• Sanket S Dhruva, Pinar Karaca-Mandic, Nilay D Shah, Daniel L Shaw, and Joseph S Ross.
• Yale School of Medicine, 333 Cedar St, SHM I-456, Box 208088, New Haven, CT 06520-8088. E-mail: sanket.dhruva@yale.edu.
• Am J Manag Care. 2017 Sep 1; 23 (9): e310-e315.

ObjectivesTo assess whether Medicare formularies restrict access to drugs receiving new FDA black box warnings for which safer drug alternatives are available.Study DesignA retrospective analysis using Medicare Prescription Drug Plan Formulary files to determine formulary changes for drugs receiving FDA black box warnings between 2007 and 2013.MethodsWe identified all FDA-approved medications available in tablet or capsule formulation that received a black box warning between 2007 and 2013 related to death and/or cardiovascular risk. We then determined formulary coverage of these drugs pre-black box warning, 1 year after, and 2 years after. For each formulary, we identified formulary restrictiveness, defined as: unrestrictive coverage (no prior authorization or step therapy), restrictive coverage (prior authorization or step therapy required), or no coverage.ResultsNine drugs with at least 1 FDA-approved safer drug alternative received 10 new black box warnings for death and/or cardiovascular risk between 2007 and 2013. In response to FDA black box warnings, overall formulary restrictiveness increased for 40% (n = 4) of drugs at 1 year, and for 50% (n = 5) at 2 years. However, for the majority of drugs (n = 7), most formularies remained unrestrictive 2 years after a new black box warning.ConclusionsMedicare formularies became more restrictive for half of the drugs that recently received new FDA black box warnings for death and/or cardiovascular risk and for which safer drug alternatives are available. However, a substantial proportion of formularies remained unrestrictive, suggesting inconsistent responses to new safety information to curtail the use of these medications.

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