President says maker J&J should provide the antidepressant to the VA for free.

Johnson and Johnson’s (J&J’s) ketamine nasal spray Spravato (esketamine) was approved by the U.S. Food and Drug Administration (FDA) in March 2019 for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). People who are currently struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.

Shortly following approval of Spravato, the U.S. Department of Veterans Affairs (VA) indicated that it approved the drug for TRD. Clinicians at the department voted not to put it on the formulary, however, preferring to use it only for veterans that have not responded to other treatments and have gone through an authorization process.

Spravato raises some safety concerns. It comes with a boxed warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults. Side effects can include dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting and feelings of drunkenness. As a result, healthcare professionals must be present to monitor the use of Spravato.

The drug is, however, also known for its quick effect in curbing suicidal thoughts.

President Trump has been pushing for the VA to offer Spravato to all veterans in need and recently “instructed the top officials to go out and get as much of it as you can from Johnson & Johnson.” He has also called J&J and urged the company to “make a contribution” for the country. He said., “They’ve done so well in this country, they’ve made so much money, I think they should give it to us for free.”

In addition to the restrictions placed on the use of Spravato by VA clinicians, Trump may also be facing a pricing issue, unless of course J&J does provide the drug at no cost. J&J has been accused by the drug price watchdog ICER (Institute for Clinical and Economic Review) of overpricing Spravato at an annual list price of $32,400.