HTA QUARTERLY | FALL 2016
Rapid Access in the US, UK, and France: How Do the US Expedited Programs for Serious Conditions Compare to EAMS and the ATU?
As the gatekeeper for regulatory approval in the US, the Food and Drug Administration (FDA) has remarkable power to incentivize drug development in key areas by providing a speedier pathway for approval, either via a shortened review time or by modifying the evidence required for approval. Similarly, early access to medicines granted by the National Health Service (NHS) in the UK and the Haute Autorite de Sante (HAS) in France via specialized programs hopes to encourage development of innovative medicines addressing key unmet needs. While not all products are eligible, these programs aim to provide early access to new technologies that can help patients who are afflicted by serious diseases with a high unmet need.