One area of health care rapidly gaining popularity is digital therapeutics (DTx). These are advanced medical devices that deliver software-based interventions to patients to treat, manage, or prevent a disease or disorder. With software, DTx deliver a clinical intervention either alone or in combination with other standard of care treatments including medicine to improve patient outcomes.
Examples of DTx
- Sleepio: a program scientifically proven to improve patients’ sleep pattern without medication.
- reSET/reSET-O: utilizes cognitive behavioral therapy to treat substance-dependent patients.
- Propeller: a sensor attached to inhalers for asthma or chronic obstructive pulmonary disease medications, designed to track and increase treatment adherence through reminders.
DTx are not any of the following:
- Mobile health apps that simply store or share information, such as My Fitness Pal.
- Health information technology, such as electronic medical records.
- Devices, sensors, or wearables, such as insulin pumps.
- Telehealth platforms.
Who Is the Ideal Candidate for DTx?
People who could benefit the most from DTx are patients with chronic conditions needing high-touch therapeutic interventions, patients who have diseases without existing treatments or treatments that have a high risk of side effects, or patients with diseases associated with stigma that may impact their willingness to interact with health care providers.
DTx may help close critical gaps in care for underserved populations and make health care more accessible. This is achieved by:
- Utilizing smartphones, tablets, etc. to deliver interventions.
- Offering a safe haven for patients to undergo therapy at home, without the stigma associated with in-clinic treatment of certain illnesses.
- Increasing patient access to clinically safe and effective therapies.
- Providing therapies in multiple languages to reach a wider audience.
- Providing meaningful results and insights on personalized goals and outcomes to patients and their health care providers.
How Are DTx Regulated?
The 21st Century Cures Act allows some DTx to be approved through the 510(k) pathway. This pathway is a fast-track process for devices where the sponsor shows the new device is similar to an existing device that is already approved and marketed. If there is not a similar device already on market, the manufacturer must petition the U.S. Food and Drug Administration to state its device is low-risk or complete the full pre-market approval process.
Are DTx Covered Under the Pharmacy Benefit?
Currently, most DTx are excluded from pharmacy benefit coverage. CVS Caremark offers some DTx to plan sponsors via its Point Solutions Management program. These include Daylight, Torchlight, Sleepio, and Weight Watchers. If you are a National CooperativeRx member and are interested in covering specific DTx, please reach out to your account representative to discuss the best option for your plan.
For more on DTx, watch our one-minute video!