Understanding the complexity of regulatory approval systems is an essential part of the success of our access programs. Sometimes that understanding can be critical to patients’ well-being too.
In 2012, we implemented a mature managed access program for an oncology treatment that had been withdrawn from all markets except the US. While the medicine is supplied free of charge everywhere in the world, the eligibility criteria and medical review process is complex.
This is Idis MA’s largest running mature access program, we have delivered product to over 10,000 Oncology/Haematology patients in over 60 countries across the world (Europe, North, Central and South America, Asia Pacific, Africa, Middle East).
In the set-up phase, Idis MA managed a challenging transition of an existing brand to unlicensed supply which required extensive regulatory and healthcare professional interactions. We also had extensive interactions with the client’s local affiliates to manage the transition. As this is a cold chain product, it also demonstrates our experience in storing, handling and shipping worldwide under controlled conditions.
The complexity of the program requires a high standard of customer service and reporting, including activities such as proactive follow ups with healthcare professionals, monitoring of product usage and liaising with client’s Medical Review team. Besides the day-to-day supervision of the program, Idis MA also helped the client with both financial and stock forecasts.