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.
Cognoa, a Palo Alto, CA-based pediatric behavioral health company developing digital medicines, announced the launch of a pivotal study of its digital diagnostic aid for autism. The results of this pivotal study will be the basis for the submission to FDA next year.
Study of Diagnostic Aid for Autism
Cognoa is developing AI-powered digital therapeutics and medicines to advance the standard of care in pediatric behavioral health and improve lifelong outcomes for children. The study is intended to enable pediatricians and physicians in primary care settings to make an autism diagnosis in children as young as 18 months, so that children can receive earlier treatment.
Abbott and Omada Health announced today they are partnering to integrate Abbott’s revolutionary FreeStyle Libre system, a continuous glucose monitoring (CGM) technology, with Omada Health’s pioneering digital care program, aiming to create a new paradigm for people with Type 2 diabetes. More than 30 million Americans are living with diabetes – with roughly 95% of them living with Type 2 diabetes – and many are looking for simple ways to better manage their condition and overall health.
Today, we announced the publication of our fifth peer-reviewed study titled Estimating the impact of novel digital therapeutics in type 2 diabetes and hypertension: Health economic analysis. Key findings were presented earlier this year at The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual conference in New Orleans, LA.
Chronic diseases including diabetes and heart disease affect half of all adults in the US and account for nearly 80 cents of every healthcare dollar spent. Digital therapeutics that deliver behavioral interventions focused on lifestyle demonstrate potential benefits over traditional therapies like medications and surgeries that treat the effects of disease while leaving the causes in place. They can increase patient access because they are inherently scalable, continuously delivered, and have demonstrated both clinical and cost-effectiveness in diabetes and hypertension.
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.”
CVS Health wants to help millions of American workers improve their sleep. So for the first time, the big pharmacy benefits manager is offering a purely digital therapy as a possible employee benefit.
The company is encouraging employers to cover the costs for their workers to use Sleepio, an insomnia app featuring a cartoon therapist that delivers behavior modification lessons.
CVS Health’s push could help mainstream the nascent business of digital therapeutics, which markets apps to help treat conditions like schizophrenia and multiple sclerosis. The company recently introduced, along with Sleepio, a way for employers to cover downloads as easily as they do prescription drugs. The company said it had already evaluated about a dozen apps.
Happify Health, a global leader in mental health technology, today announced it signed an agreement with global biopharmaceutical company Sanofi (NASDAQ: SNY) to advance the application of digital therapeutics to address key co-morbidities for individuals living with multiple sclerosis (MS), including depression and anxiety.
Happify Health will develop a version of its digital platform specifically for people with MS and plans to submit the co-developed digital therapy to the U.S. Food and Drug Administration for clearance as a medical device.
“We’ve been preparing for our entry into prescription digital therapeutics for several years,” said Ofer Leidner, co-founder and president of Happify Health. “Our experience as a successful direct-to-consumer application with nearly 4 million users and our commercial relationships with some of the nation’s largest health plans and multinational employers, has allowed us to develop some highly differentiated capabilities. These capabilities, along with Sanofi’s demonstrated commitment to digital transformation, made for an ideal collaboration rooted in exploring innovative, safe and effective therapies aiming to improve the lives of individuals with MS.”
Dance Biopharm Holdings, Inc., a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies, announced today it has formed a strategic alliance with DarioHealth Corp. “Dario” (Nasdaq: DRIO), a leading, global digital therapeutics company, to expand access to a personalized digital health management platform for patients with chronic diseases. Under the terms of the agreement, Dance Biopharm will integrate its gentle mist smart inhaler into DarioHealth’s digital therapeutics platform to provide patients automated, real-time treatment data through an advanced mobile application. Dario will immediately start the design of the integrated solution for Dance to accommodate clinical trials and, upon regulatory approval, any marketed solutions.
Cognoa, a company at the forefront of pediatric behavioral health, and EVERSANA™, the leading independent provider of global commercial services to the life science industry, today announced a partnership to advance the industry standard by which digital medicines will be ordered, dispensed, and covered by insurance. By leveraging the existing healthcare infrastructure utilized by pharmaceutical companies and medical device manufacturers, EVERSANA will ease adoption by physicians, payers and patients at commercial launch of Cognoa’s prescription digital medicines.
On October 19 in 2017, Jada Bennett-Cross remembers feeling fed up. She was sick of waking up feeling anxious and unmotivated, of having arguments with her husband, of her short fuse with her children and of feeling the need to binge on wine to cope with the day.
“I realised it was a crutch and I knew I needed to stop what I was doing,” says the mother-of-two from Ashfield. She had heard about Daybreak, an app developed to help people cut back or quit alcohol, and decided to download it.