The Challenge
Inbeeo’s client is currently developing a product in a highly competitive CNS indication (PD). After an online survey provided early perspectives into the business case for the refined TPP (see slide), they requested Inbeeo’s support in gathering deeper insights from payer experts into the Phase II and Phase III trial designs and market access strategy.
As a potential best-in-class product, thoughtful considerations of the trial design would be needed to support differentiation, access, and launch of the product in such a highly competitive environment.
The Approach
With the product approaching the latter stages of clinical development, and with limited understanding of the payer perspective on the current plan, Inbeeo held an advisory board with payers from the EU4 and the US to discuss further refinements to the clinical programme, in particular:
- Study population
- Product positioning
- Comparators
- Clinical outcomes
- Trial duration
Each advisory board was attended by a clinical expert, who provided clinical input into the trial design, and addressed payer uncertainties on the design when relevant.
The Impact
Inbeeo’s client has refined the clinical development program and market access strategy for their novel therapy, with changes to the primary endpoint and study population based on what is most valuable to payer audiences in the US and EU4, and which will support product differentiation amongst a highly competitive launch environment.
