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Value Communications for Market Access: Case Study 3


A leading microbiome therapeutics company was preparing for regulatory review and launch of a novel therapy designed to treat recurrent Clostridium difficile infection (RCDI), the leading hospital acquired infection in the US.   A challenge for this investigational therapy was that although it was being reviewed by FDA as a breakthrough biological therapy, its proof of concept was based on a highly effective, low-cost, non-FDA regulated treatment that was regarded in the professional community as a treatment of last resort.


3D conducted an analysis of stakeholder positions, competitor data and manufacturing practices.  We also conducted a detailed market analysis, including:

  • coverage of current non-approved, potential competitors in all US market segments ascertained by billing codes and coverage policy;
  • quality metrics associated with the disease;
  • stakeholder development of real-world data around the disease; and
  • payment reforms that could influence market access.

Based on findings of all this research, 3D developed messaging to communicate the unique value and benefits of this therapy for RCDI patients, and the hospitals and long-term care facilities that care for them. To ensure that these messages would resonate with key audiences, 3D convened a panel of experts who provided critical feedback, insights, and guidance on messaging and strategies that could address potential future market access issues.


The company has messaging and recommended strategies for partnerships with key stakeholders that will support value, market access, and uptake of this treatment, once approved.  These key stakeholders include: regulatory agencies, payers, infectious disease specialists, gastroenterologists, hospital administrators, pharmacists, and the C. diff patient community.