Patients and advocates have asked me this question over the course of my career, especially those outside of the United States. The repetitive nature of the question shows there is an information gap regarding expanded access – one that needs to be filled.

It can be very challenging to determine if expanded access is available in certain countries or how the request process works. Expanded access is a pathway seriously ill patients who are not eligible for a clinical trial and have exhausted commercially available treatment options may explore with their treating physicians.

For these patients, time is a precious commodity. Expanded access information needs to be clear, "people friendly," and readily available. To support the information gap for patients, caregivers and providers, Patient Strategies & Solutions (PS&S), a team that I lead at Janssen within the Office of the Chief Medical Officer (OCMO), collaborated with Bionical Emas, patients, and patient representatives to create a first-of-its-kind Guide to Expanded Access. Co-creating with patients and making them part of the process, not the recipient of the outcome, is the only way to help ensure we meet the true need.

Together, we identified what patients feel is most relevant about expanded access and then culled the content into a list of nine key questions and answers from patients. The Guide presents information on expanded access for 28 European countries and Canada. It has already been shared with a wide array of patient groups and we look forward to continuing engaging, listening and acting on what we learn on behalf of patients.

If you would like to read the Guide to Expanded Access or watch a video on its creation, visit our Patient Resources page.

October 4, 2021