Starting today, Lucid News is partnering with The Trip Report on its Psychedelic Business News Roundup. Each Wednesday we’ll provide a round-up of the most important psychedelic business news of the week with brief commentary and context.
Esketamine Rejected by England’s National Institute for Health and Care Excellence for a Second Time
Last week England’s National Institute for Health and Care Excellence (NICE), the organization that chooses which drugs the UK National Health Service (NHS) serving England and Wales will purchase and distribute, decided to reject Spravato, the esketamine nasal spray developed by the Janssen pharmaceutical unit of Johnson & Johnson. Pharmaphorum reports that “NICE has rejected regular NHS funding for Janssen’s depression spray Spravato (esketamine) for a second time, although the company says it could salvage the situation by providing further data and “additional discussions.”’
The NICE guidance document raised multiple issues concerning Spravato including:
- whether any improvements in symptoms continue after treatment stops and if this will improve someone’s quality of life
- the costs of repeated courses of treatment with esketamine
As we’ve reported before, ketamine is the canary in the coal mine of psychedelic medicine. Discussions about ketamine therapies are revealing a lot about the preferences of patients, providers, and healthcare systems concerning FDA approved psychedelic treatments, such as the non-dissociative Spravato. This is compared to response to off-patent, off-label, non-reimbursed options such as IV, sublingual and intramuscular ketamine – as well as the challenges of the patient supervision for psychedelic medicines.
So far, it appears that there is continuing pushback against Spravato and this NICE decision is a recent high profile example.
Future insurance reimbursement for FDA approved MDMA and psilocybin therapies could face challenges from decriminalization and rescheduling efforts, like those from Canada and Australia, respectively, and state efforts like Oregon’s Ballot Measure 109 which may provide more options for patients
If the first ‘psychedelic pharmaceutical’ is not recommended for the NHS, what does the future look like?
Large Psychiatry & Behavioral Health Conference to Focus on Psychedelics
Many psychiatrists, psychologists, and other behavioral health professionals will be given a proper introduction to psychedelic-assisted therapies this week as some of the most prominent names in psychedelics including Rick Doblin, Robin Carhart-Harris, Usona’s Malynn Utzinger and Charles Raison, and Bob Jesse will present at Psych Congress 2020.
Psych Congress, an independent mental health conference for professionals, runs from September 10-13th and will be virtual this year. It is presented by The Psychiatry and Behavioral Health Learning Network a large industry group that hosts conferences and continuing education for the field.
Why this matters
Perhaps as you’ve experienced, psychedelics are unique.
Unique in the experiences they create, unique in the insights gained, unique in the medical conditions they have the potential to treat, unique in their history of long term cultural and religious use, unique in their legal status and the manner by which they became outlawed.
Psychedelics are also unique in the manner in which they will be delivered as a licensed medicine. This is not the old scenario in which a drug rep buys the office staff lunch enough times until the doctor is won over and writes scripts for x instead of y.
For those of us watching closely, it may feel like psychedelics are going mainstream and greater acceptance is an inevitable next step. But medical providers are generally a conservative crowd and change happens slowly. Bringing more therapists, psychiatrists, counselors, and specialists into the psychedelic fold, getting them up to speed on the science, the challenges, the opportunities, the unique features, not to mention training and credentialing providers and recipients, will be a large undertaking.
It seems like a good sign that people with extensive experience working with psychedelic therapies will be guiding the way at such a large industry conference.
AWAKN Life Sciences Launches Clinical Research Division
From the Press Release:
“AWAKN Life Sciences Inc, the European psychedelic assisted psychotherapy company, today announces the launch of its Commercial Clinical Research Division…
AWAKN’s Commercial Clinical Research Division focuses on sponsoring, designing and delivering existing compound, new indication psychedelic assisted psychotherapy clinical trials, for both for profit and not for profit organisations.”
The team includes Ben Sessa as CMO and David Nutt as Chairman of the Scientific Advisory Board. The clinic-based approach is set up for treatment, conducting clinical trials and training practitioners.
Bottlenecks to psychedelic-assisted therapies are the rigors of the regulatory approval process, including larger, multi-site Phase II & III trials and scaling therapist training.
AWAKN’s strategy addresses both.
Recently, MAPS announced a partnership with Naropa University to offer MDMA assisted-psychotherapy training and COMPASS’ recent F-1 documents filed by the company in preparation for its upcoming IPO, noted its reliance on therapists trained at third-party clinics. These moves highlight the trend of licensing out the training of psychedelic therapists to make this instruction more accessible.
While we’re seeing the emergence of clinics offering psychedelic therapies, it is difficult to know how many are incorporating therapy in addition to simply delivering ketamine to patients. It seems likely, however, that the clinics that most effectively contribute to the responsible expansion of psychedelic medicines will be those that are actively involved in clinical research in addition to outpatient services.
AWAKN and Cedar Psychiatry are the only two that, as far as I can tell, are currently going this route, though there may be others.
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