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Real-World Data Reveals Variability in Access to, and Use of, Spravato

Janssen’s esketamine nasal spray product, Spravato, was first approved around half a decade ago in 2019, initially indicated for use alongside an oral antidepressant for treatment-resistant depression (TRD). The next year, FDA allowed Janssen to add major depressive disorder (MDD) with acute suicidal ideation or behaviour to the product’s label (where it was again indicated for use alongside an oral antidepressant).

After a relatively slow start, Spravato revenues have ramped up substantially, with the product on track to become a blockbuster drug (>$1bn in annual sales) as early as this year. This success has been touted by psychedelic drug developers as a model to replicate, with several companies seeking to cast their programs in a Spravato-like light.

But, as Spravato sales continue to rise, access to the product—which is exceedingly expensive when compared to racemic ketamine—remains a key Achilles heel for patients and their providers.

Barriers to accessing Spravato come in many forms, including insurance coverage (or lack thereof), socioeconomic status (which is inextricably linked, of course, to varying levels of insurance coverage, but also raises or reinforces other barriers such as the logistical challenges with esketamine’s treatment schedule), geography (facilities that offer Spravato are often located in more densely populated areas of the U.S.; healthcare systems like the VA’s are not offering Spravato in large swathes of the U.S; and, internationally, providers like England and Wales’ NHS do not cover the product), and so on.

In this article, we explore these dynamics further with the help of two recent publications and interviews with their respective (co-)authors. The first explores variability in U.S. health insurance plan coverage criteria for Janssen’s esketamine product, while the latter looks at variability in real-world use of the nasal spray...

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