This is pt. 3 of "The State of Innovative Mental Health Care."  Pt.1 covers insurance barriers to coverage and treatment costs; pt.2 covers tech barriers and solutions. The current article addresses clinician attitudes toward providing other psychedelic treatments such as MDMA and Psilocybin. We explore clinicians' concerns and paths forward.

‍

When it comes to psychedelic treatments for mental health, four things often coalesce to spark innovation:

‍

1) Desperation: Clearly our current mental healthcare system isn’t meeting the demand. 70% of people with major depressive disorder relapse/go into remission after trying traditional treatments like selective serotonin reuptake inhibitors (SSRIs) and talk therapy.

Treatment-resistant depression leaves patients and clinicians desperate for new treatments.

‍

2) Cultural demand: Innovative treatments are entering the cultural zeitgeist and breaking long-held stigmas, with families discussing Michael Pollan’s “How to Change Your Mind” at the dinner table.

‍‍

3) Political willpower: Just this summer, a bipartisan group of lawmakers introduced legislation urging the Biden administration to explore psychedelic-assisted therapies like MDMA and psilocybin as designated breakthrough therapies for PTSD and depression.

‍

4) Research: We’re seeing a recent resurgence in psychedelics research for the first time in over 50 years, largely due to easing of the Controlled Substances Act of 1970.

‍

With these forces converging, there are a number of innovative mental healthcare treatments currently undergoing FDA clinical trials:

• MDMA-assisted therapy, which is being developed by MAPS PBC, is in Phase III trials, with approval expected in ~2024. The Phase III interim results were published in Nature.

• In 2021 a study showed that 67% of participants who received MDMA-assisted therapy no longer met the diagnostic criteria for PTSD after having PTSD for an average of 15 years.

• Psilocybin, psilocybin-derived compounds, and psilocybin-assisted therapy are in various stages of development. The compound closest to approval is COMPASS Pathways’ psilocybin-assisted therapy, currently in Phase II trials, with approval expected in ~2026.

‍

We’re at a powerful tipping point in the development of new psychiatric interventions, similar to the precision oncology transformation of the past 20 years. - Lucia Huang, CEO at Osmind.org

Clinicians want to offer psychedelic treatments, and ketamine is a legal alternative that can have psychedelic effects at higher doses.

Ketamine is the only FDA-approved compound under the broad umbrella of psychedelic compounds—serving as an early indicator of future trends in psychedelic therapies at large.

‍

Our survey found that 76.7% of respondents who currently offer ketamine treatments plan to offer psychedelic therapies, such as MDMA and psilocybin-assisted therapy, in the future.

‍

However, despite all the excitement in the space, clinicians are hesitant to dive in.

‍

The top 3 concerns clinicians from our survey have about providing psychedelic-assisted therapies:

1. Legality
2. Efficacy
3. Lack of training in the associated therapy

‍

Here’s how we can address each of these concerns:

‍

1) Easing legal concerns

Clinicians will face the same regulatory, compliance, administrative, and clinical barriers with new therapies as with ketamine. It remains to be seen if psychedelic compounds will be descheduled, or if there will be gray areas where clinical practice is allowed, but recreational use isn’t. The latest legal and regulatory updates are summarized here.

‍

Innovative treatments are slowly moving through the mainstream healthcare system (e.g. clinical trials, FDA approval, payers, etc.), but there are certain jurisdictions that are legalizing psychedelics.

‍

For example, Measure 109 in Oregon allows trained practitioners to offer psilocybin for medical use; however, many traditional healthcare institutions (e.g. malpractice carriers, insurance) don’t recognize this as a legitimate form of treatment given how it clashes with federal law. Given all of these nuances, it’s no wonder providers are concerned about legality and losing their license. Osmind plans to help clinicians by designing EHR software that captures and automates necessary compliance mandates (similar to how we automate the SPRAVATO REMS form).

‍

2) Easing long-term efficacy concerns

Providers want to see more data about the long-term efficacy of psychedelic treatments. Real-world data and research (for example, what we’re doing at Osmind) will be critical to continuing to establish clinical evidence beyond the clinical trials setting.

‍

Our survey found that 65% of clinicians treating TRD with Ketamine are interested in sending their patients to clinical trials for research purposes. Osmind helps clinicians to get involved in research. Within our software, we collect, de-identify, and pool real-world data with the hopes to prove the efficacy of innovative treatments outside of controlled trials.

‍

Real-world evidence can help payers better understand the effectiveness of these innovative therapies and help provide broader access to the patients that need them most.

‍

3) Easing qualification and training concerns

Currently, the world of psychedelics is a bit of a wild-west. Companies spend thousands on marketing, making it hard for consumers to know which options are evidence-based. Meanwhile, ethical clinicians may be concerned with their own lack of clinical knowledge. To bridge the gap, programs are emerging to train and certify clinicians in certain models of practice.

‍

Some of the more established programs for psychedelic-assisted therapy (not affiliated with Osmind) include:

‍

• MAPS MDMA Therapy Training Program
• Chacruna Institute’s workshops and courses
• Sage Institute’s Ketamine-Assisted Psychotherapy Training

‍

As research and training programs evolve, we at Osmind intend to educate clinicians and patients, and encourage evidence-based practices that have appropriate safety measures in place.

‍

Beyond training programs, we also need to break down silos between primary care providers, specialists, and therapists. Mental healthcare needs to be more connected and collaborative, with certain clinicians providing certain areas of expertise (e.g. an MD providing medical assessment and prescription management, and a therapist providing adjunctive psychotherapy).

‍

We are stronger together. At Osmind, we support continued collaboration so we can bridge the gap between research and clinical practice, and learn from each other as the field evolves.

‍

Conclusion

With ketamine, we’ve seen how much not having adequate insurance coverage impacts patient access: our survey shows that over a third of prospective patients are lost because they are not willing to pay the out-of-pocket costs for ketamine treatment.

‍

There is a fundamental mismatch, where the unmet need for the services is sky-high, but access is still limited.

‍

We at Osmind aim to lower the barriers to entry and keep contributing research to prove these treatments’ value. Let’s enable clinicians to safely offer these life-saving treatments to their patients. If not, we will squander a once-in-humanity opportunity to help millions of patients who have been failed by our mental healthcare system and who need it most.