Centrally assessed progression-free survival data might be more reliable than locally assessed progression-free survival data in the presence of differences in adverse-event rates. |
When the overall survival data from the trial are immature, different (e.g. partial or full) progression-free survival to overall survival surrogacy approaches should be explored in different scenario analyses, with different parameter realisations, which all should be taken into account in the decision-making process. |
When there are more than one simultaneous/recent appraisals in the same indication, this can be beneficial as the results of the other appraisal might be used for external validation purposes. |
The iterative nature of appraisal meetings may provide an opportunity to find a middle ground between the company assumptions and the Evidence Review Group point of view. The company may provide enhanced patient access scheme discounts to reduce the uncertainty surrounding the cost effectiveness of the drug in this process. |