Psychedelic Insurance; Patent Pledge; Subjective Experience > Therapeutic Alliance
Plus Psychedelics Discussed in the EU Parliament
Today, we’re taking a quick look at a few developments that, on the surface, are very different but are unified by their implications for patient access.
Enthea to roll out nationwide psychedelic therapy employer benefit program
Data from Compass Pathways’ Phase II trial points to subjective effects predicting improvement and not the therapeutic alliance.
Journey Colab creates a patent pledge to preserve the sacred use of Peyote and other mescaline-containing plant medicines.
Enthea Raises $2 Million to Scale Psychedelic Employer Benefit Program
Ketamine Assisted Therapy (KAP) is a promising approach to treating depression, and unlike the compounds in the FDA approval pipeline, it has been available through prescription for over fifty years.
However, its use to treat depression is off-label (it was FDA approved in 1970 as an anesthetic), which means that health insurance plans usually do not pay for it.
But efforts are underway to gather data on the use of generic (racemic) ketamine through Real-World Evidence such as the Osmind Real-world Ketamine Analyses (OKRA). This data, generated from ketamine practices around the country, could be used to show health plans that it is worth covering.
Another approach to creating insurance coverage for ketamine therapy is through employer benefits packages since 49% of Americans have health insurance through their work.
This is the aim of Enthea and how they plan to spend the $2 million they recently raised.
From the press release:
Enthea, the first provider of insurance plans for psychedelic healthcare, announces today its successful $2M seed round raise, led by Tabula Rasa Ventures…
The funds will be used to launch its services into 40 markets across the U.S. next year as well as grow Enthea’s customer base and provider network to further its mission of providing affordability and access to safe and effective psychedelic-assisted therapies for all who can benefit...
Enthea provides a turn-key operation that makes it easy for employers to include these treatments as part of their health care coverage to employees and their families. Its plans currently cover ketamine-assisted therapy; MDMA- and psilocybin-assisted therapies will be added as they become FDA-approved in the next several years.
“And as a workplace benefit, this treatment becomes affordable. Next year, most employers across the U.S will be able to offer these innovative treatments, covered under insurance, for the first time.”
As compounds like MDMA and psilocybin approach an FDA decision, insurance coverage becomes top of mind since the expected costs of a course of treatment are projected to be significant.
Adding further complexity is the matter of the psychotherapy component.
The FDA has never had to consider psychotherapy a drug approval decision, and reimbursement for mental health services—especially counseling and therapy— is already a problem area as insurance companies reliably shortchange mental health services.
In this environment, the hope is that the robust effect sizes and economic savings of psychedelic-assisted therapies inspire more expansive coverage of PAT, specifically and mental health services more broadly.
Subjective Experience, not Therapeutic Alliance, Predicts Symptom Severity In Compass Phase II trial
h/t to Michael Haichin.
Data analysis of Compass Pathways’ Phase II trial of COMP360 (psilocybin) for Treatment-Resistant Depression suggests that specific elements of the psychedelic experience better predict symptom improvement than therapeutic alliance.
The poster below was presented this week at the American College of Neuropsychopharmacology annual meeting.
This analysis points to specific qualities of the acute subjective experiences as the driver of symptomatic improvement and the first data (as far as I am aware) to support the idea that psychotherapy and therapeutic support may not be as important as many think.
The predictive elements were
the degree of emotional breakthrough (as measured by the Emotional Breakthrough Inventory (EBI), which “measures aspects relating to emotional release, trauma or internal personal conflict resolution, and facing difficult emotions and feelings that are usually avoided.”) and
the intensity of three subjective effects: visual restructuralization, oceanic boundlessness, and auditory alterations.
In other words, it follows the line of research supporting the idea that the mystical experience is the ‘active ingredient’ in persisting positive effects from psychedelic experiences but goes a step further to untangle the impact of the therapeutic alliance.
The Twitter Peer Review is already working on this, as commenters note oddities in the data and point to the economic incentive of unbundling psychotherapeutic support.
Journey Colab Unveils Patent Pledge
Journey Colab, the company developing a synthetic form of Mescaline for the treatment of addiction, has taken a step to ensure the indigenous use of Peyote will never be threatened by its IP portfolio by committing itself (and any future patent holders) to a patent non-assertion pledge.
From the Patent Pledge:
“Pursuing patents on psychedelics, and in particular those with a long history of use like mescaline, has stirred controversy and criticism, much of which Journey Colab agrees with. Thus, in crafting a patent strategy, our wish is for it to embody our same commitment to the ethical stewardship of mescaline as our general approach to developing mescaline for the market, which is in alignment with the goal of reciprocity and benefit sharing…
Pledgors promise to any person or entity that uses peyote or another mescaline-containing plant, any natural preparation made therefrom, or any naturally-derived mescaline isolated or obtained therefrom, for non-commercial purposes, and to Indigenous communities and practitioners who use mescaline for bona fide traditional ceremonial purposes, along with those in participation therewith (each, a “Pledge Recipient”), that Pledgors will not bring suit for infringement of a Pledged Patent.
This Pledge shall be legally binding, irrevocable, and enforceable against Pledgors, entities controlled by Pledgors, and their successors and assigns, including all subsequent transferees, exclusive licensees, and others who may subsequently come into a position of effective ownership or control.”
🇪🇺 PAREA hosted the first policy meeting in the European Parliament on psychedelic-assisted therapies in the treatment of brain disorders.
That’s it for this week, have a great weekend!