220 Patients or 20,000? Clinics Split on Psychedelics’ First Year

A Lightning Round of Predictions

Joy Sun Cooper opened with a lightning round, flipping the usual panel structure on its head.

Within the first 12 months of the first FDA approval, how many patients will have received treatment?

The most bullish was Journey’s Myriam Barthes, who said 20,000, acknowledging that her prediction was “bold”. Behind that was Osmind’s William Sauvé, who landed at around 5,000 patients.

Sunstone’s Kim Roddy and Community Health Center’s Daniel Bryant were much more conservative. Roddy said that she hopes it will be in the thousands, but conceded that could be “a really high estimate”.

Bryant, meanwhile, said that he expects just 220 patients will have received treatment within the first year after approval, “and almost all of them will be at the VA.”

Next up, the panellists were asked how many months from approval it might be until a typical eligible patient can actually book an appointment.

DEA rescheduling adds time, Roddy said, leading her to estimate four to six months. Sauvé agreed on the latter, also guessing it would be around six months.

Barthes was again the most optimistic of the panellists, predicting it could be just two to three months before an eligible patient can get booked in. And Bryant was again the most pessimistic. “I think probably more like 36 months,” he told the audience. “If the typical patient has a healthcare shortage, then they can’t book a session.”

Next, Sun Cooper asked whether the two-facilitator model used in many psychedelic trials would survive in real-world practice.

It was a unanimous ‘no’ from the panellists. “No, and that’s a bad thing,” Bryant added.

The last rapid-fire question Sun Cooper asked of the panellists was whether, five years after approval, a typical patient will be getting psychedelic therapy, or a psychedelic drug with monitoring.

“It depends on what you want to call typical,” Roddy responded first. “I think that there’s going to be different classes of what that will look like.”

Barthes thinks that both will be on offer, while Bryant brought some optimism: “I’m really hoping it’s psychedelic therapy; I’m going to be optimistic on this one.” Sauvé also predicted therapy.

Formularies, Floor Space, and Inventory

Following the rapid-fire round, Sun Cooper invited the panellists into a deeper discussion of these topics, starting with what they might expect to see in the gap between approval and actual availability.

Bryant said that, on day one, he will be looking at when the next Medicaid formulary meeting is, “because that’s who I serve, and that’s at least six months from then, which is ten months from FDA approval at that point, or more.”

Roddy shared that Sunstone is expecting “a surge of demand, and so I do feel like we’ll be able to treat people out of the gate.” But thereafter, it could slow down, she went on, referring to the example of state-regulated programs, which saw an initial rush followed by a slowdown.

Barthes highlighted how similar she anticipates the delivery of psychedelics to be to that of Spravato. “It’s very much a similar process,” she told the audience, referring primarily to COMP360. That process includes, she went on, identifying patients, getting medical clearance, and so on.

Sauvé said he could perhaps treat his first patient two to three months after commercial availability. Treatment centres will need to work on physical space and how they will handle a Schedule II or III drug, and thereafter may have to negotiate reimbursement via single case agreements, he said.

Sauvé also mentioned buy-and-bill, which he said could overcome the waiting times associated with using the specialty pharmacy route, though this would mean having “probably close to six figures of inventory” on site.

If You Build It, Will They Come?

The panellists then dived a little deeper into patient demand, and the types of patients who might be the first to access psychedelic therapies.

“We have a pretty consistent demand right now for our clinical trials,” Roddy said, with participants travelling from across the U.S. and about 300 inquiries a month. “We don’t advertise… this is just word of mouth, being on clinicaltrials.gov,” she went on, “people want access to this care.”

“I think there’s a little bit of a myth of the demand amongst folks here,” Bryant contended, suggesting that his patients are more focused on what is going to help them rather than a specific drug or modality. “There’s an education component that’s necessary,” he added.

Barthes agreed on the latter point, emphasising the role of education for patients and the workforce, including those who might refer patients to psychedelic services. In doing that, she added, “we need to make sure that we don’t lean into the hype or don’t lean into the fear, because both of these extremes tend to happen”.

“If you build it, they will come,” Sauvé said, “if what you build is sufficiently inviting.”

He also agreed with an educational push. “After more than fifteen years of TMS, half of my colleagues don’t know what TMS is,” he went on, “and the patients don’t know it.” He cited the story of a patient he treated who had achieved remission via TMS, and was simultaneously happy to be in remission “and enraged that she had waited twenty years and no one had told her”.

When patients do reach out, Sauvé said, it’s important to pick up the phone and get them in the door. “When I built the first TMS shop in Richmond, we called it a one-phone-call shop because that’s what has to happen”, he said.

Roddy appeared to agree. “When people actually reach us, we have a human that actually picks the phone up to speak to them,” she said, noting that “the first thing we do is educate them about what this is and what this isn’t, and what we actually can offer.” Sunstone also runs similar education sessions with providers in its area.

“If we’re educating somebody who’s interested in it, but then they go back to the provider who knows nothing about it,” Roddy added, that provider could discourage the patient from participating.

What Should Carry Over From Trials?

Sunstone has learned a great deal through running psychedelic trials, but what does it believe should carry over into real-world practice?

Roddy first emphasised the importance of “really good screening.” “And then when somebody needs additional care and support, you gotta build a system that’s going to hold them all the way through that,” she went on. “The safety protocols absolutely need to be in place,” Roddy continued, “when somebody is having chest pain during an experience, the provider has to be able to make a call: is their blood pressure elevated? Are they having a heart attack? Or is it because their heart is broken?” Who is making those calls in the room really matters, she added.

“This question: does everybody need therapy? I don’t know the answer to it,” she went on. “We don’t have clinical evidence around that. It’s something that we want to do as a large-scale clinical trial to answer that kind of question,” she added.

Who Gets Served: The Safety Net and Rethinking ‘Well’

How to keep a patient safe might look different from site to site, too. Bryant shared that his patients are more likely to be poorer, unhoused, and/or living in unsafe environments, which means it’s not possible to assume that a patient is going home to a stable or conducive home environment. “These are the people we have to find a way to serve,” he added.

“One in 10 patients gets seen at an FQHC [federally qualified health centre] nationwide,” Bryant explained, “it’s a huge patient population.” But these centres have “some unique billing structures that are going to make caring for them a little more tricky,” he acknowledged.

He also noted that, while there has been a great deal of focus on veterans, “they are not the people who carry the trauma in our society, that is women, gender minorities, people of colour; it is sexual trauma, it is trauma of poverty and racism and oppression.”

“Do you feel like that necessitates a rethinking of what well means?”, Sauvé asked after Bryant’s comments. All the panellists seemed to agree.

“It absolutely does,” Roddy said, “because if we’re not addressing the systems that people are going back into, and the systemic harms that are happening, we’re creating a cycle, and the whole point is to try to break it for people.”

And some patients will need more care than others in the clinic, too, Roddy added. “We’re doing a trial right now in women survivors of sexual abuse,” she told the audience, adding that some of the women are “needing eight additional integration sessions on top of what we’ve got for the normal three prep, the dosing, and three integrations.” “We have a responsibility to hold them,” she added, “and then we actually transition their care out, because it matters, you can’t just drop somebody off.”

Who Goes First? Early Adopters

In terms of which types of sites will be the early adopters of psychedelic therapies, Sauvé, like many, views interventional psychiatry sites as the most obvious fit. Of those sites, he thinks providers that are offering TMS are likely to be “the types that’ll take the leap”, and said that there are “maybe no more than 1,000 clinicians in the entire field that can do something like TMS.”

Bryant, meanwhile, thinks that the specifics of the REMS will decide who raises their hand first to provide psychedelic treatments. Reimbursement models will impact FQHCs’ ability to participate meaningfully in the delivery of psychedelics, though, he noted, as their per-visit rates are set by statute: Bryant gets the same ~$200 for a 30-minute session as he would for sitting with a patient for eight hours, he said. Getting paid appropriately for psychedelic care in these contexts, Bryant said, would require “an act of Congress”.

For her part, Barthes shared that around 95% of the 3,000-odd therapists who have joined Journey Clinical expressed interest in integrating newly approved psychedelics into their practice, according to an onboarding survey. The company has supported its clients in getting their offices REMS-compliant to deliver Spravato, she added.