Digital Therapeutics: The Future of Healthcare

What are digital therapeutics?

According to the Digital Therapeutics Alliance (DTA), whose members include health technology companies, pharma companies, and others, “digital therapeutics” (sometimes abbreviated “DTx”) are:

“Clinically-validated solutions [that] may be used as standalone interventions or in association with other treatments to engage patients and improve the overall quality, cohesion, outcomes, and value of healthcare delivery.”

Another way of describing digital therapeutics would be technology as a treatment or combined with a drug or device to monitor or improve patient outcomes.  The DTA lists a variety of conditions for which patients may benefit from the use of digital therapeutics solutions, including:

  • Respiratory
  • Cardiovascular
  • Endocrine
  • Mental health conditions

Digital therapeutics pose multi-faceted challenges for a variety of stakeholders, including FDA, the drug compendia, CMS and other payers, prescribers, pharmacies, and patients.  It remains unclear under what pathway(s) digital therapeutics will be approved.  For example, the FDA has established a dosage form called “tablet with sensor.”  This was presumably created for Abilify MyCite®, as it appears to be the only FDA approved product with this dosage form today.  However, not all digital therapeutics have a drug component.  In PHSI’s view, digital therapeutics may include a variety of potential combinations, such as:

  • Technology built into a drug, such as the recently approved Abilify MyCite®
  • Technology built into a device
  • Drug + app (Rx or OTC)
  • Device + app
  • App alone, such as Pear reSET

One area of focus is how the drug compendia will list digital therapeutics.  Their decisions to depict these innovative treatments in the databases will influence prescribers issuing prescriptions and/or orders, payers adjudicating claims for these items, and pharmacies dispensing them.

Once digital therapeutics are commercially available and listed in the compendia, payers may be presented with the decision of whether to cover these solutions as an insured benefit, and if so, whether they fit under the pharmacy or medical benefit, or perhaps a different coverage approach.

Prescribers and pharmacies will need to understand their role in the provision of digital therapeutics.  For solutions that combine a drug with a device, app, or other technology component, it will be important to be able to differentiate the digital therapeutic from other products that may be similar but do not contain the technology.  For digital therapeutics solutions that do not contain a drug, the process for transporting the digital solution from its creator into patients’ hands is less well defined.

PHSI continues to work with companies creating digital therapeutics to help them understand the implications of how their solution(s) may fit within the existing health IT infrastructure and welcomes the opportunity to explore new innovations to bring this technology into the market.


Published: October 2018

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