The digital therapeutics market is witnessing considerable growth globally thanks to the confluence of the development of new technologies, the increasing prevalence of chronic diseases and lifestyle-associated diseases and an aging population.

In addition, digital therapeutics are beginning to emerge into the broader digital health landscape and bring, according to the Digital Therapeutics Alliance, "software-generated therapeutic interventions directly to patients to prevent, manage, or treat a medical disorder or disease." With products already receiving the U.S. FDA's green light, the market is set to expand rapidly. Exactly how the technology will impact the health care milieu was the subject of a panel held at the Biotechnology Innovation Organization's 2019 international convention earlier this month, organized by Accel-Rx, Canada's health sciences accelerator that supports promising early stage companies developing therapeutics, diagnostics and medical devices.

Panel moderator Natalie Dakers, founding president and CEO of Accel-Rx, noted that there are many aspects to the emerging field and posed the question to the panelists of how it differentiates itself from the digital health area. One important aspect is that those evidence-based therapeutic interventions are used independently or in concert with other devices or therapies to optimize patient care and improve health outcomes, explained Megan Coder, executive director at the Digital Therapeutics Alliance. As such, they come under regulatory oversight, and products in that category must undergo randomized clinical trials to prove their effectiveness before they can be marketed.

Advantage

One advantage that those products have is that their clinical trials are generally faster and cheaper to conduct. They are roughly one-third of the cost vs. a typical drug trial, said Antoun Nabhan, vice president, corporate development at Pear Therapeutics Inc. That is because no preclinical testing is involved, which reduces costs considerably.

Last November, his company, along with Sandoz, a Novartis AG division, commercially launched Reset, an FDA-authorized prescription digital therapeutic for patients with substance use disorder. The product is a 12-week (90-day) prescription digital therapeutic to be used in conjunction with outpatient clinician-delivered care. It offers interactive treatment modules that deliver cognitive behavioral therapy and fluency training to reinforce proficiency.

One month later, they launched Reset-O for patients with opioid use disorder (OUD) after being cleared by the FDA. The prescription digital therapeutic is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. It is available by prescription only for patients 18 and older under the care of a clinician.

The efficacy of the product was evaluated in a pivotal, randomized trial of 170 patients seeking treatment for OUD, who received supervised buprenorphine treatment paired with a behavior therapy program.

More approvals

Another digital therapeutic also received the FDA green light. In December, Teva Pharmaceutical Industries Ltd. won approval for Proair Digihaler (albuterol sulfate 117 mcg) inhalation powder, which has built-in sensors connecting to a companion mobile application and provides inhaler use information to people with asthma and chronic obstructive pulmonary disease. The inhaler is indicated for the treatment or prevention of bronchospasm in patients 4 and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients 4 and older.

The built-in digital technology detects when the inhaler is used and measures inspiratory flow and sends that information to a companion mobile app so patients can review their data over time.

Business model

On the subject of the business model of a digital therapeutics company, Nabhan said that while companies do not require the infrastructure needed for preclinical work, development and regulatory personnel still are required because ultimately revenues need to be generated from product sales. Their products are provided by prescription, and while it is still early, there is evidence that payers appear willing to provide reimbursements for digital therapeutics.

He cited the fact that Express Scripts is planning to introduce the industry's first, stand-alone digital health formulary next year to help payers ensure the safety, effectiveness and usability of digital health technology tools made available to their members.

Like a medication formulary, Express Scripts said it will employ a comprehensive process overseen by physicians, pharmacists and experts in health research and user experience, who will review clinical outcomes and therapeutic benefit data to determine inclusion on the formulary.

Each digital solution included on the formulary first must demonstrate therapeutic value, effective usability, and stringent security and privacy standards, followed by cost effectiveness.

Picking up steam

There is no doubt that interest in digital therapeutics will increase, judging by the volume of new investments and business development that already have taken place this year. Panelists also noted that governments are responding to the expanding field and examining whether new regulations need to be implemented.

Last year, for example, under its Regulatory Review of Drugs and Devices initiative, Health Canada reported that it was establishing a new division within the Therapeutic Products Directorate's Medical Devices Bureau to allow for a more targeted premarket review of digital health technologies.

Dakers also noted that digital health investments now make up 28% of the total directed to all therapeutics innovation.

Pear Therapeutics, for example, attracted $64 million in a series C financing in January to support the company's clinical-stage pipeline, and will allow it to acquire additional assets as required.

Those factors are clear indications of just how quickly prescription-based digital therapeutics have evolved and the economic opportunities that they bring.

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