Table 1.
Description and distribution of attributes (complete case analysis N = 91)
| Variable name | Description | Possible values | Frequency | Association between recommendation and attribute | ||||
|---|---|---|---|---|---|---|---|---|
| Approved | Conditional | Rejected | Chi2 p value | |||||
| Clinical benefit | ||||||||
| Overall clinical benefita | Conclusion of pERC with respect to overall clinical benefit | 1 | Net benefit | 62 (68%) | 14 | 48 | 0 | < 0.001 |
| 2 | Uncertain benefit | 13 (14%) | 0 | 4 | 9 | |||
| 3 | No benefit | 16 (18%) | 0 | 1 | 15 | |||
| Relative survival gain | Survival gain relative to comparator in the clinical study measured as overall survival, progression free survival, 5 year survival or 1 year survival | 1 | Survival > comparator | 72 (79%) | 11 | 44 | 17 | 0.48 |
| 0 | Survival ≤ comparator | 19 (21%) | 3 | 9 | 7 | |||
| Overall survival flag | Identifies whether the clinical trial reported OS data or a different clinical endpoint | 1 | OS reported | 55 (60%) | 6 | 20 | 10 | 0.91 |
| 0 | OS not reported | 36 (40%) | 8 | 33 | 14 | |||
| Quality of clinical evidence | The quality of the clinical study in terms of phase of study, and results | 1 | High quality | 72 (79%) | 12 | 48 | 12 | < 0.001 |
| 0 | Low quality | 19 (21%) | 2 | 5 | 12 | |||
| Severity of side effects | Severity of adverse events (AE) measured in relation to existing treatment | 1 | Lower AE | 75 (82%) | 14 | 46 | 15 | 0.01 |
| 0 | High/uncertain AE | 16 (18%) | 0 | 7 | 9 | |||
| Economic evaluation | ||||||||
| ICER | The size of the incremental cost effectiveness ratio in relation to a threshold value | 1 | ICER ≥ $150,000 | 52 (57%) | 0 | 37 | 15 | < 0.001 |
| 0 | ICER < $150,000 | 39 (43%) | 14 | 16 | 9 | |||
| ICER quality | Model uncertainty (outcomes of sensitivity analysis, lack of clarity around methods) | 1 | High/unknown uncertainty | 75 (82%) | 12 | 44 | 19 | 0.86 |
| 0 | Low uncertainty | 16 (18%) | 2 | 9 | 5 | |||
| Patient based values | ||||||||
| Type of drug | Type of drug used as a proxy for the burden experienced by patient | 1 | IV | 46 (51%) | 8 | 25 | 13 | 0.74 |
| 0 | Oral | 45 (49%) | 6 | 28 | 11 | |||
| Alternatives | Are alternatives available | 1 | No alternatives | 23 (25%) | 3 | 16 | 4 | 0.42 |
| 0 | Alternatives | 68 (75%) | 11 | 37 | 20 | |||
| Adoption feasibility | ||||||||
| Infrastructure | Additional costs of infrastructure or testing | 1 | High | 52 (57%) | 7 | 29 | 16 | 0.52 |
| 0 | Low | 39 (43%) | 7 | 24 | 8 | |||
| Budget impact | Impact estimated on the basis of patient population size and available alternatives | 1 | High/uncertain budget impact | 72 (79%) | 10 | 41 | 21 | 0.44 |
| 0 | Low budget impact | 19 (21%) | 4 | 12 | 3 | |||
pERC pan-Canadian Oncology Drug Review, pERC pCODR Expert Review Committee, ICER incremental cost-effectiveness ratio
aAttribute was excluded from the full model specifications