Forward movement for digital therapeutics?

This week got off to a fast start for digital therapeutics with a new survey by the Peterson Health Technology Institute highlighting the role of digital support tools and care management in treating chronic conditions, particularly diabetes and mental health. The survey comes just months after the Centers for Medicare and Medicaid Services (CMS) proposed new reimbursement codes for mental health digital therapeutics, finally creating a pathway for prescriber reimbursement.

Maybe. Related to the new codes, there are more questions than answers about their actual implementation (will it really be January?) and how – or if – such codes resolve payer concerns related to providing coverage and patient access.

Keep in mind that when payers vet digital technologies for coverage they need to understand more than their effectiveness and budget impact. Payers must also calculate the clinical value of these products relative to available therapies, as well as the likely prescriber demand and if/how patients will actually use them. In other words, it’s not necessarily a simple calculus.

That’s why it’s not surprising that one of the key findings from the Peterson survey was a continued discussion of the need for risk-based guarantees that share risk based on the ability of the digital therapeutics to improve clinical outcomes.?

Given current uncertainties about digital therapeutics – both clinically and from the user experience perspective – Real Endpoints believes that as complicated as they are to construct and implement, risk-based agreements will be a basic requirement for coverage of, and access to, these novel therapies for the immediate future.

We’re hopeful that the more frequent use of risk-based agreements as a commercialization strategy for digital therapeutics – to directly address payer concerns related to coverage and access - ?plus new coverage codes will unlock use of innovative digital therapeutics and enable patients to achieve better outcomes via this new treatment paradigm.

We’re not na?ve to the challenges ahead though. We’ve advised and tested a number of different styles of risk-based contracts for digital therapeutics companies. There isn’t a one-size fits all approach to digital therapeutics access, particularly since risk-based contracts need to be designed based on the evidence currently available and the payers’ main uncertainties.

What works in the mental health space won’t exactly apply to diabetes or obesity or even brain health. However, we have uncovered some simple strategies that can unlock patient access to these new treatment options. And as an industry, we’ve learned important lessons about the commercialization of digital therapeutics, especially prescription digital therapeutics, that should help unlock the true value of these new treatment options in the coming years.

CC Rob O'Brien Ellen Licking Roger Longman Jeff Berkowitz Jane F. Barlow, MD, MPH, MBA Ryan Walsh Susan Raiola Julia Murphy Alec Doherty