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After FDA nod, Better Therapeutics races to boost dwindling cash
Better Therapeutics has cleared one hurdle: The Food and Drug Administration last week authorized the company to market AspyreRx, its prescription app which uses CBT to treat type 2 diabetes. Better now needs money, and fast. The public company recently raised $6.5 million in a stock sale to supplement its existing reserves, but it’s on the hunt for a medical device or pharmaceutical company partner that can provide the capital needed to fuel commercialization. CEO Frank Karbe told me the company hopes to have a deal in place by the end of the year.
Regardless the nature of the partnership it lands, Karbe said Better stands behind AspyreRx’s potential for profit. So far, there haven’t been any successful prescription digital therapeutics companies, though there have been some notable failures. Karbe said that targeting diabetes will lead to success with payers where companies focused on mental health have fallen short. He also believes the company’s clinical evidence will help it standout from a glut of diabetes management companies that sell to employers.
Perhaps optimistically, Better Therapeutics projects that AspyreRx could generate peak annual sales of $2 billion — remember that number for the future, everyone — but despite dwindling cash, Karbe is wary of rushing.
“What we want to be very cautious about is that we don’t launch prematurely, and we generate sort of the same, let’s say, underwhelming performance that has been observed to date,” he said. “Because it would be detrimental to us, [and] it would be detrimental to the PDT space in general. What we really need is a success case.”
Hospital billing for MyChart messages picks up steam
Technology has made it easier than ever to message your doctor — and now, their inboxes are overflowing. In response, health systems including Cleveland Clinic and the University of Washington have started billing for responses. Depending on insurance, patients may have to pay as much as $50 for a message if it requires extra effort like checking a patient’s medical record. Hospitals told STAT’s Mohana Ravindranath they are charging for just small number of messages, but it’s a step that’s necessary to start addressing heavy burden carried by care teams.
“This is part of a broader conversation about expectations patients and providers have of each other,” said Anthony Cheng, who heads digital health at Oregon Health & Science University. Introducing fees might remind patients that there’s a human on the other end of the patient portal, pushing them to “pause and think before they send a message.”
UCSF digital health leaders jumps to Notable
After more than a decade as a doctor and digital health leader at the University of California at San Francisco, Aaron Neinstein — also a member of the Health Information Technology Advisory Committee guiding Congressional policy — is joining health automation company Notable as its chief medical officer. At UCSF, Neinstein oversaw efforts like simplifying the referral intake process and setting up a digitally enhanced diabetes practice. In the policy world, his team advocated for greater data interoperability and easing restrictions on virtual care. I shot him a few questions on his way out.
How do you think you’ll be able to impact digital health differently from the private sector?
In a health system, you are at the front lines of care delivery, working with other leaders and staff to improve processes, workflows, staff and patient experience, and care outcomes. To successfully drive change and improvement in a health system requires close partnership with the private sector… In moving to Notable, I am excited by the opportunity to have impact at a broader scale, learning from and working with health systems all over the country, large and small, rural and urban, adult and pediatrics.
Why Notable?
I have spent more than a decade assessing, deploying, and using a wide variety of health care technologies in my role at UCSF. I have also seen a lot of the reasons that certain products struggle: being too early and requiring too far a leap into the future, not solving a real pain point, lacking a clear business model, failing to integrate into EHRs or existing workflows, requiring impractical care model changes, or technology that cannot be successfully or efficiently built and scaled.
[Notable’s] platform is built to solve today’s most pressing pain points, respects and integrates seamlessly into current workflows and EHRs, delivers real outcomes and return on investment, and has the most powerful and capable technology platform that I have seen … In an industry riddled with overblown promises, Notable is refreshingly pragmatic, hyperfocused on offering what customers need now, prioritizing practical solutions over a grandiose future vision.
Why is now the right time to transition?
First, challenges continue to accumulate in our health care system: increases in physician and nursing burnout, unacceptable access and affordability of care, rising labor costs, disparities and uneven care outcomes and quality, and poor patient experience. Second, we have finished transitioning from paper to electronic health records, ready to make the next leap toward digital transformation. Yet, technology has not yet driven the gains in productivity nor in consumer experience in health care that we typically see in other industries.
Third, we are at an inflection point in what is increasingly possible with artificial intelligence. The rise of large language models presents an unparalleled opportunity to relieve the administrative burden of going to the doctor or delivering care, and return the focus to building meaningful, human relationships.
I think this culminates in a unique moment, with conditions ripe for bringing automation and artificial intelligence to eliminate cumbersome administrative and operational workflows, improving care team and patient experience, and driving lower costs and better outcomes.
GSK researchers use ML to identify hepatitis B subgroups
In search of new ways to treat hepatitis B, researchers from GSK applied machine learning to data from a Phase 2 trial of its drug bepirovirsen to identify subgroups of people who respond to treatment. The trial showed positive results, but the treatment only cleared markers of the virus below the lower limit of detection in 9% to 10% of patients. That’s progress, but leaves a lot of people out.
“It’s really critical actually to find out what are the drivers of that functional cure, how can we achieve that functional cure in more people — can we predict potentially who might achieve that functional cure based on their characteristics?” GSK senior director Patrick Schwab told me.
To identify the subgroups, which include people whose initially responded but didn’t see sustained results, researchers used millions of data points, including clinical data, lab tests, genotypes of the virus, liver fibrosis measurements, and more. The data were collected over 48 weeks, including both the treatment and follow-up period.
According to Schwab, the research could be used to generate hypotheses for potential combination therapy approaches for people who were partial responders or to create software tools doctors can use to help direct treatment.
GSK is currently conducting a phase 3 trial of bepirovirsen in a subgroup that was identified without using machine learning. Still, the research highlights the potential for AI to slice and dice populations into complex groupings that humans could not identify without help. “Computers are actually excellent at actually trying to surface this type of information,” said Schwab.
Industry news
- CVS Caremark teamed up with pharmacy discounts portal GoodRx to launch Caremark Cost Saver, which will give eligible members automatic access to GoodRx’s discounted prescription pricing on some generic medicines.
- North Carolina-based Novant Health will begin using behavioral health tech company NeuroFlow’s screening tools and educational resources for patients and staff.
- Chip giant NVIDIA invested $50 million in AI drug discovery company Recursion.
What we’re reading
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- The longevity clinic will see you now—for $100,000, Wall Street Journal
- Reducing primary cesarean delivery rate through implementation of a smart intrapartum surveillance system, npj Digital Medicine
- Elon Musk’s new xAI company launches to ‘understand the true nature of the universe’, The Verge
- One year into 988 hotline, staff push for fixes to ambitious new system, STAT