THOUGHT PIECE PREVIEW: Alternative Access Pathways: A Bridge to the Future?

Innovation marches on with breakneck speed as oncology products with novel approaches to stopping cancer cruise through regulatory pathways on their way to FDA approval.  However, the gap between FDA approval and EMA approval, as well as the subsequent local reimbursement / pricing assessment can create major disturbances to patient access.  Over time, a variety of methods for bridging this temporary gap in access between clinical trials and reimbursement have naturally evolved.  Among these, it is the pathways organised by governments in Europe that provide the most effective solutions to patient access needs in the early stages of a product’s lifecycle.  Other government-initiated pathways have been created out of necessity, including drug funds for products that have been rejected by value assessment methodologies ill-suited for properly evaluating small-population, but innovative, high-cost therapies.  Benefiting from these alternative access pathways is not with its risks – but if the alternative access strategy is planned effectively, these concerns can be transformed into assets in the pursuit of access within the very same countries.  While the future of these pathways is still unknown, the industry must turn to work with public payers throughout Europe and other established markets to identify sustainable access pathways in both the short- term and long-term.