Where oversight increased
The lack of ketamine clinic oversight stands in stark contrast to regulation of Janssen Pharmaceuticals’ Spravato. Janssen received a patent by isolating esketamine, a molecule found in ketamine. The FDA approved the branded drug in 2019 for treatment-resistant depression and later for major depressive disorder with acute suicidal ideation. Ketamine is a generic drug and has never been approved for an indication other than as an anesthetic.
Spravato is distributed by providers under one of the strictest Risk Evaluation and Mitigation Strategies systems from the FDA. The agency usually uses REMS for drugs that have higher risk profiles and don’t have much real-world data as it learns more about the treatment’s safety and use in clinical practice.
For every patient who receives Spravato, providers must submit forms to a registry, and must follow a long list of other requirements and standards.
In June 2020, not-for-profit Mental Health Center of Denver opened up Spravato treatment to a small number of patients. Medicare and Medicaid, which cover the majority of their patients, reimburse for the drug, which usually costs thousands of dollars for a month of treatment. Meanwhile, ketamine costs a fraction of that price.
The clinic administers the Spravato nose spray to patients and blocks a two-hour window to monitor them. Patients receive treatment twice a week for four weeks, and then one treatment over four weeks.
But providers spend more time on administrative work and receive lower reimbursement for monitoring patients.
“Just looking at all the guidelines that the FDA has put forth for the Spravato, it’s a little concerning that there are many clinics that are just out there giving IV ketamine infusions, and I don’t know how much of a background or what kind of medical history they’re taking on folks,” said Denise Hosier, a nurse practitioner and director of adult integrated care and nursing services at Mental Health…
