Current Market Access to PCSK9 Inhibitors

A federal appeals court on Feb. 11 rejected Amgen Inc.’s bid to resuscitate antibody patents for its PCSK9 inhibitor Repatha, a victory for Regeneron Pharmaceuticals, Inc. and Sanofi S.A., the manufacturers of Repatha’s only rival, Praluent. (Praluent was developed by both companies, but following a 2020 restructuring of their arrangement, Regeneron is now solely responsible for the drug in the U.S.). The judge in the case agreed with a lower court ruling that Amgen could not make patent claims over monoclonal antibodies without more thoroughly describing their molecular structure, a decision that could have wider implications for the pharmaceutical industry. In another cholesterol win for Regeneron, the FDA — also on Feb. 11 — approved its drug Evkeeza as an adjunct treatment to other homozygous familial hypercholesterolemia (HoFH) therapies. HoFH is an ultra-rare genetic form of high cholesterol that can be managed by PCSK9s. Unlike Repatha, however, Praluent is not yet approved to treat HoFH. The graphics below show how Praluent and Repatha are currently covered among commercial health plans, health exchanges and Medicare and Medicaid programs, plus their utilization management restrictions.

NOTES: Access that requires prior authorization and/or step therapy is represented by the abbreviation (PA/ST). Under the pharmacy benefit, the covered lives under commercial, health exchange, Medicare and Medicaid formularies are 171.1 million, 10.5 million, 47.5 million and 68.0 million, respectively. Under the medical benefit, the covered lives under commercial, health exchange, Medicare and Medicaid formularies are 169.2 million, 10.5 million, 49.4 million and 68.0 million, respectively.

SOURCE: Managed Markets Insight & Technology, LLC database as of February 2021.

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