Confronted by a rising rate of suicides in some groups of veterans., the Department of Veterans Affairs on Friday decided to approve the use of a new and costly depression drug, despite concerns among doctors and other experts about the drug’s effectiveness.
The decision to endorse the drug — called Spravato, and manufactured by Janssen, a unit of Johnson & Johnson — came days after President Trump offered to negotiate a deal between the drug maker and the agency. Johnson & Johnson reportedly was working with associates at Trump’s Mar-a-Lago club, and the company has been supporting V.A. suicide-prevention efforts.
A spokesman for the V.A. said that the decision to approve the drug, which would cover its use by doctors in its nearly 1,000 clinics nationwide, was a medical one. In a statement, the agency said, “V.A. will closely monitor the use of esketamine” — the generic name for Spravato — “in veterans to more fully understand its relative safety and effectiveness as compared to other available treatments. Based on this information, V.A. may revise its clinical guidance” and the availability of the drug.
The V.A. stopped short of putting Spavato on its formulary, the list of drugs it requires to be carried in its 260 or so pharmacies. The approval enables V.A. doctors to offer the drug to patients they believe could benefit.
Some Congressional Democrats expressed concern at the fast approval process. “I am incredibly alarmed by reporting today that suggests Spravato, a controversial new drug, is being rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits,” said Mark Takano, Democrat of California and chairman of the House Committee on Veteran’s Affairs, in a prepared statement released Wednesday.
The top Republicans on the House and Senate Veteran’s Affairs committees said this week that they had yet to take a position on the issue.
The V.A. has rushed to distribute Spravato through its system ever since the Food and Drug Administration approved the drug, in March, for severe depression. The approval stirred excitement among doctors, because it represented a new direction in depression treatment: Spravato is a nasal-spray derived from an old and widely used anesthetic, ketamine, rather than an iteration of commonly used antidepressants like Prozac.
The spray contains esketamine, an active portion of the ketamine molecule, and the recommended course is twice a week, for four weeks, with boosters as needed, along with one of the commonly used oral antidepressants.
But psychiatrists, pharmacologists and suicide experts who have seen the data presented to the F.D.A. are far from persuaded that the drug will be a game-changing addition.
“It’s doing something, all right, but it’s not all it’s cracked up to be,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “I just don’t think it’s going to live up to all the hype.”
Cost is another issue. Janssen is charging the public from $ 4,720 to $ 6,785 for a course of treatment, and clinic costs will add more to the bill, not to mention monthly boosters, if needed. The V.A., not veterans, would foot the bill for whatever price it negotiates with Janssen. But nasal-spray formulations of generic ketamine are already cheaply available from compounding pharmacies, which mix individually tailored doses to order for doctors.
F.D.A. approval requires that people taking Spravato be monitored in a doctor’s office for at least two hours, and their experience entered in a registry. Like ketamine, the drug often causes out-of-body sensations and hallucinations. It is unclear how much of that cost insurers would cover.
The V.A. and the Department of Defense have been trying to reverse an alarming trend of suicide among veterans and members of the military since the late 2000s, when rates began to rise. Suicide rates in the V.A. system have been higher than in the general population for at least a decade, according to Robert Bossarte, an associate professor in the department of behavioral medicine at West Virginia University, in Morgantown. The overall veteran suicide rate decreased recently, from 30.5 per 100,000 in 2015 to to 30.1 per 100,000 in 2016, but longer-term trends are alarming in some groups. In 2015, the suicide rate for male veterans age 18 to 34 rose to 44 in 100,000 per year, from 25 in 100,000 in 2005.
“I’ve tried the generic ketamine nasal spray in about 20 patients with treatment-resistant depression, and a handful of them have done very well on it,” said Dr. William Niederhut, a psychiatrist in private practice in Denver. Dr. Niederhut had the patients take four or five doses over a month, making sure a friend or family member was present, given the disorienting effects. He had the spray made at a local compounder.
The development of Spravato followed a number of small studies over the past decade, which found that doses of the generic anesthetic ketamine could provide fast relief to some severely depressed people who hadn’t responded to other treatments. Generic ketamine has been available for years, at hundreds of clinics around the country; these provide a course of intravenous doses, at $ 400 to $ 500 a dose, usually a half dozen over a couple weeks with boosters as needed, for mood problems.
The V.A. is already running its own trials of IV ketamine for severe depression, and the agency could easily have the nasal spray made very cheaply, experts said. Ketamine and esketamine seem to have similar benefits and risks, although careful comparisons have not been done. For depression, esketamine has been studied far more rigorously than generic ketamine.
“It cost me $ 35 for five doses” of generic ketamine, said Dr. Niederhut, who recently retired. “That’s $ 7 a dose. I don’t know why anyone would pay thousands of dollars, or whatever they’re charging, when you can get the generic spray for $ 7.”
“The V.A. has prioritized suicide prevention at every level, and it is in a unique position to address it in a way no one else can,” Dr. Bossarte said. “In this case, they could perform trials of this drug, so we can see who benefits and who has unintended reactions to fast-track studies, rather than have a blanket rollout policy” where everyone deemed at risk of suicide gets the drug.