Challenge:
A clinical stage biopharma company developing a novel small molecule to treat a rare respiratory disorder had conducted an Advisory Board to finalize the design of later stage clinical studies for the asset. The Board wanted to understand the best positioning of the small molecule and particularly whether the clinical endpoints selected to date were sufficient for reimbursement approval. The company asked Alacrita to conduct a study investigating payer perspectives so that a robust clinical development strategy could be crafted for discussion with regulators, as well gain a preliminary understanding of the price range that could be achieved for the product.
Solution
Alacrita’s experts provided market access input through payer interviews and combining their findings with secondary data collection and synthesis. We first drafted a TPP outlining details about the product, clinical studies and value proposition which was shared with payers ahead of interview. We also prepared a discussion guide to focus the interviews on particular areas of most importance to the company. Alacrita recruited payers from EU5 and Scandinavia and interviewed them on the payer environment, patient journey for the disease, unmet needs, views on clinical trial design and in particular the primary and secondary endpoints, views on pricing, and appropriate study and pricing comparators.
We conducted this work over a 4-week period and presented the findings to the company’s executive team. Based on the findings, Alacrita’s recommendations were to investigate alternative options for primary endpoints, increase the study size and build a KOL network to influence payer views of the data package.
New Product Planning
As the demands of the pharmaceutical market rise, and new products challenge established principles, it is more important than ever that product strategies meet the needs of providers, payers and patients. Innovations in oncology and immunology are challenging the concept of an approved indication, curative gene and cell therapies are changing payment models, and specialty pharmaceuticals are evolving the supply chain. Alacrita’s commercial consultants bring first-hand experience across a broad range of products and diseases, to help our clients define and execute successful product strategies.