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| Category | Number of PRO data sets (n) | Percentage of events in relation to overall number of processes (%) |
|---|
| Industry – type of PRO data submitted (module 4) |
| Clinical PROs | 41 | 51% |
| HRQoL | 61 | 75% |
| Preferences | 2 | 2% |
| Satisfaction | 1 | 1% |
| Industry - extent of PRO data submitted (module 4) |
| No PRO data submitted | 13 | 16% |
| Data on one PRO category | 35 | 43% |
| Data on two PRO categories | 31 | 38% |
| Data on three PRO categories | 2 | 2% |
| Early benefit assessment – type of PRO data considered in synopsis |
| Clinical PRO | 39 | 48% |
| HRQoL | 58 | 72% |
| Preferences | 0 | 0% |
| Satisfaction | 0 | 0% |
| Early benefit assessment – extent of PRO data submitted |
| No PRO data considered | 43 | 53% |
| One PRO category | 63 | 78% |
| Two PRO categories | 54 | 67% |
| Three PRO categories | 2 | 2% |
| GBA decision – extent of PRO data considered in the decision |
| No PRO data considered | 31 | 38% |
| One PRO category | 25 | 31% |
| Two PRO categories | 25 | 31% |
| Three PRO categories | 0 | 0% |
| GBA decision – type of PRO data considered in the decision |
| Clinical PROs | 39 | 48% |
| HRQoL | 59 | 73% |
| Preferences | 0 | 0% |
| Satisfaction | 0 | 0% |
| Comparison between data submitted and data considered by the GBA |
| Identical number of PRO categoriesa | 42 | 50% |
| Diverging number of PRO categoriesa | 29 | 40% |
| Clinical PROs - not considered by GBA | 8 | 21% |
| Clinical PROs - added by GBA | 6 | 15% |
| HRQoL - not considered by GBA | 19 | 31% |
| HRQoL – added in GBA decision | 2 | 3% |
| Preferences – not considered by GBA | 2 | 100% |
| Satisfaction – not considered by GBA | 1 | 100% |
- GBA German Federal Joint Committee, HRQoL Health Related Quality of Life, PRO Patient-reported Outcomes. aThe number does not add up to n = 81 (all regarded processes) as some manufacturers did not provide PRO data
