Cross-Border Expanded Access Programs: Reducing Barriers to Treatment Access
Imagine you have a new, exciting therapy recently approved in one market. It’s going to save lives, inspire further innovations, and perhaps even shape the future of healthcare. It requires specialist treatment that is only available through certain approved and trained treatment centers. Then you hear about patients on the other side of the world who desperately need your therapy. How can they possibly get to your specialist centers for treatment? Navigate the complexities of obtaining a visa? Pay for the trip and treatment? How can they even communicate with your team?
Many sponsors and pharmaceutical companies that work with nuanced therapies requiring specialist centers for treatment may face this dilemma. Durbin offers a unique solution: a cross-border Expanded Access Program (EAP) service called Cross-Border Access Navigator (CBAN).
What Is a Cross-Border EAP?
Cross-border EAPs, sometimes called cross-border Compassionate Use Programs, provide services and support to a patient or family so they can go abroad for a not-yet-commercialized treatment only offered in a restricted number of specialist centers. These programs allow sponsors to compliantly and sustainably reduce barriers to treatment access for patients who would not otherwise be able to obtain the therapy.
Durbin’s CBAN service is a unique, patient-centric solution offering custom-built, flexible support programs that address key cross-border access challenges. CBAN not only accounts for the medical and administrative nuances related to the indication for which the therapy is approved, but also features one-on-one, concierge-level support to patients and families who are looking to obtain cross-border access to the therapy. Our Care Concierges are professional, experienced, and highly trained to offer patient support when requested, including:
- Compliant treatment awareness and communication to patients and the necessary medical communities
- International travel information and support
- Design and management of innovative financial support solutions, including flexible payment options
- Translation services
- Coordination between the patient, their referring healthcare professional, and the destination treatment center
- Facilitation of ongoing real-world data collection
CBAN Success With a Personalized Cell Therapy
The true power of CBAN lies in its customizability. We tailor each CBAN program to meet the unique needs of individual patients and therapies, exemplified in the recent successful launch of a cross-border EAP for a personalized cell therapy.
The cell therapy had such niche medical and administrative requirements, such as cell collection, manipulation and culturing of the cells, infusion, and long-term patient monitoring, that there were only two treatment centers providing the therapy in a specific region. However, there were pediatric patients from several countries within that region who urgently needed the treatment, creating challenges with travel and visa arrangements, language and cultural barriers, time pressure, and program compliance.
Durbin’s team of experts, drawing on extensive experience with specialty pharmaceuticals, thoroughly reviewed all aspects of the therapy to build a customized cross-border EAP from the ground up. The program addressed therapy and patient challenges by providing:
- Travel and visa support
- Fast and uncomplicated access to information for patients in their time zone and language
- A fully staffed, multilingual support team with robust governance structure
- Mapping of funding options and support for cross-border payments in multiple currencies
- White-glove guidance of compliant communication materials
- A customized tech platform with tracking, reporting, real-world data management, and advanced telephony capabilities
The Durbin CBAN team not only created a tailored program encompassing every regulatory and patient requirement, but — perhaps of even greater importance with EAPs — they did it fast enough to meet the patients’ urgent needs.
The Global Possibilities of CBAN Solutions
Durbin is a true partner to pharmaceutical companies and sponsors for achieving their cross-border EAP objectives. Because we already have the Care Concierge infrastructure in place, our CBAN solutions are sustainable for ultra-rare diseases. Given that infrastructure and our experience in cross-border access, these solutions are also easily scalable to additional countries and therapies.
Most importantly, CBAN is patient-centric. Care and compassion for the needs of patients is built deep into the model, as the whole reason behind cross-border EAPs is to support patients on their uniquely challenging journeys. With our customized cross-border EAP solution, those patients on the other side of the world, in desperate need of your new therapy, can become your patients, gaining access to treatment that would otherwise be far out of reach. And, in the years to come, you can globally scale that solution to help many more.