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.

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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.

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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.”

The VA told STAT it is paying $437.34 for a 56-milligram dose, and $656.03 for an 84-milligram dose. The dose varies by patient. Patients receive two doses a week for the first month of treatment, once a week during the second month, and then are moved to either weekly or biweekly treatments for maintenance therapy.

By comparison, the wholesale acquisition cost of Spravato, or list price, is between $590 and $885 per treatment session. A review published in June by the Institute for Clinical and Economic Review — a nonprofit that reviews the cost-effectiveness of drugs — claimed that the drug was not cost-effective at Janssen’s chosen price.

The VA said it has spent $80,605.40 on Spravato as of Dec. 10.

  • As a veteran, I have kept up with the progress being made with esketamine (Spravato) to treat depression. It is now FDA approved and we know how hard it is to get FDA approval. I think if veterans are willing to try it and sign off on it, it should be prescribed, of course with the close follow-up monitoring. It is rarely used otherwise as it is so expensive. This would allow closer and a greater understanding of this medication for widespread use.

  • Thank you for addressing this. I hope you will pursue this further. I’m a vet with treatment resistant depression. Since the day the VA/Esketamine news hit, I started Googling to find out when it’ll be available at the VA. I’ve messaged and spoken with my psych at the VA several times. Asking when it will be available. He always tells me he hasn’t heard anything and he’ll recommend me for the treatment as soon as it’s available…but he has no idea when that will be. So I contacted the pharmacy. Same thing. They have no idea. I’ve talked to everybody I can think of and there is absolutely NO information being shared with the veterans who need it. There is no news regarding availability online. Nobody to talk to. Nobody to ask. I’ve even volunteered to travel to a different facility, at my own expense, just to receive the treatment…nobody knows anything about it, though. I’ve been actively pursuing this for many months, and your article is the first time I’ve heard anything about it being available at any VA facility. This is the first I’ve heard about it since they approved it. I wonder how many veterans have just given up, due to the VA’s silence, and ended their own life. The VA needs to communicate with us…just tell us what’s happening and what we need to do to receive treatment.

    • I agree with you one hundred percent, however my phsychotrist who became the medical director is pushing hard and said there now 8 months away as a few days ago. Being 100 percent disabled from PTSD he’s worked with us and even though the care in the community insurance coverage originally got denied but I went out and found a spravato place in town whom my phsych works with and I will be starting treatment out on town soon and the VA will have no choice but to pay.
      Good stuff

  • Esketamine is a “flammable” (read questionably effective) drug with potentially very serious side effects, and its administration must be carefully monitored. Therefore : Trumps’ playing his almost poverbially equally flammable Trump Card is exemplified by The Don highly tauting and supremely over-stating of this “help” for veterans. Bogus. Load of Bull. Again and again and again. Is someone finally gutsy enough to stop this freak-show?

    • Well it saved my life. I can only go off of my experience and I highly agree this should in no means be a first second third or even fourth options but when you’ve tried every anti depressants and mood stabilizer for ptsd for years with no avail at all suicide attempts or taking slot of drugs and not caring and ideations everyday. There is a place if there wasn’t I’d be dead or in bed or crawling outa my skin somewhere.

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