March 20, 2020

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In 2020, the promising field of digital therapeutics (DTx) has run up against a classic chicken-and-egg puzzle. Payers who hold the keys to commercial success wish to see real-world outcomes data and evidence of potential cost savings from the use of these new treatments. Yet as long as patients and physicians remain uncertain about reimbursement for DTx, companies will struggle to attract users at a scale that would produce the evidence payers seek.

DTx innovators have begun to deliver unique therapeutic tools to patients, which may also bring relief to resource-strapped health systems. Programs from Akili Interactive Labs, Voluntis, AppliedVR, SilverCloud Health and others have demonstrated an ability to prevent or help manage a variety of medical disorders. 

Persuaded by data from randomized controlled trials (RCTs), regulators in the U.S. and Europe have approved some of these products to augment or replace more traditional therapies. Investors, including biopharmaceutical companies, have funneled billions of dollars into DTx. And payers themselves have warmed to the new category. Express Scripts, for example, has launched the industry’s first formulary for digital and mobile health apps and devices (see sidebar on page 5).

Nonetheless, the user base for DTx is not growing as quickly as experts once anticipated. And, in recent months, several closely watched DTx companies have encountered pushback from regulators, investors and large pharmaceutical partners— a reminder that the sector is still experiencing birth pains.

Many market observers say physicians won’t recommend DTx to their patients until there is greater clarity around coverage and reimbursement. In fact, DTx are unlike any other medical products. With most prescription drugs, there’s a clear sales chain from manufacturer to wholesaler to retail pharmacy.  The doctor then writes a prescription, the patient fills it at  the pharmacy and the health plan pays. 

But with DTx, who verifies that the patient has downloaded  the therapeutic program, and what party adjudicates the claim? How does the payer learn if iterative software updates are having an effect on medical outcomes? What is the process for ongoing collection and assessment of data? Should there be a “digital benefit,” separate from the pharmacy and medical benefits? Early experiments in digital formularies may begin to shine a light on these matters, but many perplexities remain.