The Fourth Hurdle.

The fourth hurdle in drug development and patient access to new therapeutics is reimbursement. The evidentiary requirements that are sufficient to regulators may not be sufficient to allow health technology assessment (HTA) bodies to make informed cost-effectiveness and formulary decisions. The accompanying paper by Vreman et al confirms that facilitated regulatory pathways may result in regulatory approvals but may not result in patient access to new and important medicines. This article is protected by copyright. All rights reserved.