Client issue
A leading pharmaceutical company sought support from CRA Life Sciences experts in the clinical development of several new monotherapy and combination products, each using one of two new MOAs, in a variety of solid tumors across multiple lines of therapy.
CRA approach
We developed a detailed evaluation of the seven tumor types that were of interest to our client. We helped them map out the anticipated clinical changes in the treatment paradigms and performed forward-looking analyses of expected HTA and pricing decision drivers. We conducted payer panel sessions in the US and Europe to test the payer-decision drivers for each asset in different tumor x line of therapy combinations. We asked our payers to consider how the clinical, HTA, and pricing environment was likely to change, and form an idea of what magnitude of efficacy improvement would effectively “move the needle” vs the standard of care in 3-5 years. Crucially, we sought to understand the PMA impact of building a clinical trial program that heavily relies on a backbone PD-1 inhibitor, owned by a different manufacturer, and the implications for our client’s asset as an “add-on” therapy in a future where the backbone is approaching LoE.
Client impact
The outputs of this project allowed us to rank and prioritize the client’s assets by indication and line of therapy from a future PMA perspective. It has allowed them to understand how changes (or lack thereof) in unmet needs, efficacy expectations, and the evolution of the standard of care can have a seemingly disproportionate impact on pricing. Our client is now able to make critical business decisions on the future of its pipeline using a payer-validated perspective.
