A drug approved five months ago for treating major depressive disorder could face roadblocks due to the way it’s administered and current practice patterns by psychiatrists and other clinicians who might prescribe it, according to a new medical journal article.
The article, published Friday in the Journal of the American Medical Association, pointed out several structural barriers inherent in psychiatric practice that could stand in the way of widespread adoption of the drug, Spravato (esketamine), for which Johnson & Johnson’s Janssen division win Food and Drug Administration approval in March for MDD that fails to respond to other treatments. The authors were Yale University psychiatrist Dr. Samuel Wilkinson, with Susan Busch and David Howard, respectively health policy and management researchers at Yale and Emory University.
Although it was hailed at the time of its approval as the first novel antidepressant in decades, the authors wrote that actually incorporating it into clinical practice would take considerable effort.
“For psychiatrists and other clinicians who treat patients with depression, adoption of [Spravato] may require fundamental changes to the organization and reimbursement of their medical practice,” the authors wrote.
Because of its significant side effect profile, Spravato’s label carries a black-box warning, and the drug is given under a Risk Evaluation and Mitigation Strategy, or REMS. The boxed warning states that because of the risk of sedative and dissociative side effects, patients must be monitored for two hours following administration, which takes place in a clinical setting. Patients are also advised not to operate machinery or drive until the next day, after a restful sleep.
Johnson & Johnson, based in New Brunswick, New Jersey, did not respond to a request for comment.
In the JAMA paper, the authors wrote that the requirements for administering the drug could exacerbate already existing disparities in patient access to treatment. But another factor that could be a hurdle to Spravato’s uptake is the way many psychiatrists practice.
Unlike physicians in many other specialties, psychiatrists have resisted the trend toward moving into large group practices and hospital settings, opting instead for solo practice and small group practices, the authors wrote. Those practices would have to invest in new infrastructure and staffing to provide additional space and monitoring for patients, as well as for storing a drug that is a Schedule III controlled substance and reporting REMS data to the FDA. As such, the drug could be cost-prohibitive for smaller practices and could be limited to large practices and clinics.
On the one hand, the drug’s relative high cost – $7,080-$10,620 for the initial two-month treatment episode, or $590-$885 per treatment visit – could make it an additional source of revenue for practices, which will mostly obtain it under the buy-and-bill model. That will be especially advantageous for hospitals and clinics that qualify for 340B program discounts, the authors wrote. However, psychiatric services are reimbursed at relatively low rates, and if the reimbursement for patient monitoring is too low, it will hinder uptake of Spravato.
Meanwhile, about one-third of psychiatrists do not accept commercial insurance, which presents another barrier, especially if few patients are willing to pay the drug’s high out-of-pocket price. That could force practitioners to have to decide whether to sign contracts with insurers or continue operating outside the third-party payer system.
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