Putting the Patient at the Center of an Expanded Access Program

Expanded Access Programs EAP - UBC

Putting the Patient at the Center of an Expanded Access Program

Mapping a patient’s journey through an Expanded Access Program (EAP) requires multi-dimensional perspective and foresight. At the outset of a program, consideration must be given to the patient experience continuum starting with enrollment in the EAP through to the patient’s transition to commercial product. This transition will vary in each country where the product is planned for launch, as each country will have its own timeframe for approval and for reimbursement discussions with payees.

UBC is the only company that combines all of the necessary services to provide a seamless patient journey. Utilizing experts in Clinical Development, Reimbursement Hubs, Nursing and Specialty Pharmacy at the outset of an EAP allows UBC to offer a true start-to-finish solution and a panoramic view of patient care throughout the process and across the globe.

When EAPs and post-approval commercial programs are designed and implemented in isolation, opportunities are missed to create value for manufacturers by leveraging the linkages across both service offerings. UBC is well positioned to:

  • Understand the global regulatory environment governing EAP implementation
    UBC has an extensive team of local experts throughout the world who are experienced working with national and local regulatory agencies and institutional review boards/ethics committees to effectively plan and implement EAPs.
  • Enhance understanding of the payer landscape
    In the U.S., with optimal sequencing of IRB submissions and approvals, it is possible to compress the timeframe for collection of insurance information from the EAP population, facilitating an early review of the payer landscape.
  • Accelerate benefit investigations
    By structuring the program correctly and optimizing the IRB approval sequence, our team is able to initiate benefit investigations in the U.S. rapidly upon marketing approval.
  • Show sensitivity to ethical considerations and seamlessly transition patients to commercial product
    Eliminating potential bottlenecks means we can keep patients’ welfare a top priority, accelerate patient transition to commercial product and minimize attrition due to access barriers. Our dedicated cross-service specialist team ensures 1:1 coordination of patient transition when treating physicians have indicated marketed product remains the treatment of choice, preventing any gaps in care and easing the process for reimbursement and physician staffs.
  • Coordinate with the specialty pharmacy
    In the U.S., two-way communication between the reimbursement hub and specialty pharmacy allows our team to track a patient’s prescription through the pharmacy and schedule the patient’s final EAP visit once the medication is received. Throughout the rest of the world, we work with medical liaisons and sales teams to ensure marketed product is available leading up to the planned completion of the EAP.
  • Leverage insights in post-marketing commercial programs
    Our cross-functional team utilizes knowledge gained from the EAP to tailor the design of commercial offerings, such as mandated post-authorization safety studies (PASS) or patient assistance programs.

Click here to download a free report outlining how to build patient relationships through EAPs from the editors of FirstWord, or contact us to discuss how UBC can start and end your EAP right by keeping the patient at the center of the program.