UBC has managed expanded access programs (EAPs), also known as compassionate use programs, to treat many conditions, including cancer, HIV, Alzheimer’s disease, psychosis and cystic fibrosis. We’ve gained critical insights into what processes work best for enrolling patients and capturing data quickly and efficiently. We’ve learned that teams supporting these programs should excel at three core competencies: speed, flexibility and collaboration.
Often sponsors launch a Named Patient Programme (NPP) and quickly become overwhelmed navigating the hurdles to provide access to pre-approval medication. Our recent blog highlights the solutions we implemented for a global NPP supporting a rare-disease patient population.
Designing and implementing expanded access programs (EAPs) requires a unique perspective and a breadth of services that span the product development process. Starting with the end in mind is critical to supporting patients’ access to therapy in the EAP and seamlessly transitioning those patients to commercial product.
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.
Development of specialty therapies is on the rise, especially for rare diseases, fueling an increase in patient awareness and advocacy. More often manufacturers are being asked to implement Expanded Access Programs (EAPs) while products conclude clinical trials. These programs set the tone for the relationship between the brand and the patient, making it critical to design the EAP with a variety of factors in mind. Download our free report that outlines key insights that every manufacturer should know about EAPs