The Benefits of Prescription Digital Therapeutics for Gastrointestinal Conditions

Jana K. Hoffman
May 28, 2020 · 9 min read
Photo by Polina Zimmerman from Pexels
  • GI diseases affect more than 60 million people in the United States and billions worldwide.
  • A growing body of evidence has shown that Cognitive Behavioral Therapy (CBT) interventions have the potential to treat GI conditions by reducing symptom severity.
  • Prescription digital therapeutics (PDTs) are clinically-validated software treatments prescribed by a doctor and have the potential to vastly improve life outcomes for millions of people.
  • Mahana Therapeutics is designing and developing CBT-based PDTs for Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD), among other GI conditions.
  • PDTs offer substantial benefits for patients, providers, and payers.

The traditional prescription drug landscape is starting to catch up to the era of all-things digital. It was really only a matter of time before doctors would one day prescribe an app, better known as a prescription digital therapeutic (PDT), in addition to a prescription pharmaceutical or biologic treatment.

As such, people living with chronic gastrointestinal (GI) conditions, who historically haven’t had success using medications, may deeply benefit from a PDT. That’s why I joined Mahana Therapeutics, a digital healthcare startup in San Francisco and London launched by patients for patients. I value its mission to support people living with chronic health conditions and find great purpose in contributing to products that have the potential to impact their lives in meaningful ways. We’ve made a commitment to developing evidence-based Cognitive Behavioral Therapy (CBT) PDTs for people with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD) and are well on the way to delivering on our promise.

Let’s take a closer look at the innovative PDT space, Mahana’s small but fiercely dedicated team building them, and why it’s more critical now than ever before to make PDTs accessible to everyone.

Prescription Digital Therapeutics Defined

Not all mobile health (mHealth) apps are created equal. Digital health apps (think Calm for meditation and Fitbit for fitness tracking) are widely available for consumer download on an app store. They support lifestyle changes and overall well-being and generally don’t require rigorous clinical evidence and regulatory clearance before commercialization as a medical device.

Prescription digital therapeutics, on the other hand, are evidence-based software products that treat a medical condition or disease. They require strong clinical evidence, real-world outcomes, and regulatory clearance; most often as a class II medical device (Software as a Medical Device or SaMD). reSET for substance use disorder and Somryst for insomnia — both by Pear Therapeutics—are two such examples. Prescription digital therapeutics are prescribed by doctors or other qualified healthcare professionals, and the cost of the product may be covered by a third-party payer (more on that in a bit).

A CBT PDT for GI Conditions

GI diseases affect more than 60 million people in the United States alone¹ and billions worldwide². Conditions such as IBS, IBD, Gastroesophageal reflux disease (GERD or acid reflux), and others come with painful physical symptoms that are incredibly disruptive to everyday life. People living with them can feel ashamed and embarrassed and experience mental health comorbidities like depression and anxiety³,⁴,⁵. Plus, GI conditions are a growing problem — yearly, they account for 105 million outpatient care visits, 14 million hospital admissions, and 236,000 deaths; the prevalence of digestive diseases is expected to increase with an aging population⁶ — doctors and patients are frustrated, and there’s a need for effective treatment⁷.

Within the last decade, research on the brain-gut connection⁸, , ¹⁰ related to GI conditions has been pioneered by Dr. Emeran Mayer, one of Mahana’s advisors, and other top scientists. A growing body of evidence has shown that CBT interventions have the potential to treat or reduce symptom severity associated with GI conditions¹¹. That’s because the brain and the gut (called the second brain or little brain) are in constant communication with one another.

When people living with GI conditions become aware of the ways stress and anxiety contribute to their symptoms and learn how to change their thoughts and behaviors connected to them, they discover that they’re in control — not their GI condition. This can be achieved via software-based CBT programs in the comfort of their own homes and has the potential to vastly improve life outcomes for millions of people.

Woman holds smartphone in hands
Photo by Porapak Apichodilok from Pexels

A Passionate and Dedicated Team of Innovators

Of course, none of this would be possible without a thoughtful, intentional, and multidisciplinary approach to building a team that sits at the intersection of technology, human-centered design, and healthcare. Mahana, founded by Robert Paull and Simon Levy, is a compassionate group of software engineers, product leaders, regulatory experts, and clinical innovators. Our backgrounds range from Intuit and Google, to Kaiser Permanente and Airbnb, to Harvard Medical School and Johns Hopkins University, and beyond. Collectively and collaboratively, we’re reimagining healthcare interventions with data security and patient privacy at its core.

Our initial focus is to design CBT-based programs to treat IBS and IBD. Mahana’s clinical innovation team, led by Megan Oser, Ph.D., researches, develops, and designs CBT interventions and clinical trials for GI conditions. This is no easy feat, which is why Mahana has called upon Alice Sibelli, Ph.D., who was instrumental in helping to develop the original Parallel™ program (formerly known as Regul8) for IBS in the United Kingdom; Jocelynn Owusu, Ph.D., a user-centered clinical researcher with a background in sleep health from the Mental Health department in the School of Public Health at Johns Hopkins University; and Taryn Losch-Beridon MPH, a 20-year veteran in the GI drug world experienced in clinical trial design, FDA, and Medicines and Healthcare products Regulatory Agency (MHRA) interactions, to help us forge the path forward.

Mahana’s advisors, including Rona Moss-Morris, Ph.D.; Emeran Mayer M.D.; Carlo di Lorenzo M.D.; Miranda van Tilburg, Ph.D.; Tonya Palermo, Ph.D.; Lee Ritterband Ph.D.; and Rona Levy, Ph.D.; among others, are leaders in gastroenterology and psychology. They’ve become an insightful sounding board for some of Mahana’s most important decisions along the way and bring a great depth of knowledge to our team.

Together, we’ve made major strides in a short amount of time. This includes the development of Parallel™, Mahana’s first product, based on an 8-week, clinically-validated, minimal-contact digital program for people with IBS. Our agile software and clinical development processes allow us to continually iterate, redefine, and build quickly. Just like agile development, agile science allows our researchers to test efficacy, usability, and more as products are being built. This is especially significant in the time of COVID-19.

PDTs in a COVID-19 World

Complementary scalable psychological treatments for GI conditions are long overdue. There’s no more urgent of a time — when so many people with GI conditions are stuck indoors sheltering in place due to a global pandemic and dealing with heightened stress and anxiety — to provide access to a psychology-based PDT.

If there’s one silver lining among the devastation this crisis has left in its wake, it’s the swift action that’s been taken to make digital health and telemedicine more accessible. Forbes recently published an article articulating the dire need for digital therapeutics as remote care becomes a more desirable option for people around the globe.

Digital healthcare is a growing market that shows no signs of stopping. According to Global Market Insights, the sector is expected to reach half a trillion dollars by 2025. PDTs are just one slice of the pie, and investments continue to be pumped into digital healthcare startups. According to Rock Health, digital health companies raised $3.1 billion in funding (a total of 107 deals) during Q1 of 2020 alone.

The Benefits of PDTs for Patients, Physicians, and Payers

With that in mind, let’s look at the impact that GI conditions have on healthcare. GI diseases in the U.S. are at least a $135 billion a year problem¹². IBS alone is estimated to be a $30 billion dollar annual problem in the U.S. GI diseases also contribute to some of the largest costs of chronic disease management per person; with some GI diseases, like IBD, contributing even greater cost to the system per patient per year than diabetes and obesity¹³,¹⁴,¹⁵,¹⁶,¹⁷. According to the IBS Global Impact Report in 2017 and 2018, 55% of patients believe their prescription medications are ineffective, and 79% feel they had either no control or partial control of their symptoms.

The benefits of software-based treatments for patients, providers, and payers are compelling. PDTs often have a faster path to patient efficacy data, enabling a quicker overall regulatory clearance process and speedier time to commercialization. This is because PDTs are frequently adjunct or complementary (i.e., not a replacement) to standard medications. And because they’re software-based, PDTs are generally safe, non-invasive, and non-toxic.

For people with GI conditions struggling to get a handle on their symptoms, PDTs aim to be a cost-effective, complementary way to close the gap between treatment for both mental and physical health, too. Most PDTs are intended to be used alongside medication. PDT software even has the capacity to personalize treatments for every user.

For physicians, PDTs help address some of the frustration attached to ineffective treatments. Psychology-based PDTs offer a much-needed yet oft-overlooked solution by providing increased access to mental health resources and new treatment options.

Further, PDTs have the potential to reduce the economic burden that a chronic condition has on patients and insurance companies. As an example, IBD patients, who also have a mental health diagnosis (such as anxiety or depression), can have average costs that are roughly twice that of patients without mental health diagnoses ($35,740 vs. $18,520). Also, IBD patients with at least one emergency room visit had costs that were more than twice as high as patients without ED visits ($37,759 vs. $15,237)¹⁸.

Biotech and pharma stand to benefit, too. There’s an increasing incentive for pharmaceutical or biotech companies to partner with digital therapeutics companies because it could help them better serve patients. This melding of minds and expertise on both sides could help accelerate getting PDTs into the hands of more people who need them most.

PDTs are in varying stages of testing to demonstrate clinical and health economic evidence showing they can positively impact healthcare costs. Currently, there are just a few PDTs on the market covered by insurance. None, to our knowledge, are covered by Medicare, and very few states cover them via Medicaid. Widespread adoption and reimbursement is the next major stage for the PDT sector. We’re encouraged by how quickly insurance companies began covering telehealth amid COVID-19 and anticipate coverage decisions will only accelerate for this new category of PDTs.

This is Just the Beginning

PDTs are the future of healthcare. They have the potential to substantially impact people’s health and well-being in a way that some medications simply can’t. They’re also poised to redefine healthcare in a more meaningful, personalized way. People living with GI conditions deserve to live happy, healthy, normal lives, and Mahana is eager to help them meet this reality.

SOURCES

¹National Institutes of Health, U.S. Department of Health and Human Services. Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases. Bethesda, MD: National Institutes of Health; 2009. NIH Publication 08–6514.

²Sperber Ami D, Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study, Gastroenterology, April 2020

³Mikocka-Walus A, et al, Symptoms of Depression and Anxiety Are Independently Associated With Clinical Recurrence of Inflammatory Bowel Disease.

,Drossman DA, Morris CB, Schneck S, et al. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009a;43(6):541–50.

IBS Global Impact Report (2018)

Almario, Christopher V et al. “Burden of Gastrointestinal Symptoms in the United States: Results of a Nationally Representative Survey of Over 71,000 Americans.” The American journal of gastroenterology vol. 113,11 (2018): 1701–1710. doi:10.1038/s41395–018–0256–8

Mayer, Emeran A. “The Role of Gut-Brain Interactions in Influencing Symptoms of Irritable Bowel Syndrome.” Gastroenterology & hepatology vol. 14,1 (2018): 44–46.

Mayer, Emeran A. “Gut feelings: the emerging biology of gut-brain communication.” Nature reviews. Neuroscience vol. 12,8 453–66. 13 Jul. 2011, doi:10.1038/nrn3071

¹⁰Martin CR, Osadchiy V, Kalani A, Mayer EA. The Brain-Gut-Microbiome Axis. Cell Mol Gastroenterol Hepatol. 2018;6(2):133‐148. Published 2018 Apr 12. doi:10.1016/j.jcmgh.2018.04.003

¹¹Weibert E, Stengel A. Die Rolle Der Psychotherapie Beim Reizdarmsyndrom [The Role of Psychotherapy in the Treatment of Irritable Bowel Syndrome]. Psychother Psychosom Med Psychol. 2019;69(9–10):360‐371. doi:10.1055/a-0829–6990

¹²Peery, Ann F Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018, Gastroenterology 2019 Jan;156(1):254–272

¹³Buono JL, Mathur K, Averitt AJ, Andrae DA. Economic Burden of Irritable Bowel Syndrome with Diarrhea: Retrospective Analysis of a U.S. Commercially Insured Population. J Manag Care Spec Pharm. 2017;23(4):453‐460. doi:10.18553/jmcp.2016.16138

¹⁴Doshi JA, Cai Q, Buono JL, et al. Economic burden of irritable bowel syndrome with constipation: a retrospective analysis of health care costs in a commercially insured population. J Manag Care Spec Pharm. 2014;20(4):382‐390. doi:10.18553/jmcp.2014.20.4.382

¹⁵Nyrop et al Costs of health care for irritable bowel syndrome, chronic constipation, functional diarrhoea and functional abdominal pain Aliment Pharmacol Ther. 2007 (adjusted for 2019 $)

¹⁶Bommer C, Sagalova V, Heesemann E, et al. Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030. Diabetes Care. 2018;41(5):963‐970. doi:10.2337/dc17–1962

¹⁷Biener, Adam et al. “The High and Rising Costs of Obesity to the US Health Care System.” Journal of general internal medicine vol. 32,Suppl 1 (2017): 6–8. doi:10.1007/s11606–016–3968–8

¹⁸The Cost of Inflammatory Bowel Disease: An Initiative From the Crohn’s & Colitis Foundation https://doi.org/10.1093/ibd/izz104

Mahana Therapeutics

Developing digital treatments for people living with gastrointestinal conditions

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