Immuno-Oncology Medicines: Policy Implications and Economic Considerations.

Significant progress has taken place in the field of cancer immunotherapy in recent years. Cancer immunotherapy, particularly immune checkpoint inhibitors, have shown rather dramatic results and are believed to have completely transformed the field of oncology. However, these transformational therapies are more expensive than previous cancer therapies. As more cancer immunotherapy agents are being developed, with some already being marketed, it is important to consider how economic constraints will shape health policy and value assessment related to these agents. A number of strategies have been suggested to alleviate the price burden and the ensuing concerns about the sustainability of publicly funded healthcare systems. Among these strategies, value-based pricing (VBP) for innovative drugs dominates the headlines in the field of oncology. The specifics of how VBP may be implemented in the United States is still unclear. Nonetheless, policy reform and economic considerations will have to be incorporated into the planning of VBP. The objective of this paper is multifold: (i) to identify the factors affecting the impact of cancer immunotherapy on healthcare cost; (ii) to critically appraise current approaches used to assess the value of novel cancer therapies; (iii) to assess the methodological challenges associated with the economic evaluation of cancer immunotherapy. As the health care system in the U.S transitions toward a value-based model, the need for a formal value assessment framework is warranted in cancer immunotherapy.