Impact of Restrictive Drug Coverage Policies on Heart Failure Care

Despite proven benefits, many patients with heart failure with reduced ejection fraction (HFrEF) are not prescribed life-saving, guideline-recommended medications. This gap in prescribing occurs in up to 75% of eligible patients, leading to an estimated 68,000 preventable deaths per year nationwide. Moreover, patients often do not consistently adhere to these life-saving medications up to 60% of the time. A major reason for these gaps in prescribing and adherence may due to be restrictive coverage policies, such as cost-sharing (patients pay out of pocket through copayment or co-insurance), and prior authorization (providers required to justify use of a medication before it is covered). These policies can have harmful effects when applied to life-saving therapies. For example, high out-of-pocket costs can result in reduced medication adherence, or may worsen health differences by differentially impacting different subpopulations. Moreover, physicians are often unaware of these policies’ existence or magnitude, and often do not discuss cost with their patients, despite the majority of patients wanting their providers to initiate this conversation. We propose to utilize a large, integrated database combining publicly available insurance formulary information, electronic health record (EHR) data, pharmacy data, and neighborhood-level census information. In Aim 1, we will use this database to quantify the effects of restrictive drug coverage policies for guideline-recommended HFrEF regimens on provider prescribing, patient adherence, and clinical outcomes. In Aim 2, we will develop models to ascertain whether certain subgroups of patients with HFrEF are at higher risk of negative impacts of these policies. Finally, in Aim 3, we will use implementation science methodologies to develop and pilot-test an EHR-embedded intervention that will identify patients at risk for coverage-related challenges, and promote discussions between physicians and patients on cost-related challenges and alternatives. This proposal addresses the NHLBI strategic vision by investigating differences among populations, optimizing implementation research, and leveraging opportunities in data science. Moreover, the proposed research and training plan will advance Dr. Mukhopadhyay as an independent investigator in cardiovascular health services research. Specifically, this proposal will allow her to develop proficiency in quasi-experimental methods, master skills required for integrated population database analysis, and cultivate competency in implementation science methods. Dr. Mukhopadhyay’s interdisciplinary mentorship team unites established investigators with expertise in large population database analysis, advanced quasi-experimental methods, implementation science, EHR-based research, and cardiovascular medicine. This team will guide Dr. Mukhopadhyay towards her goal of becoming an independent investigator committed to finding ways to reduce gaps in cardiovascular care.