Overview
Real-world data (RWD) can play a crucial role in complementing clinical trial data in Health Technology Assessment (HTA) decision-making. When local RWD is not available in a timely manner, data from other countries may be considered. However, this raises concerns about whether RWD from one country can be applied to another, a concept known as "transportability.”
This research evaluates the transportability of overall survival estimates from the U.S. to England for HER2+ metastatic breast cancer (mBC) using the US nationwide Flatiron Health electronic health record-derived deidentified database and the ESTHER study, a registry of UK patients with advanced HER2+ breast cancer. It was seen that overall survival estimates for patients with HER2+ mBC in the U.S. were similar to those in the UK, with or without population adjustment.
Why this matters
By identifying solutions to pool international data to answer local questions, it's possible to reduce uncertainty in how non-local real-world evidence can be used for local regulatory decision making, including for health technology assessments. The findings of this research indicate the U.S. overall survival estimates are a reasonable proxy for overall survival estimates in the UK HER2+ mBC population. However, additional research is needed to evaluate the transportability of real-world evidence across additional diseases and between other countries, along with the suitability of other methods of adjustment.