Reimbursement and Resources: Preparing Clinics for Psilocybin Therapy

CONFERENCE REPORTER

Gus Alva, MD, shared that intranasal esketamine has potential to serve as a model for implementing treatments governed by a risk evaluation and mitigation strategy designed to safeguard patients. Patients receiving esketamine required supervision after dosing: "somebody needs to be under observation for 2 hours after the last dose that they've actually received," Alva said.¹ Early adoption may be challenging because clinics were uncertain how they would be compensated for the observation period, and many anticipated financial losses under that model given their fiduciary responsibilities. Esketamine delivery exemplified the operational lessons clinics had to learn to apply when dispensing agents in real-world clinical settings. With time, clinics like Alva's had established approaches that allowed esketamine to be deployed while the clinic was reimbursed for the time used.

Alva anticipated a similar trajectory for psilocybin. COMP360 is anticipated to receive a US Food and Drug Administration decision later in the year, according to Alva, and he predicted that some patients would be deterred while others would seek the treatment. A fair number of patients were expected to want to try psilocybin for depression. In clinical trials of COMP360, therapists worked with each patient, who was observed for approximately 8 hours.² That construct was difficult to carry out without adequate resources, and compensation for the time was equally important because "clinics aren't necessarily going to be wanting to do things that they're not being reimbursed for," Alva said.

Psychotherapy-guided work was part of the proprietary COMP360 model, whereas some psychedelics did not require it, according to Alva. The model included a dedicated psychedelic room and appropriately trained personnel involved in care delivery, and therapists would need to be prepared to conduct the psychotherapy-guided work. Preparing therapists for that work would be a necessary step, according to Alva. Agents needed to remain available to patients who required them, Alva said, even as clinics weighed the resources and reimbursement required. Alva expected the rollout to be uneven initially but was confident that the field would adapt, as it had with intranasal esketamine.

Dr Alva is a board-certified psychiatrist and the Mood Disorders Section Editor for Psychiatric Times.

References

1. Spravato (esketamine) nasal spray, CIII: prescribing information. US Food and Drug Administration. Accessed October 8, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211243s026lbl.pdf

2. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med. 2022;387(18):1637-1648.