Generating Comparative Evidence on New Drugs and Devices Before Approval

Fewer than half of new drugs approved in Europe and the US have comparative evidence against existing treatments at the time of approval, and this gap is even more pronounced for medical devices, creating uncertainty that is exacerbated by expedited regulatory programmes. The authors propose five stratgies to ensure the appropriate generation of comparative effectiveness data: including a statement of comparative data availability on drug, more selective use of expedited approval pathways, regulator encouragment of active-comparator randomized trials, use of prospective network meta-analyses, and leveraging payer negotiating power to incentivize comparative evidence generation.