President Donald Trump said the Department of Veterans Affairs will buy “a lot” of a controversial new drug to help fight veteran suicides, despite a decision by the agency not to put it on its approved medications list.
“There’s a product that’s made right now that just came out by Johnson & Johnson which has a tremendously positive, pretty short term, but nevertheless a positive effect. I’ve instructed the head of the VA to go out and buy a lot of it. And we are buying a lot of it,” Trump said to reporters at the White House Wednesday as he prepared to depart for a national veterans conference in Kentucky.
But even the VA isn’t sure about the drug, named Spravato. Its medical advisory panel voted in June to classify the drug, known in its generic form as esketamine, as “non-formulary,” meaning it was not included on a list of VA-approved medications that are covered by the agency’s pharmacy benefits. The Center for Public Integrity was the first to report on the June vote.
The VA on Thursday said that the drug’s non-formulary status was unchanged, but that veterans could get access to it through an “individualized treatment plan developed by their provider in collaboration with the veteran.”
“VA developed clinical and procedural guidance and other tools to promote thoughtful patient selection and safe administration practices, in keeping with the FDA-approved indications for esketamine use and safety requirements,” the agency said in a statement. “VA will closely monitor the use of esketamine in veterans to more fully understand its relative safety and effectiveness as compared to other available treatments. Based on this information, VA may revise its clinical guidance and formulary status if warranted.”
The Food and Drug Administration greenlighted Spravato in March, despite concerns that were published in a final rule on Aug. 16, including that in testing the drug had a higher rate of adverse effects than drugs currently available, and that testing did not appear to show that Spravato had a higher rate of successful treatment.
“There does not appear to be a consistent statistically significant positive primary efficacy outcome for Spravato-treated patients compared to placebo-treated patients,” the FDA wrote in a response included in a final rule published by the Federal Register. Despite the concerns, the FDA approved the drug to be eligible to be covered by additional Medicare and Medicaid payments that typically offset the higher cost of breakthrough drugs to make them more affordable to the market at large.
Spravato is a nasal spray that is intended to treat depression in cases where the patient has not improved under other antidepressant drugs or treatments. The cost for one dose of Spravato is $295, patients will typically require 2.5 nasal spray units per treatment for a cost per day of $737.50. FDA’s approval of the additional payments means Medicare and Medicaid would cover 65 percent of the cost of each dose. The spray has to be administered by a physician.
“Hopefully we are getting it at a very good cost,” Trump said. “I guess it’s a form of a stimulant where if somebody is really in trouble from the standpoint of suicide it can do something,” he said.
“I’ve instructed the top officials to go out and get as much of it as you can from Johnson & Johnson. I think they have done so well,” Trump said in Kentucky at the AMVETS annual veterans conference, in remarks broadcast by C-SPAN. “They have made so much money. I think they should give it to us for free.”
Updates with VA statement Thursday.