A biotech company that had recently completed a late-stage clinical trial for its first-in-class mAb therapy for a chronic inflammatory skin disease wanted to test the use of a newly established clinical endpoint with European payers. The purpose of this work was to help the company further develop its clinical strategy by better understanding the preferred positioning of its product, optimal design of the pivotal trial, and most realistic reimbursement strategy in Europe.
Alacrita supported the company with qualitative primary research with European payers to better understand the market dynamics and potential pricing for the product. In preparation for the research, we refined the target product profile (TPP), detailing the proposed positioning and clinical usage of the therapeutic; the TPP was formulated into a pre-read for the payers ahead of the interviews. Alacrita recruited payers currently or recently involved in Health Technology Assessments (HTA), and reimbursement and pricing decisions at national or regional level, particularly those with direct experience with the disease. We explored their views on impact of the disease, unmet need (clinical and economic), value proposition of the client’s novel product and views on clinical trial design, specifically regarding the use of the new endpoint. We summarized the findings in a report which served to guide the biotech company to strategically design its upcoming Phase III trial to support favorable product positioning and pricing when launched commercially.