Our client was developing a CAR-T therapy in Multiple Myeloma (MM) across multiple lines of therapy. One of the indications being explored was its use as a maintenance therapy in MM after autologous stem cell transplantation (ASCT).
In order to inform their market access strategy and maximise the access / reimbursement opportunity in transplant not intended (TNI) newly diagnosed multiple myeloma (NDMM), our client needed to identify the key value drivers and optimal clinical trial design.
Following an initial scoping and desk research phase, we conducted focus groups with payers and KOLs in the EU and Canada in order to understand the MM maintenance landscape, the perceived value of our client’s new therapy, the optimal clinical trial design, and the potential pricing and reimbursement impact.
We were able to determine the optimal clinical trial design for our client’s CAR-T therapy including the value of maintenance therapy, the optimal patient population, comparator selection and key endpoints critical for success. In addition, we evaluated the likely positioning within TNI NDMM and assessed the anticipated reimbursement challenges and opportunities in each market as wells as potential solutions. The results of our study gave our client the insights they needed in the following four areas: