Clinigen GAP - case study
Situation
- A pharmaceutical company developing a novel treatment for respiratory disease started to receive requests for access to its investigational medicine
- The pivotal Phase III study had just completed, and the company were committed to providing access to this chronic treatment until the product became commercially available
- The company asked Clinigen GAP for advice on how to manage patients exiting the clinical study through supply of product on a free-of-charge basis, while providing access to appropriate patients on a paid for Named Patient basis
The Clinigen GAP Solution
For patients exiting the
clinical study
A free-of-charge Named Patient Program transitioning to commercial supply
The transition to commercial supply was planned once the marketing authorization was granted
For new patient
access requests
A “Paid For” Named Patient Program
Patients were screened against program criteria and had a diagnostic test to assess tolerability to the product. Suitable patients were enrolled on the “Paid For” Named Patient Program
Clinigen GAP was able to co-ordinate the successful implementation of the two programs in parallel, running the free-of-charge program and transitioning to commercial supply when appropriate. We also managed the screening process, patient enrollment, regulatory process and financial reconciliations of the “Paid For” Named Patient Program.