Digital Therapeutics Edition (ep 03): In the previous episode, Brian Dolan and I discussed the definition of digital therapeutics. The term ‘digital therapeutics’ has been used since about 2012, and in 2017 the Digital Therapeutics Alliance, aka DTA, came on the scene.
In this two-part deep dive we go inside the DTA and in this episode, we start with Megan Coder, the Executive Director.
I remember meeting the energetic, polished, and absolutely no BS, Megan, at the 2017 Frontiers Health in Berlin – yes, when face-to-face conferences were still a thing. At that conference, the DTA was officially launched. I strongly believe this was a historic moment for the overall industry.
MedCityNews (Eddie Martucci) — This burgeoning industry has been propelled to the forefront of medicine with the onset of the Covid-19 pandemic, which shined a light on the need for innovative treatment options that can be used at home from your phone or tablet.
In medicine, we’re getting real-time experience with what many believed was an inevitable but potentially distant future – fully digital treatments.
In what may have sounded like a futuristic scenario mere months ago, doctors today can prescribe a video game treatment for their patients. Children with ADHD are now “playing” their medicine thanks to an emerging category of medicine – digital therapeutics (DTx).
STAT (Erin Brodwin & Rebecca Robbins) — A prominent trade group is calling on the federal government to cover digital health tools for people with public health insurance during the coronavirus pandemic, which has forced widespread delays in routine care.
These tools, known as digital therapeutics, use software and smartphone apps to connect patients with tips and coaching for diseases like diabetes. For the most part, they are not currently covered for Medicare or Medicaid patients, though some private Medicare Advantage plans and Medicaid managed care organizations have contracted with digital diabetes prevention and care providers. Employers and commercial insurance plans, however, are increasingly paying to make the tools available for their workers and members.
Our industry-first Digital Health Formulary will allow employers and health plans to manage this fast-growing segment of health care while improving access for patients.
As more people turn to digital programs to help manage serious illnesses and take better control of their health, Express Scripts is making it easier to connect consumers with the apps, devices and digital therapeutics that work best for them.
In May, we announced we were developing the first-ever formulary for digital health. Since then, we have been building this industry changing platform, establishing a four-stage formulary review and selection protocol and reviewing hundreds of submissions from digital health developers.
World Economic Forum (Ceri Parker) — We asked members of our Global Future Councils – academics, business leaders and members of civil society – to imagine a better world in 2030. Only by thinking about where we want to be tomorrow can we prompt the action we need today. Here’s what they had to say…
STAT News (Corey McCann) — Smartphones and tablets have transformed almost every facet of our daily lives, making it nearly impossible to imagine a world without being connected. That same technology has now crossed into health care. Prescription digital therapeutics, or PDTs, are reimagining the way we think about treating disease by using smartphones and tablets to deliver treatment anytime and anywhere.
Prescription digital therapeutics operate at the intersection of biology and technology, with researchers, clinicians, and engineers working in tandem to leverage the power of software to treat disease. They are designed so patients can access treatment when and where they need it. Similar to traditional medicines, PDTs are prescribed by physicians and backed by clinical data and subject to authorization by the Food and Drug Administration.
Scientific American — The past few years have illustrated the startling speed with which medicine can evolve. Since 2018, the US Food & Drug Administration (FDA) has approved first-of-their-kind drugs based on RNA, gene therapy, and cancer-killing chimeric antigen receptor (CAR) T-cells and signed off on human trials to explore the clinical use of CRISPR-mediated genome editing. And throughout this process, the US Pharmacopeia (USP) has been working in the background to ensure that quality standards are in place for new medical products reaching the market. “200 years ago, our first monographs were basically recipes: ‘take bark from this tree and boil it for this long and you should get a brown liquid’,” says Michael Levy, Head of Research & Innovation (R&I) at USP. “Obviously we’ve evolved tremendously since then, but it’s just a continuation of what we’ve always done—we’re just doubling down on it.”
MobiHealthNews (Dave Muoio) — Vetting digital health products for distribution and reimbursement is another step forward for novel digital treatments hoping to stand alongside traditional biologics. Fortunately, the past few months have seen entities toeing the line between pharma and payer taking steps to validate and support specific digital health products, thereby paving the way to reimbursement and widespread adoption.
Pharmaphorum (Richard Staines) — Germany has passed a law allowing doctors to prescribe digital apps with health benefits, which can be reimbursed by the country’s health insurance system.
The new system is made possible by the Digitalisation and Innovation Act (Digital Supply Act), drawn up in draft by federal health minister Jens Spahn and approved by the federal cabinet yesterday.
Germany is following the example of the US, which over the last few years has introduced a system where the FDA is able to approve apps that have trial evidence showing clinical benefits.
STAT News (Kate Sheridan) —
As the major digital therapeutics trade association, [the] Digital Therapeutics Alliance includes some of the nascent industry’s movers and shakers — including Pear, Akili, and Madison, Wis.-based Propeller Health, which produces devices that track how often people use a rescue inhaler — as members.
More than 30 companies in 10 different countries have joined the group; the alliance is intended to have an international perspective, Coder noted, so it doesn’t just understand issues companies may face in one particular country or with one particular regulator.