Development of Franchise Molecular Diagnostics Strategy

CLIENT: A leading pharmaceutical company with a large oncology portfolio looking to understand the impact of molecular diagnostic test utilization on their products.
BUSINESS QUESTION: How should a manufacturer support appropriate, clinically validated molecular diagnostic testing across their oncology franchise?
  • ISA’s Oncology & Specialty Therapeutics Team utilized their existing Molecular Diagnostics Database as well as the current literature on diagnostic tests to prioritize those diagnostics most relevant to the client’s brands
  • The ISA Team conducted in-depth discussions with their continuously updated and validated extensive network of KOLs, payers, physicians, pathologists and molecular diagnostics vendors to further assess:
    • Which tests are most frequently used, when they are performed, and how results help guide treatment decisions
    • How the use of diagnostic tests is anticipated to change in the future
    • How stakeholders assess the clinical value of molecular diagnostic tests and the factors that influence utilization
    • Payer policies and capabilities to manage utilization of tests
    • Competitor manufacturer strategies to support use of diagnostic tests
    • Remaining unmet needs in molecular diagnostics
    • ISA developed criteria by which the available diagnostic tests could be segmented to prioritize those requiring additional clinical validation or educational initiatives to support appropriate use
RESULT: ISA recommended vendor and payer partnerships and internal initiatives that could be used to support both brand-specific and franchise-wide molecular diagnostics strategies. The client recently decided to partner with a molecular diagnostic company to support future testing.