Growth Maximization Case Study: Loss-of-Exclusivity Assessment for Ultra-Rare Orphan Drug

Client Situation

Our client was a small, global biopharma company focused on the development of new treatments for severe, rare genetic diseases. Leaders at the company sought an understanding of the potential impact of loss of exclusivity (LOE) on sales of its drug for an ultra-rare orphan disease and recommendations for mitigating loss to a generic.

Promidian Solution

This project focused on the US market access landscape, specifically strategies for engagement of payer and specialty pharmacy customers.

In developing a robust LOE assessment, we conducted primary research with 30 external stakeholders, including managed care organizations, managed Medicaid, and specialty pharmacy.

We also developed in-depth analog case studies for three companies facing LOE in various orphan diseases to identify key learnings for the client.

We then developed a detailed view of the likely market situation at LOE and implications for the brand with regard to pricing, sales, and risks to the brand with each stakeholder in the buying process.

Finally, we identified potential strategies for each stakeholder in the buying process, including physicians, patients, payers, and specialty pharmacy.