Reimbursement challenges with cancer immunotherapeutics.

Today the task of cancer vaccine developers is not only to excel in cancer immunology and art of conducting immunotherapy trials but also in the analysis and forecasting the cost-effectiveness of the final product. This article reviews methodology used by EU health-technology bodies in the appraisal of new therapies based on economic and clinical values and different budgetary uncertainties. Increasingly, new oncology treatments were able to access EU market only under provision of risk-sharing agreements with payers and examples of such agreements are given here. Cancer vaccine developers should consider early collection of patient reported outcomes in order to project additional clinical and economic value with immunotherapy. Furthermore, early interaction with different stakeholders including patient organizations, physicians and payer bodies can facilitate market access.