A novel patient support program to address isotretinoin adherence: proof-of-concept analysis

The iPLEDGE protocol for isotretinoin treatment requires multiple steps to be completed within strict timing windows, resulting in many interruptions or discontinuations of treatment. The US Food and Drug Administration has indicated that approximately 40% of isotretinoin prescriptions written over the course of one year of the iPLEDGE program were denied due to failure to comply with iPLEDGE. Insurance restrictions add to the likelihood of prescriptions not being filled. Here, we describe a novel program implemented specifically to assist patients and providers with improving isotretinoin therapy adherence. This innovative isotretinoin support program provides assistance with insurance questions and hurdles, an uninterrupted treatment supply, educational support, reminder communications, and an indigent patient assistance program. Proof-of-concept analysis shows that 17 months after implementation of the program, 93% of prescriptions received have been filled. Utilization of the program appears to improve adherence to an isotretinoin treatment regimen, with fewer interruptions due directly to unfilled prescriptions.