Optimizing Phase 3 Design to Achieve a Higher Price Point
Challenge
We worked closely with cross-functional client teams to map out various scenarios, considering regulatory timelines, price potential, net present value (NPV), and associated risks. This detailed scenario planning offered a comprehensive view of the implications of different regulatory and market strategies.
Solution
Impact
The in-depth scenario planning provided the board with a robust foundation for decision-making, ensuring that all aspects—regulatory, financial, and commercial—were considered. While the ultimate decision regarding the best path is still pending, our work ensured that the company avoided the regret of hindsight, empowering them with the knowledge needed to make fully informed strategic choices.
A client’s clinical development plan involved a staggered regulatory approval—initially with surrogate data followed by outcome data 18 months later. While this approach accelerated the time to market, there was concern that launching based on surrogate data might establish a lower price point that could not be adjusted upward even after the release of compelling outcome data.