Methodological Gaps in the Assessment of the Utility and Burden of Risk Minimisation Interventions.

ISPOR 18th Annual European Congress (2015), Milan, Italy • Risk minimization interventions (RMIs) aim at optimizing the benefitsrisks of medicines with important identified safety concerns. • In some situations, stringent RMIs (e.g., restricted distribution programs or mandatory prescription certification) are required. However, these measures could be costly, time-consuming, and/or challenging to implement in the real-life clinical practice setting. • Although regulatory authorities recommend an evaluation of the burden associated with such measures, there are currently no methodological guidance available. A non-systematic literature review was conducted using three complementary data sources: