Case Study : European Managed Access Program
Orphan Drug manufacturer has submitted dossiers to the FDA and EMA, the product was a new class and treatment for a rare condition.
They had requests from physicians and patients from across Europe and Globally. The company although established had conducted no Access Programs before and did not have a global regulatory or operational footprint. They wished to assess the options and potentially implement a global program.
Uniphar specialist teams
- Provided strategic consultancy reviewing all regulatory options in differing countries designing a European and Global Access Program.
- Implemented a range of country specific programs encompassing
- Cohort programs – charged and free of charge
- Named patient programs – charged and free of charge
- Designed all materials, processes, procedures and Liaised with Country regulatory agencies to submit relevant applications.
- Provided bespoke registration & data collection systems with a specialist online portal.
- Provided all logistics operations including storage, dispatch and monies collection.
- Over 1500 patient treatments delivered in compliant programs
- RWD collected and analysed for HEOR and regulatory submissions
- Increased experience of product by thought leaders.