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Tag: digital therapeutics

What’s behind all these assessments of digital health?

By MATTHEW HOLT

A decent amount of time in recent weeks has been spent hashing out the conflict over data. Who can access it? Who can use it for what? What do the new AI tools and analytics capabilities allow us to do? Of course the idea is that this is all about using data to improve patient care. Anyone who is anybody, from John Halamka at the Mayo Clinic down to the two guys with a dog in a garage building clinical workflows on ChatGPT, thinks they can improve the patient experience and improve outcomes at lower cost using AI.

But if we look at the recent changes to patient care, especially those brought on by digital health companies founded over the past decade and a half, the answer isn’t so clear. Several of those companies, whether they are trying to reinvent primary care (Oak, Iora, One Medical) or change the nature of diabetes care (Livongo, Vida, Virta et al) have now had decent numbers of users, and their impact is starting to be assessed. 

There’s becoming a cottage industry of organizations looking at these interventions. Of course the companies concerned have their own studies, In some cases, several years worth. Their  logic always goes something like “XY% of patients used our solution, most of them like it, and after they use it hospital admissions and ER visits go down, and clinical metrics get better”. But organizations like the Validation Institute, ICER, RAND and more recently the Peterson Health Technology Institute, have declared themselves neutral arbiters, and started conducting studies or meta-analyses of their own. (FD: I was for a brief period on the advisory board of the Validation Institute). In general the answers are that digital health solutions ain’t all they’re cracked up to be.

There is of course a longer history here. Since the 1970s policy wonks have been trying to figure out if new technologies in health care were cost effective. The discipline is called health technology assessment and even has its own journal and society, at a meeting of which in 1996 I gave a keynote about the impact of the internet on health care. I finished my talk by telling them that the internet would have little impact on health care and was mostly used for downloading clips of color videos and that I was going to show them one. I think the audience was relieved when I pulled up a video of Alan Shearer scoring for England against the Netherlands in Euro 96 rather than certain other videos the Internet was used for then (and now)!

But the point is that, particularly in the US, assessment of the cost effectiveness of new tech in health care has been a sideline. So much so that when the Congressional Office of Technology Assessment was closed by Gingrich’s Republicans in 1995, barely anyone noticed. In general, we’ve done clinical trials that were supposed to show if drugs worked, but we have never really  bothered figuring out if they worked any better than drugs we already had, or if they were worth the vast increase in costs that tended to come with them. That doesn’t seem to be stopping Ozempic making Denmark rich.

Likewise, new surgical procedures get introduced and trialed long before anyone figures out if systematically we should be doing them or not. My favorite tale here is of general surgeon Eddie Jo Riddick who discovered some French surgeons doing laparoscopic gallbladder removal in the 1980s, and imported it to the US. He traveled around the country charging a pretty penny to  teach other surgeons how to do it (and how to bill more for it than the standard open surgery technique). It’s not like there was some big NIH funded study behind this. Instead an entrepreneurial surgeon changed an entire very common procedure in under five years. The end of the story was that Riddick made so much money teaching surgeons how to do the “lap chole” that he retired and became a country & western singer.

Similarly in his very entertaining video, Eric Bricker points out that we do more than double the amount of imaging than is common in European countries. Back in 2008 Shannon Brownlee spent a good bit of her great book Overtreated explaining how the rate of imaging skyrocketed while there was no improvement in our diagnosis or outcomes rates. Shannon by the way declared defeat and also got out of health care, although she’s a potter not a country singer.

You can look at virtually any aspect of health care and find ineffective uses of technology that don’t appear to be cost effective, and yet they are widespread and paid for.

So why are the knives out for digital health specifically?

And they are out. ICER helped kill the digital therapeutics movement by declaring several solutions for opiod use disorder ineffective, and letting several health plans use that as an excuse to not pay for them. Now Peterson, which is using a framework from ICER, has basically said the same thing about diabetes solutions and is moving on to MSK, with presumably more categories to be debunked on deck.

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Matthew’s health care tidbits: The drug model for DTx was wrong

Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

If you were to look at pharmaceuticals in the US you might make three observations. 1) They are the most important way health conditions are helped, cured or eradicated. 2) The way they are delivered to patients (via pharmacies) is very badly integrated with the health care delivery system. 3) They are way too expensive.

OK, so those are my observations not yours but I think you’ll agree they’re all true.

Now I am going to tell you that we’ve developed a technology that lives in your phone that has the same impact as a drug, if not better. It will cure your depression, insomnia, pain, even maybe Alzheimer’s. And because it is a software product, not a drug you ingest, it has no (or at least few) dangerous side effects. And because it’s software and easy to distribute to millions of people, it can be cheap. Wouldn’t it be a great idea for the people managing health conditions—a patient’s clinical care team—to directly integrate this technology into the care they are delivering?

Some of the people building these technologies agreed, but most of them decided that they liked the current model of prescription pharmaceuticals. They built these cool technologies and decided to distribute them via physician prescriptions and charge for them like pharmaceuticals. To do that, they had to get FDA approval for their “Prescription Digital Therapeutics” (DTx) via expensive clinical trials. Additionally, of course, they hoped to get government-backed monopoly status–called patents in the pharma business.

In general in health care, the FDA regulates things that go into the body and may cause damage. The rest of clinical medicine has great latitude for experimentation, technique and technology development, and allows others to copy what works.

The companies heading down the Prescription DTx route also used the business model of regular pharma and biotech companies. They raised large amounts of money up front, applied for patents, went through the FDA clinical trial process, and hoped to charge significant amounts per patient once their DTx were approved and prescribed.

None of them seemed to care that if they succeeded, their DTx would necessarily only be accessed by a small population at great cost. None of them seemed to notice that their DTx were usually an electronic distillment of teaching, patient advice, coaching therapy or other activities that look more like extensions of traditional clinical care, as opposed to ingested pharmaceuticals.

Many of these companies are now in deep trouble. They raised money when it was cheap or even, like Pear and Better Therapeutics, took advantage of the SPAC vehicles to IPO. Now they have found that they cant get their DTx through the FDA process quickly enough or aren’t seeing the prescribing numbers they needed to make their products a success. Since the digital health stock crash, it’s very hard for them to raise more money. Pear Tx this week announced it was trying to sell itself.

My hope is that we get a reset. I want digital therapies that are extensions of clinical care to be widely used and widely available as part of the care process, and for their care to be integrated into clinical care –rather than to be prescribed and then delivered by some third-party. And, because they are software and because software scales, I want them to be cheap. Hopefully that is the future of DTx.

On second thoughts, that wouldn’t be a bad future for regular pharmaceuticals either!

Digital Therapeutics, Megan & Me!

Anyone who follows me knows that I’ve been questioning whether digital therapeutics are real and more importantly whether the people building and trying to sell them are simply trying to replicate the American drug pricing model–patent, protect, prescribe & price gouge. So who better to have this conversation with than the person in charge of explaining and selling the notion of digital therapeutics to the world? Megan Coder is Executive Director of the Digital Therapeutics Alliance. She graciously and bravely agreed to talk to me. Who won the argument? You’ll have to watch to decide, but I found our discussion to be a lot of fun and very interesting and I hope you will too Matthew Holt

The transcript is below

Matthew Holt:

Hi, it’s Matthew Holt with a  THCB spotlight. I’m here with Megan Coder. Megan is the executive director of the Digital Therapeutics Alliance. And we’re here to talk about this thing called digital therapeutics, as to what they are, what the alliance does and whether they really exist and how we should treat them. Megan, thanks for coming on. I know we’ve done a little bit of sparring online and in-person, but I’ve never interviewed you. So I’m looking forward to this. So how are you doing?

Megan Coder:

Good. It’s more fun to spar in-person, but I miss the in-person aspect.

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The Digital Therapeutics Startup Following Pharma’s Formulary Model | David Klein, Click Therapeutics

By JESSICA DaMASSA, WTF HEALTH

Click Therapeutics is a digital therapeutics company that develops and commercializes “software as medical treatments” — basically building digital formularies of prescribable software tools the same way a traditional pharma company would create a formulary of prescription drugs. CEO David Benshoof Klein stops by to talk about Click’s array of solutions and the support they’ve received from those traditional pharma companies, including investment from Sanofi-Genzyme BioVentures (which led their last funding round of $27.4M in October 2018) and a new partnership with Otsuka America, Inc. to fully fund development of an app to combat Major Depressive Disorder.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

Leading Mental Health Platform on DTx Reimbursement, Scaling | Ken Cahill, SilverCloud Health

By JESSICA DaMASSA, WTF HEALTH

Digital mental health platform SilverCloud Health is the digital-therapeutic-of-choice for mental health services in the UK’s National Health Service (NHS) and serves nearly 250 healthcare organizations around the world, racking up 1.5 million therapy hours and 5 million clinical interactions. CEO Ken Cahill stops by to catch us up on SilverCloud Health’s impressive clinical outcomes and how he’s tackling challenges around reimbursement that are common for many digital therapeutics startups. His unique approach (spoiler alert: he partners with providers to approach payers for exception codes) may give some inspiration to those in a similar situation, but tune in for Ken’s full explanation and details on how the company plans to double over the next year.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

Digital Therapeutics Category Outlook for Reimbursement | Megan Coder, Digital Therapeutics Alliance

BY JESSICA DAMASSA

What’s ahead for digital thereaputics as the category carves out its place in the broader world of digital health and health tech? Megan Coder, Executive Director of the Digital Therapeutics Alliance (the professional org founded in 2017 to guide the development of the category), swings by to level set with some definitions, talk reimbursement trends in US and Europe, and explain the intention behind the DTA’s recently published code of conduct and best practices for DTX companies.

Filmed at Frontiers Health in Berlin, Germany, November 2019.

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Leading Innovation in Dermatology | Francesca Wuttke, Chief Digital Officer, Almirall

BY JESSICA DAMASSA, WTF HEALTH

Almirall is a dermatology-focused pharmaceutical company based in Spain, and its investment in R&D for developing new therapeutics leads the way as the largest within the country’s pharma industry. It’s no surprise, then, that Almirall has also adopted a digital therapeutics and digital health strategy to augment it’s molecular innovations with a ‘beyond the pill’ approach. We sat down with Almirall’s first-ever Chief Digital Officer, Francesca Wuttke, to hear about the pharma company’s digital strategy which is centered on laying the framework for advanced analytical platforms that gather more health data about patients and skin health. For help and fresh ideas, Francesca has opened Almirall’s doors to health tech startups, launching a brand-new accelerator program cutely called ‘Almirall’s Digital Garden,’ to ‘seed’ and ‘grow’ innovative solutions. Are there lots of health startups out there that focus on treating psoriasis, acne, and other dermatological conditions? Francesca tells us what she hopes ‘reap’ from the Digital Garden and how she hopes her broader digital strategy will flourish at the boutique pharma company.

Filmed at Barcelona Health Hub Summit in Barcelona, Spain, October 2019.

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The Applied Health Signals Category of Health Tech | Jennifer Schneider, Livongo

BY JESSICA DAMASSA, WTF HEALTH

Before Livongo set digital health records for its IPO, it started 2019 by launching a brand-new category of healthcare company: the Applied Health Signals company. How is this category different than what we already think of when we think about digital health and healthcare? How is it distinct from health tech’s other emerging classification, digital therapeutics? Jennifer Schneider, Livongo’s President, explains why the company started the new category, which is intended for those who are working at the intersection of data science, clinical impact, and behavioral outcomes. Could your company be an Applied Health Signals Company? Listen in to hear Jenny talk about how Livongo’s “AIAI engine” drove the decision to start the new classification. If your tech works like hers…maybe you are!

Filmed at HLTH 2019 in Las Vegas, October 2019.

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How Health Plans Pick Startups for Partnerships & Investment | Bryony Winn, BCBS North Carolina

By JESSICA DAMASSA, WTF HEALTH

It’s the ‘holy grail’ of advice for health tech startups. BlueCross BlueShield of North Carolina’s Chief Strategy & Innovation Officer, Bryony Winn, tells what it takes for digital health and digital therapeutics startups to gain partnership agreements, reimbursement, and possible investment from health plans. How do you figure out how to “align incentives” in a way that perks up a payer’s ears? Bryony gives us some VERY FRANK advice about how startups can bring innovation to BCBS of North Carolina, other Blues plans, or their VC funds (which in this case is Echo Health Ventures where BCBS North Carolina partners with Cambia Health Solutions.) To play the game, you have to know the players. Tune in for more.

Filmed at HLTH 2019 in Las Vegas, October 2019.

WTF are Digital Therapeutics? | Digital Therapeutics Alliance Executive Director, Megan Coder

By JESSICA DaMASSA, WTF HEALTH

Digital therapeutics has exploded as the new hot buzzword in digital health. But how are digital therapeutics different from digital health applications, applied health signals, or m-health technologies? The Digital Therapeutics Alliance was formed to answer that exact question. DTA Executive Director Megan Coder sets the record straight, hint: it involves software algorithms.

Filmed at JP Morgan Healthcare in San Francisco, CA, January 2019.

Jessica DaMassa is the host of the WTF Health show & stars in Health in 2 Point 00 with Matthew Holt.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health