In August, President Trump proudly proclaimed that he had directed the Department of Veterans Affairs to buy “a lot” of a drug known as
esketamine, the first new major depression treatment with a novel mechanism to hit the U.S. market in decades.
“Its results are incredible,” Trump
said at a veterans convention in Kentucky. “I’ve instructed the top officials to go out and get as much of it as you can.”
As of mid-December, the VA had treated just 15 veterans across the country with the drug. The nasal spray, which was developed by Janssen and named Spravato, was only available at seven of the agency’s facilities — out of more than 1,200. The VA treated its first patient with Spravato in June.
Experts disagree on whether the VA’s rollout has been slower than is reasonable. Some have raised safety and efficacy concerns about the treatment, and the effort to get it covered and administered in the private health care system has been rocky. But there is little doubt that the VA’s moves to make Spravato accessible stand in sharp contrast with Trump’s claims that the drug could deliver widespread relief for veterans struggling with depression.
“This was supposed to be a big game-changer,” said Dr. Erick Turner, a psychiatrist at Oregon Health and Science University. But the data on the drug was “nothing to write home about,” he added.
Esketamine is similar to ketamine, an anesthetic that is sometimes misused recreationally but that has also been used
off-label for depression. The VA said it initially limited its launch of the new drug only to clinics that had experience with ketamine.
“The roll-out of the drug has been successful due to VA’s implementation plan, which used existing facility expertise to launch at sites with previous experience using ketamine treatment for mental health,” said Susan Carter, a VA spokesperson.
In June, the agency’s medical advisory board
declined to approve widespread coverage of Spravato for all veterans, instead restricting the drug’s use to patients who haven’t responded to other treatments and requiring an authorization before it can be prescribed. The drug must be administered under the supervision of a physician and patients must be monitored for two hours after each dose. The monitoring requirements are similar to the process for providing ketamine. The VA turned to clinics with experience in those protocols for the initial use of Spravato.
The VA’s limited rollout mirrors the cautious approach that some in the psychiatric community have taken toward esketamine. That hesitation, in part, stems from looming questions about the data on the drug. Johnson & Johnson, which owns Janssen, submitted five studies in its application to the FDA, only two of which were positive. One of those was a maintenance-of-effect study, which historically has not counted toward the two positive studies the FDA typically wants to see for approval. In particular, experts have questioned whether there is enough data to show the medication is effective in patients age 65 and over, given that many VA patients are in that population.
“[The studies] are not robust. They’re not strong results. You pull one thread and the whole thing unravels,” said Turner.
But some experts expressed surprise that only 15 patients had been treated in the six months since Spravato was made available to veterans and that only a smattering of clinics could provide the drug.
“If you’re going to make a treatment available, make sure there is ease of access to the treatment,” said M. David Rudd, a psychologist who co-founded the National Center for Veterans Studies at the University of Utah and is now the president of the University of Memphis.
Other experts said the agency’s implementation of Spravato has actually been much faster than the drug’s rollout in private clinics and hospital systems, which have struggled to secure preauthorization from insurers to administer the drug or reimbursement for the monitoring required to provide it.
“My take would be they have already implemented across [several] facilities,” said Dr. Cristina Cusin, co-director of a ketamine clinic at Massachusetts General Hospital. Cusin served as a site leader for an esketamine trial sponsored by Janssen.
Cusin said her clinic has not been able to treat a single patient with esketamine since the drug was approved. Some insurers won’t cover the drug. Others won’t pay for the staff to monitor a patient after each dose. Some have said they are working on a bundled insurance code for the drug and monitoring, but Cusin said it’s not clear what reimbursement under such a code would look like. Meanwhile, she said, the clinic is flooded with calls from patients asking about Spravato.
Because the VA doesn’t have to deal with a dozen different insurers like a private hospital system might, Spravato coverage has been more straightforward for the agency, she said.
“It’s been relatively rapid compared to private systems,” she said. Janssen said in a statement that it is working with a variety of appropriate treatment centers to increase the number of locations certified to administer Spravato.
Beyond pushing for the VA to embrace the drug, Trump also made a point in August of saying he hoped the government was “getting [Spravato] at a very good cost.”
