The crisis of affordability for drugs and other therapeutics has only intensified since the origi- nal Vital Directions initiative was convened in 2016.2,37 Highly effective therapeutics may lower aggregate spending by reducing the need for costly interventions or hospitalizations, but many of these novel medicines command high prices.40 More challenging is the fact that high prices are not always aligned with value. Prices on existing, branded drugs have increased sub- stantially during thepast decade, limitingafford- ability and access.37,41,42 And even in circumstanc- es where the benefits are unclear or modest, many new therapeutics are still reimbursed at high rates.37,43
With continued innovation on the horizon— including gene therapy—these challenges will become more acute. Broadening the pool of Americans who can obtain and afford high-value therapeutics will require reimbursement struc- tures that align payment with value and balance affordability with the continued need for inno- vation. Such efforts face a number of challenges: regulatory barriers that limit generic and bio- similar development; a lack of robust informa-
Although difficult trade-offs are inevitable, we believe there are opportunities to simultaneously improve access, affordability, and equity.