Understanding DTx

DTx Evaluation Toolkit

As healthcare decision makers (HCDMs) across the world seek out, assess, approve, and implement DTx products, it is important for these clinicians, policymakers, and payors to have access to reliable resources and frameworks that enable more consistent evaluation and implementation of DTx products across local, national, and regional settings.

Increasing Patchwork of Frameworks

HCDMs play a critical role in providing patients with access to high-quality, clinically validated digital therapeutic (DTx) products.

Policymakers and payors already use consistent frameworks to evaluate other evidence-based clinical therapies such as pharmaceuticals. However, given the recent growth of the DTx industry and lack of frameworks defining what “good” looks like, many HCDMs have needed to develop their own methods to evaluate DTx products.

As a result, a patchwork of HCDM requirements and frameworks are emerging for DTx manufacturers at the local, national, and regional levels.

Harmonizing DTx Requirements

DTA developed this Toolkit to provide a common language and process for HCDMs and DTx manufacturers to jointly use throughout DTx product evaluation and implementation processes. It addresses a wide spectrum of HCDM considerations across various settings—ranging from health systems, employers, and private payors, to single-payor government systems—and will continue to be updated to ensure ongoing relevance in this quickly evolving ecosystem.

Policymaker & Payor DTx Evaluation Toolkit

To evaluate and implement DTx products, HCDMs should consider the following steps and resources: 

Understand the digital health technologies (DHT) that are available to patients, caregivers, and clinicians today

Account for DHT products that have multiple functions and components

Know how to define a digital therapeutic (DTx)

Recognize DTx industry core principles and policy positions

Understand DTx place in clinical therapy

Identify specific DTx products to consider, review, and evaluate

Note: DTA does not endorse, review, or certify DTx products

Review existing regulatory and reimbursement pathways for DTx products

Develop, or refine, a formal process to evaluate DTx foundational components

Develop, or refine, a formal process to evaluate DTx clinical impact

Educate target end users, including patients, caregivers, and clinicians

Develop, or refine, a formal process to evaluate DTx health economic impact

Implement and scale DTx products to enable appropriate patient access

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