Table 1 Adapted from the Transparent Value Framework [4]
Criterion | Degree of fulfilment | ||
|---|---|---|---|
Lower degree | Medium degree | High degree | |
Are there available alternatives, including non-pharmaceutical treatment options (unmet need) | Yes, new medicine does not address unmet need | Yes, but major unmet need still remains | No alternatives, except best supportive care—new drug addresses major unmet need |
(Relative) effectiveness, degree of net benefit (clinical improvement, quality of life, etc. vs. side effects, societal impact, etc.) relative to alternatives, including no treatment | Incremental | Major | Curative |
Response rate (based on best available clinically relevant criteria) | < 30% | 30–60% | > 60% |
Degree of certainty (documentation) | Promising but not well-documented | Plausible | Unequivocal |