On Changing the System

Developers of innovative pharmaceuticals often face the challenge of healthcare systems that are not optimally designed to support the commercialization of their products. Advocacy, public affairs and policy shaping efforts aspire to address those challenges and drive change.

In planning for the introduction of a new product, it is important to decouple aspirations regarding systemic change from baseline commercialization plans. We have to acknowledge that: a) the aspired change is not directly in our control and therefore may never occur, and b) if it does, it may take a significant amount of time to get there.

In most cases, the baseline go-to-market plan should make the conservative assumption that the current system will remain unchanged while ongoing policy efforts could create a favorable upside in the future.

The fascinating field of cell and gene therapies (CGTs) serves as an example here: While many manufacturers had the ambition to create a new payer system for CGTs (especially in Europe), those companies that were willing to find solutions within the boundaries of the prevailing systems were most successful, while others trying to “push” a new approach were sometimes not able to launch at all.