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The Mental Health ‘Formulary of the Future’? Otsuka’s Work in DTx, Psychedelics, & More

By JESSICA DaMASSA, WTF HEALTH

Otsuka Pharmaceuticals is expanding its mental health formulary – looking beyond traditional medications to psychedelics, and to the “intersection of technology and psychiatry” with digital therapeutics currently in clinical trials for Major Depressive Disorder. Kabir Nath, Senior Managing Director of Otsuka’s Global Pharmaceutical Business, lets us in on the thinking behind these bold moves, why the pharma co is even innovating to expand the spectrum of treatments available for mental illness in the first place, and how soon these new therapies will reach patients.

“Follow the science” is a key undercurrent of this conversation, particularly as we talk through Otsuka’s investments in psychedelic medicine start-ups Compass Pathways and, more recently, Mindset. Kabir says the body of clinical evidence for these therapies is building and we get his prediction on when they might become more mainstream and readily available.

We also get his take on digital therapeutics (DTx) and the work Otsuka is doing with Click Therapeutics in Major Depressive Disorder. Their clinical trial, done in partnership with Verily, is the first-ever fully remote clinical trial conducted in this space, and the hope is that it not only generates evidence to support the emerging DTx category, but that it also sets a precedent for a new, tech-enabled way to run clinical trials.

This is just the beginning. There’s lots more on the innovations changing pharma and the future of mental health care in this one. Watch now!

Vida Health Starts Prescribing: Meds, Labs, Devices, & More for Mental Health & Diabetes

By JESSICA DaMASSA, WTF HEALTH

Big news coming out of Vida Health today as the chronic condition care startup announces that it will now be able to prescribe meds, med devices, lab tests, and more to its members. This puts Vida Health among the first of the digital health chronic care companies to evolve its offerings beyond apps-and-coaching, leading on this trend to take digital health chronic care into a more full expression of virtual care.

Vida Health’s Chief Medical Officer, Dr. Patrick Carroll, introduces us to the new offering which he tipped us off about when we met him a few months ago, new to his role at Vida and coming in hot from Hims & Hers where he built similar services as he took that company public as CMO.

The new prescribing services will cover both sides of Vida Health’s integrated model: mental health and cardiometabolic health, but in different ways. On the mental health side, Pat says members will be able to receive prescription meds for anxiety and depression ONLY at this time; on the cardiometabolic side, members working with Vida Health will NOT be able to get prescription drugs to help with diabetes or heart health, but would instead be able to get continuous glucose monitors (CGMs) prescribed, specialized diets, and labs, like A1C testing, that require a script.

Do these prescribing services begin to turn Vida Health into a primary care provider? If not, how do these new prescribing and medication management roles integrate with whatever other primary care offering is in place through a member’s plan or employer without adding cost or confusion to the patient experience? We talk through the evolution of both care model and business model as Vida Health adds another layer to its full-stack chronic condition management platform.

988 and 911: Justice System Involvement in Mental Health Crises

BY BEN WHEATLEY

A woman was walking in the crosswalk of a busy intersection as the rain started to come down. She looked cold, but more than that, she looked off. She had no shoes on her feet and her countenance was in disarray. It seemed to me that she was in the midst of a mental health crisis. 

The woman approached where I was standing and I suggested that she go into the Starbucks on the corner to look for her shoes. At least in there, it would be warm. She didn’t go inside, but instead went to the entrance and sat down on the ground. 

Someone must have called 911 because a policeman and an ambulance with an emergency medical technician showed up. The EMT brought a stretcher down from the ambulance as the policeman watched over the situation. The woman got on the stretcher and the EMT placed a blanket over her. As this played out, the policeman stood in the background, allowing the EMT to take primary responsibility for the interaction. Since the woman seemed to pose little risk to herself or others, the response seemed to be the appropriate one. 

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Pithiatism Redux

BY MARTIN SAMUELS

Those of us in medicine have all seen the famous painting of the Tuesday afternoon lessons at the Salpȇtrière in Paris in the 19th century. In Pierre Aristide André Brouillet’s painting, one can clearly see the great professor, Jean-Martin Charcot, holding forth while the patient, Blanche Whitman, is being supported by a tall young man, Joseph Jules Francois Felix Babinski, the Chef de Clinique (the chief resident) and allegedly the favorite to succeed Charcot. He never did as he was failed repeatedly on the exam necessary to become a faculty member at the university by a jealous, xenophobic, anti-immigrant rival, Charles Bouchard. Babinski was born in France and served in the army twice, but his name was Polish as his parents had emigrated to France to escape bias in Poland (sound familiar?).  Ironically almost no one remembers Bouchard (his only contribution being the Charcot-Bouchard aneurysm which may be the cause of some intracerebral hemorrhages), but there is no doctor on earth who does not know Babinski’s name. This is one of many reasons why Babinski is my neurological hero.  

A Clinical Lesson at the Salpêtrière, Pierre Aristide Andé Brouillet
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Big Health’s Softbank Money, FDA Board Member Send Strong Signals About Digital Therapeutics Market

By JESSICA DaMASSA, WTF HEALTH

With a $75 million investment from Softbank last week, and the addition of former FDA Deputy Commissioner Dr. Anand Shah to its Board of Directors this week, Big Health has sure kicked 2022 off with some noise! But, this is more than just big news for Big Health as CEO Peter Hames is here to tell us. This is a story about the market potential for an all-tech approach to mental health care, AND an important endorsement for digital therapeutics – specifically, those that do NOT require a prescription.

Big Health sits at the intersection of two of the hottest health-tech markets: digital mental health care and digital therapeutics. Its approach, via apps Daylight (for anxiety) and Sleepio (for insomnia), has been flagged as unique because 1) unlike other leading digital mental health companies like Headspace Health or Lyra Health, Big Health’s approach to care is tech-driven and does not depend on coach or clinician intervention, and 2) unlike its digital therapeutics rivals, Pear Therapeutics or Click Therapeutics, Big Health’s business model isn’t relying on prescriptions to get paid.

Big Health is, in other words, proving the market potential for a different “breed” of tech-first, PBM-backed digital therapeutics, and I ask Peter about it head-on as we discuss Softbank’s investment. The mega-fund has placed bets on all sides now, having invested in Cerebral, which delivers clinician-first mental health care and prescription medication, and prescription DTx company Pear, which went public in December 2021. So, what should the market make of the fact that Softbank sees room for Big Health alongside Cerebral and Pear? How have high-profile deals with CVS Health and the NHS in Scotland proven out the model? And, what does the addition of Anand Shah (and his insider perspective on the FDA’s sentiment toward digital therapeutics) indicate about what’s ahead when it comes to the regulatory environment for DTx in the future? So many market dynamics at play, so much to talk about!

The Intersection of 911 and 988: Decriminalizing Mental Health Crises

By BEN WHEATLEY

Effective July 2022, a new three-digit telephone number (988) will become the number to call in the case of mental health emergencies. Currently, 911 serves as the default number for people to call, placing the acutely mentally ill on a direct track toward police involvement. The new system is meant to ensure that every person experiencing a mental health crisis will receive a mental health response instead—help, not handcuffs.

In November 2021, 15 prominent organizations including NAMI (the National Alliance on Mental Illness) and Well Being Trust joined together to reimagine what a crisis response system might look like. Their Consensus Approach included the response to mental health crises, cases of suicidal behavior, and instances of substance use disorder. They argued that “Without a systems approach to transformation, simply implementing a new number to call will have little impact on those who are in need.” 

The Consensus Approach detailed seven critical pillars upon which a new crisis response system could be based, including Equity and Inclusion, Integration and Partnership, and Standards for Care. Pillar #4 stated that “Law enforcement should take a secondary role in crisis response.” This, they said, would be “a paradigm shift” that recognizes mental health conditions as “matters of health care, not criminal justice.” 

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Rcube Health’s ‘Resony App’ Catches Bayer Support for Mental Health DTx for Resonance Breathing

By JESSICA DaMASSA, WTF HEALTH

Digital mental health startups are leaning into the fact that mental health care is not “one-size-fits all” and, as a result, we’re seeing new offerings hit the market that seek to combine typical therapies and their human-plus-machine delivery in novel ways in order to better meet different patient needs. In this interview, we hear about Resony, a digital therapeutic that’s tackling anxiety and stress through a completely autonomous, AI-driven program that brings together resonance breathing and physical relaxation exercises with cognitive behavioral therapy. In other words… working on the physical side of that mind-body connection for the overall benefit of mental well-being.

Resony is just the first DTx coming out of Rcube Health, one of four early-stage startups that have gained the backing of Bayer G4A as part of their Digital Health Partnerships Program Growth Track. CEO and co-founder Ravi Janapureddy introduces us to the business that he’s building on the thesis that true scalability for digital therapeutics in mental health care relies on full automation – no clinical intervention. In a crowded space, how will Resony stand-out as a stand-alone business, instead of a ‘feature’ for a larger, full-service virtual-first mental health care provider? Is this where Bayer might see the opportunity for an “around the pill” or “alongside the pill” approach? Another digital mental health use case to explore!

988: A New Lifeline for Mental Health Emergencies

By BEN WHEATLEY

Miles Hall, a 23-year-old Black man experiencing a psychotic episode, was shot and killed by police after 911 received calls of a disturbance in his Walnut Creek, California neighborhood. His mother Taun Hall had taken steps to warn the local police that her son had been diagnosed with schizoaffective disorder and that he might be prone to mental health crises. She believed she had done enough to ensure that, in the event of a crisis, her son would be treated with care. But when the crisis came, authorities viewed Miles’ behavior through the lens of public safety, not through the lens of mental health, and it cost him his life. 

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Rumor Check with Vida Health’s CEO: Buyer Sentiment on Virtual Care, At-Risk Models, Mental Health

By JESSICA DaMASSA, WTF Health

To hear Vida Health’s CEO Stephanie Tilenius talk about what she’s hearing from payers, providers, and employers about at-risk value-based models, the shift to virtual care, and the growing importance of mental health services as a culture-builder for businesses forced into a part-virtual-part-in-office world, you get a sense of how her past work leading the various payments and commerce businesses of Google, eBay, and PayPal probably comes in handy. For example, the shift to virtual care, she says, is, “like the Internet in 1999…It’s happening.”

We get an update on exactly how Vida Health is making it happen themselves, and how they expect their newly expanded at-risk model will help. Vida’s always been fees-at-risk on physical outcomes related to diabetes management, hypertension, etc. BUT the mental health side of their offering (which experienced 6000% growth year-over-year during the pandemic) is now at-risk on outcomes too. With so much happening across the industry to move to value-based models, we deep-dive with Stephanie to hear what she’s hearing from her clients, including client-and-investor Centene and hear about growth in the employer market where she sees a major shift in how employers are thinking about healthcare as the new sexy job perk. “Instead of snacks or transportation or other benefits,” says Stephanie. “It’s all about healthcare.”

It takes a pandemic: Mental Health parity may finally have its day!

By EMILY EVANS

Emily Evans is the health policy guru at equity research company HedgeEye. She sends out these reports in emails to her clients regularly but (since I asked nicely) she allowed me to publish this one from late last week on THCB. You can catch Emily in person on the “How Much Are These Companies Really Worth? The IPO & SPAC Panel” at Policies|Techies|VCs–What’s Next for Health Care, the conference Jess Damassa & I are chairing on September 7-8-9-10 — Matthew Holt

Politics. President Biden is going to have more important things to do this week than worry about the mask/vaccine wars. At some point though, probably soon, Biden will need a scapegoat at the CDC. Several reversals on guidance around masks for the vaccinated and the unvaccinated have left local governments confused and people, most notably, parents of school age children, angry. The spread of the Delta variant isn’t helping matters.

While there may be political motivations for some of CDC Director, Dr. Rochelle Walensky’s guidance. A better approach, this last week anyway, would be never assign to cunning that which can be explained by incompetence.

Bringing a large, sprawling bureaucracy into line after a decade or more of being considered irrelevant is not a simple matter. It is made particularly difficult by the agency’s remote location in Atlanta to which Dr. Walensky commutes. 

For the time being eclipsed by a messy exit in Afghanistan, the CDC’s failures are still being noted by longstanding supporters of the agency like former Food and Drug Commissioner, Scott Gottlieb. As the Delta variant follows the same summer path as Alpha from south to north and break-through infections become identified as more common than previously thought (though mild for the vaccinated), the pressure to get the CDC reorganized will grow.

The good news, notwithstanding the vitriol over mask wearing and vaccine mandates, is the assumption underlying the CDC’s guidance on masks/vaccines is that children will be going to school and college students to class. It is, we can all hope, the first step in recognizing that there is no Zero-COVID; no magic bullet; just adaptation and adjustment, something at which humans excel.

Policy. Last week, the Department of Labor simultaneously filed and settled a lawsuit against UNH for violations under the Mental Health Parity and Addiction Equity Act of 2008. The dollar value of the settlement was immaterial but United HealthGroup (UNH) agreed to take corrective action which will be substantive.

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