Histology independent therapies (also known as tumour agnostics) are a new class of medicines that target a genomic alteration within a tumour regardless of where it is in the body. These novel treatments face significant methodological and policy challenges related to evidence development and acceptance, value assessment and reimbursement pathways, and diagnostic infrastructure availability.

While these therapies have been able to gain accelerated access via adaptive regulatory pathways in various countries, existing HTA processes prove more challenging. Positive reimbursement recommendations are scarce and usually limited to specific indications. Potential ways to overcome the HTA hurdles include better alignment of evidence sources and endpoint requirements, acceptability of post-authorisation data collection models and innovative payment models. Yet, while the challenges for histology independent treatment are quite similar in various countries, solutions will likely have to be diverse and include methodological advancements as well as policy-makers’ willingness to adopt new approaches.

This Educational Session will 1) provide insight in the current regulatory and HTA landscape for histology independent therapies in various countries in North-America, Europe and Asia; and 2) discuss how to move forward from here. Global experts on histology independent therapies will provide their insights and discuss how to make a positive change from a patient representative perspective, a medical perspective and an HTA and policy perspective.

With an increasing amount of histology independent therapies coming towards market, there is a need to find solutions today. This session will sharpen your thinking and inspire to move beyond the unsustainable status quo.