Case Study: Rapid US P&MA Assessment of a Product with Potential Indications in Ulcerative Colitis and Atopic Dermatitis
Project Objective
Our client had to make a business development decision regarding a potential new asset which would be developed in ulcerative colitis (UC) and atopic dermatitis (AtD)
To assess the asset, the client sought a rapid price and market assessment in both indications
Windrose Approach
We consolidated previous work in UC and AtD with client materials and new secondary research to confirm the disease burden, current and future treatment options, and establish the unmet needs in both UC and AtD
In the context of the current landscape, the value proposition of the target product profiles (TPPs) in both indications was assessed
We then developed hypotheses on how payers will manage each category in the future, and price and access issues to test in primary research
Finally, we conducted 13 in-depth payer interviews and 2 dyads between a key opinion leader (KOL) and a payer
Impact
Windrose provided the following:
Assessment of future payer management with biosimilars available and new agents in UC, and new treatments in AtD
Assessment of the value perceptions of the UC and AtD TPPs, including differentiation from current and / or future therapies of the same mechanism of action and current first line therapies
KOL expectations on the product utilization in each line of therapy in UC and AD
Price potential and price / access trade-offs for the product in both UC and AD
Strategies for first-line access in UC
The final output was a final report with integrated feedback from primary research, and key price optimization recommendations across indications; this was used to inform the client’s business development decision