Acupuncture, ketamine infusions, and electroconvulsive therapy are just a few of the options available for individuals diagnosed with Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). These treatments, while potentially effective, can often feel daunting or expensive.
Now, research from Emory University suggests that psilocybin-assisted therapy (PSIL-AT), using the active ingredient in hallucinogenic mushrooms, could provide transformative benefits to more than five million people in the U.S., pending FDA approval.
The study highlights the urgent need for therapies featuring psilocybin while addressing the logistical and economic considerations that policymakers, insurance providers, and public health agencies will face in making such treatments widely accessible.
Using national data on individuals currently being treated for MDD and TRD, Emory researchers applied exclusionary criteria to identify those who would be medically eligible for PSIL-AT.
Factors such as comorbidities, including mania, heart failure, and diabetes, were used to refine the eligible population.
The analysis revealed that 56 to 62% of patients with MDD and TRD – approximately 5.1 to 5.6 million people – could benefit from this therapy.
Study lead author Fayzan Rab is an M.D. candidate at Emory University’s School of Medicine.
“This information is significant because much of the current focus on psychedelic therapies is about its efficacy within clinical trials, and very few people are studying what would be the broader implications of implementing these novel therapeutics,” said Rab.
“Our study is one of the first to look at the bigger public health and economic consequences of a world where psilocybin therapy is made more available to Americans.”
Psilocybin-assisted therapy is currently designated as a breakthrough therapy by the FDA, allowing for an expedited review of Phase III clinical trial results due to its potential to address depression.
The findings from this study provide actionable data to inform the FDA’s decision-making process.
“What is really timely about this research is that it provides a data-driven number that is interpretable to the FDA,” Rab said.
“This is how many Americans we think are at stake. I think that will be a meaningful estimate for the FDA to weigh when they consider whether to approve psilocybin for therapeutic use.”
If approved, the availability of PSIL-AT will be heavily influenced by decisions from private and public insurance providers, including the Centers for Medicare & Medicaid Services (CMS).
According to the study, nearly 20% of Medicaid’s 85 million beneficiaries – approximately 17 million people – are likely to have clinical depression. How Medicaid and other insurers decide to reimburse for psilocybin-assisted therapy will significantly impact its accessibility and demand.
One notable advantage of psilocybin therapy is its rapid efficacy. Previous clinical trials have shown that a single 25 mg dose of psilocybin can substantially reduce symptoms of depression.
Dr. George Grant, co-director of Emory University’s Center for Psychedelics and Spirituality (ECPS), emphasized the potential cost savings for the healthcare system.
“Psychedelic medicines have promise because the intervention is so fast-acting, whereas right now, insurance providers and payers often need to fund the use of antidepressants throughout their lives,” said Grant, who is also the executive director for Spiritual Health at the Woodruff Health Sciences Center.
This quick-acting treatment could alleviate the financial burden on both insurers and patients while delivering significant relief for those with depression.
Supported by Emory University’s ECPS, the study integrates clinical psychiatry with spiritual health to explore the therapeutic potential of psychedelic medicines. The center aims to foster a deeper understanding of how psychedelics can bring patients to a state of mental and spiritual wellness.
“Coming to the aid of people who are suffering is very important, and psilocybin-assisted therapy could help people arrive at a place of satisfaction within themselves so that their lives achieve optimal meaning and purpose,” Grant said.
Rab also highlighted the impartial academic environment in which the research was conducted, stressing that it was independent of pharmaceutical influence.
“I am glad to be supported by the Center for Psychedelics and Spirituality, which is an academic environment, providing an objective third-party perspective to policymakers, the FDA, and public health agencies,” Rab said.
“I am really hopeful that continued research in the area of psychedelic medicine and therapeutics could benefit the millions of Americans that might qualify for it.”
The study provides a roadmap for the potential rollout of psilocybin-assisted therapy, offering actionable insights for healthcare providers, insurers, and policymakers.
By addressing the needs of millions of Americans suffering from MDD and TRD, PSIL-AT could represent a paradigm shift in the treatment of depression, bridging clinical efficacy with accessible and holistic care.
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