Following the formation of the  European DTx Policy Coalition between the Digital Therapeutics Alliance (DTA) and Healthware, in June 2022, the joint team have now launched a dedicated website and released a report “DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends” outlining policy pathways for digital health adoption in Europe. In addition, the DTA has adopted the IInternational Organization for Standards (ISO) new definition of digital therapeutic. 

Why it’s notable:

• The report brings together the collective knowledge and efforts of a multitude of stakeholders with the aim of establishing a comprehensive framework for utilisation of digital medical devices (DMD) including DTx. The report focuses on Europe, with deep dives into England, Germany, France, Italy, and Catalonia as a region of Spain. 

• The pairing have also launched a dedicated website dtxpolicylandscape.org, providing a resource for information and clarity on the evolving reimbursement landscape, as well as the evolving topic of digital therapeutics, particular fit-for-purpose appraisal criteria, policies and access, and reimbursement pathways.

Industry Implications: 

• Increasingly, countries across Europe as well as worldwide have developed or are developing appraisal criteria, access reimbursement policies for DTx, in addition to the broader DMD category. While some countries are successfully ensuring fair access and promoting widespread adoption of clinically-proven DMDs, others lack effective frameworks which hinders equitable, scalable, and timely access to these validated treatments. The report addresses these issues, offering a comprehensive overview of the current and developing policy frameworks in Europe. In countries with established frameworks, the report outlines the evaluation criteria employed, assessing this based on the Health Technology Assessment (HTA) Core Model. Furthermore, the report identifies emerging trends that could guide the harmonisation and scalability efforts in Europe and beyond.

• The tools and resources available on the new website have been developed with the aim of offering best practices for integrating DTx into healthcare systems. These resources empower clinicians, decision-makers, and policymakers to acknowledge and incorporate DTx within regional and national frameworks. By making these resources accessible, the website will play a significant role in advancing equitable digital healthcare for patients worldwide.

• In addition, the DTA has announced they will adopt the International Organization for Standards (ISO) recently published digital therapeutic definition “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health”. The new definition will bring further clarity and increase accessibility into the digital therapeutic sphere, such as broadening the definition to enable patients with certain or suspected diseases, disorders, or conditions to utilise a DTx product even if the disease, disorder,or condition has not been formally diagnosed by a qualified clinician.