Table 1.
Change # | Description |
---|---|
1 | Fixing programming errors (mostly affected scenario analyses) |
2 | Updating the PFS-related clinical model inputs for the first line with the MONALEESA-2 data from the most recent data cut-off date (January 2017) |
3 | Incorporating the wastage costs (for the unused tablets in the last treatment cycle) |
4 | Using the inflation-adjusted post-progression treatment-related cost estimate from the fulvestrant appraisal (£1140) for monthly third-line treatment costs [32] |
5 | Changing the modelling of the post-treatment discontinuation survival after second-line chemotherapy (so that the arbitrary Weibull scale parameter assumption in the CS is not used) |
6 | Implementing the partial PFS to OS surrogacy approach. This de novo approach decreases the time spent in states after first-line PFS in the ribociclib arm of the model in such a way that it would result in a “gain in median OS/gain in median PFS” ratio close to 38.5% (4.2 months/10.9 months) from the PALOMA-1 trial, instead of the full PFS to OS surrogacy or threshold-based PFS to OS surrogacy approaches in the company CS |
CS company submission, OS overall survival, PFS progression-free survival