New Digital Therapeutics Toolkit Aims to Support Adoption

In pursuit of enhanced efficiency surrounding software-based medical care, the Digital Therapeutics Alliance (DTA) launched the Policymaker & Payor DTx Evaluation Toolkit, a program to support the understanding and growth of digital therapeutics (DTx) in healthcare.

DTx resources are in a period of rapid growth. With various applications, the International Organization for Standardization (ISO) indicated that DTx tools “generate and deliver software-based medical interventions to patients to treat or alleviate a disease or disorder.”

With a mission supporting the growth of DTx in healthcare, DTA created the Policymaker & Payor DTx Evaluation Toolkit to support healthcare users and leaders. Developed through the DTx Policy Coalition that began in June 2022, this resource includes various components.

These components include foundation-setting materials, DTx assessment guides, and implementation resources.

The foundation-setting materials consist of the categorization of the Digital Health Technology (DHT) ecosystem, the definition of DTx from ISO, and DTx uses. The DTx assessment guides cover product impact along with criteria surrounding privacy and security. The implementation resources include market access pathways, prescription status, and what must be considered when integrating DTx tools.

Amid the ongoing evolution of DTx in clinical care, the Policymaker & Payor DTx Evaluation Toolkit aims to serve as a foundation pathway to applying forms of the software-based therapy.

“Digital therapeutics will undoubtedly become a critical part of patient care. With the appropriate frameworks and pathways, this is the first treatment modality that can equitably scale across global healthcare settings to deliver personalized, high quality, impactful healthcare,” said Megan Coder, chief policy officer of DTA, in a press release. “The Policymaker & Payor DTx Evaluation Toolkit offers decision makers a full spectrum approach to understanding the complexities of DTx value assessment, legal and regulatory guidelines, and implementation, in addition to optimizing the impact of DTx therapies on patient care.”

The growth of digital therapeutics has led to many expansion efforts and opportunities for application.

In September 2022, Trinity Health and Orexo US announced plans to offer two DTx solutions for depression and alcoholism.

The organizations aimed to improve access following a history of success with these tools. At the onset of the COVID-19 pandemic, Trinity Health began a pilot program that offered DTx tools to staff. After being proven effective, the system expanded the tools' availability.

However, more research from July 2022 indicated that DTx might result in many challenges alongside benefits.

Conducted by Forrester, this research found that the strengths of DTx solutions primarily relate to ease of use, high access levels, and ease of data collection. Patient engagement levels were also high in instances of DTx use. Challenges, however, relate to limited clarity surrounding reimbursement, utilization, and differentiation.