Lev Facher and Ed Silverman, STAT News; June 21, 2019
WASHINGTON — A Department of Veterans Affairs committee has declined to approve widespread coverage of a new depression treatment that has generated controversy but also received an express endorsement from President Trump. Instead, the drug was approved on a more limited basis.
Many experts have embraced the medication, which is known as esketamine and is being sold by Johnson & Johnson (JNJ) under the brand name Spravato, as a critical option for patients in dire need of new treatments — particularly because it might work faster than existing antidepressants.
But it has faced pushback since its approval in March, with some watchdog groups citing effectiveness and safety concerns.
It is chemically related to ketamine, which has been long used as an anesthetic during surgery and misused recreationally as a club drug. Since its approval, watchdog groups have also raised questions about deaths by suicide among three individuals who had used Spravato in a clinical trial.
In a decision Thursday, a VA committee declined to cover the drug for all beneficiaries, instead restricting the nasal spray to patients who have not responded to other treatments and requiring an authorization process before it can be prescribed.
The decision came just one week after Trump gave an unconventional endorsement of the treatment. During an Oval Office event on June 12, he predicted to Veterans Affairs Secretary Robert Wilkie that Johnson & Johnson would be “very generous” in pricing the treatment.
“And if you like,” Trump said, “I’ll help you negotiate.”
A VA spokesperson said in a statement that drug was approved on a “non-formulary” basis, likening it to “prior authorization” that many private insurers mandate before permitting the use of potentially risky or expensive treatments.
The decision “will enable VA psychiatrists to offer esketamine to patients when clinically indicated,” the spokesperson said, ensuring “the medication is prioritized for use in Veterans who have not previously responded to adequate trials of other available treatments for major depression.”
The agency will continue to monitor the drug for safety and effectiveness compared to other depression treatments, the agency said, and could revise the drug’s status if called for.
A spokesman for Johnson & Johnson did not immediately reply to a request for comment.
The VA panel’s decision not to mandate coverage of the drug was “absolutely the correct decision,” said Diana Zuckerman, president of the National Center for Health Research, a nonpartisan institute that studies science and health in Washington.
“The effectiveness data weren’t particularly good,” she said. “Especially for men and people over 65, and that’s mostly who the VA serves.”
In briefing documents submitted to a Food and Drug Administration advisory committee, the agency noted six deaths — including the three suicides — among patients who were taking the drug. Since the patients in question had severe illnesses and there were no distinct patterns observed among the deaths, the FDA reviewers said they did not necessarily see the deaths as drug-related.
[…]