Burden and Utility of Risk Minimisation Intervention in Canada

Vandetanib (CAPRELSA) is a receptor tyrosine kinase inhibitor for the treatment of symptomatic or progressive medullary thyroid cancer in adults with unresectable locally advanced or metastatic disease. Vandetanib was approved in Canada in 2012 with a highly restrictive controlled distribution model to address three important safety concerns, QTc prolongation, diarrhea and rash. Although the vandetanib Risk Minimisation Intervention has been shown to be effective as evaluated through a knowledge and understanding survey (KAU) or prescribers and by a drug utilisation study, there are no data available to understand what components of the current program have the greatest utility and where undue burden may have been unnecessarily introduced. Furthermore, there is little understanding as to where there may be components delivered in the Risk Minimisation Intervention that may already be effectively delivered through routine healthcare delivery and are therefore imposing additional burden. Finally, we have no visibility as to what components of the program may constitute roadblocks to treatment for patients in rural settings. The current study is aimed at understanding the utility and burden of the vandetanib risk minimisation intervention in Canada.