Tips for Navigating Prior Authorization and Out-of-Pocket Costs for HFrEF Medications

Larry A. Allen, MD, MHS; Sarah J. Sarni, BSN, BA


May 11, 2021

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Will Generics Break Down Prior Authorization Barriers?

Widespread entry of generic equivalents of the newer HFrEF drugs into the US market promises to change the dynamic of how prior authorizations are processed in the future. However, it will be some time before generic formulations of ivabradine, ARNIs, and SGLT2 inhibitors become available. Although ivabradine was eligible for patent challenges in April 2019, owing to patents and regulatory protections, its generic entry into the pharma market is not likely to occur until 2026. Similarly, sacubitril-valsartan was eligible for patent challenges in July 2019, but we're not likely to have a generic until 2027. And dapagliflozin was eligible for patent challenges in January 2018 but is unlikely to have generic entry until 2030. Regarding empagliflozin, its generic entry is estimated for 2034.

In the meantime, to minimize the negative impact on patients' health and care, clinicians should become familiar with intricacies of the prior authorization process; make use of available reporting and decision-support tools; continue to advocate for prior authorization reform; and discuss health insurance coverage and out-of-pocket costs with patients, recommending resources such as the ACC/CPPCD patient decision-aid tools.

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