Medicare Formularies Are Inconsistent in their Response to FDA Black Box Warnings
Sanket Dhruva
Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine
Sanket Dhruva, MD is a cardiologist and Robert Wood Johnson Foundation Clinical Scholar at Yale University School of Medicine. He graduated from UCSF School of Medicine as an Alpha Omega Alpha awardee in 2009 and stayed at UCSF for internal medicine residency. He then completed cardiology fellowship at UC Davis in Sacramento, California where he was twice fellow of the year in the Department of Internal Medicine. Dr. Dhruva has studied the FDA’s premarket regulation of medical devices and defined the strength of evidence for device approval. He has also identified differences in the safety and effectiveness of devices in women. Dr. Dhruva also studies Medicare formulary coverage, seeking to understand how Medicare can provide coverage of safer, more effective, and more cost-effective medications. He is interested in developing and assessing the evidence base for novel medical products and ensuring that medical interventions have an acceptable risk/benefit profile. He also collaborates on an annual literature update on medical overuse.
Abstract
Introduction: The US Food & Drug Administration (FDA) issues black box warnings for drugs with serious safety risks. The impact of black box warnings on formulary coverage is unknown. Methods: We identified all FDA-approved... [ view full abstract ]
Introduction: The US Food & Drug Administration (FDA) issues black box warnings for drugs with serious safety risks. The impact of black box warnings on formulary coverage is unknown.
Methods: We identified all FDA-approved medications available in tablet or capsule formulation that received a black box warning between 2007-2013 related to death and/or cardiovascular risk. We included only drugs with at least one FDA approved alternative without a black box warning. Next, we analyzed Medicare Prescription Drug Plan Formulary files to determine Medicare formulary coverage for all identified drugs pre-black box warning, 1 year post-black box warning, and 2 years post-black box warning. For each formulary, we identified whether the drug was covered, and if it was, whether prior authorization or step therapy was required. Our primary outcome was formulary restrictiveness, defined as: unrestrictive (coverage, no prior authorization/step therapy), moderately restrictive (coverage, prior authorization/step therapy required), or no coverage.
Results: Nine drugs with at least one FDA approved alternative therapy received 10 new black box warnings: 7 for death and 5 for cardiovascular risk. Overall formulary restrictiveness increased for 40% (n=4) of drugs at 1 year, and for 50% (n=5) of drugs at 2 years (Figure). Formularies became less restrictive for 1 (10%) drug at 1 and 2 years. For the majority of drugs (n=7), however, a majority of formularies remained unrestrictive 2 years after the black box warning.
Discussion: Medicare formularies became more restrictive for approximately half of drugs that recently received FDA black box warnings for death and/or cardiovascular risk, and for which safer alternatives are available. However, a substantial proportion of Medicare formularies remained unrestrictive, suggesting formularies are inconsistently responding to new safety information to curtail use of these medications. Increasing formulary restrictiveness for unsafe drugs may help decrease their prescribing when safer alternatives are available.
Authors
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Sanket Dhruva
(Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine)
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Pinar Karaca-mandic
(University of Minnesota)
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Nilay Shah
(Mayo Clinic)
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Daniel Shaw
(Yale University School of Medicine)
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Joseph Ross
(Yale University School of Medicine)
Topic Areas
Prevalence and drivers of overuse , Overuse in the care of the elderly and at end of life
Session
AS-1B » Abstract Slams: Education & Policy (12:00 - Friday, 5th May, Salons 6, 7, & 8)
Presentation Files
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