Transatlantic Convergence with Respect to the Fourth Hurdle?

Abstract

There appears to be movement towards convergence between the US and Europe in terms of the objectives of prescription drug cost containment, improvement in and more equitable access to pharmaceuticals, and minimisation of variation in clinical practice. In addition, policymakers in the US and Europe are resorting to the use of similar evidence-based approaches to achieve these policy objectives. However, using the examples of clinical practice guidelines, new drug appraisals for reimbursement, reference pricing and prescription to over-the-counter switching, I illustrate how the development and implementation of such approaches are a function not only of evidence but also of politics. Because all politics is local and differs across countries, and settings within countries, this logically has resulted in instances of divergence in the development and implementation of evidence-based approaches. Evidence improves policy decisions by offering quantitative insight into how well new technologies work, and for whom, but such data do not eliminate vexing trade-offs between the benefits provided and the acceptability of risks and costs incurred to achieve those benefits. Judgments on trade-offs depend in part on the interests and values of stakeholders. And these interests and values help shape how policy makers responsible for drug reimbursement in the US and Europe develop and apply the same types of evidence-based approaches differently.