An Exploratory Comparison Of US And EU Approaches To Oncology Management. Are US Payers Ready For Management Tools Incorporating HTA Methodologies?

OBJECTIVES: US payers are exploring innovative cost containment management tools (value frameworks, pathways, shifting risk, etc.) in oncology today. Compared to their European colleagues, payers in the US face significant barriers to implementing tools designed to drive value based decisions. This research aims to 1) assess difference in the scope and scale of barriers to implementing such tools in the EU and the US, 2) explain market and legislative conditions that likely create the differences in implementation, and 3) propose the necessary conditions for US payers to implement more value based decision making in oncology. METHODS: We compared the current price and access of drugs indicated for CLL and NSCLC in the US and 4 EU countries. To assess how price and access decisions are made, we reviewed HTA reports published in Europe and conducted an oncology web-based survey with 20 US payers for an industry assessment of the barriers to implementation and effectiveness of innovative cost containment management tools today. RESULTS: Compared to the US, EU countries have lower list prices and more stringently controlled access. In the US, the use of value frameworks remains limited to date. Pathways of care are largely not designed with value considerations. Where pathways of care do exist, they are weakly enforced or incentivized. Payer management in the US is limited by the lack of comparative data, limited competition in patient sub-populations, rapid evolution of the guidelines, and outside pressure to maintain broad formularies. CONCLUSIONS: Payers are willing to implement innovative management tools, but in absence of a profound public policy change, these tools will be effectively implemented only in oncology indications with mature evidence and robust competition. Value frameworks or other HTA type of value assessment will not significantly influence the evaluation of innovative drugs with high unmet need and low competition.