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 AffairsSecretary Robert Wilkie that Johnson & Johnson would be very generous in pricing the treatment.
And if you like, Trump said, Ill 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 drugs status if called for.
A J&J spokesman wrote that Spravato is the first new type of medicine for treatment-resistant depression in decades and offers significant and sustained improvement, bringing hope to patients who have cycled through multiple medicines without relief. We firmly believe that people suffering from treatment-resistant depression, including our nations veterans, deserve the opportunity to benefit from this breakthrough medicine.
The VA panels 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 werent particularly good, she said. Especially for men and people over 65, and thats 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.
The VAs decision to exclude Spravato from formulary coverage also came a day after the Institute for Clinical and Economic Review, a Boston nonprofit that reviews drugs and health services for cost-effectiveness, released an analysis claiming the true value of the drug was between 25% and 52% lower than Johnson & Johnsons chosen price.
Currently, its wholesale acquisition cost stands between $590 and $885 per treatment session. Costs for the first month of treatment, which includes two sessions per week, could range from $4,720 to $6,785.
Maybe its become politically untenable to cover it because of the media coverage, despite the pressure from the administration or Trump directly, Zuckerman said. We know that members of Congress were looking into this.
The offices of Sens. Johnny Isakson (R-Ga.) and Jon Tester (D-Mont.), the chairman and ranking member on the Senate Veterans Affairs Committee, respectively, did not immediately respond to requests for comment.
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