Addressing evidence generation in a phase-specific manner provides mutually reinforcing benefits: trials contribute to the value argument and the value data inform the design of the trials. In this way, utilizing the best available secondary research to inform primary research can reduce the risk of regulatory and reimbursement rejections.
A phase-dependent approach has potential to cut costs by avoiding investing in riskier assets, utilizing secondary evidence for multiple assets (thereby using resources more efficiently), and creating payer value while simultaneously meeting regulatory requirements.
The best way to plan evidence generation for the value story is from the beginning. But if you didn’t do that already, the sooner you start the better.