Indirect comparison incorporating Real-World Evidence

Challenge

Significant uncertainty in the estimated survival for the comparator treatment:

  • New innovative treatment option and no gold standard in this indication
  • Comparator used in pivotal trial not available in Europe; high level of crossover to study drug (>70%)

Request

Estimate survival advantage compared to current clinical practice as per HTA requirements

Response

  • Conducted indirect comparison and crossover adjustment
  • Supervised analysis of real-world evidence (RWE) which provided an alternative source of comparator estimated survival
  • Conceptualised new economic model in area with no precedence