Background
Our client needed to consider how to optimise pivotal study design concepts to ensure appropriate evidence is generated for maximum possible differentiation and optimal access with respect to the evolving treatment landscape and future standard of care.
The cross-functional team wanted to understand how key external stakeholders would perceive the proposed evidence-generation plan, specifically around the type and approach to patient-centred endpoints and how best to utilise such data to support optimal access.
Valid Insight Approach
Valid Insight developed a multi-stakeholder advisory board, including:
- Key global opinion leaders to share the complex clinical background of the disease and the lack of optimal therapeutic options, and to share such insights with payers.
- Patient advocacy representatives (patients themselves) to provide deep insight into the clinical, physiological, and emotional burden of the disease and implications of existing therapies.
- ‘Payers’ to use these insights to align on what optimal evidence would be needed to support the desired positioning, pricing and reimbursement position based on various clinical design scenarios.
Results
The company was able to determine the most effective evidence-generation scenario that would yield optimal position, price, and reimbursement.
The company could also determine the education needs of payers to help them interpret patient-centric evidence correctly and assign true product value to the product.