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CASE STUDY: Innovative, Unique Distribution Strategy Design and Implementation

A well-known, existing specialty therapy in open distribution was challenged by the pending approval of an additional orphan indication. The brand was working to address FDA comments and concerns regarding the potential for dosing errors and a request to perform additional HF studies. Our Advisors were engaged to support the design/development of a limited distribution and channel support strategy for the new orphan indication.

Our Advisors rapidly worked with the brand and managed markets teams to:

  • Competitive Market Analysis 
  • Serve in a senior brand leadership advisory role
  • Identify examples of relevant analog open to orphan indication channel strategies
  • Design and develop a risk management/REMS program
  • Design a wholesale distribution and limited specialty pharmacy network
  • Develop a HUB services integration plan
  • Develop program recommendations and participate in presentation/approval process with manufacturer senior leadership
  • Support development of the FDA proposal
  • Create wholesaler and specialty pharmacy provider contract addendum
  • Exception Access Strategy / Support contract negotiation and execution
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