Can Virtual Reality Reduce Costs, Improve Scalability and Access to Psychedelics?

According to the National Institute of Mental Health, more than one in five U.S. adults live with a mental illness and approximately half of all Americans will experience a mental illness during their lifetimes.

Fortunately, there are dozens of clinical trials currently underway studying how the combination of psychedelic drugs and psychological support therapy can be used to treat some of the most recalcitrant mental health conditions facing individuals in our society, like treatment-resistant depression, post-traumatic stress disorder (PTSD), and alcohol-use disorder.   Unlike many psychiatric drugs currently on the market, such as the SSRIs, SNRIs, and tricyclic antidepressants, the treatment protocols for psychedelic medications include a comprehensive and time-consuming psychological support component.  In other words, an FDA-approved psychedelic drug would require extensive psychological support as part of its administration.

While the ‘drug+therapy’ approach may be therapeutically beneficial, the American healthcare system lacks the human capital — in the form of a sufficient number of trained mental health professionals — to deliver these therapies at scale. Even if the current shortage of mental health professionals were resolved, it is unclear that insurers would have the appetite to pay for a therapeutic approach requiring extensive psychological support for each patient.

In order to ensure equitable access to psychedelics, innovative solutions are required, such as the adoption of digital tools and in particular, virtual and augmented reality-mediated psychological support platforms.

Psychedelic medicine will introduce a new paradigm of care that combines pharmacological intervention with extensive psychological support

There are currently three Phase 3 and twenty-eight phase 2 FDA clinical trials underway for psychedelic-assisted therapy (“PAT”) targeted at indications with a cumulative U.S. patient population of about 177 million.  If approved, the FDA will mandate comprehensive psychological support as part of the administration protocol for psychedelic drugs[1].

Protocols for PAT are highly variable[2] but generally include screening followed by preparation, medication session(s), and integration[3].  The screening phase is used to assess patients for eligibility for psychedelic-assisted therapy and identify any contraindications.  In the preparation phase, therapists work with patients to educate them about the psychedelic experience, prepare them for the medication sessions, build trust/rapport, teach calming / grounding techniques, and establish intentions/goals for treatment. During the drug treatment phase, the goals are to reduce adverse events, provide a safe environment, and generally facilitate the therapeutic session. The integration phase aims to process the insights gained during the psychedelic experience and generalize them to everyday life.  Finally, during the maintenance phase of treatment, patients are encouraged to continue to incorporate what they learned during the medication sessions into their lives, and are monitored for relapse.

Figure 1. Schematic showing an example of a Psychedelic Assisted Therapy protocol and the time associated with each phase.

Scalability obstacles and high treatment costs threaten to severely limit patient access to psychedelic medicine

There is a common misconception that FDA approval is the rate limiting step standing in the way of widespread access to psychedelic therapies.  In actuality, the need for suitably trained psychological support staff and a reimbursable treatment model present the most serious obstacles.

In order to gain a quantitative understanding of the issue, we examined patient populations for each indication for which there was an FDA phase 2 or phase 3 clinical trial underway[4].  We next estimated the number of psychological support hours that would be required for each patient.  We used these estimates to derive the number of psychological support therapists that would be required to meet this demand and the associated costs, as a function of adoption rate.

In total, we estimate that there are 177 million U.S. patients across 17 indications for which there are phase 2 or 3 clinical trials underway.  We further estimated that each patient would require an average of 32 hours of psychological support from trained therapists.  We estimated the cost of psychological support at $125/hour and assumed each psychological support therapist would work 1,750 hours per year.

The resulting calculations define an estimated demand of 3 million full-time therapists at a cost of $707 billion per year ($4,000 per patient) at an adoption rate of 100%.

Even if we were to assume a much lower patient population given the high degree of co-morbidities along with only a limited number of FDA approvals of psychedelic drug approvals, our analysis yields daunting numbers. For example, an adoption rate of just 5% would require more than 160,000 new therapists and annual cost of more than $35 billion.

This analysis helps demonstrate how vital it will be to identify innovative and scalable solutions to ensure equitable access to psychedelic medicine.

Table 1. Shows patient populations, estimated therapist demand, and costs as a function of the adoption rate of psychedelic assisted therapy in a scenario where all currently running phase 2 and 3 clinical trials are approved.

An Extended Reality platform to deliver psychological support would reduce the burden on therapists, reduce costs, and provide improved patient access

What is XR?

Virtual reality (“VR”) and augmented reality (“AR”) technologies are systems that either fully immerse a user in a computer generated environment or overlay digital content over real world environments. Collectively these technologies are sometimes referred to as Extended Reality (“XR”).  A XR system typically comprises a head mounted display (“HMD”) that fits over users’ eyes like a pair of ski goggles, and handheld controllers.  XR has been around in one form or another since at least the 1980s, but it has seen a significant resurgence since the 2012 launch of the Oculus Rift.  As of this writing, there are several commercially available XR systems capable of delivering powerful and compelling immersive experiences to users.

While XR has not yet realized its full potential in the consumer electronics market, it has found substantial enterprise success and adoption, particularly in the medical field.  There are currently 40 FDA filings at various stages of review that utilize VR as a medical device for various indications and functions[5] and there are two FDA approved VR medical devices – EaseVRx and InVisionOSTM.

EaseVRx is a prescription-use immersive VR system based on cognitive behavioral therapy principles that is used as an in-home device for the reduction of chronic lower back pain and InVisionOSTM is an immersive visualization tool that enables surgeons to utilize 3d models for surgical planning.

In addition to the medical device filings, there are 407 registered clinical trials that utilize VR interventions[6].

XR can be used to provide psychological support for Psychedelic Assisted Therapy

Due to its unique characteristics, XR may provide a mechanism for providing a scalable psychological support platform that reduces the burden on existing therapists and reduces the urgency of the need to train additional therapists.

In a recent article, Agnieszka Sekula, et. al[7]., argued that VR is a useful tool to “catalyze the innately therapeutic aspects of the psychedelic experience…”[8] In recognition of the potential of VR for psychedelic medicine several commercial ventures have been launched to explore potential use cases.

PsyAssist, a company that was acquired by Tripp Inc., developed a VR program for use in ketamine clinics that aimed to assist patients during the preparation, medication, and integration components of their treatments.  A similar offering has been developed by Enosis Therapeutics, an Australian company, which describes their platform as: “four science-backed VR scenarios that help therapists guide patients through the entire healing journey[.]”

While the offerings of PsyAssist and Enosis Therapeutics offer some innovative and compelling use cases for XR as part of a psychological support framework for PAT, they do not appear designed to directly address the accessibility and scalability issues facing psychedelics.

A successful XR psychedelics platform ought to be directed at reducing the burden on psychological support staff to a sustainable level and providing a reimbursable model acceptable to payors.  By incorporating XR technologies in this way, psychedelic therapeutics will be more likely to realize its potential as a game-changing mental health paradigm accessible to all.

Statement of Conflict of Interest

The author is the owner of one or more pending patents covering the use of extended reality systems as part of psychedelic assisted therapy and is working towards commercialization of these systems.

[1] The FDA will likely effectuate this mandate through a combination of labeling requirements under 21 CFR 201.57(c)(2)(i)(A) and risk evaluation and mitigation strategies (“REMS”).

[2] https://www.frontiersin.org/articles/10.3389/fpsyg.2022.887255/full

[3]https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/D60BADBD57B442CB4BEAEB80164702D18DB728F5AAA1?noSaveAs=1

[4] Comorbidities may reduce the overall patient counts.

[5]https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices

[6] https://clinicaltrials.gov/ct2/results?term=%22virtual+reality%22&recrs=a bdef&type=Intr

[7] https://www.frontiersin.org/articles/10.3389/fpsyg.2022.813746/full

[8] Note that these authors are the founders of Enosis Therapeutics discussed in more detail infra.

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