There's a Prescription App for That? Digital Therapeutics on the Rise

^{In the near future, digital therapeutics could become common treatments.}

If a software program improves patient outcomes, is it a drug? Not quite, but that does make the app a form of treatment — a digital therapeutic — and, in some cases, necessitates a prescription from a physician.

More and more, digital therapeutics are making headlines, from the work being done to treat schizophrenia and multiple sclerosis by Pear Therapeutics and Novartis to a prescription-restricted app for patients with substance abuse disorder. In fact, the U.S. Food and Drug Administration has approved about 30 of these apps this year alone.

But are digital therapeutics really medicine? And how might prescribers better understand these mobile health (mHealth) apps so that they may effectively use them in and out of the clinic?

>> READ: First Clinical Trial of mHealth Adherence App as a Standalone Yields Little Improvement

“They’re really similar to drugs — it’s just that the mechanisms of action are not encapsulated in a pill. They’re not in a syringe or an IV bag,” Joel Sangerman, chief commercial officer of Click Therapeutics, said last week at Digital Pharma East in Philadelphia, Pennsylvania. “But the mechanisms of action are in a smartphone.”

Click Therapeutics understands the potential of digital medicine more than most. The startup recently scored $17 million in funding from pharma giant Sanofi, who was impressed with Click’s patient engagement tech and therapeutic targets. So far, the company has seen encouraging results in early trials for apps that are designed to treat depression and help smokers quit, Sangerman told audience members.

Although he was there to speak to a primarily pharma audience, Sangerman delivered a speech that could help providers, physicians and all healthcare decision makers better understand digital therapeutics and what they could mean for clinicians and patients.

What Is a Digital Therapeutic?

A digital therapeutic must be a piece of software that can effectively treat a medical condition. The treatment can include other components — like, say, in-person behavioral therapy — but software must be an independent contributor to the treatment.

So far, digital therapeutics appear most applicable for conditions whose first-line intervention is behavior change, as noted by guidelines, Sangerman said.

He went on to describe a blood pressure support drug called milrinone, which was praised as a powerful force for its ability to improve how the heart contracts and resists. But new digital therapeutics might be capable of accomplishing a similar achievement by activating the fight-or-flight response.

“The point is, you can elicit a biological response in other ways than drugs,” he said.

Will Physicians Prescribe Digital Therapeutics?

When Sangerman became a pharma rep in 1989, he learned that most doctors preferred to treat diseases organically. The problem was that there was no way to monitor the real-time progress or patient adherence to such regimens. Over time, pharma companies have succeeded in getting physicians on board, but it’s possible that the pendulum will swing back.

The FDA, meanwhile, is regulating digital therapeutics, a fact that Sangerman said he welcomes. Clinical trials offer a chance for digital therapeutics companies to prove their products’ efficacy, simultaneously bolstering their legitimacy in the minds of prescribers.

Then we must consider the patient.

“There are target populations who cannot tolerate drugs or don’t want to take drugs,” Sangerman said, pointing to adolescents, pregnant women and geriatric patients, in particular.

And they just might become the catalysts that drive physicians to buy into digital therapeutics.

Will Digital Therapeutics Succeed?

Still, the burgeoning digital therapeutics market faces an uphill battle.

“We think physicians will prescribe them,” Sangerman said, “but are payers going to pay for them? That’s a question.”

On one hand, patients with a couple of chronic conditions might require nine different prescriptions filled per year, which means digital therapeutics can mitigate polypharmacy risks. But whether each digital treatment is safe, effective, in line with clinical guidelines and priced to market will help influence how payers receive them.

Then there’s an old conundrum: Insurers often don’t want to cover a treatment without physician demand, and physicians don’t want to prescribe a treatment that isn’t covered.

Despite these challenges, Sangerman and others in the digital therapeutics space are optimistic. Perhaps the most convincing argument is patient engagement. Healthcare has advanced evidence-based medicine, clinical integration of providers and information technology and value-based payments, but it has failed to engage patients — and digital therapeutics could prove capable of helping patients become active members of their own care teams.

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