Last week, Srinivas Rao, MD, Chief Scientific Officer of ATAI Life Sciences, took to the stage alongside other leaders in psychedelic medicine at the 2019 Mapping the Mind conference in Toronto. The conference, which featured speakers like Dr. David Nichols, founding president of the Heffter Insitute, and Dr. Matthew Johnson, associate director of the Johns Hopkins Center for Psychedelic and Consciousness Research, is an annual event designed to educate and improve public perception of psychedelics, as well as to promote psychedelic research initiatives.
Speaking to more than 300 students and academics, Dr. Rao began by introducing the epidemiology underlying the mental health epidemic and the limits of current treatments. For example:
- More than 300m people suffer from depression worldwide
- Depression is the leading cause of disability worldwide
- Close to 800,000 people commit suicide every year; suicide is the 2nd leading cause of death among 15 to 29-year olds
- More than 100mn people suffer from treatment-resistant depression, meaning they don’t respond to currently available therapies
“Given the scale of this problem, it’s critical that we develop alternatives to current treatments,” said Dr. Rao. “The question is, how do we bring new therapies to the millions with depression?”
Symptoms often seep into every corner of the lives of those suffering. While mild forms of the disease may impair the ability to focus, feel motivated, and maintain social relationships, more severe forms often leave the patient unable to function normally, and in some cases, lead to the ultimate cost — the patient’s life.
Importantly, this pain is not solely limited to those diagnosed. On a micro-level, depression also profoundly impacts the lives of those close to the affected person, from friends and family to co-workers and acquaintances. On a macro-level, with 4.4% (322 million people) of the global population suffering across the world, even if an individual is not being directly affected by a friend or loved one’s illness, he or she is indirectly impacted by society at large.
”When you’re in the midst of a depressive episode, every mental phenomena comes with an edge to it, an extra weight – something that needs to be overcome before you can continue with everyday experiences.” – Anonymous Patient
Dr. Rao went on to outline the promising science behind ATAI’s diverse portfolio of compounds and companies – which range from psilocybin and arketmine to the anxiolytic GRX-917 – before diving into the challenges inherent to drug development, regulatory approval, and patient access.
Using Johnson & Johnson’s SpravatoTM as a case study, Dr. Rao walked attendees through the extensive research standards required for a drug to become an FDA-approved medicine, citing the more than 30 studies – with an estimated cost of more than $300m – that led to esketamine’s eventual approval. In addition, he highlighted the pre-market activities required for broad impact, such as developing a network of treatment centers and building payer-partnerships to ensure broad access, both factors that are critical to ensuring broad patient access to psychedelic assisted therapy. In short:
To maximize access and minimize costs for the patient, developing a robust body of evidence that appeals to both regulators and payers is critical.
Securing regulatory approval requires a drug developer to definitely show that, compared to available treatments for a particular condition, a novel treatment carries a favorable risk-benefit profile, and that any risks associated with the new medicine can be managed once it is on the market.
Then, for insurers to cover the treatment (thereby ensuring that patients do not bear the financial burden) it must be apparent that the cost-benefit profile is also favorable.
Ensuring payer coverage is particularly important for treatments like psilocybin, since psilocybin’s complex administration is likely to be expensive, given that it involves both supervised administration over several hours and concurrent psychotherapy. Demonstrating the long-term cost effectiveness of such intense therapy to payers is critical to ensuring coverage and thus reducing the patient burden of such costs.
“Ultimately, getting psychedelics to patients will take capital, strategy, and creative thinking, particularly regarding the clinical & reimbursement models,” said Dr. Rao in his closing statements. “However, the benefits to the patient are likely to be enormous.”
For more information about Mapping the Mind, click here.
Srinivas Rao is the Chief Scientific Officer at ATAI Life Sciences AG. Dr. has over 19 years of professional experience in the pharmaceutical and biotechnology industries. Prior to ATAI, Dr. Rao has held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture backed startups to vertically-integrated, publicly traded pharmaceutical companies. Dr. Rao completed an internship in Internal Medicine at Yale-New Haven Hospital. He received his Ph.D. in neurobiology from Yale Graduate School and his M.D. from Yale School of Medicine. He holds both a Bachelor of Science and Master of Science degree in Electrical Engineering from Yale College and Yale Graduate School, respectively.
Photo credit: Andrija Dimitrijevic www.adphotografe.com