DIGITAL THERAPEUTICS PRODUCTS

To affirm the essential role of the pharmacist in the team-based evaluation, implementation, use, and ongoing assessment of digital therapeutic products to ensure the safety, effectiveness, and efficiency of medication use; further,

To encourage the pharmacy workforce to promote broader and more equitable use of digital therapeutic products by identifying and addressing barriers to patient and healthcare worker access to those products; further,

To encourage clinicians and researchers to establish evidence-based frameworks to guide use of digital therapeutic products; further,

To advocate that insurance coverage and reimbursement decisions regarding digital therapeutic products be made on the basis of those evidence-based frameworks.

Rationale

Digital health is a broad, multi-faceted term used to describe a broad category of practices, products, and processes. The Food and Drug Administration (FDA) describes digital health as “the broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.” The Digital Therapeutics Alliance describes digital therapeutics products, a component of digital health, as products that “deliver evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” Generally, digital therapeutic products are used to monitor indicators of a patient’s condition (e.g., blood pressure, hemoglobin A1c) or encourage behaviors (e.g., adherence to medication or behavioral therapies) and share several similar features: a digital interface used by patients, clinicians, and sometimes medical devices; wearable devices that provide information about a patient’s conditions to patients, clinicians, or medical devices; integration of disparate sources of data; enhanced patient engagement with their data and treatment; and automated or live digital coaching features to improve patient adherence with medication and/or behavioral therapies. The Access to Prescription Digital Therapeutics Act of 2022 would expand Medicare coverage to prescription digital therapeutics products and would help ensure that these products are tested for safety and efficacy and have a defined FDA approval process.

The proliferation of digital therapeutics products has the potential to create fundamental shifts in patient care. When digital therapeutics products impact medication use, pharmacists can and should participate in the evidence- and team-based decision-making about how those products are selected and used. Pharmacist expertise is essential in the team-based evaluation, implementation, use, and ongoing assessment of those products to ensure the safety, effectiveness, and efficiency of medication use. Pharmacists’ medication-use expertise can assist in appropriate patient selection, product prescribing and ordering, and patient education regarding product use.

Appropriate use of digital therapeutics products will require healthcare decision-makers (e.g., clinicians, researchers, pharmacy and therapeutics committees, and payers) to establish evidence-based frameworks to guide use of and coverage and reimbursement decisions regarding use. Although evidence used in the approval process for these products should inform these decisions, ongoing research will be required to assess the absolute and comparative safety and effectiveness of digital therapeutics products. In addition, to promote optimal use, members of the pharmacy workforce will require education and training in the evaluation and use of digital therapeutics products.

Finally, one of the major drivers of societal inequities is the digital divide that separates those with access to technology from those without. ASHP encourages the pharmacy workforce to promote broader and more equitable use of digital therapeutic products by identifying and addressing barriers to patient and healthcare worker access to those products.