The U.S. healthcare market is shifting rapidly, with an increasing number of products receiving U.S. Food and Drug Administration (FDA) accelerated approval. This process, particularly with the use of surrogate endpoints, has created increased uncertainty for payers and HTA bodies when making coverage decisions. Leveraging lessons from abroad, there may be options that US payers have for coping with accelerated approval.
Specifically, this webinar will review:
- The significance of the shifting landscape and the dilemmas of the FDA accelerated approval process;
- The current landscape of accelerated approval processes in the U.S. and globally;
- Global responses to the accelerated approval of products; and
- U.S. payer options for managing coverage decisions given accelerated drug approvals.