Table 2 Pre-workshop attribute reference levels and basis of selection
Cluster | Attribute | Metric | Lower level | Basis | Higher level | Basis |
|---|---|---|---|---|---|---|
Therapeutic Impact | Overall survival | months | 0 | Minimum limit of the scale | 6.2 | BSC |
HRQoL | utility score (EQ-5D) | 0.6 | Lower score used for progressive state in TA307 [22] | 0.75 | BSC | |
Progression free survival | months | 0 | Minimum limit of the scale | 1.9 | BSC | |
Objective response rate | % of patients | 0 | Minimum limit of the scale | 11 | FOLFIRI + Placebo (VELOUR trial) [32] | |
Safety Profile | Grade 3 AEs | % of patients | 68 | 10% higher than the worst performing option | 32 | Median of BSC (AMGEN trial) [65] and FOLFIRI + Placebo (VELOUR trial) |
Grade 4 AEs | % of patients | 24 | 10% higher than the worst performing option | 10 | Median of BSC (AMGEN trial) and FOLFIRI + Placebo (VELOUR trial) | |
Contra-indications | types of contra- indications | Lower expected benefit and higher expected risk | Minimum limit of the scale | Lower expected benefit | Median of options | |
Innovation Level | ATC Level 1 | relative market entrance | 5th | Minimum limit of the scale | 4th | Median of options |
ATC Level 2 | relative market entrance | 5th | Minimum limit of the scale | 4th | Median of options | |
ATC Level 3 | relative market entrance | 5th | Minimum limit of the scale | 3rd | Median of options | |
ATC Level 4 | relative market entrance | 5th | Minimum limit of the scale | 1st | Median of options | |
ATC Level 5 | relative market entrance | 5th | Minimum limit of the scale | 1st | Median of options | |
Phase 1 | number of new indications | 0 | Minimum limit of the scale | 17 | Median of options | |
Phase 2 | number of new indications | 0 | Minimum limit of the scale | 55 | Median of options | |
Phase 3 | number of new indications | 0 | Minimum limit of the scale | 18 | Median of options | |
Marketing authorisation | number of new indications | 0 | Minimum limit of the scale | 2 | Median of options | |
Posology | duration of administration & frequency of doses | Many hours, every 2 weeks | Minimum limit of the scale (worst performing option) | Up to an hour, every 2 weeks | Maximum limit of the scale (best performing option) | |
Socio-economic Impact | Medical costs impact | GBP (£) | 7,086 | 10% higher than the worst performing option | 4,589 | Median of options |