I recently attended a Digital Therapeutics (DTx) workflow workshop sponsored by the Digital Therapeutics Alliance and the National Council for Prescription Drug Programs (NCPDP). The DTx Alliance was formed in 2017 and is a non-profit trade association.
The DTx space is really fascinating and the availability and diversity of DTx products is growing. There was a wide range of stakeholders in attendance at last week’s event, which is evidence of further growth to come. In addition to health IT developers, I spoke with drug compendia representatives, digital therapeutics manufacturers, health system administrators, and health plans and PBMs– all asking similar questions about how clinical decision makers can better prescribe or dispense DTx products, how patients can access them, and if payers will cover DTx on their formularies.
So before going any further, lets talk about what is considered a DTx. DTx products are evidence-based therapeutic interventions that use advanced software programs or mobile apps to treat, manage, or prevent a disease or disorder. They are used independently or in concert with medications, devices, or other therapies. Patients may interact with a computer-based program within the doctor’s office as part of their appointment, or they may log onto the program via the Internet from their home computer or even their phone.
The difference between prescription digital therapeutics and non-prescription digital health tools or wellness apps depends on whether the product developer has sought approval from the Food and Drug Administration (FDA). It may be necessary to have FDA approval in order to be included in payers’ formularies so that the costs of using a DTx are covered by a patient’s health plan.
The Calm app is an example of a DTx that is available without a prescription and can be downloaded to iOS and Android devices from the App Store. It is the leading mindfulness and meditation app and uses evidence-based therapies to improve mental and physical health. Many mental health providers recommend the app and believe that it helps their patients. However, once the one-week free trial ends and the patient is billed $69.99 for one year of access, this cost may not be covered by the patient’s insurance provider. The ongoing expense may affect the patient’s ability to continue its use.
EndeavorRx is an example of a DTx that requires a prescription and may be covered by the patient’s health plan with prior authorization. EndeavorRx is an ADHD treatment for kids ages 8-12. The immersive video game is an FDA-authorized medical device and must be dispensed through a specialty pharmacy, Phil Pharmacy, which will issue a verification code that can be used to download the program from the App Store. The cash price to access EndeavorRX with a prescription but no pharmacy benefits is $100 per month, but coinsurance can reduce that by 80%.
The FDA has not yet established a clear definition of what constitutes a digital therapeutic. As of December 2022, approximately 40 DTx products have been authorized by the FDA and require a doctor’s prescription. Kaia Health’s mobile app is currently included in more than 50 health plans formularies, including Express Scripts and United Healthcare. Evernorth, the parent company of Express Scripts, includes more than 25 digital therapeutics in their digital formulary including applications for mental health, smoking cessation, musculoskeletal pain management, and other conditions. Government-based insurers like Medicare have been slower to cover DTx likely due to outdated regulatory framework.
2022 Brought Proposed Regulations for Prescription Digital Therapeutics
In March 2022, the U.S. Senate introduced the Access to Prescription Digital Therapeutics Act of 2022 which would provide Medicare coverage and reimbursement for prescription digital therapeutics by amending the Social Security Act. The legislation defines a prescription digital therapeutic as a product, device, app or other technology that primarily uses software; has received clearance or approval by the FDA; "has a cleared or approved indication for the prevention, management or treatment of a medical disease, condition or disorder"; and is exempt from Section 801.109 of the Federal Food, Drug, and Cosmetic Act, meaning a device that can safely be used without direct medical supervision. In December 2022, the Senate introduced a bill that would require the Administrator of the Centers for Medicare and Medicaid Services to provide guidance on coverage of prescription digital therapeutics under Medicaid and the State Children’s Health Insurance Program (CHIP).
Some health industry leaders believe that its premature to establish reimbursement of prescribed digital therapeutics before the FDA has provided clearly defined methods for certifying and overseeing the DTx products. Others are advocating to policymakers to speed the pace of regulations to help improve access to DTx products for individual on Federal health plans, particularly those that are clinically proven to improve mental health and are currently covered by private payer health plans.
Healthcare decision makers play a critical role in providing patients with access to high-quality, clinically validated digital therapeutics. DTx product manufacturers not only have a responsibility but an opportunity to publish clinical trial results to educate HCPs about the effectiveness of their DTx products. DTx vendors will need to ensure their platforms are integrated within the electronic health record (EHR) or software that physicians’ already use to prescribe medical therapies. POCP has helped DTx vendors create implementation guides for EHR systems with instructional information about adding a DTx to the list of available medical therapies and how to ePrescribe DTx products. If your organization needs support in this area, please reach out to us.
The Digital Therapeutics Alliance has developed DTA Resources to aid healthcare providers and other stakeholders, including evaluation tools, an integration guide, overview of regulatory and reimbursement pathways, and a DTx product library. The 2023 Digital Therapeutics Alliance Inaugural Summit will be held in Washington D.C., June 7-9, 2023. Register here.
Point-of-Care Partners will continue to monitor the DTx space and contribute our ideas on how to move standardizing and normalizing the prescribing and dispensing of DTx as part of patient’s overall treatment plans. I’ll be working with participants from the workshop on documenting the next steps and findings from the DTx Alliance Workshop that will be published in the coming weeks. Please feel free to reach out to me at firstname.lastname@example.org with questions.