An established US biotech, aware of the importance of incorporating market access factors into clinical trial design, wanted to conduct strategic research for a novel advanced breast cancer therapy about to enter Phase II trials.


We developed hypotheses for payer value metrics from research of the current market for breast cancer therapies, focusing particularly on labels and clinical trial designs for recently launched products. Based on two scenarios for the product’s performance, we conducted a series of interviews with payers and key opinion leaders in the USA, Germany, France and the UK. The key objective was to understand the extent to which health economics and outcomes research (HEOR) data would be valued by payers in each scenario and exactly what kinds of HEOR data would be useful, for example, mobility, pain, QoL metrics preferred by payers, caregiver burden and any other patient reported outcomes. We also explored the broader market access environment in advanced breast cancer. Our findings informed the design of Phase II trials, ensuring that the differentiation elements perceived and valued by payers were adequately captured.


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