Case Study: Transitioning Egetis Therapeutics’ Expanded Access Program to Anovo
March 28, 2025
As Egetis prepared for its first launch, it made the strategic decision to partner for the management of its Expanded Access Program (EAP) to maximize the program’s impact. This approach ensured a seamless transition while prioritizing an optimal experience for both patients and healthcare providers.
Challenge
While Egetis was satisfied with the capabilities of their initial EAP partner, they recognized an opportunity to enhance the program’s flexibility and personalization to better meet their unique needs. With this in mind, they turned to Anovo to explore a more tailored approach that could align more closely with their patient population and therapy administration as they prepared for commercialization.
Solution
Anovo provided a customized EAP solution that offered immediate and growing flexibility and personalization Egetis needed to ensure a seamless experience for both patients and healthcare providers.
- Exclusive Model: Anovo’s exclusive model provided a tailored approach for Egetis that aligned with their requirements in the rare disease space.
- Consultative Support: Anovo acts as an extension of the Egetis team, helping to drive decisions that are clear, informed, and aligned with everyone’s best interests – from manufacturer to patient, caregiver, and pharmacy.
- Customization and Collaboration: Anovo demonstrated a willingness to customize Standard Operating Procedures (SOPs) for Egetis based on their specific needs, providing a more collaborative approach.
Implementation
During the transition, Anovo worked closely with the previous EAP administrator and Egetis to create a solid foundation for the program. Their efforts focused on:
- Seamless Collaboration: Anovo partnered closely with the previous EAP administrator to ensure a smooth transfer of existing documentation and maintain continuity in the program’s setup. This collaborative effort minimized disruptions, allowing for a seamless transition and uninterrupted support for patients and healthcare providers.
- Personalized Training: Collaborative calls between Egetis, Anovo, and healthcare institutions fostered trust, alignment, and a deeper understanding among all stakeholders. These discussions enabled Anovo to customize standard operating procedures (SOPs) that seamlessly integrated with Egetis’s unique workflows.
- Education and Support: Anovo proactively immersed themselves in understanding the diagnostic journey of patients, enabling them to enhance communication and deliver more informed, patient-centered care throughout the treatment process.
“Anovo has shown great commitment in educating themselves about the patient journey—gaining a deep understanding of where these patients come from, how they receive their diagnosis, and what their treatment entails.”
- Data Collection Initiatives: While the EAP was still in its infancy, Egetis and Anovo began discussions on enhancing their encrypted data collection related to patient titration schedules and treatment responses, which would be valuable for future strategy and regulatory discussions.
Results
The collaboration between Egetis and Anovo ensured a well-coordinated and patient-centered approach, delivering meaningful outcomes for the Expanded Access Program.
- Real-Time Issue Resolution: Anovo’s proactive communication allowed Egetis to address potential issues in real time rather than waiting for scheduled meetings, significantly improving the responsiveness of the EAP.
“One of the aspects we noticed right away [after partnering with Anovo] was how seamlessly the process flowed. When setting up an EAP with large institutions, there are always complexities to navigate, but Anovo’s approach made it easy to address needs and respond quickly.”
- Streamlined Processes: Anovo’s expertise with EAPs streamlined the process for documentation and agreements, enabling faster turnaround times and reducing delays in site activation.
“What we really value about working with Anovo is their efficiency in handling documentation. These documents move quickly on our end, typically within a couple of days for review, thanks to Anovo’s excellent facilitation. Their ability to streamline the process has been instrumental in ensuring quick turnaround times and keeping things on track.”
- Efficient Therapy Delivery: Anovo’s ability to deliver medications directly to patients’ homes within 24 hours reduced logistical burdens for families, especially those dealing with the challenges of ultra-rare diseases.
“Anovo’s ability to contact families to ensure someone is home to receive therapy or to schedule a convenient day has been invaluable. They can coordinate within 24 hours if needed, or schedule for a specific day, like next Wednesday, to accommodate the family’s needs. This flexibility has been a significant factor in enhancing patient satisfaction.”
Partnering with Anovo for the management of their Expanded Access Program has enabled Egetis Therapeutics to address current patient needs effectively while maintaining operational flexibility. The collaboration has delivered significant benefits in terms of customization, responsiveness, and overall operational efficiency, ensuring Seamless program execution.
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