Accelerating a New Product Launch in Europe Without Jeopardizing Reimbursement and Access

A top 10 pharma company was developing an innovative, high-cost therapy for solid tumors. It would likely be first to market, but competitors would be soon to follow. The client needed to decide how to accelerate approval, access, and launch in the top four EU markets plus the UK without jeopardizing market access or price. Several acceleration options existed (e.g., leveraging innovative study designs, providing interim data, etc.), but each option presented different access and pricing risks in different countries. Trade-offs were needed to achieve a coherent global plan.

We began by conducting an in-depth analog assessment to identify similar products that had accelerated their launches. We then analyzed their regulatory pathways, data packages, timelines, and reimbursement and pricing outcomes. Next, we layered in a series of expert interviews to understand the correlations among disease/product characteristics, the data package at approval, and access outcomes. This enabled us to Identify five strategic options for accelerated approval and access based on requirements for indication and product potential. To complete the project, we aligned with the client’s cross-functional team on the preferred option.

Our team recommended a strategic option that we characterized as medium- to high-risk. This approach was selected because of the product’s transformative potential and because we had developed contingency plans for specific countries.