Of course, this conclusion begs the questions: Why were more new cancer drugs approved in the US than in Europe, and among
the 29 drugs common to both regions, why were all of them approved and marketed first in the US? The answer is that approvals
are, in part, a function of both regulatory policy (e.g., access to priority review and accelerated approval procedures) as
well as institutional features, such as whether an environment is more conducive to the marketing of products. The US has
fewer price controls and has less institutionalization of cost-effectiveness assessments as a possible barrier to market access.
Consequently, pharmaceutical companies are more likely to seek approval and market their products first in the US.
If the following policy goal is presupposed—that is, to maximize aggregate health outcomes subject to a budget constraint—then
the European scenario of granting less access to medicines deemed to offer less value (i.e., less cost-effective) may make
sense. This scenario, however, is a societal or payer perspective and may not represent the best interests of individual
patients, who are unlikely to care much about average, aggregated data. To them, having more immediate access offers hope,
a chance at an extension of life, or an improvement in quality of life.
There may be a trade-off between access and pricing: greater access at the expense of higher, possibly unaffordable prices
to patients. It's a "cruel irony."
Kenneth I. Kaitin, PhD, is professor and director, and Joshua P. Cohen, PhD, is assistant professor, both at the Tufts Center for the Study of Drug Development, Tufts School of Medicine, Kenneth.Kaitin@tufts.edu
1. K.I. Kaitin, Ed., "US Offers Patients Faster, Greater Access to Cancer Drugs than Europe," Tufts CSDD Impact Report 14
(4), 1–4 (2012).