per 8 weeks (%) between 6 and 12 monthsb | 93.4% | N/A | N/A | 80.0% | |
| Sustained response per 8 weeks (%) between 12 and 24 monthsb | 93.3% | N/A | N/A | 63.6% | |
| Among patients at first recurrence | |||||
| Treatment success (%) 8 weeks | 60.0% | N/A | N/A | PUNCH CD3 [6] | 60.0% |
| Sustained response per 8 weeks (%) between 8 weeks and 6 monthsb | 93.0% | N/A | N/A |
PUNCH CD3 (8 weeks and 6 months) [6] Assumption |
85.0% |
| Sustained response per 8 weeks (%) between 6 and 12 monthsb | 93.4% | N/A | N/A | 80.0% | |
| Sustained response per 8 weeks (%) between 12 and 24 monthsb | 93.3% | N/A | N/A | 63.6% | |
| Subsequent antibiotic treatment, applied if patients experienced rCDI after entering the model | |||||
| Treatment success (%) 8 weeks | 54.3% | N/A | N/A | PUNCH CD3 [6] | 54.3%c |
| rCDI-related surgery rates | |||||
| Colectomy | 1.3% | N/A | N/A | Feuerstadt 2020 [11] | 7.3% (over 12 months) |
| Ileostomy reversal | 40.6% | N/A | N/A | Neal 2011 [12] | 79.0% (over 6 months) |
| Utility inputs | |||||
| Utility by health state | |||||
| Absence of CDI | 0.88 | 0.66 | 1.00 | Rajasingham 2020 [13] | – |
| rCDI | 0.42 | 0.32 | 0.53 | Wilcox 2017 [14] | – |
| Colectomy | 0.54 | 0.40 | 0.67 | Bartsch 2012 [15] | – |
| Ileostomy | 0.70 | 0.53 | 0.88 | Bartsch 2012 [15] | – |
| Ileostomy reversal | 0.86 | 0.65 | 1.00 | Rajasingham 2020 [13] | – |
| Mortality | |||||
| rCDI-related mortality | 1.8% | 0.6% | 3.2% | Olsen 2020 [16] | 10.9% (over 1 year) |
| Colectomy-related mortality | 55.5% | 43.6% | 66.1% | Peprah et al. 2019 [17] | 35.2% (over 30 days) |
Parameters were varied on the basis of clinical input from key opinion leaders, 95% confidence intervals in the case of efficacy inputs in the sensitivity analysis
CDI C. difficile infection, FMBL fecal microbiota, live-jslm, N/A not applicable, rCDI recurrent C. difficile infection, SOC standard of care
aInputs were converted to per 8-week cycle where applicable. Rates were transformed using the following formula 1 − e[ln(1 − original rate)/(time frame in weeks/8)]
bSustained response rates were reported among responders at the previous time point
cThe treatment success rate of subsequent antibiotic treatment was calculated among patients with at least three previous CDI episodes in the PUNCH CD3 trial